Influence of habitat heterogeneity on distribution, occupancy patterns, and productivity of breeding peregrine falcons in central west Greenland

USGS Publications Warehouse

Wightman, C.; Fuller, Mark R.

2006-01-01

We used occupancy and productivity data collected at 67 cliffs used for nesting from 1972 to 1999 to assess patterns of distribution and nest-site selection in an increasing population of Peregrine Falcons (Falco peregrinus) in central West Greenland. Peregrine Falcons breeding at traditionally occupied cliffs used for nesting had significantly lower variation in productivity and thus these cliffs were better quality sites. This indicates that Peregrine Falcons occupied cliffs according to a pattern of despotic distribution. Falcons breeding at cliffs that were consistently occupied during the breeding season had higher average productivity and lower variation in productivity than falcons at inconsistently occupied cliffs, and thus consistent occupancy also was indicative of cliff quality. Features of high quality habitat included tall cliffs, greater change in elevation from the lowest point within 3 km of the cliff to the cliff top (elevation gain), and protection from weather on the eyrie ledge. Spacing of suitable and occupied cliffs also was an important feature, and the best cliffs generally were more isolated. Increased spacing was likely a mechanism for reducing intraspecific competition. Our results suggest that Peregrine Falcons use a resource defense strategy to compete for better quality habitats and may use spacing and physical features of a nest site to identify good quality breeding habitat.

Development of a multichannel hyperspectral imaging probe for property and quality assessment of horticultural products

USDA-ARS?s Scientific Manuscript database

This paper reports on the development, calibration and evaluation of a new multipurpose, multichannel hyperspectral imaging probe for property and quality assessment of food products. The new multichannel probe consists of a 910-miscrometer fiber as a point light source and 30 light receiving fibers...

Improving Service Quality: Achieving High Performance in the Public and Private Sectors.

ERIC Educational Resources Information Center

Milakovich, Michael E.

Quality-improvement principles are a sound means to respond to customer needs. However, when various quality and productivity theories and methods are applied, it is very difficult to consistently deliver quality results, especially in quasi-monopolistic, non-competitive, and regulated environments. This book focuses on quality-improvement methods…

Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

PubMed

O'Connor, Thomas F; Yu, Lawrence X; Lee, Sau L

2016-07-25

Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies. Published by Elsevier B.V.

Implementation of 350-2500 nm diffuse reflectance spectroscopy and High-Performance Thin-Layer Chromatography to rapidly assess manufacturing consistency and quality of cotrimoxazole tablets in Tanzania.

PubMed

Kaale, Eliangiringa; Hope, Samuel M; Jenkins, David; Layloff, Thomas

2016-01-01

To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance programme. Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated HPTLC techniques (including weight variation and disintegration evaluations). Based on results from the primary test methods, the first group of product was <80% compliant, whereas subsequent groups reached >99% compliance. This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost-effective than traditional pharmaceutical testing techniques. © 2015 John Wiley & Sons Ltd.

Productivity Research and Development Planning Workshop.

DTIC Science & Technology

1986-03-01

mission. These ideas must come from everyone in all echelons of the Comand. The MAC quality of worklife efforts consist of quality circles, labor-manage...that would not have been captured by the measure as initially formulated by the PIG. The balance of the plan and recommenda- tions made by the PMWG...people are doing things. We have the suggestion program, the quality of worklife program, and the Tech Mod program. All of these programs are productivity

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

Influence of habitat heterogeneity on distribution, occupancy patterns, and productivity of breeding peregrine falcons in central West Greenland

USGS Publications Warehouse

Wightman, C.S.; Fuller, M.R.

2006-01-01

We used occupancy and productivity data collected at 67 cliffs used for nesting from 1972 to 1999 to assess patterns of distribution and nest-site selection in an increasing population of Peregrine Falcons (Falco peregrinus) in central West Greenland. Peregrine Falcons breeding at traditionally occupied cliffs used for nesting had significantly lower variation in productivity and thus these cliffs were better quality sites. This indicates that Peregrine Falcons occupied cliffs according to a pattern of despotic distribution. Falcons breeding at cliffs that were consistently occupied during the breeding season had higher average productivity and lower variation in productivity than falcons at inconsistently occupied cliffs, and thus consistent occupancy also was indicative of cliff quality. Features of high quality habitat included tall cliffs, greater change in elevation from the lowest point within 3 km of the cliff to the cliff top (elevation gain), and protection from weather on the eyrie ledge. Spacing of suitable and occupied cliffs also was an important feature, and the best cliffs generally were more isolated. Increased spacing was likely a mechanism for reducing intraspecific competition. Our results suggest that Peregrine Falcons use a resource defense strategy to compete for better quality habitats and may use spacing and physical features of a nest site to identify good quality breeding habitat. ?? The Cooper Ornithological Society 2006.

Assessing sensory quality of rice to meet industry needs.

USDA-ARS?s Scientific Manuscript database

Food industries need consistent supplies of rice that are well-defined in terms of functional, nutritional, and sensory characteristics associated with intrinsic product quality to allow them to be directed to the most appropriate, highest value markets. Defining the sensory quality of rice is prob...

Sentinel 2 products and data quality status

NASA Astrophysics Data System (ADS)

Clerc, Sebastien; Gascon, Ferran; Bouzinac, Catherine; Touli-Lebreton, Dimitra; Francesconi, Benjamin; Lafrance, Bruno; Louis, Jerome; Alhammoud, Bahjat; Massera, Stephane; Pflug, Bringfried; Viallefont, Francoise; Pessiot, Laetitia

2017-04-01

Since July 2015, Sentinel-2A provides high-quality multi-spectral images with 10 m spatial resolution. With the launch of Sentinel-2B scheduled for early March 2017, the mission will create a consistent time series with a revisit time of 5 days. The consistency of the time series is ensured by some specific performance requirements such as multi-temporal spatial co-registration and radiometric stability, routinely monitored by the Sentinel-2 Mission Performance Centre (S2MPC). The products also provide a rich set of metadata and auxiliary data to support higher-level processing. This presentation will focus on the current status of the Sentinel-2 L1C and L2A products, including dissemination and product format aspects. Up-to-date mission performance estimations will be presented. Finally we will provide an outlook on the future evolutions: commissioning tasks for Sentinel-2B, geometric refinement, product format and processing improvements.

Validation of high-quality potato seed production protocol under controlled conditions (CETS System) in cultivated potato species (Solanum tuberosum L.)

USDA-ARS?s Scientific Manuscript database

Low potato yield in Peru and other countries in the region are attributed to the use of low quality seeds and tuber recycling. Therefore, there is consensus on the need of incorporating seed production technologies that are effective and efficient but also consistent with the reality of potato in La...

An approach to optimize the batch mixing process for improving the quality consistency of the products made from traditional Chinese medicines*

PubMed Central

Yan, Bin-jun; Qu, Hai-bin

2013-01-01

The efficacy of traditional Chinese medicine (TCM) is based on the combined effects of its constituents. Variation in chemical composition between batches of TCM has always been the deterring factor in achieving consistency in efficacy. The batch mixing process can significantly reduce the batch-to-batch quality variation in TCM extracts by mixing them in a well-designed proportion. However, reducing the quality variation without sacrificing too much of the production efficiency is one of the challenges. Accordingly, an innovative and practical batch mixing method aimed at providing acceptable efficiency for industrial production of TCM products is proposed in this work, which uses a minimum number of batches of extracts to meet the content limits. The important factors affecting the utilization ratio of the extracts (URE) were studied by simulations. The results have shown that URE was affected by the correlation between the contents of constituents, and URE decreased with the increase in the number of targets and the relative standard deviations of the contents. URE could be increased by increasing the number of storage tanks. The results have provided a reference for designing the batch mixing process. The proposed method has possible application value in reducing the quality variation in TCM and providing acceptable production efficiency simultaneously. PMID:24190450

An approach to optimize the batch mixing process for improving the quality consistency of the products made from traditional Chinese medicines.

PubMed

Yan, Bin-jun; Qu, Hai-bin

2013-11-01

The efficacy of traditional Chinese medicine (TCM) is based on the combined effects of its constituents. Variation in chemical composition between batches of TCM has always been the deterring factor in achieving consistency in efficacy. The batch mixing process can significantly reduce the batch-to-batch quality variation in TCM extracts by mixing them in a well-designed proportion. However, reducing the quality variation without sacrificing too much of the production efficiency is one of the challenges. Accordingly, an innovative and practical batch mixing method aimed at providing acceptable efficiency for industrial production of TCM products is proposed in this work, which uses a minimum number of batches of extracts to meet the content limits. The important factors affecting the utilization ratio of the extracts (URE) were studied by simulations. The results have shown that URE was affected by the correlation between the contents of constituents, and URE decreased with the increase in the number of targets and the relative standard deviations of the contents. URE could be increased by increasing the number of storage tanks. The results have provided a reference for designing the batch mixing process. The proposed method has possible application value in reducing the quality variation in TCM and providing acceptable production efficiency simultaneously.

Biotechnological Approach To Preserve Fresh Pasta Quality.

PubMed

Angiolillo, L; Conte, A; Del Nobile, M A

2017-12-01

Fresh pasta is highly susceptible to microbial contamination because of its high water activity and nutrient content. In this study, a new biopreservation system was examined that consists of an active sodium alginate solution containing Lactobacillus reuteri and glycerol, which was added during the production process of pasta. Our aim was to extend the fresh pasta shelf life by the in situ production of reuterin, thereby avoiding the use of thermal treatments that generally compromise food sensory characteristics. Two experimental studies were carried out with the product packaged under either ordinary or modified atmospheric conditions. Microbiological and sensory quality indices were monitored to determine the effectiveness of biopreservation on product quality during storage. The use of the active solution with L. reuteri and glycerol during the production process of pasta improved both microbial and sensory quality, particularly when combined with modified atmosphere.

Functional Measurement Analysis of Brand Equity: Does Brand Name Affect Perceptions of Quality?

ERIC Educational Resources Information Center

Hilgenkamp, Heather; Shanteau, James

2010-01-01

This research project used Functional Measurement to examine how the brand name of consumer products impacts intended purchasing decisions. Thirty undergraduate students tested actual products from three different product categories (crayons, tissues, and tortilla chips). Each product category consisted of three different brands; one with high…

Measuring quality progress

NASA Astrophysics Data System (ADS)

Lambert, Larry D.

The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

Measuring quality progress

NASA Technical Reports Server (NTRS)

Lambert, Larry D.

1992-01-01

The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

Total Quality Management (TQM) as the Procedure for Management of Integrated Academics.

ERIC Educational Resources Information Center

Anderson, Lowell D.

Total Quality Management (TQM) is a way of doing business that involves every employee, both labor and management, in an effort to improve quality and productivity. The quality management concept consists of common principles: (1) customer focus; (2) process focus; (3) failure prevention; (4) mobilization of work force; (5) decision making based…

The impact of onsite workplace health-enhancing physical activity interventions on worker productivity: a systematic review.

PubMed

Pereira, Michelle Jessica; Coombes, Brooke Kaye; Comans, Tracy Anne; Johnston, Venerina

2015-06-01

The aim of this study is to investigate the effects of onsite workplace health-enhancing physical activity (HEPA) programmes on worker productivity. The PROSPERO registration number is CRD42014008750. A search for controlled trials or randomised controlled trials (RCTs) that investigated the effects of onsite workplace HEPA programmes on productivity levels of working adults was performed. Risk of bias of included studies was assessed, and the inter-rater reliability of the quality assessment was analysed. Qualitative synthesis of available evidence is presented. Eight studies were included in the review. There is consistent evidence that onsite workplace HEPA programmes do not reduce levels of sick leave. There appears to be inconsistent evidence of the impact of onsite workplace HEPA programmes on worker productivity. A high-quality study of an onsite combination (aerobic, strengthening and flexibility) HEPA regime and a moderate-quality study of a Tai Chi programme improved worker productivity measured with questionnaires in female laundry workers and older female nurses, respectively. Two high-quality studies and four moderate-quality studies did not show benefit. Studies that showed benefit were mainly those designed with productivity measures as primary outcomes, delivered to occupations involved with higher physical loads, and had higher compliance and programme intensity. The small number of studies and the lack of consistency among studies limited further analyses. There is inconsistent evidence that onsite workplace HEPA programmes improve self-reported worker productivity. Future high-quality RCTs of onsite workplace HEPA programmes should be designed around productivity outcomes, target at-risk groups and investigate interventions of sufficient intensity. High attendance with improved recording is needed to achieve significant results in augmenting worker productivity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Atlantic Ocean CARINA data: overview and salinity adjustments

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tanhua, T.; Steinfeldt, R.; Key, Robert

2010-01-01

Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic Mediterranean Seas, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon dioxide IN the Atlantic Ocean). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the threemore » data products: merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. the Arctic Mediterranean Seas, the Atlantic and the Southern Ocean. These products have been corrected to be internally consistent. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30 S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report the details of the secondary QC (Quality Control) for salinity for this data set. Procedures of quality control including crossover analysis between stations and inversion analysis of all crossover data are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal consistency of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA data products are consistent both internally was well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.« less

Atlantic Ocean CARINA data: overview and salinity adjustments

NASA Astrophysics Data System (ADS)

Tanhua, T.; Steinfeldt, R.; Key, R. M.; Brown, P.; Gruber, N.; Wanninkhof, R.; Perez, F.; Körtzinger, A.; Velo, A.; Schuster, U.; van Heuven, S.; Bullister, J. L.; Stendardo, I.; Hoppema, M.; Olsen, A.; Kozyr, A.; Pierrot, D.; Schirnick, C.; Wallace, D. W. R.

2010-02-01

Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic Mediterranean Seas, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon dioxide IN the Atlantic Ocean). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the three data products: merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. the Arctic Mediterranean Seas, the Atlantic and the Southern Ocean. These products have been corrected to be internally consistent. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30° S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report the details of the secondary QC (Quality Control) for salinity for this data set. Procedures of quality control - including crossover analysis between stations and inversion analysis of all crossover data - are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal consistency of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA data products are consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

Experimental and theoretical study of the influence of water on hydrolyzed product formation during the feruloylation of vegetable oil.

PubMed

Compton, David L; Evans, Kervin O; Appell, Michael

2017-07-01

Feruloylated vegetable oil is a valuable green bioproduct that has several cosmeceutical applications associated with its inherent anti-oxidant and ultraviolet-absorption properties. Hydrolyzed vegetable oil by-products can influence product quality and consistency. The formation of by-products by residual water in the enzymatic synthesis of feruloylated vegetable oil was investigated using chemical theory and experimental studies by monitoring the reaction over a 22-day period. The hydrolysis of vegetable oil is thermodynamically favored over the hydrolysis of the ethyl ferulate starting material. These results suggest that hydrolyzed vegetable oil products will be experimentally observed in greater concentrations compared to hydrolyzed ethyl ferulate products. Quantum chemical studies identified several reaction mechanisms that explain the formation of side products by water, suggesting that residual water influences product quality. Efforts to reduce residual water can improve product consistency and reduce purification costs. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

[Special aspects of quality of Tibetan medicines--insights from over 40 years of manufacturing experience in Switzerland].

PubMed

Schwabl, Alexandra; Gämperle, Erich

2013-01-01

Tibetan recipes are complex formulas from plant and mineral ingredients. Padma Inc. has been producing selected formulas from Tibetan Medicine in Switzerland since more than 40 years. Modern quality standards and Good Manufacturing Practice (GMP) guidelines are followed, ensuring the quality of the raw materials through the manufacturing processes to the finished product. The aim is to provide these valuable formulas to people in the West in a consistently high quality 'made in Switzerland'. The production according to modern quality standards is challenging, draws on many resources, and requires specialized expertise, e.g. in the procurement of raw materials and the quality analysis including pharmacognostic and botanical knowledge.

Experimental and theoretical study of the influence of water on hydrolyzed product formation during the feruloylation of vegetable oil

USDA-ARS?s Scientific Manuscript database

Feruloylated vegetable oil is a valuable green bioproduct that has several cosmeceutical applications associated with its inherent anti-oxidant and UV-absorption properties. Hydrolyzed vegetable oil by-products can influence product quality and consistency. The formation of by-products by residual w...

National Beef Quality Audit-2011: In-plant survey of targeted carcass characteristics related to quality, quantity, value, and marketing of fed steers and heifers

USDA-ARS?s Scientific Manuscript database

The National Beef Quality Audit – 2011 (NBQA-2011) assessed the current status of quality and consistency of fed steers and heifers. Beef carcasses (n = 9,802), representing approximately 10 percent of each production lot in 28 beef processing facilities, were selected randomly for the survey. Car...

International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.

PubMed

2006-06-02

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

PubMed

Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

2016-11-01

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

If You Don't Know, Ask! Using Expert Knowledge to Determine What Content Is Needed in an Undergraduate Food Quality Management and Control Course

ERIC Educational Resources Information Center

Joyner, Helen S.; Stevenson, Clinton D.

2017-01-01

Quality management and quality control of food products are critical to producing food that is safe to consume and has consistent quality and sensory attributes. The extent to which undergraduate students are equipped with competencies in quality management/control, in theory, has a direct connection with their career potential to ensure food…

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Competition and disclosure incentives: an empirical study of HMOs.

PubMed

Jin, Ginger Zhe

2005-01-01

I examine Health Maintenance Organizations' (HMOs) voluntary disclosure of product quality, which is not as complete as unraveling theories predict. After controlling for cost and demand factors, I find that HMOs use voluntary disclosure to differentiate from competitors, with lower disclosure rates in highly competitive markets. These findings are consistent with product differentiation, but challenge the intuition that competition should lead to more provision of quality information.

Productive performance, egg quality, and hatching traits of Japanese quail reared under different levels of glycerin.

PubMed

Ghayas, A; Hussain, J; Mahmud, A; Javed, K; Rehman, A; Ahmad, S; Mehmood, S; Usman, M; Ishaq, H M

2017-07-01

This study evaluated subsequent effects of glycerin on productive performance, egg quality, and hatching traits in Japanese quail. A total of 200 birds was arranged according to a completely randomized design into 5 treatment groups having 5 replicates of 8 birds each (6 females and 2 males). Treatments consisted 5 levels of glycerin, i.e., 2.5, 5, 7.5, and 10% and the control group. Birds were fed with different levels of glycerin during a rearing period of 6 wk and their subsequent effects on productive performance, egg quality, and hatching traits were observed. Data were collected regarding productive performance for 16 wk; however, egg quality and hatching traits were recorded during pre-peak (at fourth wk), peak (at 12th wk), and post peak (at 16th wk) phase. Productive performance, egg quality, and hatching traits did not differ significantly throughout the experimental period. It was concluded that glycerin can be used as a replacement energy source, having no effect on productive and reproductive performance in Japanese quail. © 2017 Poultry Science Association Inc.

Overview of the Nordic Seas CARINA data and salinity measurements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Olsen, Are; Key, Robert; Jeansson, Emil

2009-01-01

Water column data of carbon and carbon relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruises in the Arctic, Atlantic, and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon IN the Atlantic). The data have been subject to rigorous quality control (QC) in order to ensure highest possible quality and consistency. The data for most of the parameters included were examined in order to quantify systematic biases in the reported values, i.e. secondary quality control. Significant biases have been corrected for in the data products, i.e. the three merged files with measured, calculatedmore » and interpolated values for each of the three CARINA regions; the Arctic Mediterranean Seas (AMS), the Atlantic (ATL) and the Southern Ocean (SO).With the adjustments the CARINA database is consistent both internally as well as with GLODAP (Key et al., 2004) and is suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation. The Arctic Mediterranean Seas include the Arctic Ocean and the Nordic Seas, and the quality control was carried out separately in these two areas. This contribution provides an overview of the CARINA data from the Nordic Seas and summaries the findings of the QC of the salinity data. One cruise had salinity data that were of questionable quality, and these have been removed from the data product. An evaluation of the consistency of the quality controlled salinity data suggests that they are consistent to at least 0.005.« less

A variation reduction allocation model for quality improvement to minimize investment and quality costs by considering suppliers’ learning curve

NASA Astrophysics Data System (ADS)

Rosyidi, C. N.; Jauhari, WA; Suhardi, B.; Hamada, K.

2016-02-01

Quality improvement must be performed in a company to maintain its product competitiveness in the market. The goal of such improvement is to increase the customer satisfaction and the profitability of the company. In current practice, a company needs several suppliers to provide the components in assembly process of a final product. Hence quality improvement of the final product must involve the suppliers. In this paper, an optimization model to allocate the variance reduction is developed. Variation reduction is an important term in quality improvement for both manufacturer and suppliers. To improve suppliers’ components quality, the manufacturer must invest an amount of their financial resources in learning process of the suppliers. The objective function of the model is to minimize the total cost consists of investment cost, and quality costs for both internal and external quality costs. The Learning curve will determine how the employee of the suppliers will respond to the learning processes in reducing the variance of the component.

Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

PubMed

Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

2013-02-01

Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

Kpejigaou: an indigenous, high-protein, low-fat, cowpea-based griddled food proposed for coastal West Africa.

PubMed

Amonsou, Eric Oscar; Sakyi-Dawson, Esther; Saalia, Firibu Kwesi; Houssou, Paul

2008-12-01

Griddled cowpea paste foods have high nutritional potential because they are low in fat but high in protein. A good understanding of process and product characteristics of kpejigaou is necessary to improve its quality and enhance acceptability. To describe the product, evaluate critical variables in traditional processing, and determine consumer quality criteria and preferences for kpejigaou. A survey of kpejigaou processing was carried out among processors and regular consumers of kpejigaou. Kpejigaou is flat and circular in shape, with uniform thickness and porous structure. The production process of kpejigaou was found to be simple and rapid, but the quality of the finished product varied among processors and among batches. Critical processing variables affecting quality were dehulling of the cowpeas, type of griddling equipment, and griddling temperature. Texture (sponginess) is the most important quality index that determines the preference and acceptability of kpejigaou by consumers. Traditionally processed kpejigaou does not meet current standards for high-quality foods. This study provides the basis for efforts to standardize the kpejigaou process to ensure consistent product quality and enhance the acceptability of kpejigaou among consumers. Kpejigaou has a potential for success if marketed as a low-fat, nutritious fast food.

Use of a small molecule cell cycle inhibitor to control cell growth and improve specific productivity and product quality of recombinant proteins in CHO cell cultures.

PubMed

Du, Zhimei; Treiber, David; McCarter, John D; Fomina-Yadlin, Dina; Saleem, Ramsey A; McCoy, Rebecca E; Zhang, Yuling; Tharmalingam, Tharmala; Leith, Matthew; Follstad, Brian D; Dell, Brad; Grisim, Brent; Zupke, Craig; Heath, Carole; Morris, Arvia E; Reddy, Pranhitha

2015-01-01

The continued need to improve therapeutic recombinant protein productivity has led to ongoing assessment of appropriate strategies in the biopharmaceutical industry to establish robust processes with optimized critical variables, that is, viable cell density (VCD) and specific productivity (product per cell, qP). Even though high VCD is a positive factor for titer, uncontrolled proliferation beyond a certain cell mass is also undesirable. To enable efficient process development to achieve consistent and predictable growth arrest while maintaining VCD, as well as improving qP, without negative impacts on product quality from clone to clone, we identified an approach that directly targets the cell cycle G1-checkpoint by selectively inhibiting the function of cyclin dependent kinases (CDK) 4/6 with a small molecule compound. Results from studies on multiple recombinant Chinese hamster ovary (CHO) cell lines demonstrate that the selective inhibitor can mediate a complete and sustained G0/G1 arrest without impacting G2/M phase. Cell proliferation is consistently and rapidly controlled in all recombinant cell lines at one concentration of this inhibitor throughout the production processes with specific productivities increased up to 110 pg/cell/day. Additionally, the product quality attributes of the mAb, with regard to high molecular weight (HMW) and glycan profile, are not negatively impacted. In fact, high mannose is decreased after treatment, which is in contrast to other established growth control methods such as reducing culture temperature. Microarray analysis showed major differences in expression of regulatory genes of the glycosylation and cell cycle signaling pathways between these different growth control methods. Overall, our observations showed that cell cycle arrest by directly targeting CDK4/6 using selective inhibitor compound can be utilized consistently and rapidly to optimize process parameters, such as cell growth, qP, and glycosylation profile in recombinant antibody production cultures. © 2014 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.

Pragmatic quality metrics for evolutionary software development models

NASA Technical Reports Server (NTRS)

Royce, Walker

1990-01-01

Due to the large number of product, project, and people parameters which impact large custom software development efforts, measurement of software product quality is a complex undertaking. Furthermore, the absolute perspective from which quality is measured (customer satisfaction) is intangible. While we probably can't say what the absolute quality of a software product is, we can determine the relative quality, the adequacy of this quality with respect to pragmatic considerations, and identify good and bad trends during development. While no two software engineers will ever agree on an optimum definition of software quality, they will agree that the most important perspective of software quality is its ease of change. We can call this flexibility, adaptability, or some other vague term, but the critical characteristic of software is that it is soft. The easier the product is to modify, the easier it is to achieve any other software quality perspective. This paper presents objective quality metrics derived from consistent lifecycle perspectives of rework which, when used in concert with an evolutionary development approach, can provide useful insight to produce better quality per unit cost/schedule or to achieve adequate quality more efficiently. The usefulness of these metrics is evaluated by applying them to a large, real world, Ada project.

Ballistic Testing and Product Quality Surveillance for the Interceptor Body Armor - Vest Components Need Improvement

DTIC Science & Technology

2011-01-03

six contracts. Interceptor Body Armor – Vest Components IBA is a modular body armor system that consists of an OTV, ceramic plates , and components...Armor - Vest Components Need Improvement Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden for the...Ballistic Testing and Product Quality Surveillance for the Interceptor Body Armor - Vest Components Need Improvement 5a. CONTRACT NUMBER 5b. GRANT

Discriminating nutritional quality of foods using the 5-Color nutrition label in the French food market: consistency with nutritional recommendations.

PubMed

Julia, Chantal; Ducrot, Pauline; Péneau, Sandrine; Deschamps, Valérie; Méjean, Caroline; Fézeu, Léopold; Touvier, Mathilde; Hercberg, Serge; Kesse-Guyot, Emmanuelle

2015-09-28

Our objectives were to assess the performance of the 5-Colour nutrition label (5-CNL) front-of-pack nutrition label based on the Food Standards Agency nutrient profiling system to discriminate nutritional quality of foods currently on the market in France and its consistency with French nutritional recommendations. Nutritional composition of 7777 foods available on the French market collected from the web-based collaborative project Open Food Facts were retrieved. Distribution of products across the 5-CNL categories according to food groups, as arranged in supermarket shelves was assessed. Distribution of similar products from different brands in the 5-CNL categories was also assessed. Discriminating performance was considered as the number of color categories present in each food group. In the case of discrepancies between the category allocation and French nutritional recommendations, adaptations of the original score were proposed. Overall, the distribution of foodstuffs in the 5-CNL categories was consistent with French recommendations: 95.4% of 'Fruits and vegetables', 72.5% of 'Cereals and potatoes' were classified as 'Green' or 'Yellow' whereas 86.0% of 'Sugary snacks' were classified as 'Pink' or 'Red'. Adaptations to the original FSA score computation model were necessary for beverages, added fats and cheese in order to be consistent with French official nutritional recommendations. The 5-CNL label displays a high performance in discriminating nutritional quality of foods across food groups, within a food group and for similar products from different brands. Adaptations from the original model were necessary to maintain consistency with French recommendations and high performance of the system.

ProSens: integrated production control by automated inspection planning and efficient multisensor metrology

NASA Astrophysics Data System (ADS)

Glaser, Ulf; Li, Zhichao; Bichmann, Stephan, II; Pfeifer, Tilo

2003-05-01

By China's entry into the WTO, Chinese as well as German companies are facing the question, how to minimize the risk of unfamiliar cooperation partners when developing products. The rise of customer demands concerning quality, product diversity and the reduction of expenses require flexibility and efficiency with reliable component suppliers. In order to build and strengthen sino-german cooperations, a manufacturing control using homogenized and efficient measures to assure high quality is of vital importance. Lack of unifications may cause identical measurements conducted at subcontractors or customers to be carried out with different measurement processes which leads to incomparable results. Rapidly growing company cooperations and simultaneously decreasing of manufacturing scope cause substantial difficulties when coordinating joint quality control activities. "ProSens," a sino-german project consortium consisting of industrial users, technology producers and research institutes, aims at improving selected production processes by: Creation of a homogeneous quality awareness in sino-german cooperations. Sensitization for process accompanying metrology at an early stage of product development. Increase of the process performance by the use of integrated metrology. Reduction of production time and cost. Unification of quality control of complex products by means of efficient measurement strategies and CAD-based inspection planning.

Multicapillary SDS-gel electrophoresis for the analysis of fluorescently labeled mAb preparations: a high throughput quality control process for the production of QuantiPlasma and PlasmaScan mAb libraries.

PubMed

Székely, Andrea; Szekrényes, Akos; Kerékgyártó, Márta; Balogh, Attila; Kádas, János; Lázár, József; Guttman, András; Kurucz, István; Takács, László

2014-08-01

Molecular heterogeneity of mAb preparations is the result of various co- and post-translational modifications and to contaminants related to the production process. Changes in molecular composition results in alterations of functional performance, therefore quality control and validation of therapeutic or diagnostic protein products is essential. A special case is the consistent production of mAb libraries (QuantiPlasma™ and PlasmaScan™) for proteome profiling, quality control of which represents a challenge because of high number of mAbs (>1000). Here, we devise a generally applicable multicapillary SDS-gel electrophoresis process for the analysis of fluorescently labeled mAb preparations for the high throughput quality control of mAbs of the QuantiPlasma™ and PlasmaScan™ libraries. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Strategies for analysing and improving the expression and quality of recombinant proteins made in mammalian cells.

PubMed

Jenkins, Nigel; Meleady, Paula; Tyther, Raymond; Murphy, Lisa

2009-05-06

The production of monoclonal antibodies and other recombinant proteins is one of the highest growth areas in the pharmaceutical industry. Mammalian cells are used to manufacture the majority of biotherapeutics, largely due to their ability to perform complex post-translational modifications. Although significant progress has been made recently in improving product yields and protein quality, many challenges still lie ahead to achieve consistently high yields while avoiding potentially damaging protein modifications. The present review first considers the strategies used to analyse and improve recombinant protein expression of industrial cell lines, with an emphasis on proteomic technologies. Next, cellular and environmental influences on protein production and quality are examined, and strategies for improvements in product yield and quality are reviewed. The analytical techniques required to detect these protein changes are also described, together with prospects for assay improvements.

Process quality planning of quality function deployment for carrot syrup

NASA Astrophysics Data System (ADS)

Ekawati, Yurida; Noya, Sunday; Widjaja, Filemon

2017-06-01

Carrot products are rarely available in the market. Based on previous research that had been done using QFD to generate product design of carrots products, the research to produce the process quality planning had been carried out. The carrot product studied was carrot syrup. The research resulted in a process planning matrix for carrot syrup. The matrix gives information about critical process plan and the priority of the critical process plan. The critical process plan on the production process of carrot syrup consists of carrots sorting, carrots peeling, carrots washing, blanching process, carrots cutting, the making of pureed carrots, filtering carrot juice, the addition of sugar in carrot juice, the addition of food additives in carrot juice, syrup boiling, syrup filtering, syrup filling into the bottle, the bottle closure and cooling. The information will help the design of the production process of carrot syrup.

Exploring the Classroom Practice of Productive Pedagogies of the Malaysian Secondary School Geography Teacher

ERIC Educational Resources Information Center

Ahmad@Shaari, Mohammad Zohir; Jamil, Hazri; Razak, Nordin Abd

2012-01-01

The productive pedagogies as a framework to enhance teaching and learning outcomes were developed by Lingard et al. (2001) consisted of four main dimensions--intellectual quality, connectedness, supportive classroom environment, and working with and valuing differences. This study is to investigate the productive pedagogical practices among…

Fermentanomics: Relating quality attributes of a monoclonal antibody to cell culture process variables and raw materials using multivariate data analysis.

PubMed

Rathore, Anurag S; Kumar Singh, Sumit; Pathak, Mili; Read, Erik K; Brorson, Kurt A; Agarabi, Cyrus D; Khan, Mansoor

2015-01-01

Fermentanomics is an emerging field of research and involves understanding the underlying controlled process variables and their effect on process yield and product quality. Although major advancements have occurred in process analytics over the past two decades, accurate real-time measurement of significant quality attributes for a biotech product during production culture is still not feasible. Researchers have used an amalgam of process models and analytical measurements for monitoring and process control during production. This article focuses on using multivariate data analysis as a tool for monitoring the internal bioreactor dynamics, the metabolic state of the cell, and interactions among them during culture. Quality attributes of the monoclonal antibody product that were monitored include glycosylation profile of the final product along with process attributes, such as viable cell density and level of antibody expression. These were related to process variables, raw materials components of the chemically defined hybridoma media, concentration of metabolites formed during the course of the culture, aeration-related parameters, and supplemented raw materials such as glucose, methionine, threonine, tryptophan, and tyrosine. This article demonstrates the utility of multivariate data analysis for correlating the product quality attributes (especially glycosylation) to process variables and raw materials (especially amino acid supplements in cell culture media). The proposed approach can be applied for process optimization to increase product expression, improve consistency of product quality, and target the desired quality attribute profile. © 2015 American Institute of Chemical Engineers.

Make or buy analysis model based on tolerance allocation to minimize manufacturing cost and fuzzy quality loss

NASA Astrophysics Data System (ADS)

Rosyidi, C. N.; Puspitoingrum, W.; Jauhari, W. A.; Suhardi, B.; Hamada, K.

2016-02-01

The specification of tolerances has a significant impact on the quality of product and final production cost. The company should carefully pay attention to the component or product tolerance so they can produce a good quality product at the lowest cost. Tolerance allocation has been widely used to solve problem in selecting particular process or supplier. But before merely getting into the selection process, the company must first make a plan to analyse whether the component must be made in house (make), to be purchased from a supplier (buy), or used the combination of both. This paper discusses an optimization model of process and supplier selection in order to minimize the manufacturing costs and the fuzzy quality loss. This model can also be used to determine the allocation of components to the selected processes or suppliers. Tolerance, process capability and production capacity are three important constraints that affect the decision. Fuzzy quality loss function is used in this paper to describe the semantic of the quality, in which the product quality level is divided into several grades. The implementation of the proposed model has been demonstrated by solving a numerical example problem that used a simple assembly product which consists of three components. The metaheuristic approach were implemented to OptQuest software from Oracle Crystal Ball in order to obtain the optimal solution of the numerical example.

Evaluation of Ammunition Data Cards (REDACTED)

DTIC Science & Technology

2016-04-29

Procuring Contracting Officer ( PCO ), the manufacturer shall include, in the components sections on ADC representing the munition, all assemblies...lot components or evidence of PCO waiver approval. As a result, ADCs did not consistently include component items that make up the ammunition, and...Energetics PCO Procuring Contract Officer PQM Product Quality Manager QALI Quality Assurance Letter of Instruction QAR Quality Assurance Representative

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein

PubMed Central

McCue, J; Osborne, D; Dumont, J; Peters, R; Mei, B; Pierce, G F; Kobayashi, K; Euwart, D

2014-01-01

Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing process utilized a transferable and scalable platform approach established for therapeutic antibody manufacturing and adapted for production of the rFIXFc molecule. rFIXFc was produced using a process free of human- and animal-derived raw materials and a host cell line derived from human embryonic kidney (HEK) 293H cells. The process employed multi-step purification and viral clearance processing, including use of a protein A affinity capture chromatography step, which binds to the Fc portion of the rFIXFc molecule with high affinity and specificity, and a 15 nm pore size virus removal nanofilter. Process validation studies were performed to evaluate identity, purity, activity and safety. The manufacturing process produced rFIXFc with consistent product quality and high purity. Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses. The rFIXFc manufacturing process produces a highly pure product, free of non-human glycan structures. Validation studies demonstrate that this product is produced with consistent quality and purity. In addition, the scalability and transferability of this process are key attributes to ensure consistent and continuous supply of rFIXFc. PMID:24811361

The role of non-financial performance measures in predicting hospital financial performance: the case of for-profit system hospitals.

PubMed

Vélez-González, Heltie; Pradhan, Rohit; Weech-Maldonado, Robert

2011-01-01

Non-financial measures have found increasing acceptance in the business world--however, their application in the health care industry remains limited. The purpose of this article is to understand the influence of non-financial measures (efficiency, productivity, and quality) on the financial performance of for-profit system hospitals. The sample consists of 499 for-profit system hospitals in the United States from 1999 to 2002. Data analyzed include the American Hospital Association's Annual Survey, Medicare Cost Reports, Joint Commission's quality scores, and the Centers for Medicare & Medicaid Services' Hospital Case Mix Index. Dependent variables consist of financial measures (operating and total margins), while independent variables include measures of efficiency, productivity, and quality. Our results suggest the influence of non-financial performance measures on financial performance; occupancy rate positively influences financial performance while greater labor intensity may have negative implications for financial performance. In addition, we show that quality positively influences financial performance thereby offering a potential business case for quality. This result has important managerial and policy implications as it may incentivize capital and human resource investments required to improve hospital quality of care.

High-Quality TiS2 For Li/TiS2 Cells

NASA Technical Reports Server (NTRS)

Huang, Chen-Kuo; Surampudi, Subbarao; Shen, David H.; Delgiannis, Fotios; Halpert, Gerald

1992-01-01

Modified process for synthesis of battery-grade titanium sulfide (TiS2) yields substantially improved material for Li/TiS2 electrochemical cells. Includes all-vapor-phase reaction between sulfur and titanium. Product less dense and more homogeneous, consists of smaller particles of higher crystalline quality, and purer. Cells have high cathode utilization and long cycle life performance. Expected to find applications in rechargeable lithium batteries for spacecraft, military equipment, telecommunication systems, automobiles, and consumer products.

Rural Productivity Zones (RPZs) for microenterprises

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, R.D.

1997-12-01

In this paper the authors discuss the concept of rural productivity zones (RPZs) which are defined as a business incubator to foster income-producing opportunities for the rural poor. The essential ingredients of such a program include: electric power; business development assistance; office services; and quality work space. The electric power source must be a good quality system, consisting of a diesel/wind/photovoltaic hybrid type system, providing reliable service, with a local maintenance program and a functional load management program.

Development of a multichannel hyperspectral imaging probe for food property and quality assessment

USDA-ARS?s Scientific Manuscript database

This paper reports on the development, calibration and evaluation of a new multipurpose, multichannel hyperspectral imaging probe for property and quality assessment of food products. The new multichannel probe consists of a 910-miscrometer fiber as a point light source and 30 light receiving fibers...

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-4 Inspections and.... (b) Manufacturer's inspections and tests. Manufacturers of approved work vests shall maintain quality... samples from each lot to maintain the quality of their product. (c) Lot size. A lot shall consist of not...

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-4 Inspections and.... (b) Manufacturer's inspections and tests. Manufacturers of approved work vests shall maintain quality... samples from each lot to maintain the quality of their product. (c) Lot size. A lot shall consist of not...

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-4 Inspections and.... (b) Manufacturer's inspections and tests. Manufacturers of approved work vests shall maintain quality... samples from each lot to maintain the quality of their product. (c) Lot size. A lot shall consist of not...

Allele-Specific Transcription Factor Binding in Pig Calpastatin Promoter Regions

USDA-ARS?s Scientific Manuscript database

The identification of predictive DNA markers for pork quality would allow U.S. pork producers and breeders to more quickly and efficiently select genetically superior animals for production of consistent, high quality meat. Genome scans have identified QTL for tenderness on pig chromosome 2 which ha...

Predictive markers in calpastatin for tenderness in commercial pig populations

USDA-ARS?s Scientific Manuscript database

The identification of predictive DNA markers for pork quality would allow U.S. pork producers and breeders to more quickly and efficiently select genetically superior animals for production of consistent, high quality meat. Genome scans have identified QTL for tenderness on pig chromosome 2 which ha...

Association of Functional SNPs in Pig Calpastatin Regulatory Regions with Tenderness

USDA-ARS?s Scientific Manuscript database

The identification of predictive DNA markers for pork quality would allow U.S. pork producers and breeders to more quickly and efficiently select genetically superior animals for production of consistent, high quality meat. Genome scans have identified QTL for tenderness on pig chromosome 2 which ha...

Establishment of one-step approach to detoxification of hypertoxic aconite based on the evaluation of alkaloids contents and quality.

PubMed

Zhang, Ding-Kun; Han, Xue; Tan, Peng; Li, Rui-Yu; Niu, Ming; Zhang, Cong-En; Wang, Jia-Bo; Yang, Ming; Xiao, Xiao-He

2017-01-01

Aconite is a valuable drug and also a toxic material, which can be used only after detoxification processing. Although traditional processing methods can achieve detoxification effect as desired, there are some obvious drawbacks, including a significant loss of alkaloids and poor quality consistency. It is thus necessary to develop a new detoxification approach. In the present study, we designed a novel one-step detoxification approach by quickly drying fresh-cut aconite particles. In order to evaluate the technical advantages, the contents of mesaconitine, aconitine, hypaconitine, benzoylmesaconine, benzoylaconine, benzoylhypaconine, neoline, fuziline, songorine, and talatisamine were determined using HPLC and UHPLC/Q-TOF-MS. Multivariate analysis methods, such as Clustering analysis and Principle component analysis, were applied to determine the quality differences between samples. Our results showed that traditional processes could reduce toxicity as desired, but also led to more than 85.2% alkaloids loss. However, our novel one-step method was capable of achieving virtually the same detoxification effect, with only an approximately 30% alkaloids loss. Cluster analysis and Principal component analysis analyses suggested that Shengfupian and the novel products were significantly different from various traditional products. Acute toxicity testing showed that the novel products achieved a good detoxification effect, with its maximum tolerated dose being equivalent to 20 times of adult dosage. And cardiac effect testing also showed that the activity of the novel products was stronger than that of traditional products. Moreover, particles specification greatly improved the quality consistency of the novel products, which was immensely superior to the traditional products. These results would help guide the rational optimization of aconite processing technologies, providing better drugs for clinical treatment. Copyright © 2017 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

Group for High Resolution Sea Surface Temperature (GHRSST) analysis fields inter-comparisons—Part 2: Near real time web-based level 4 SST Quality Monitor (L4-SQUAM)

NASA Astrophysics Data System (ADS)

Dash, Prasanjit; Ignatov, Alexander; Martin, Matthew; Donlon, Craig; Brasnett, Bruce; Reynolds, Richard W.; Banzon, Viva; Beggs, Helen; Cayula, Jean-Francois; Chao, Yi; Grumbine, Robert; Maturi, Eileen; Harris, Andy; Mittaz, Jonathan; Sapper, John; Chin, Toshio M.; Vazquez-Cuervo, Jorge; Armstrong, Edward M.; Gentemann, Chelle; Cummings, James; Piollé, Jean-François; Autret, Emmanuelle; Roberts-Jones, Jonah; Ishizaki, Shiro; Høyer, Jacob L.; Poulter, Dave

2012-11-01

There are a growing number of level 4 (L4; gap-free gridded) sea surface temperature (SST) products generated by blending SST data from various sources which are available for use in a wide variety of operational and scientific applications. In most cases, each product has been developed for a specific user community with specific requirements guiding the design of the product. Consequently differences between products are implicit. In addition, anomalous atmospheric conditions, satellite operations and production anomalies may occur which can introduce additional differences. This paper describes a new web-based system called the L4 SST Quality Monitor (L4-SQUAM) developed to monitor the quality of L4 SST products. L4-SQUAM intercompares thirteen L4 products with 1-day latency in an operational environment serving the needs of both L4 SST product users and producers. Relative differences between products are computed and visualized using maps, histograms, time series plots and Hovmöller diagrams, for all combinations of products. In addition, products are compared to quality controlled in situ SST data (available from the in situ SST Quality Monitor, iQUAM, companion system) in a consistent manner. A full history of products statistics is retained in L4-SQUAM for time series analysis. L4-SQUAM complements the two other Group for High Resolution SST (GHRSST) tools, the GHRSST Multi Product Ensemble (GMPE) and the High Resolution Diagnostic Data Set (HRDDS) systems, documented in part 1 of this paper and elsewhere, respectively. Our results reveal significant differences between SST products in coastal and open ocean areas. Differences of >2 °C are often observed at high latitudes partly due to different treatment of the sea-ice transition zone. Thus when an ice flag is available, the intercomparisons are performed in two ways: including and excluding ice-flagged grid points. Such differences are significant and call for a community effort to understand their root cause and ensure consistency between SST products. Future work focuses on including the remaining daily L4 SST products, accommodating for newer L4 SSTs which resolve the diurnal variability and evaluating retrospectively regenerated L4 SSTs to support satellite data reprocessing efforts aimed at generating improved SST Climate Data Records.

Quality assessment of the Harmonized Landsat and Sentinel-2 (HLS) data set

NASA Astrophysics Data System (ADS)

Masek, J. G.; Claverie, M.; Ju, J.; Vermote, E.

2017-12-01

The Harmonized Landsat and Sentinel-2 (HLS) project is a NASA initiative aiming to produce a compatible surface reflectance (SR) data set from a virtual constellation consisting of the US Landsat-8 and the European Sentinel-2 satellites. The creation of such a long-term surface reflectance data record requires the development and implementation of Quality assessment (QA) methods to evaluate the quality of the product. QA is built as an integral part of the HLS production chain. The QA includes three components: (i) the comparison of the HLS data with MODIS data, (ii) an analysis of the geometric accuracy of the Landsat-8 OLI and Sentinel-2 MSI Level-1 products, and (iii) an evaluation of the temporal consistency of the HLS products.The methodology of the cross-comparison of the HLS product with MODIS products was introduced by Claverie et al. (2015, RSE, vol. 169). It consists in comparing HLS SR (L30 products for Landsat-8 and S30 products for Sentinel-2) with MODIS SR (MOD09CMG), after adjustment of sun-view geometry and bandpass differences. The overall uncertainties and biases between MODIS and HLS SR do not exceed, depending on the band (excluding blue bands), 9% and 3%, respectively. No significant spatial or temporal patterns were identified. The most important source of uncertainty comes from the cloud detection omission on the MSI data.The HLS and Level-1 products geometric accuracy was assessed and improved using the automated registration and orthorectification package, AROP (Gao et al., 2009, SPIE JARS, vol. 3). The use of AROP reduces the geometric co-registration error in Level-1 products by about 40% and 60% during HLS processing of OLI and MSI, respectively. The final CE-90 are 6.2 m and 18.8 m, for HLS MSI (computed with 10m pixels) and OLI (30 m pixels), respectively.Finally, the time series (TS) smoothness of the data set was analyzed by computing the time series noise (Vermote et al., 2009, TGRS, vol. 47). We showed that major issue is related to the MSI cloud mask quality. After filtering TS outliers, we demonstrated that the HLS TS noise (i.e., including MSI and OLI data) do not exceed 0.006 for the visible bands and 0.014 for the NIR and SWIR bands.

Quality appraisal of generic self-reported instruments measuring health-related productivity changes: a systematic review

PubMed Central

2014-01-01

Background Health impairments can result in disability and changed work productivity imposing considerable costs for the employee, employer and society as a whole. A large number of instruments exist to measure health-related productivity changes; however their methodological quality remains unclear. This systematic review critically appraised the measurement properties in generic self-reported instruments that measure health-related productivity changes to recommend appropriate instruments for use in occupational and economic health practice. Methods PubMed, PsycINFO, Econlit and Embase were systematically searched for studies whereof: (i) instruments measured health-related productivity changes; (ii) the aim was to evaluate instrument measurement properties; (iii) instruments were generic; (iv) ratings were self-reported; (v) full-texts were available. Next, methodological quality appraisal was based on COSMIN elements: (i) internal consistency; (ii) reliability; (iii) measurement error; (iv) content validity; (v) structural validity; (vi) hypotheses testing; (vii) cross-cultural validity; (viii) criterion validity; and (ix) responsiveness. Recommendations are based on evidence syntheses. Results This review included 25 articles assessing the reliability, validity and responsiveness of 15 different generic self-reported instruments measuring health-related productivity changes. Most studies evaluated criterion validity, none evaluated cross-cultural validity and information on measurement error is lacking. The Work Limitation Questionnaire (WLQ) was most frequently evaluated with moderate respectively strong positive evidence for content and structural validity and negative evidence for reliability, hypothesis testing and responsiveness. Less frequently evaluated, the Stanford Presenteeism Scale (SPS) showed strong positive evidence for internal consistency and structural validity, and moderate positive evidence for hypotheses testing and criterion validity. The Productivity and Disease Questionnaire (PRODISQ) yielded strong positive evidence for content validity, evidence for other properties is lacking. The other instruments resulted in mostly fair-to-poor quality ratings with limited evidence. Conclusions Decisions based on the content of the instrument, usage purpose, target country and population, and available evidence are recommended. Until high-quality studies are in place to accurately assess the measurement properties of the currently available instruments, the WLQ and, in a Dutch context, the PRODISQ are cautiously preferred based on its strong positive evidence for content validity. Based on its strong positive evidence for internal consistency and structural validity, the SPS is cautiously recommended. PMID:24495301

Application of a tablet film coating model to define a process-imposed transition boundary for robust film coating.

PubMed

van den Ban, Sander; Pitt, Kendal G; Whiteman, Marshall

2018-02-01

A scientific understanding of interaction of product, film coat, film coating process, and equipment is important to enable design and operation of industrial scale pharmaceutical film coating processes that are robust and provide the level of control required to consistently deliver quality film coated product. Thermodynamic film coating conditions provided in the tablet film coating process impact film coat formation and subsequent product quality. A thermodynamic film coating model was used to evaluate film coating process performance over a wide range of film coating equipment from pilot to industrial scale (2.5-400 kg). An approximate process-imposed transition boundary, from operating in a dry to a wet environment, was derived, for relative humidity and exhaust temperature, and used to understand the impact of the film coating process on product formulation and process control requirements. This approximate transition boundary may aid in an enhanced understanding of risk to product quality, application of modern Quality by Design (QbD) based product development, technology transfer and scale-up, and support the science-based justification of critical process parameters (CPPs).

Assessment of Predictable Productivity of Nurses Working in Kerman University of Medical Sciences' Teaching Hospitals via the Dimensions of Quality of Work Life.

PubMed

Borhani, Fariba; Arbabisarjou, Azizollah; Kianian, Toktam; Saber, Saman

2016-10-01

Despite the existence of a large community of nurses, specific mechanisms have not been developed yet to consider their needs and the quality of their work life. Moreover, few studies have been conducted to analyze the nature of nursing, nursing places or nurses' quality of work life. In this regard, the present study aimed to assess predictable productivity of nurses working in Kerman University of Medical Sciences' teaching hospitals via the dimensions of Quality of Work Life. The present descriptive-correlational study was conducted to assess predictable productivity of nurses via the dimensions of Quality of Work Life. The study's population consisted of all nurses working in different wards of teaching hospitals associated with Kerman University of Medical Sciences. Out of the whole population, 266 nurses were selected based on the simple random sampling method. To collect data, the questionnaires of 'Quality of Nursing Work Life' and 'Productivity' were used after confirming their reliability (test-retest) and content validity. Finally, the collected data were analyzed through the SPSS software (version 16). Although the quality of work life for nurses was average and their productivity was low but the results showed that quality of life is directly related to nurses' productivity. Quality of life and its dimensions are predictive factors in the in the nurses' productivity. It can conclude that by recognizing the nurses' quality of work life situation, it can realize this group productivity and their values to the efficiency of the health system. For the quality of working life improvement and increasing nurses' productivity more efforts are needed by authorities. The findings can be applied by managers of hospitals and nursing services along with head nurses to enhance the quality of health services and nursing profession in general.

Securing quality of camera-based biomedical optics

NASA Astrophysics Data System (ADS)

Guse, Frank; Kasper, Axel; Zinter, Bob

2009-02-01

As sophisticated optical imaging technologies move into clinical applications, manufacturers need to guarantee their products meet required performance criteria over long lifetimes and in very different environmental conditions. A consistent quality management marks critical components features derived from end-users requirements in a top-down approach. Careful risk analysis in the design phase defines the sample sizes for production tests, whereas first article inspection assures the reliability of the production processes. We demonstrate the application of these basic quality principles to camera-based biomedical optics for a variety of examples including molecular diagnostics, dental imaging, ophthalmology and digital radiography, covering a wide range of CCD/CMOS chip sizes and resolutions. Novel concepts in fluorescence detection and structured illumination are also highlighted.

Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.

PubMed

Borg, John Joseph; Robert, Jean-Louis; Wade, George; Aislaitner, George; Pirozynski, Michal; Abadie, Eric; Salmonson, Tomas; Vella Bonanno, Patricia

2009-01-01

The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU's centralised procedure. We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications. Frequencies and trends on quality deficiencies have been recorded and presented for 52 marketing authorisation applications. 32 "Major Objections" originated from 13 marketing authorisation applications. 13 concerned were raised regarding drug substances and 19 for drug products. Furthermore, 905 concerns on drug substance and 1,054 on drug product were also adopted. The impact of the frequencies and trends in quality deficiencies that were identified are discussed from a regulatory point of view. It is expected that the results of this study will not only be of interest to pharmaceutical companies but will also aid regulators' in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

St John's wort (Hypericum perforatum) products - an assessment of their authenticity and quality.

PubMed

Booker, Anthony; Agapouda, Anastasia; Frommenwiler, Débora A; Scotti, Francesca; Reich, Eike; Heinrich, Michael

2018-02-01

St John's wort products (Hypericum perforatum L.) are widely available for sale in many countries including the UK via the internet. In the UK, these products are required to hold either a marketing authorisation or Traditional herbal registration (THR) to be sold legally. The THR and other regulatory schemes help to ensure product safety and quality providing an example of best practice but there is a risk if both regulated and un-regulated products continue to be available to consumers. The project is embedded in a larger study aiming to investigate the quality of different herbal medicinal products along diverse value chains. Here we focus on a comparison of the quality of the finished products and assess phytochemical variation between registered products (THRs) and products obtained from the market without any registration. 47 commercial products (granulated powders and extracts) were sourced from different suppliers. We analysed these samples using high performance thin layer chromatography (HPTLC) and 1 H NMR spectroscopy coupled with multi-variate analysis software following a method previously developed by our group. The consistency of the products varies significantly. Adulteration of the products (36%), possibly with other Hypericum species obtained from China or use of chemically distinct H. perforatum cultivars or chemotypes, and adulteration of the products (19%) with food dyes (tartrazine, amaranth, brilliant blue, sunset yellow) were the principle findings of this study. There is significant compositional variation among commercial finished products and two main causative quality problems were identified as adulteration by incorrect species or adulteration with food dyes. Generally, food supplements and unlicensed products were found to be of poorer quality than the regulated ones including THRs. Copyright © 2017 Elsevier GmbH. All rights reserved.

Physicochemical and immunochemical assays for monitoring consistent production of tetanus toxoid.

PubMed

Metz, Bernard; Tilstra, Wichard; van der Put, Robert; Spruit, Nanda; van den Ijssel, Jan; Robert, Jolanda; Hendriksen, Coenraad; Kersten, Gideon

2013-07-01

The detoxification of tetanus toxin by formaldehyde is a crucial step in the production of tetanus toxoid. The inactivation results in chemically modified proteins and it determines largely the ultimate efficacy and safety of the vaccine. Currently, the quality of tetanus toxoid lots is evaluated in potency and safety tests performed in animals. As a possible alternative, this article describes a panel of in vitro methods, which provides detailed information about the quality of tetanus toxoid. Ten experimental lots of tetanus toxoid were prepared using increasing concentrations of formaldehyde and glycine to obtain tetanus toxoids having differences in antigenicity, immunogenicity, residual toxicity and protein structure. The structural properties of each individual toxoid were determined using immunochemical and physicochemical methods, including biosensor analysis, ELISA, circular dichroism, TNBS assay, differential scanning calorimetry, fluorescence and SDS-PAGE. The quality of a tetanus toxoid lot can be assessed by these set of analytical techniques. Based on antigenicity, immunogenicity and residual toxicity data, criteria are formulated that tetanus toxoids lot have to meet in order to have a high quality. The in vitro methods are a valuable selection of techniques for monitoring consistency of production of tetanus toxoid, especially for the detoxification process of tetanus toxin. Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project.

PubMed

Bonertz, A; Roberts, G; Slater, J E; Bridgewater, J; Rabin, R L; Hoefnagel, M; Timon, M; Pini, C; Pfaar, O; Sheikh, A; Ryan, D; Akdis, C; Goldstein, J; Poulsen, L K; van Ree, R; Rhyner, C; Barber, D; Palomares, O; Pawankar, R; Hamerlijnk, D; Klimek, L; Agache, I; Angier, E; Casale, T; Fernandez-Rivas, M; Halken, S; Jutel, M; Lau, S; Pajno, G; Sturm, G; Varga, E M; Gerth van Wijk, R; Bonini, S; Muraro, A; Vieths, S

2018-04-01

Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. As the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines. © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Innovative hyperspectral imaging-based techniques for quality evaluation of fruits and vegetables: a review

USDA-ARS?s Scientific Manuscript database

New, non-destructive sensing techniques for fast and more effective quality assessment of fruits and vegetables are needed to meet the ever-increasing consumer demand for better, more consistent and safer food products. Over the past 15 years, hyperspectral imaging has emerged as a new generation of...

Complete Genome Sequence of the Quality Control Strain Staphylococcus aureus subsp. aureus ATCC 25923

PubMed Central

Treangen, Todd J.; Maybank, Rosslyn A.; Enke, Sana; Friss, Mary Beth; Diviak, Lynn F.; Karaolis, David K. R.; Koren, Sergey; Ondov, Brian; Phillippy, Adam M.; Bergman, Nicholas H.

2014-01-01

Staphylococcus aureus subsp. aureus ATCC 25923 is commonly used as a control strain for susceptibility testing to antibiotics and as a quality control strain for commercial products. We present the completed genome sequence for the strain, consisting of the chromosome and a 27.5-kb plasmid. PMID:25377701

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein.

PubMed

McCue, J; Osborne, D; Dumont, J; Peters, R; Mei, B; Pierce, G F; Kobayashi, K; Euwart, D

2014-07-01

Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing process utilized a transferable and scalable platform approach established for therapeutic antibody manufacturing and adapted for production of the rFIXFc molecule. rFIXFc was produced using a process free of human- and animal-derived raw materials and a host cell line derived from human embryonic kidney (HEK) 293H cells. The process employed multi-step purification and viral clearance processing, including use of a protein A affinity capture chromatography step, which binds to the Fc portion of the rFIXFc molecule with high affinity and specificity, and a 15 nm pore size virus removal nanofilter. Process validation studies were performed to evaluate identity, purity, activity and safety. The manufacturing process produced rFIXFc with consistent product quality and high purity. Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses. The rFIXFc manufacturing process produces a highly pure product, free of non-human glycan structures. Validation studies demonstrate that this product is produced with consistent quality and purity. In addition, the scalability and transferability of this process are key attributes to ensure consistent and continuous supply of rFIXFc. © 2014 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

Image recording requirements for earth observation applications in the next decade

NASA Technical Reports Server (NTRS)

Peavey, B.; Sos, J. Y.

1975-01-01

Future requirements for satellite-borne image recording systems are examined from the standpoints of system performance, system operation, product type, and product quality. Emphasis is on total system design while keeping in mind that the image recorder or scanner is the most crucial element which will affect the end product quality more than any other element within the system. Consideration of total system design and implementation for sustained operational usage must encompass the requirements for flexibility of input data and recording speed, pixel density, aspect ratio, and format size. To produce this type of system requires solution of challenging problems in interfacing the data source with the recorder, maintaining synchronization between the data source and the recorder, and maintaining a consistent level of quality. Film products of better quality than is currently achieved in a routine manner are needed. A 0.1 pixel geometric accuracy and 0.0001 d.u. radiometric accuracy on standard (240 mm) size format should be accepted as a goal to be reached in the near future.

Productivity, or quality of work as the decisive factor in marketing ergonomics? Design considerations for a new ergonomic welding-table.

PubMed

van der Veen, F; Regensburg, R E

1990-04-01

Quality tools should be designed from the starting point of adjusting tasks and equipment to human possibilities and limitations. Companies should consider an investment in ergonomic equipment as a profitable addition to indispensable productive machinery. As an example to support this statement, the authors describe the health risks of welders and the possible solutions. As the result of investigations a list of requirements was drafted for a product that would have less of the disadvantages of the products mentioned. The designed product, the 'ergonomic welding-table', aims to be a quality tool for welders working at small and medium-sized tasks. The product consists of a cabin (2.35 m wide) with a built-in ventilator for very efficient welding-fume extraction (90%-95%). Welders can set their preferred working height at any time. Another advantage is the option of performing the welding task while standing or sitting. The results of user-evaluation among welders and purchasers indicates considerable satisfaction.

Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein.

PubMed

Rouiller, Yolande; Solacroup, Thomas; Deparis, Véronique; Barbafieri, Marco; Gleixner, Ralf; Broly, Hervé; Eon-Duval, Alex

2012-06-01

The production bioreactor step of an Fc-Fusion protein manufacturing cell culture process was characterized following Quality by Design principles. Using scientific knowledge derived from the literature and process knowledge gathered during development studies and manufacturing to support clinical trials, potential critical and key process parameters with a possible impact on product quality and process performance, respectively, were determined during a risk assessment exercise. The identified process parameters were evaluated using a design of experiment approach. The regression models generated from the data allowed characterizing the impact of the identified process parameters on quality attributes. The main parameters having an impact on product titer were pH and dissolved oxygen, while those having the highest impact on process- and product-related impurities and variants were pH and culture duration. The models derived from characterization studies were used to define the cell culture process design space. The design space limits were set in such a way as to ensure that the drug substance material would consistently have the desired quality. Copyright © 2012 Elsevier B.V. All rights reserved.

Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long Term Stability of Monoclonal Antibodies.

PubMed

Luis, Lin M; Hu, Yuzhe; Zamiri, Camellia; Sreedhara, Alavattam

2018-05-31

Monoclonal antibodies (mAbs) are exposed to light during drug product (DP) manufacturing and the acceptable levels of light exposure needs to be determined based on the impact on product quality. In this study, a mild and more representative light model consisting of ambient light instead of stress light as prescribed by ICH Q1B was used to evaluate the impact of light exposure on mAb DP quality. The immediate effect of ambient light exposure on protein drug product quality was determined to be dependent on the amount of light exposure rather than light intensity (up to 5000 lux). The impact on quality of mAbs is product specific due to their differences in light sensitivity, in which mAb II shows larger increases in IEC basic variants and larger decreases in SEC monomer when compared to mAb I after 0.24 million lux hours of light exposure. The acceptable ambient light exposure for mAb II drug product manufacturing was determined to be 0.13 million lux hours, in which no impact on product quality was observed after the short-term light exposure. Additionally, real-time storage (5°C) of the DP after the prescribed ambient light exposure showed no impact to various product quality attributes. The light model used in this study is capable of determining the acceptable amount of ambient light exposure for mAbs, especially during DP manufacturing processes. Copyright © 2018, Parenteral Drug Association.

Metafrontier frameworks for studying hospital productivity growth and quality changes.

PubMed

Chen, Kuan-Chen; Chien, Li-Nien; Hsu, Yi-Hsin; Yu, Ming-Miin

2016-12-01

The objective of this study was to evaluate productivity growth and quality changes among different levels of accredited hospitals. This study used an attribute-incorporating Malmquist productivity index (MPI) under the metafrontier framework. This is the first attempt to compare productivity changes among hospitals operating under different production frontiers. The data consisted of 20 academic medical centers (AMCs), 61 metropolitan hospitals (MPs) and 112 local community hospitals (LCs) in Taiwan during the period 2007-2010. This study measured productivity growth and further identified technological gaps and catch-ups in different groups of hospitals with respect to the metafrontier. At the same time, comparisons of changes in quality among different levels of hospitals were also examined. We found that the sample hospitals of AMCs and MPs experienced productivity improvements mainly due to technological progress, but their efficiency and technology gap ratio (TGR) deteriorated. As for LCs, progress in technology along with improvements in their efficiency and TGR led to the highest productivity upgrade among the three groups of hospitals. We also found that the sample hospitals among the three groups showed improvements in quality. Moreover, hospitals in the local community group exhibited greater quality progress than the AMCs and MPs over the sample period. This paper presents a number of useful decompositions of the metafrontier MPI, which can provide useful insights into changes that are due to efficiency, quality improvements and/or technological changes in the healthcare sector. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Quality By Design: Concept To Applications.

PubMed

Swain, Suryakanta; Padhy, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

2018-03-08

Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA). This review highlighted about the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected and consistently manufacture the required product. Risk assessment tools and design of experiments are its prime components. This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Moving beyond quality control in diagnostic radiology and the role of the clinically qualified medical physicist.

PubMed

Delis, H; Christaki, K; Healy, B; Loreti, G; Poli, G L; Toroi, P; Meghzifene, A

2017-09-01

Quality control (QC), according to ISO definitions, represents the most basic level of quality. It is considered to be the snapshot of the performance or the characteristics of a product or service, in order to verify that it complies with the requirements. Although it is usually believed that "the role of medical physicists in Diagnostic Radiology is QC", this, not only limits the contribution of medical physicists, but is also no longer adequate to meet the needs of Diagnostic Radiology in terms of Quality. In order to assure quality practices more organized activities and efforts are required in the modern era of diagnostic radiology. The complete system of QC is just one element of a comprehensive quality assurance (QA) program that aims at ensuring that the requirements of quality of a product or service will consistently be fulfilled. A comprehensive Quality system, starts even before the procurement of any equipment, as the need analysis and the development of specifications are important components under the QA framework. Further expanding this framework of QA, a comprehensive Quality Management System can provide additional benefits to a Diagnostic Radiology service. Harmonized policies and procedures and elements such as mission statement or job descriptions can provide clarity and consistency in the services provided, enhancing the outcome and representing a solid platform for quality improvement. The International Atomic Energy Agency (IAEA) promotes this comprehensive quality approach in diagnostic imaging and especially supports the field of comprehensive clinical audits as a tool for quality improvement. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case Study.

PubMed

Paolantonacci, Philippe; Appourchaux, Philippe; Claudel, Béatrice; Ollivier, Monique; Dennett, Richard; Siret, Laurent

2018-01-01

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.The advantages of this quality by design approach were improved process knowledge for industrial design and process validation and a clear justification of the process and product specifications as a basis for control strategy and future comparability exercises. © PDA, Inc. 2018.

Landsat Image Map Production Methods at the U. S. Geological Survey

USGS Publications Warehouse

Kidwell, R.D.; Binnie, D.R.; Martin, S.

1987-01-01

To maintain consistently high quality in satellite image map production, the U. S. Geological Survey (USGS) has developed standard procedures for the photographic and digital production of Landsat image mosaics, and for lithographic printing of multispectral imagery. This paper gives a brief review of the photographic, digital, and lithographic procedures currently in use for producing image maps from Landsat data. It is shown that consistency in the printing of image maps is achieved by standardizing the materials and procedures that affect the image detail and color balance of the final product. Densitometric standards are established by printing control targets using the pressplates, inks, pre-press proofs, and paper to be used for printing.

Optical Sensing of Polarization States Changes in Meat due to the Ageing

NASA Astrophysics Data System (ADS)

Tománek, Pavel; Mikláš, Jan; Abubaker, Hamed Mohamed; Grmela, Lubomír

2010-11-01

Food materials or biological materials display large compositional variations, inhomogeneities, and anisotropic structures. The biological tissues consist of cells which dimensions are bigger than a wavelength of visible light, therefore Mie scattering of transmitted and reflected light occurs and different polarization states arise. The meat industry needs reliable meat quality information throughout the production process in order to guarantee high-quality meat products for consumers. The minor importance is still given to the food quality control and inspection during processing operations or storing conditions. The paper presents a quite simple optical method allowing measure the freshness or ageing of products. The principle is to study temporal characteristics of polarization states of forward or backward scattered laser light in the samples in function of meat ageing.

Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

PubMed

Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

2015-08-26

The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

JRC Copernicus Climate Change Service (C3S) F4P platform.

NASA Astrophysics Data System (ADS)

Mota, Bernardo; Cappucci, Fabrizio; Gobron, Nadine

2016-04-01

With the increasing number of Earth Observation satellites and derived land surface products, concerns of quality assurance led the Global Climate Observing System (GCOS) to establish accuracy criteria and standards. In this context, the Climate Change Copernicus Service (C3S) fitness-for-purpose (F4P) platform, developed at the Joint Research Centre, aims assessing the quality of land Essential Climate Variables (ECVs) in compliance with GCOS criteria. In this paper, we first summarize the JRC C3S FP4 goals and secondly present the automatic review platform to assess multi-mission physical consistencies and physical coherence of and between various land products, at global and regional scales. We propose new metrics, such as Gamma Index and Triple Collocation Error Model, for multi-mission product inter-comparison and stability assessment, and resource selection statistical methods to assess physical coherence with other related ECV products. Examples concern the consistency of five global albedo products (GlobAlbedo, GLASS, MCD43C3, GIO and MISR), between 2000 And 2011, and their coherence with four burnt area products (MCD45A1, MCD64A1, Fire_CCI and GIO) for the overlapping period (2006 to 2008). Preliminary results show reasonable agreement with the inherent limitations of each product algorithm and sensor resolution.

Complete Genome Sequence of the Quality Control Strain Staphylococcus aureus subsp. aureus ATCC 25923.

PubMed

Treangen, Todd J; Maybank, Rosslyn A; Enke, Sana; Friss, Mary Beth; Diviak, Lynn F; Karaolis, David K R; Koren, Sergey; Ondov, Brian; Phillippy, Adam M; Bergman, Nicholas H; Rosovitz, M J

2014-11-06

Staphylococcus aureus subsp. aureus ATCC 25923 is commonly used as a control strain for susceptibility testing to antibiotics and as a quality control strain for commercial products. We present the completed genome sequence for the strain, consisting of the chromosome and a 27.5-kb plasmid. Copyright © 2014 Treangen et al.

Relating instrumental texture, determined relating instrumental texture, determined attachments, to sensory analysis of rainbow trout, Oncorhynchus mykiss, fillets

USDA-ARS?s Scientific Manuscript database

Texture is one of the most important quality attributes of fish fillets, and accurate assessment of variation in this attribute, as affected by storage and handling, is critical in providing consistent quality product. Trout fillets received 4 treatments: 3-d refrigeration (R3), 7-d refrigeration (R...

Water-quality trends in the nation's rivers

USGS Publications Warehouse

Smith, R.A.; Alexander, R.B.; Wolman, M.G.

1987-01-01

Water-quality records from two nationwide sampling networks now permit nationally consistent analysis of long-term water-quality trends at more than 300 locations on major U.S. rivers. Observed trends in 24 measures of water quality for the period from 1974 to 1981 provide new insight into changes in stream quality that occurred during a time of major changes in both terrestrial and atmospheric influences on surface waters. Particularly noteworthy are widespread decreases in fecal bacteria and lead concentrations and widespread increases in nitrate, chloride, arsenic, and cadmium concentrations. Recorded increases in municipal waste treatment, use of salt on highways, and nitrogen fertilizer application, along with decreases in leaded gasoline consumption and regionally variable trends in coal production and combustion during the period appear to be reflected in water-quality changes.Water-quality records from two nationwide sampling networks now permit nationally consistent analysis of long-term water-quality trends at more than 300 locations on major U. S. rivers. Observed trends in 24 measures of water quality for the period from 1974 to 1981 provide new insight into changes in stream quality that occurred during a time of major changes in both terrestrial and atmospheric influences on surface waters. Particularly noteworthy are widespread decreases in fecal bacteria and lead concentrations and widespread increases in nitrate, chloride, arsenic, and cadmium concentrations. Recorded increases in municipal waste treatment, use of salt on highways, and nitrogen fertilizer application, along with decreases in leaded gasoline consumption and regionally variable trends in coal production and combustion during the period appear to be reflected in water-quality changes.

A Classification System for Navy Teams. Volume I. Technical Report.

DTIC Science & Technology

1981-09-01

studies are summarized in the following manner: 1. Democratic leadership yields more and better productivity than laissez-faire leadership. 2. Autocratic...leadership yields better short-term productivity, while democratic leadership obtains better long-term product- ivity, with consistently better...quality of output in demo- cratic leadership groups. 3. Less absenteeism and fewer dropouts exist under democratic leadership . 4. The absence of the leader

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality.

PubMed

Içten, Elçin; Giridhar, Arun; Nagy, Zoltan K; Reklaitis, Gintaras V

2016-04-01

The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

Ethanol production using a soy hydrolysate-based medium or a yeast autolysate-based medium

DOEpatents

Ingram, Lonnie O.

2000-01-01

This invention presents a method for the production of ethanol that utilizes a soy hydrolysate-based nutrient medium or a yeast autolysate-based medium nutrient medium in conjunction with ethanologenic bacteria and a fermentable sugar for the cost-effective production of ethanol from lignocellulosic biomass. The invention offers several advantages over presently available media for use in ethanol production, including consistent quality, lack of toxins and wide availability.

Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

PubMed

Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

2018-02-01

The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

Assessing Subjectivity in Sensor Data Post Processing via a Controlled Experiment

NASA Astrophysics Data System (ADS)

Jones, A. S.; Horsburgh, J. S.; Eiriksson, D.

2017-12-01

Environmental data collected by in situ sensors must be reviewed to verify validity, and conducting quality control often requires making edits in post processing to generate approved datasets. This process involves decisions by technicians, data managers, or data users on how to handle problematic data. Options include: removing data from a series, retaining data with annotations, and altering data based on algorithms related to adjacent data points or the patterns of data at other locations or of other variables. Ideally, given the same dataset and the same quality control guidelines, multiple data quality control technicians would make the same decisions in data post processing. However, despite the development and implementation of guidelines aimed to ensure consistent quality control procedures, we have faced ambiguity when performing post processing, and we have noticed inconsistencies in the practices of individuals performing quality control post processing. Technicians with the same level of training and using the same input datasets may produce different results, affecting the overall quality and comparability of finished data products. Different results may also be produced by technicians that do not have the same level of training. In order to assess the effect of subjective decision making by the individual technician on the end data product, we designed an experiment where multiple users performed quality control post processing on the same datasets using a consistent set of guidelines, field notes, and tools. We also assessed the effect of technician experience and training by conducting the same procedures with a group of novices unfamiliar with the data and the quality control process and compared their results to those generated by a group of more experienced technicians. In this presentation, we report our observations of the degree of subjectivity in sensor data post processing, assessing and quantifying the impacts of individual technician as well as technician experience on quality controlled data products.

Organizational Governance and the Production of Academic Quality: Lessons from Two Top U.S. Research Universities

ERIC Educational Resources Information Center

Thoenig, Jean-Claude; Paradeise, Catherine

2014-01-01

Does organizational governance contribute to academic quality? Two top research universities are observed in-depth: Berkeley and the MIT. Three key factors are listed that help generate consistent and lasting high performance. Priority is allocated to self-evaluation and to the development of talent. Values and norms such as community membership,…

A new large-scale manufacturing platform for complex biopharmaceuticals.

PubMed

Vogel, Jens H; Nguyen, Huong; Giovannini, Roberto; Ignowski, Jolene; Garger, Steve; Salgotra, Anil; Tom, Jennifer

2012-12-01

Complex biopharmaceuticals, such as recombinant blood coagulation factors, are addressing critical medical needs and represent a growing multibillion-dollar market. For commercial manufacturing of such, sometimes inherently unstable, molecules it is important to minimize product residence time in non-ideal milieu in order to obtain acceptable yields and consistently high product quality. Continuous perfusion cell culture allows minimization of residence time in the bioreactor, but also brings unique challenges in product recovery, which requires innovative solutions. In order to maximize yield, process efficiency, facility and equipment utilization, we have developed, scaled-up and successfully implemented a new integrated manufacturing platform in commercial scale. This platform consists of a (semi-)continuous cell separation process based on a disposable flow path and integrated with the upstream perfusion operation, followed by membrane chromatography on large-scale adsorber capsules in rapid cycling mode. Implementation of the platform at commercial scale for a new product candidate led to a yield improvement of 40% compared to the conventional process technology, while product quality has been shown to be more consistently high. Over 1,000,000 L of cell culture harvest have been processed with 100% success rate to date, demonstrating the robustness of the new platform process in GMP manufacturing. While membrane chromatography is well established for polishing in flow-through mode, this is its first commercial-scale application for bind/elute chromatography in the biopharmaceutical industry and demonstrates its potential in particular for manufacturing of potent, low-dose biopharmaceuticals. Copyright © 2012 Wiley Periodicals, Inc.

International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.

PubMed

Prior, Sandra; Hufton, Simon E; Fox, Bernard; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian

2018-01-01

The intrinsic complexity and heterogeneity of therapeutic monoclonal antibodies is built into the biosimilarity paradigm where critical quality attributes are controlled in exhaustive comparability studies with the reference medicinal product. The long-term success of biosimilars will depend on reassuring healthcare professionals and patients of consistent product quality, safety and efficacy. With this aim, the World Health Organization has endorsed the need for public bioactivity standards for therapeutic monoclonal antibodies in support of current controls. We have developed a candidate international potency standard for rituximab that was evaluated in a multi-center collaborative study using participants' own qualified Fc-effector function and cell-based binding bioassays. Dose-response curve model parameters were shown to reflect similar behavior amongst rituximab preparations, albeit with some differences in potency. In the absence of a common reference standard, potency estimates were in poor agreement amongst laboratories, but the use of the candidate preparation significantly reduced this variability. Our results suggest that the candidate rituximab standard can support bioassay performance and improve data harmonization, which when implemented will promote consistency of rituximab products over their life-cycles. This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab. However, we submit that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product.

Manufacturing Bms/Iso System Review

NASA Technical Reports Server (NTRS)

Gomez, Yazmin

2004-01-01

The Quality Management System (QMS) is one that recognizes the need to continuously change and improve an organization s products and services as determined by system feedback, and corresponding management decisions. The purpose of a Quality Management System is to minimize quality variability of an organization's products and services. The optimal Quality Management System balances the need for an organization to maintain flexibility in the products and services it provides with the need for providing the appropriate level of discipline and control over the processes used to provide them. The goal of a Quality Management System is to ensure the quality of the products and services while consistently (through minimizing quality variability) meeting or exceeding customer expectations. The GRC Business Management System (BMS) is the foundation of the Center's ISO 9001:2000 registered quality system. ISO 9001 is a quality system model developed by the International Organization for Standardization. BMS supports and promote the Glenn Research Center Quality Policy and wants to ensure the customer satisfaction while also meeting quality standards. My assignment during this summer is to examine the manufacturing processes used to develop research hardware, which in most cases are one of a kind hardware, made with non conventional equipment and materials. During this process of observation I will make a determination, based on my observations of the hardware development processes the best way to meet customer requirements and at the same time achieve the GRC quality standards. The purpose of my task is to review the manufacturing processes identifying opportunities in which to optimize the efficiency of the processes and establish a plan for implementation and continuous improvement.

Removing Size as a Determinant of Quality: A Per Capita Approach to Ranking Doctoral Programs in Finance

ERIC Educational Resources Information Center

White, Roger McNeill; White, John Bryan; Barth, Michael M.

2011-01-01

Rankings of finance doctoral programs generally fall into two categories: a qualitative opinion survey or a quantitative analysis of research productivity. The consistency of these rankings suggests either the best programs have the most productive faculty, or that the university affiliations most often seen in publications are correlated with…

Studies on Osmo-air dehydration of different Indian apricot (Prunus armeniaca L.) cultivars.

PubMed

Raj, Dev; Sharma, P C; Sharera, Sanjay K

2015-06-01

Suitability of seven cultivars of apricot viz. New Castle, Kaisha, Royal, Suffaida, Nari, Kullu (Local) and Chulli (wild apricot) was evaluated for dehydration. Osmotic dehydration of fruits consisting of dipping prepared fruits in 70° Brix sucrose syrup containing 2,000 ppm potassium metabisulphite (KMS) for 24 h followed by cabinet air drying (55 °C) to desired moisture (20 ± 0.5 %) gave better dried product with good colour and appeal. Dried whole or halved fruits after removal of stones were preferred over whole fruits with stones with respect to appearance, texture and overall acceptability. Among different cultivars of apricot; cv. Kaisha followed by New Castle were found better with respect to yield as well as quality of dried product. Further, the quality of the osmo-air dried wild apricot fruits was found statistically at par with the quality of the osmo-air dried product obtained from cultivated apricots. Therefore, wild apricot fruits can also be utilized for preparation of acceptable quality of dried product.

The production and quality of tomato concentrates.

PubMed

Hayes, W A; Smith, P G; Morris, A E

1998-10-01

The standards and specifications for the quality and composition of tomato concentrates are reviewed. The main quality parameters of tomato puree and paste are color, consistency and flavor. Overall, there is an absence of standardization of methods and instruments to define quality. While color can now be measured objectively, there are currently no standard color requirements for tomato concentrates. Rheological measurements on both tomato juice and concentrates are reviewed; the power law finds wide applicability, although other rheological characteristics, particularly time dependency, have received far less attention and there has been little effort to relate rheological understanding to the commonly used empirical tests such as consistency measurements. The volatiles responsible for flavor and odor have been identified to the point where the natural odor of tomato paste can be imitated. Attempts to develop objective methods as a substitute for sensory assessment are reviewed.

A Different Perspective: How Much Innovation Is Really Needed for Monoclonal Antibody Production Using Mammalian Cell Technology?

PubMed

Kelley, Brian; Kiss, Robert; Laird, Michael

2018-05-03

As biopharmaceutical companies have optimized cell line and production culture process development, titers of recombinant antibodies have risen steadily to 3-8 g/L for fed-batch mammalian cultures at production scales of 10 kL or larger. Most new antibody products are produced from Chinese Hamster Ovary (CHO) cell lines, and there are relatively few alternative production hosts under active evaluation. Many companies have adopted a strategy of using the same production cell line for early clinical phases as well as commercial production, which reduces the risk of product comparability issues during the development lifecycle. Product quality and consistency expectations rest on the platform knowledge of the CHO host cell line and processes used for the production of many licensed antibodies. The lack of impact of low-level product variants common to this platform on product safety and efficacy also builds on the established commercial history of recombinant antibodies, which dates back to 1997.Efforts to increase titers further will likely yield diminishing returns. Very few products would benefit significantly from a titer greater than 8 g/L; in many cases, a downstream processing bottleneck would preclude full recovery from production-scale bioreactors for high titer processes. The benefits of a process platform based on standard fed-batch production culture include predictable scale-up, process transfer, and production within a company's manufacturing network or at a contract manufacturing organization. Furthermore, the confidence in an established platform provides key support towards regulatory flexibility (e.g., design space) for license applications following a quality-by-design strategy.These factors suggest that novel technologies for antibody production may not provide a substantial return on investment. What, then, should be the focus of future process development efforts for companies that choose to launch antibody products using their current platform? This review proposes key focus areas in an effort to continually improve process consistency, assure acceptable product quality, and establish appropriate process parameter limits to enable flexible manufacturing options.

The Experience Factory: Strategy and Practice

NASA Technical Reports Server (NTRS)

Basili, Victor R.; Caldiera, Gianluigi

1995-01-01

The quality movement, that has had in recent years a dramatic impact on all industrial sectors, has recently reached the system and software industry. Although some concepts of quality management, originally developed for other product types, can be applied to software, its specificity as a product which is developed and not produced requires a special approach. This paper introduces a quality paradigm specifically tailored on the problem of the systems and software industry. Reuse of products, processes and experiences originating from the system life cycle is seen today as a feasible solution to the problem of developing higher quality systems at a lower cost. In fact, quality improvement is very often achieved by defining and developing an appropriate set of strategic capabilities and core competencies to support them. A strategic capability is, in this context, a corporate goal defined by the business position of the organization and implemented by key business processes. Strategic capabilities are supported by core competencies, which are aggregate technologies tailored to the specific needs of the organization in performing the needed business processes. Core competencies are non-transitional, have a consistent evolution, and are typically fueled by multiple technologies. Their selection and development requires commitment, investment and leadership. The paradigm introduced in this paper for developing core competencies is the Quality Improvement Paradigm which consists of six steps: (1) Characterize the environment, (2) Set the goals, (3) Choose the process, (4) Execute the process, (5) Analyze the process data, and (6) Package experience. The process must be supported by a goal oriented approach to measurement and control, and an organizational infrastructure, called Experience Factory. The Experience Factory is a logical and physical organization distinct from the project organizations it supports. Its goal is development and support of core competencies through capitalization and reuse of its cycle experience and products. The paper introduces the major concepts of the proposed approach, discusses their relationship with other approaches used in the industry, and presents a case in which those concepts have been successfully applied.

Quality and Consistency of the NASA Ocean Color Data Record

NASA Technical Reports Server (NTRS)

Franz, Bryan A.

2012-01-01

The NASA Ocean Biology Processing Group (OBPG) recently reprocessed the multimission ocean color time-series from SeaWiFS, MODIS-Aqua, and MODIS-Terra using common algorithms and improved instrument calibration knowledge. Here we present an analysis of the quality and consistency of the resulting ocean color retrievals, including spectral water-leaving reflectance, chlorophyll a concentration, and diffuse attenuation. Statistical analysis of satellite retrievals relative to in situ measurements will be presented for each sensor, as well as an assessment of consistency in the global time-series for the overlapping periods of the missions. Results will show that the satellite retrievals are in good agreement with in situ measurements, and that the sensor ocean color data records are highly consistent over the common mission lifespan for the global deep oceans, but with degraded agreement in higher productivity, higher complexity coastal regions.

Objective Evaluation Tool for Texture-Modified Food (OET-TMF): Development of the Tool and Validation.

PubMed

Calleja-Fernández, Alicia; Pintor-de-la-Maza, Begoña; Vidal-Casariego, Alfonso; Cano-Rodríguez, Isidoro; Ballesteros-Pomar, María D

2016-06-01

Texture-modified diets (TMDs) should fulfil nutritional goals, guarantee homogenous texture, and meet food safety regulations. The food industry has created texture-modified food (TMF) that meets the TMD requirements of quality and safety for inpatients. To design and develop a tool that allows the objective selection of foodstuffs for TMDs that ensures nutritional requirements and swallowing safety of inpatients in order to improve their quality of life, especially regarding their food satisfaction. An evaluation tool was designed to objectively determine the adequacy of food included in the TMD menus of a hospital. The "Objective Evaluation Tool for Texture-Modified Food" (OET-TMF) consists of seven items that evaluate the food's nutritional quality (energy and protein input), presence of allergens, texture and viscosity, cooking, storage type, useful life, and patient acceptance. The total score ranged from 0 to 64 and was divided into four categories: high quality, good quality, medium quality, and low quality. Studying four different commercial TMFs contributed to the validation of the tool. All the evaluated products scored between high and good regarding quality. There was a tendency (p = 0.077) towards higher consumption and a higher overall quality of the product obtained with the OET-TMF. The product that scored highest with the tool was the best accepted; the product with the lowest score had the highest rate of refusal. The OET-TMF allows for the objective discrimination of the quality of TMF. In addition, it shows a certain relationship between the observed and assessed quality intake.

Verifying Architectural Design Rules of the Flight Software Product Line

NASA Technical Reports Server (NTRS)

Ganesan, Dharmalingam; Lindvall, Mikael; Ackermann, Chris; McComas, David; Bartholomew, Maureen

2009-01-01

This paper presents experiences of verifying architectural design rules of the NASA Core Flight Software (CFS) product line implementation. The goal of the verification is to check whether the implementation is consistent with the CFS architectural rules derived from the developer's guide. The results indicate that consistency checking helps a) identifying architecturally significant deviations that were eluded during code reviews, b) clarifying the design rules to the team, and c) assessing the overall implementation quality. Furthermore, it helps connecting business goals to architectural principles, and to the implementation. This paper is the first step in the definition of a method for analyzing and evaluating product line implementations from an architecture-centric perspective.

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

PubMed

Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

2011-08-01

Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

Segments from red blood cell units should not be used for quality testing.

PubMed

Kurach, Jayme D R; Hansen, Adele L; Turner, Tracey R; Jenkins, Craig; Acker, Jason P

2014-02-01

Nondestructive testing of blood components could permit in-process quality control and reduce discards. Tubing segments, generated during red blood cell (RBC) component production, were tested to determine their suitability as a sample source for quality testing. Leukoreduced RBC components were produced from whole blood (WB) by two different methods: WB filtration and buffy coat (BC). Components and their corresponding segments were tested on Days 5 and 42 of hypothermic storage (HS) for spun hematocrit (Hct), hemoglobin (Hb) content, percentage hemolysis, hematologic indices, and adenosine triphosphate concentration to determine whether segment quality represents unit quality. Segment samples overestimated hemolysis on Days 5 and 42 of HS in both BC- and WB filtration-produced RBCs (p < 0.001 for all). Hct and Hb levels in the segments were also significantly different from the units at both time points for both production methods (p < 0.001 for all). Indeed, for all variables tested different results were obtained from segment and unit samples, and these differences were not consistent across production methods. The quality of samples from tubing segments is not representative of the quality of the corresponding RBC unit. Segments are not suitable surrogates with which to assess RBC quality. © 2013 American Association of Blood Banks.

Creating quality practice environments: not easy, but essential.

PubMed

Winslow, Wendy

2004-01-01

Quality practice environments for registered nurses correlate positively with job satisfaction, productivity, recruitment, retention and client outcomes. However, when registered nurses work in environments that do not enable them to consistently meet their nursing practice standards, patient safety is jeopardized. This article describes the development of Canada's first guidelines for a quality practice environment for registered nurses in all practice environments. It is a tool healthcare leaders can use to improve the practice environment of all health professionals and to promote patient safety.

An NCME Instructional Module on Quality Control Procedures in the Scoring, Equating, and Reporting of Test Scores

ERIC Educational Resources Information Center

Allalouf, Avi

2007-01-01

There is significant potential for error in long production processes that consist of sequential stages, each of which is heavily dependent on the previous stage, such as the SER (Scoring, Equating, and Reporting) process. Quality control procedures are required in order to monitor this process and to reduce the number of mistakes to a minimum. In…

Assessing values of air quality and visibility at risk from wildland fires.

Treesearch

Sue A. Ferguson; Steven J. McKay; David E. Nagel; Trent Piepho; Miriam L. Rorig; Casey Anderson; Lara Kellogg

2003-01-01

To assess values of air quality and visibility at risk from wildland fire in the United States, we generated a 40-year database that includes twice daily values of wind, mixing height, and a ventilation index that is the product of windspeed and mixing height. The database provides the first nationally consistent map of surface wind and ventilation index. In addition,...

Product design enhancement using apparent usability and affective quality.

PubMed

Seva, Rosemary R; Gosiaco, Katherine Grace T; Santos, Ma Crea Eurice D; Pangilinan, Denise Mae L

2011-03-01

In this study, apparent usability and affective quality were integrated in a design framework called the Usability Perception and Emotion Enhancement Model (UPEEM). The UPEEM was validated using structural equation modeling (SEM). The methodology consists of four phases namely product selection, attribute identification, design alternative generation, and design alternative evaluation. The first stage involved the selection of a product that highly involves the consumer. In the attribute identification stage, design elements of the product were identified. The possible values of these elements were also determined for use in the experimentation process. Design of experiments was used to identify how the attributes will be varied in the design alternative stage and which of the attributes significantly contribute to affective quality, apparent usability, and desirability in the design evaluation stage. Results suggest that product attributes related to form are relevant in eliciting intense affect and perception of usability in mobile phones especially those directly related to functionality and aesthetics. This study considered only four product attributes among so many due to the constraints of the research design employed. Attributes related to aesthetic perception of a product enhance apparent usability such as those related to dimensional ratios. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Implementing quality/productivity improvement initiatives in an engineering environment

NASA Technical Reports Server (NTRS)

Ruda, R. R.

1985-01-01

Quality/Productivity Improvement (QPI) initiatives in the engineering environment at McDonnell Douglas-Houston include several different, distinct activities, each having its own application, yet all targeted toward one common goal - making continuous improvement a way of life. The chief executive and the next two levels of management demonstrate their commitment to QPI with hands-on involvement in several activities. Each is a member of a QPI Council which consists of six panels - Participative Management, Communications, Training, Performance/Productivity, Human Resources Management and Strategic Management. In addition, each manager conducts Workplace Visits and Bosstalks, to enhance communications with employees and to provide a forum for the identification of problems - both real and perceived. Quality Circles and Project Teams are well established within McConnel Douglas as useful and desirable employee involvement teams. The continued growth of voluntary membership in the circles program is strong evidence of the employee interest and management support that have developed within the organization.

Memory preservation made prestigious but easy

NASA Astrophysics Data System (ADS)

Fageth, Reiner; Debus, Christina; Sandhaus, Philipp

2011-01-01

Preserving memories combined with story-telling using either photo books for multiple images or high quality products such as one or a few images printed on canvas or images mounted on acryl to create high-quality wall decorations are gradually becoming more popular than classical 4*6 prints and classical silver halide posters. Digital printing via electro photography and ink jet is increasingly replacing classical silver halide technology as the dominant production technology for these kinds of products. Maintaining a consistent and comparable quality of output is becoming more challenging than using silver halide paper for both, prints and posters. This paper describes a unique approach of combining both desktop based software to initiate a compelling project and the use of online capabilities in order to finalize and optimize that project in an online environment in a community process. A comparison of the consumer behavior between online and desktop based solutions for generating photo books will be presented.

User's Guide for ERB 7 SEFDT. Volume 1: User's Guide. Volume 2: Quality Control Report, Year 1

NASA Technical Reports Server (NTRS)

Ray, S. N.; Tighe, R. J.; Scherrer, S. A.

1984-01-01

The Nimbus-7 ERB SEFDT Data User's Guide is presented. The guide consists of four subsections which describe: (1) the scope of the data User's Guide; (2) the background on Nimbus-7 Spacecraft and the ERB experiment; (3) the SEFDT data product and processing scenario; and (4) other related products and documents.

Near infrared spectroscopy based monitoring of extraction processes of raw material with the help of dynamic predictive modeling

NASA Astrophysics Data System (ADS)

Wang, Haixia; Suo, Tongchuan; Wu, Xiaolin; Zhang, Yue; Wang, Chunhua; Yu, Heshui; Li, Zheng

2018-03-01

The control of batch-to-batch quality variations remains a challenging task for pharmaceutical industries, e.g., traditional Chinese medicine (TCM) manufacturing. One difficult problem is to produce pharmaceutical products with consistent quality from raw material of large quality variations. In this paper, an integrated methodology combining the near infrared spectroscopy (NIRS) and dynamic predictive modeling is developed for the monitoring and control of the batch extraction process of licorice. With the spectra data in hand, the initial state of the process is firstly estimated with a state-space model to construct a process monitoring strategy for the early detection of variations induced by the initial process inputs such as raw materials. Secondly, the quality property of the end product is predicted at the mid-course during the extraction process with a partial least squares (PLS) model. The batch-end-time (BET) is then adjusted accordingly to minimize the quality variations. In conclusion, our study shows that with the help of the dynamic predictive modeling, NIRS can offer the past and future information of the process, which enables more accurate monitoring and control of process performance and product quality.

Effect of superdosing phytase on productive performance and egg quality in laying hens.

PubMed

Kim, Jong Hyuk; Pitargue, Franco Martinez; Jung, Hyunjung; Han, Gi Ppeum; Choi, Hyeon Seok; Kil, Dong Yong

2017-07-01

An experiment was conducted to determine the effect of superdosing phytase on productive performance and egg quality in laying hens. A total of 200 42-wk-old Hy-Line Brown laying hens were allotted into 1 of 5 dietary treatments with 5 replicates consisting of 8 hens per replicate. The positive control (PC) and negative control diets (NC) were prepared based on the recommended P levels in layer diets. Supplemental phytase was added to the negative control diet at 10,000 (SD10), 20,000 (SD20), or 30,000 (SD30) fytase units (FTU)/kg. Productive performance was summarized for 6 weeks from 42 weeks to 47 weeks of age. Egg quality was assessed from 4 eggs per replicate randomly collected at the conclusion of the experiment. The SD20 treatment had greater (p<0.05) hen-day egg production than PC, NC, and SD10 treatment groups. There was no difference in hen-day egg production between SD20 and SD30 treatment groups. However, SD30 treatment had greater (p<0.05) hen-day egg production than PC treatment, but showed no difference in hen-day egg production as compared to NC and SD10 treatment groups. However, egg weight, egg mass, feed intake, and feed conversion ratio were not affected by dietary treatments. Egg quality including eggshell strength, eggshell color, egg yolk color, and haugh unit was not influenced by dietary treatments. Superdosing level of 20,000 FTU/kg phytase in diets has a positive effect on egg production rate, but no beneficial effect on egg quality in laying hens.

Process performance and product quality in an integrated continuous antibody production process.

PubMed

Karst, Daniel J; Steinebach, Fabian; Soos, Miroslav; Morbidelli, Massimo

2017-02-01

Continuous manufacturing is currently being seriously considered in the biopharmaceutical industry as the possible new paradigm for producing therapeutic proteins, due to production cost and product quality related benefits. In this study, a monoclonal antibody producing CHO cell line was cultured in perfusion mode and connected to a continuous affinity capture step. The reliable and stable integration of the two systems was enabled by suitable control loops, regulating the continuous volumetric flow and adapting the operating conditions of the capture process. For the latter, an at-line HPLC measurement of the harvest concentration subsequent to the bioreactor was combined with a mechanistic model of the capture chromatographic unit. Thereby, optimal buffer consumption and productivity throughout the process was realized while always maintaining a yield above the target value of 99%. Stable operation was achieved at three consecutive viable cell density set points (20, 60, and 40 × 10 6 cells/mL), together with consistent product quality in terms of aggregates, fragments, charge isoforms, and N-linked glycosylation. In addition, different values for these product quality attributes such as N-linked glycosylation, charge variants, and aggregate content were measured at the different steady states. As expected, the amount of released DNA and HCP was significantly reduced by the capture step for all considered upstream operating conditions. This study is exemplary for the potential of enhancing product quality control and modulation by integrated continuous manufacturing. Biotechnol. Bioeng. 2017;114: 298-307. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

New Features of the Collection 4 MODIS LAI and FPAR Product

NASA Astrophysics Data System (ADS)

Bin, T.; Yang, W.; Dong, H.; Shabanov, N.; Knyazikhin, Y.; Myneni, R.

2003-12-01

An algorithm based on physics of radiative transfer in vegetation canopies for the retrieval of vegetation green leaf area index (LAI) and fraction of absorbed photosynthetically active radiation (FPAR) from MODIS surface reflectance data was developed, prototyped and is in operational production at NASA computing facilities since June 2000. This poster highlights recent changes in the operational MODIS LAI and FPAR algorithm introduced for collection 4 data reprocessing. The changes to the algorithm are targeted to improve agreement of retrieved LAI and FPAR with corresponding field measurements, improve consistency of Quality Control (QC) definitions and miscellaneous bug fixes as summarized below. * Improvement of LUTs for the main and back-up algorithms for biomes 1 and 3. Benefits: a) increase in quality of retrievals; b) non-physical peaks in the global LAI distribution have been removed; c) improved agreement with field measurements * Improved QA scheme. Benefits: a) consistency between MODLAND and SCF quality flags has been achieved; b)ambiguity in QA has been resolved * New 8-day compositing scheme. Benefits: a) compositing over best quality retrievals, instead of all retrievals; b) lowers LAI values, decreases saturation and number of pixels generated by the back-up * At-launch static IGBP land cover, input to the LAI/FPAR algorithm, was replaced with the MODIS land cover map. Benefits: a) crosswalking of 17 classes IGBP scheme to 6-biome LC has been eliminated; b) uncertainties in the MODIS LAI/FPAR product due to uncertainties in land cover map have been reduced

The Growth of the International Baccalaureate[R] Diploma Program: Concerns about the Consistency and Reliability of the Assessments

ERIC Educational Resources Information Center

Bunnell, Tristan

2011-01-01

The International Baccalaureate[R] (IB) world, known as "the IB World," is doubling in size every five years. The IB has become a complex educational product, but offers high levels of consistency and reliability in terms of delivery and assessment. However, since late 2008, a number of concerns have been raised about the quality and manageability…

Physical and sensory quality of hommos preserved with combined gamma radiation and refrigeration

NASA Astrophysics Data System (ADS)

Amr, A.; Al-Qadiri, H.; Saleh, M.; Shahein, M.

2018-03-01

Hommos was treated with gamma radiation and stored at 4 °C for a period of five weeks with the aim of extending its shelf life under refrigeration. Viscosity and colour of the product were evaluated instrumentally at 5-day intervals, and its sensory quality was evaluated by a taste panel at the beginning and end of the storage period. The results indicate that irradiation combined with storage caused reduction of the ΔE*ab, a*, b* and L* colour values, but have no such an effect on the apparent viscosity, flow behavior index (n) or consistency coefficient (k) of the product which exhibited a non-Newtonian, pseudoplastic behavior. Neither irradiation dose nor storage time affected the overall acceptability, flavor, smoothness, mouth- feel and colour of the product when evaluated by a taste panel. The product irradiated with 1.5 or 2.5 kGy can be stored at 4 °C for 35 days and still maintain its sensory and physical qualities indicating that the shelf life of this product, like other irradiated foods, can be extended by this combined treatment.

Product line development: a strategy for clinical success in academic centers.

PubMed

Turnipseed, William D; Lund, Dennis P; Sollenberger, Donna

2007-10-01

Academic medical centers, which have traditionally been relatively inefficient, have increasing difficulty in meeting the missions of patient care, teaching, and research in a progressively competitive medical marketplace. One strategy for improved efficiency in patient care while keeping quality high is utilization of a product line matrix. This study addresses the outcome of utilizing a product line strategy consisting of 3 service lines during the past 5 years at the University of Wisconsin Hospital and Clinics (UWHC). Service lines in heart and vascular surgery, oncology, and pediatrics have been organized since 2001, and report directly to hospital leadership as a product line. Service line leadership consists of a combination of medical leaders plus representatives of hospital administration, and service lines are allowed direct access to resources for program development, marketing, and resource allocation. Measurements of patient numbers, market share, length of stay, net margin, and patient satisfaction have been gathered and compared with the preproduct line era. In the 3 service lines, UWHC has seen variable but steady growth in patient numbers, enhanced market share, positive net margins, and improved patient satisfaction during the period of measurement. During this same period, the insurance milieu has resulted in consistent downward pressure on reimbursement, which has been offset by improved patient care efficiency as measured by length of stay, enhanced preferred provider status, and gains in market share. Scorecard measures of quality are also being developed and show enhanced teaching and research opportunities for students and trainees as well as improved Press Ganey patient satisfaction scores. At UWHC, the development of a product line matrix consisting of 3 service lines has resulted in more patient care efficiency, enhanced patient satisfaction, improved margin for the hospital, and enlargement of teaching and research opportunities. The key to successful implementation of the product line concept is a close working relationship between the hospital administration and service line medical leadership.

Cucumber fermentation

USDA-ARS?s Scientific Manuscript database

Humans have consumed fermented cucumber products since before the dawn of civilization. Although cucumber fermentation remains largely a traditional process, it has proven to be a consistently safe process by which raw cucumbers are transformed into high quality pickles that have a long shelf-life ...

Effects of late-stage nitrogen fertilizer application on the starch structure and cooking quality of rice.

PubMed

Cao, XianMei; Sun, HuiYan; Wang, ChunGe; Ren, XiaoJia; Liu, HongFei; Zhang, ZuJian

2018-04-01

With the rapid development of modern agriculture, high-quality rice production and consumption has become the current urgent demand for the development of rice production. In this paper, the effects of late-stage nitrogen fertilizer application on rice quality were studied under the same genetic background. Wx near-isogenic lines were used as test materials to study the starch composition, amylopectin structure and cooking quality of rice. Results showed that rice amylose content and gel consistency significantly differed when different Wx genes were tranformed into waxy rice. The law of apparent amylose content in rice is Wx a > Wx in > Wx b > wx at the same nitrogen level, while the trend of gel consistency was opposite to that of apparent amylose content, presenting obvious characteristics of Indica and Japonica varieties. As the amount of fertilizer application increased, apparent amylose content increased, gel consistency decreased, breakdown and peak viscosities dropped and setback viscosity and peak time increased. Moreover, the cooking quality of rice significantly decreased with the use of nitrogen fertilizer, especially under low-level nitrogen fertilizer application. Amylopectin structure varied significantly in different genotypes of the Wx gene, and the degree of branching was as follows: wx > Wx b > Wx in > Wx a . This result indicated that the closer to Indica rice, the fewer short chains of amylopectin. Starch crystallinity and swelling potential were negatively correlated with amylose content but significantly positively correlated with amylopectin branching degree, decreasing with the increase of late-stage nitrogen fertilization. Late-stage nitrogen fertilization reduced the cooking quality of rice by increasing amylose content and reducing amylopectin branching degree, which decreased starch crystallinity and aggravated pasting properties. Obviously, controlling late nitrogen application is essential to optimize rice quality. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

An Empirical Orthogonal Function-Based Algorithm for Estimating Terrestrial Latent Heat Flux from Eddy Covariance, Meteorological and Satellite Observations

PubMed Central

Feng, Fei; Li, Xianglan; Yao, Yunjun; Liang, Shunlin; Chen, Jiquan; Zhao, Xiang; Jia, Kun; Pintér, Krisztina; McCaughey, J. Harry

2016-01-01

Accurate estimation of latent heat flux (LE) based on remote sensing data is critical in characterizing terrestrial ecosystems and modeling land surface processes. Many LE products were released during the past few decades, but their quality might not meet the requirements in terms of data consistency and estimation accuracy. Merging multiple algorithms could be an effective way to improve the quality of existing LE products. In this paper, we present a data integration method based on modified empirical orthogonal function (EOF) analysis to integrate the Moderate Resolution Imaging Spectroradiometer (MODIS) LE product (MOD16) and the Priestley-Taylor LE algorithm of Jet Propulsion Laboratory (PT-JPL) estimate. Twenty-two eddy covariance (EC) sites with LE observation were chosen to evaluate our algorithm, showing that the proposed EOF fusion method was capable of integrating the two satellite data sets with improved consistency and reduced uncertainties. Further efforts were needed to evaluate and improve the proposed algorithm at larger spatial scales and time periods, and over different land cover types. PMID:27472383

Plan for compensating full-time physicians involved in medical education.

PubMed

Milad, M P; Hendricks, S K; Williford, L E

1999-04-01

In response to growing financial pressures, many academic institutions have begun rewarding full-time faculty primarily on the basis of productivity. This formula often overrewards procedure-oriented specialists while poorly compensating primary care physicians. Collections have little to do with clinical effort, and rewarding productivity alone ignores the many other qualities important to the academic mission. We developed a simple, adjustable plan for quantifying and rewarding faculty behavior consistent with the goals of the institution. Eight categories are weighed by the departmental chairperson or committee, including previous year's salary, productivity, patient satisfaction, administration, academic rank, teaching, research, and quality of care. This plan is flexible and rewards behavior consistent with departmental priorities. It also allows for individual members of the department to increase their salaries by adjusting their behavior. As federal funds for training continue to decrease, teaching, research, and other scholarly activities might not be fairly compensated. Unless each institution prospectively develops a program that rewards those activities that the institution values, many important scientific and educational activities will be completely replaced by the more tangible efforts of patient care.

An Empirical Orthogonal Function-Based Algorithm for Estimating Terrestrial Latent Heat Flux from Eddy Covariance, Meteorological and Satellite Observations.

PubMed

Feng, Fei; Li, Xianglan; Yao, Yunjun; Liang, Shunlin; Chen, Jiquan; Zhao, Xiang; Jia, Kun; Pintér, Krisztina; McCaughey, J Harry

2016-01-01

Accurate estimation of latent heat flux (LE) based on remote sensing data is critical in characterizing terrestrial ecosystems and modeling land surface processes. Many LE products were released during the past few decades, but their quality might not meet the requirements in terms of data consistency and estimation accuracy. Merging multiple algorithms could be an effective way to improve the quality of existing LE products. In this paper, we present a data integration method based on modified empirical orthogonal function (EOF) analysis to integrate the Moderate Resolution Imaging Spectroradiometer (MODIS) LE product (MOD16) and the Priestley-Taylor LE algorithm of Jet Propulsion Laboratory (PT-JPL) estimate. Twenty-two eddy covariance (EC) sites with LE observation were chosen to evaluate our algorithm, showing that the proposed EOF fusion method was capable of integrating the two satellite data sets with improved consistency and reduced uncertainties. Further efforts were needed to evaluate and improve the proposed algorithm at larger spatial scales and time periods, and over different land cover types.

Quality systems in veterinary diagnostics laboratories.

PubMed

de Branco, Freitas Maia L M

2007-01-01

Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab

PubMed Central

Prior, Sandra; Hufton, Simon E.; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian

2018-01-01

ABSTRACT The intrinsic complexity and heterogeneity of therapeutic monoclonal antibodies is built into the biosimilarity paradigm where critical quality attributes are controlled in exhaustive comparability studies with the reference medicinal product. The long-term success of biosimilars will depend on reassuring healthcare professionals and patients of consistent product quality, safety and efficacy. With this aim, the World Health Organization has endorsed the need for public bioactivity standards for therapeutic monoclonal antibodies in support of current controls. We have developed a candidate international potency standard for rituximab that was evaluated in a multi-center collaborative study using participants' own qualified Fc-effector function and cell-based binding bioassays. Dose-response curve model parameters were shown to reflect similar behavior amongst rituximab preparations, albeit with some differences in potency. In the absence of a common reference standard, potency estimates were in poor agreement amongst laboratories, but the use of the candidate preparation significantly reduced this variability. Our results suggest that the candidate rituximab standard can support bioassay performance and improve data harmonization, which when implemented will promote consistency of rituximab products over their life-cycles. This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab. However, we submit that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product. PMID:28985159

Progress towards CSR RL06 GRACE gravity solutions

NASA Astrophysics Data System (ADS)

Save, Himanshu

2017-04-01

The GRACE project plans to re-processes the GRACE mission data in order to be consistent with the first gravity products released by the GRACE-FO project. The next generation Release-06 (RL06) gravity products from GRACE will include the improvements in GRACE Level-1 data products, background gravity models and the processing methodology. This paper will outline the planned improvements for CSR - RL06 and discuss the preliminary results. This paper will discuss the evolution of the quality of the GRACE solutions, especially over the past few years. We will also discuss the possible challenges we may face in connecting/extending the measurements of mass fluxes from the GRACE era to the GRACE-FO era due quality of the GRACE solutions from recent years.

Qualitative and nutritional differences in processing tomatoes grown under commercial organic and conventional production systems.

PubMed

Barrett, D M; Weakley, C; Diaz, J V; Watnik, M

2007-11-01

Organically grown products experienced a doubling in percent penetration of organic sales into retail markets during the period from 1997 to 2003; however, there is still a debate over the perceived quality advantage of organically grown fruits and vegetables. In a study focusing on commercial production of processing tomatoes, samples were analyzed from 4 growers with matched organic and conventional fields. For the 4 growers studied, individual analysis of variance results indicated that tomato juice prepared from organically produced tomatoes on some farms was significantly higher in soluble solids ( degrees Brix), higher in consistency, and titratable acidity, but lower in red color, ascorbic acid, and total phenolics content in the microwaved juice. Results were significantly different among specific growers, and this may be attributed to differences in soil type and soil nutrients, tomato cultivar, environmental conditions, or other production-related factors. Higher levels of soluble solids, titratable acidity, and consistency are desirable for the production of tomato paste, in that tomatoes with these attributes may be more flavorful and require less thermal treatment. This has the potential to result both in cost savings from less energy required in paste manufacture and potentially a higher quality product due to less thermal degradation of color, flavor, and nutrients. Future work may involve a larger number of commercial growers and correlation to controlled university research plots.

Assessment of Satellite Ocean Colour Radiometry and Derived Geophysical Products. Chapter 6.1

NASA Technical Reports Server (NTRS)

Melin, Frederic; Franz, Bryan A.

2014-01-01

Standardization of methods to assess and assign quality metrics to satellite ocean color radiometry and derived geophysical products has become paramount with the inclusion of the marine reflectance and chlorophyll-a concentration (Chla) as essential climate variables (ECV; [1]) and the recognition that optical remote sensing of the oceans can only contribute to climate research if and when a continuous succession of satellite missions can be shown to collectively provide a consistent, long-term record with known uncertainties. In 20 years, the community has made significant advancements toward that objective, but providing a complete uncertainty budget for all products and for all conditions remains a daunting task. In the retrieval of marine water-leaving radiance from observed top-of-atmosphere radiance, the sources of uncertainties include those associated with propagation of sensor noise and radiometric calibration and characterization errors, as well as a multitude of uncertainties associated with the modeling and removal of effects from the atmosphere and sea surface. This chapter describes some common approaches used to assess quality and consistency of ocean color satellite products and reviews the current status of uncertainty quantification in the field. Its focus is on the primary ocean color product, the spectrum of marine reflectance Rrs, but uncertainties in some derived products such as the Chla or inherent optical properties (IOPs) will also be considered.

Overall Quality of Fruits and Vegetables Products Affected by the Drying Processes with the Assistance of Vacuum-Microwaves.

PubMed

Figiel, Adam; Michalska, Anna

2016-12-30

The seasonality of fruits and vegetables makes it impossible to consume and use them throughout the year, thus numerous processing efforts have been made to offer an alternative to their fresh consumption and application. To prolong their availability on the market, drying has received special attention as currently this method is considered one of the most common ways for obtaining food and pharmaceutical products from natural sources. This paper demonstrates the weakness of common drying methods applied for fruits and vegetables and the possible ways to improve the quality using different drying techniques or their combination with an emphasis on the microwave energy. Particular attention has been drawn to the combined drying with the assistance of vacuum-microwaves. The quality of the dried products was ascribed by chemical properties including the content of polyphenols, antioxidant capacity and volatiles as well as physical parameters such as color, shrinkage, porosity and texture. Both these fields of quality classification were considered taking into account sensory attributes and energy aspects in the perspective of possible industrial applications. In conclusion, the most promising way for improving the quality of dried fruit and vegetable products is hybrid drying consisting of osmotic dehydration in concentrated fruit juices followed by heat pump drying and vacuum-microwave finish drying.

Overall Quality of Fruits and Vegetables Products Affected by the Drying Processes with the Assistance of Vacuum-Microwaves

PubMed Central

Figiel, Adam; Michalska, Anna

2016-01-01

The seasonality of fruits and vegetables makes it impossible to consume and use them throughout the year, thus numerous processing efforts have been made to offer an alternative to their fresh consumption and application. To prolong their availability on the market, drying has received special attention as currently this method is considered one of the most common ways for obtaining food and pharmaceutical products from natural sources. This paper demonstrates the weakness of common drying methods applied for fruits and vegetables and the possible ways to improve the quality using different drying techniques or their combination with an emphasis on the microwave energy. Particular attention has been drawn to the combined drying with the assistance of vacuum-microwaves. The quality of the dried products was ascribed by chemical properties including the content of polyphenols, antioxidant capacity and volatiles as well as physical parameters such as color, shrinkage, porosity and texture. Both these fields of quality classification were considered taking into account sensory attributes and energy aspects in the perspective of possible industrial applications. In conclusion, the most promising way for improving the quality of dried fruit and vegetable products is hybrid drying consisting of osmotic dehydration in concentrated fruit juices followed by heat pump drying and vacuum-microwave finish drying. PMID:28042845

Potential and Prospects of Continuous Polyhydroxyalkanoate (PHA) Production

PubMed Central

Koller, Martin; Braunegg, Gerhart

2015-01-01

Together with other so-called “bio-plastics”, Polyhydroxyalkanoates (PHAs) are expected to soon replace established polymers on the plastic market. As a prerequisite, optimized process design is needed to make PHAs attractive in terms of costs and quality. Nowadays, large-scale PHA production relies on discontinuous fed-batch cultivation in huge bioreactors. Such processes presuppose numerous shortcomings such as nonproductive time for reactor revamping, irregular product quality, limited possibility for supply of certain carbon substrates, and, most of all, insufficient productivity. Therefore, single- and multistage continuous PHA biosynthesis is increasingly investigated for production of different types of microbial PHAs; this goes for rather crystalline, thermoplastic PHA homopolyesters as well as for highly flexible PHA copolyesters, and even blocky-structured PHAs consisting of alternating soft and hard segments. Apart from enhanced productivity and constant product quality, chemostat processes can be used to elucidate kinetics of cell growth and PHA formation under constant process conditions. Furthermore, continuous enrichment processes constitute a tool to isolate novel powerful PHA-producing microbial strains adapted to special environmental conditions. The article discusses challenges, potential and case studies for continuous PHA production, and shows up new strategies to further enhance such processes economically by developing unsterile open continuous processes combined with the application of inexpensive carbon feedstocks. PMID:28955015

Mathematical modeling for resource and energy saving control of extruders in multi-assortment productions of polymeric films

NASA Astrophysics Data System (ADS)

Polosin, A. N.; Chistyakova, T. B.

2018-05-01

In this article, the authors describe mathematical modeling of polymer processing in extruders of various types used in extrusion and calender productions of film materials. The method consists of the synthesis of a static model for calculating throughput, energy consumption of the extruder, extrudate quality indices, as well as a dynamic model for evaluating polymer residence time in the extruder, on which the quality indices depend. Models are adjusted according to the extruder type (single-screw, reciprocating, twin-screw), its screw and head configuration, extruder’s work temperature conditions, and the processed polymer type. Models enable creating extruder screw configurations and determining extruder controlling action values that provide the extrudate of required quality while satisfying extruder throughput and energy consumption requirements. Model adequacy has been verified using polyolefins’ and polyvinylchloride processing data in different extruders. The program complex, based on mathematical models, has been developed in order to control extruders of various types in order to ensure resource and energy saving in multi-assortment productions of polymeric films. Using the program complex in the control system for the extrusion stage of the polymeric film productions enables improving film quality, reducing spoilage, lessening the time required for production line change-over to other throughput and film type assignment.

Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody.

PubMed

Agarabi, Cyrus D; Schiel, John E; Lute, Scott C; Chavez, Brittany K; Boyne, Michael T; Brorson, Kurt A; Khan, Mansoora; Read, Erik K

2015-06-01

Consistent high-quality antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. When the process is complex and not optimized, small changes in composition and control may yield a finished product of less desirable quality. Therefore, changes proposed to currently validated processes usually require justification and are reported to the US FDA for approval. Recently, design-of-experiments-based approaches have been explored to rapidly and efficiently achieve this goal of optimized yield with a better understanding of product and process variables that affect a product's critical quality attributes. Here, we present a laboratory-scale model culture where we apply a Plackett-Burman screening design to parallel cultures to study the main effects of 11 process variables. This exercise allowed us to determine the relative importance of these variables and identify the most important factors to be further optimized in order to control both desirable and undesirable glycan profiles. We found engineering changes relating to culture temperature and nonessential amino acid supplementation significantly impacted glycan profiles associated with fucosylation, β-galactosylation, and sialylation. All of these are important for monoclonal antibody product quality. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Development and implementation of a quality assurance program for a hormonal contraceptive implant.

PubMed

Owen, Derek H; Jenkins, David; Cancel, Aida; Carter, Eli; Dorflinger, Laneta; Spieler, Jeff; Steiner, Markus J

2013-04-01

The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings. Copyright © 2013 Elsevier Inc. All rights reserved.

Designing a two-rank acceptance sampling plan for quality inspection of geospatial data products

NASA Astrophysics Data System (ADS)

Tong, Xiaohua; Wang, Zhenhua; Xie, Huan; Liang, Dan; Jiang, Zuoqin; Li, Jinchao; Li, Jun

2011-10-01

To address the disadvantages of classical sampling plans designed for traditional industrial products, we originally propose a two-rank acceptance sampling plan (TRASP) for the inspection of geospatial data outputs based on the acceptance quality level (AQL). The first rank sampling plan is to inspect the lot consisting of map sheets, and the second is to inspect the lot consisting of features in an individual map sheet. The TRASP design is formulated as an optimization problem with respect to sample size and acceptance number, which covers two lot size cases. The first case is for a small lot size with nonconformities being modeled by a hypergeometric distribution function, and the second is for a larger lot size with nonconformities being modeled by a Poisson distribution function. The proposed TRASP is illustrated through two empirical case studies. Our analysis demonstrates that: (1) the proposed TRASP provides a general approach for quality inspection of geospatial data outputs consisting of non-uniform items and (2) the proposed acceptance sampling plan based on TRASP performs better than other classical sampling plans. It overcomes the drawbacks of percent sampling, i.e., "strictness for large lot size, toleration for small lot size," and those of a national standard used specifically for industrial outputs, i.e., "lots with different sizes corresponding to the same sampling plan."

Competition in the pharmaceutical industry: how do quality differences shape advertising strategies?

PubMed

de Frutos, Maria-Angeles; Ornaghi, Carmine; Siotis, Georges

2013-01-01

We present a Hotelling model of price and advertising competition between prescription drugs that differ in quality/side effects. Promotional effort results in the endogenous formation of two consumer groups: brand loyal and non-brand loyal ones. We show that advertising intensities are strategic substitutes, with the better quality drugs being the ones that are most advertised. This positive association stems from the higher rents that firms can extract from consumers whose brand loyalty is endogenously determined by promotional effort. The model's main results on advertising and pricing strategies are taken to the data. The latter consists of product level data on prices and quantities, product level advertising data, as well as the qualitative information on drug quality contained in the Orange Book compiled by the Food and Drug Administration (FDA). The empirical results provide strong support to the model's predictions. Copyright © 2012 Elsevier B.V. All rights reserved.

Legal basis of the Advanced Therapies Regulation.

PubMed

Jekerle, V; Schröder, C; Pedone, E

2010-01-01

Advanced therapy medicinal products consist of gene therapy, somatic cell therapy and tissue engineered products. Due to their specific manufacturing process and mode of action these products require specially tailored legislation. With Regulation (EC) No. 1394/2007, these needs have been met. Definitions of gene therapy, somatic cell therapy and tissue engineered products were laid down. A new committee, the Committee for Advanced Therapies, was founded, special procedures such as the certification procedure for small- and medium-sized enterprises were established and the technical requirements for Marketing Authorisation Applications (quality, non-clinical and clinical) were revised.

Event-level impact of Promescent on quality of sexual experience in men with subjective premature ejaculation

PubMed Central

Mark, K P; Kerner, I

2016-01-01

Promescent is a lidocaine-based ejaculation delaying spray that absorbs into the skin of the penis prior to sexual activity. This article aimed to evaluate the effect of Promescent on the experience of orgasm, ejaculatory latency time and quality of sexual experience (QSE). Additionally, we assessed ease of application of Promescent and the extent to which it enhanced or interrupted the sexual experience. The analytic sample consisted of 91 men with self-reported subjective premature ejaculation who were sent a sample of Promescent and completed a 14-day internet-based prospective daily electronic report. Average ejaculatory latency time was 11.16 min during product use events, compared with 6.81 min during product non-use events. Both members of the couple had an orgasm 65.6% of the time when they used the product, compared with 44.1% when they did not use the product. QSE was significantly improved on product use days (P<0.05). Quality also significantly improved each subsequent time the product was used (P<0.01). The product was reported as easy to use and did not interrupt the sexual experience. Findings suggest that the use of this topical spray significantly improves QSE and perception of partner experience, and that these improve with longer duration of use. PMID:27557610

Event-level impact of Promescent on quality of sexual experience in men with subjective premature ejaculation.

PubMed

Mark, K P; Kerner, I

2016-11-01

Promescent is a lidocaine-based ejaculation delaying spray that absorbs into the skin of the penis prior to sexual activity. This article aimed to evaluate the effect of Promescent on the experience of orgasm, ejaculatory latency time and quality of sexual experience (QSE). Additionally, we assessed ease of application of Promescent and the extent to which it enhanced or interrupted the sexual experience. The analytic sample consisted of 91 men with self-reported subjective premature ejaculation who were sent a sample of Promescent and completed a 14-day internet-based prospective daily electronic report. Average ejaculatory latency time was 11.16 min during product use events, compared with 6.81 min during product non-use events. Both members of the couple had an orgasm 65.6% of the time when they used the product, compared with 44.1% when they did not use the product. QSE was significantly improved on product use days (P<0.05). Quality also significantly improved each subsequent time the product was used (P<0.01). The product was reported as easy to use and did not interrupt the sexual experience. Findings suggest that the use of this topical spray significantly improves QSE and perception of partner experience, and that these improve with longer duration of use.

Design, fabrication, testing, and delivery of improved beam steering devices

NASA Technical Reports Server (NTRS)

1973-01-01

The development, manufacture, and testing of an optical steerer intended for use in spaceborne optical radar systems are described. Included are design principles and design modifications made to harden the device against launch and space environments, the quality program and procedures developed to insure consistent product quality throughout the manufacturing phase, and engineering qualification model testing and evaluation. The delivered hardware design is considered conditionally qualified pending action on further recommended design modifications.

Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer.

PubMed

Linna, Anu; Korhonen, Mirka; Mannermaa, Jukka-Pekka; Airaksinen, Marja; Juppo, Anne Mari

2008-06-01

Outsourcing is rapidly growing in the pharmaceutical industry. When the manufacturing activities are outsourced, control of the product's quality has to be maintained. One way to confirm contract manufacturer's GMP (Good Manufacturing Practice) compliance is auditing. Audits can be supported for instance by using GMP questionnaires. The objective of this study was to develop a tool for the audit preparation of pharmaceutical contract manufacturers and to validate its contents by using Delphi method. At this phase of the study the tool was developed for non-sterile finished product contract manufacturers. A modified Delphi method was used with expert panel consisting of 14 experts from pharmaceutical industry, authorities and university. The content validity of the developed tool was assessed by a Delphi questionnaire round. The response rate in Delphi questionnaire round was 86%. The tool consisted of 103 quality items, from which 90 (87%) achieved the pre-defined agreement rate level (75%). Thirteen quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert panel suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good.

Effects of briakinumab treatment for moderate to severe psoriasis on health-related quality of life and work productivity and activity impairment: results from a randomized phase III study.

PubMed

Papp, K A; Sundaram, M; Bao, Y; Williams, D A; Gu, Y; Signorovitch, J E; Wang, Y; Valdes, J M; Mulani, P M

2014-06-01

Psoriasis is known to have a significant negative impact on a patient's health-related quality of life, including social, recreational and work activities. To evaluate the effects of briakinumab on quality of life and work productivity measures in patients with moderate to severe psoriasis. Patients received either briakinumab (n = 981) or placebo (n = 484) during the 12-week induction phase of trial M06-890. At week 12, patients with a Physician's Global Assessment score of 'Clear' or 'Minimal' entered the 40-week maintenance phase and were to receive briakinumab every 4 weeks, briakinumab every 12 weeks, or placebo. At weeks 12 and 52, treatment groups were compared using mean change from baseline in health-related quality of life and Work Productivity and Activity Impairment Questionnaire scores and the percentage of patients with minimum clinically important differences. At week 12, more than half of the briakinumab-treated patients achieved improvements meeting or exceeding minimum clinically important differences for Dermatology Life Quality Index (75.9%), and psoriasis- (64.8%), and psoriatic arthritis-related (54.1%) pain scores; 48.4% achieved improvements for activity impairment. Although improvements in quality of life and work productivity measures were maintained at week 52 for both briakinumab regimens, responder rates were consistently greater in the every-4-week group than in the every-12-week group. Briakinumab treatment resulted in clinically significant improvements in quality of life and work productivity in adults with moderate to severe psoriasis. Maintenance therapy was associated with a more pronounced benefit for the every-4-week briakinumab regimen. © 2013 European Academy of Dermatology and Venereology.

Quality Assessment of Collection 6 MODIS Atmospheric Science Products

NASA Astrophysics Data System (ADS)

Manoharan, V. S.; Ridgway, B.; Platnick, S. E.; Devadiga, S.; Mauoka, E.

2015-12-01

Since the launch of the NASA Terra and Aqua satellites in December 1999 and May 2002, respectively, atmosphere and land data acquired by the MODIS (Moderate Resolution Imaging Spectroradiometer) sensor on-board these satellites have been reprocessed five times at the MODAPS (MODIS Adaptive Processing System) located at NASA GSFC. The global land and atmosphere products use science algorithms developed by the NASA MODIS science team investigators. MODAPS completed Collection 6 reprocessing of MODIS Atmosphere science data products in April 2015 and is currently generating the Collection 6 products using the latest version of the science algorithms. This reprocessing has generated one of the longest time series of consistent data records for understanding cloud, aerosol, and other constituents in the earth's atmosphere. It is important to carefully evaluate and assess the quality of this data and remove any artifacts to maintain a useful climate data record. Quality Assessment (QA) is an integral part of the processing chain at MODAPS. This presentation will describe the QA approaches and tools adopted by the MODIS Land/Atmosphere Operational Product Evaluation (LDOPE) team to assess the quality of MODIS operational Atmospheric products produced at MODAPS. Some of the tools include global high resolution images, time series analysis and statistical QA metrics. The new high resolution global browse images with pan and zoom have provided the ability to perform QA of products in real time through synoptic QA on the web. This global browse generation has been useful in identifying production error, data loss, and data quality issues from calibration error, geolocation error and algorithm performance. A time series analysis for various science datasets in the Level-3 monthly product was recently developed for assessing any long term drifts in the data arising from instrument errors or other artifacts. This presentation will describe and discuss some test cases from the recently processed C6 products. We will also describe the various tools and approaches developed to verify and assess the algorithm changes implemented by the science team to address known issues in the products and improve the quality of the products.

Demonstrating PQS Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.

PubMed

Ramnarine, Emma; O'Donnell, Kevin

2018-04-18

Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. Regulatory relief and flexibility in post approval change management and overall product lifecycle management will only be possible with effective application of science and risk-based concepts and demonstrated effectiveness of the PQS in assuring a state of control. Copyright © 2018, Parenteral Drug Association.

Total quality management in blood transfusion.

PubMed

Smit-Sibinga, C T

2000-01-01

Quality management is an ongoing development resulting in consistency products and services and ever increasing customer satisfaction. The ultimum is Total Quality Management. Quality systems and quality management in transfusion medicine have gained considerable attention since the outbreak of the AIDS epidemic. Where product orientation has long been applied through quality control, Good Manufacturing Practice (GMP) principles were introduced, shifting the developments in the direction of process orientation. Globally, and particularly in the more industrialised world people and system orientation has come along with the introduction of the ISO9001 concept. Harmonisation and a degree of uniformity are needed to implement a universally applicable Quality System and related Quality Management. Where the American Association of Blood Banks (AABB) is the professional organisation with the most extensive experience in quality systems in blood transfusion, the European Union and the Council of Europe now are in the process to design a quality system and management applicable to a larger variety of countries, based on a hybrid of current GMP and ISO9001 principles. The International Federation of Red Cross and Red Crescent Societies has developed a more universally to implement Quality Manual, with a pilot project in Honduras. It is recommendable to harmonise the various designs and bring the approaches under one common denominator.

[Surveillance of phytotherapeutic drugs in the state of Minas Gerais. Quality assessment of commercial samples of chamomile].

PubMed

Brandão, M G; Freire, N; Vianna-Soares, C D

1998-01-01

Marketing of medicinal plants and phytotherapeutic products is spreading all over the world. In order to assess the commercialization of medicinal plants and phytotherapeutic products in the State of Minas Gerais, we identified and tested for the presence of adulterants and active ingredients in 27 samples of chamomile. All the samples consisted of Matricaria recutita flowers, but they were badly fragmented, a result of excessive handling and poor preservation. All samples contained contaminants, and insects were observed in 63% of the samples sold in drugstores. Only 50% of the samples in each group had the essential oils needed to produce antiinflammatory activity. Flavonoids and other phenolic constituents with a spasmolytic effect were detected in only 20% of the samples from each group. Results with chamomile indicated the poor quality with which medicinal plants and phytotherapeutic products are marketed and confirm the need for surveillance of such products in Brazil.

Dietary Protected Feed Supplement to Increase Milk Production and Quality of Dairy Cows

NASA Astrophysics Data System (ADS)

Pramono, A.; Handayanta, E.; Widayati, D. T.; Putro, P. P.; Kustono

2017-04-01

The efforts to improve and optimize productivity of dairy cows require sufficient availability of nutrients, especially high energy in the early period of lactation. Increasing energy intake in dairy cows can be conducted by increasing the density of energy. The research aimed to evaluate dietary protected feed supplement on milk production and quality, including: fat, protein, and lactose content of Friesian Holstein dairy cow milk. Protected feed supplement was produced from sardine fish oil, through saponification and microencapsulation protection methods. The experiment consists of two treatments i.e. P0: basal diet (control) and P1: basal diet + 3 % protected feed supplement. Each treatment was repeated 15 times. Data were analyzed by independent samples t-test analysis. Results showed that supplementation of protected sardine fish oil had no effect on lactose content, but increased milk yield production (p<0.01), milk fat content (p<0.05), and protein content (p<0.05).

Continuous counter-current chromatography for capture and polishing steps in biopharmaceutical production.

PubMed

Steinebach, Fabian; Müller-Späth, Thomas; Morbidelli, Massimo

2016-09-01

The economic advantages of continuous processing of biopharmaceuticals, which include smaller equipment and faster, efficient processes, have increased interest in this technology over the past decade. Continuous processes can also improve quality assurance and enable greater controllability, consistent with the quality initiatives of the FDA. Here, we discuss different continuous multi-column chromatography processes. Differences in the capture and polishing steps result in two different types of continuous processes that employ counter-current column movement. Continuous-capture processes are associated with increased productivity per cycle and decreased buffer consumption, whereas the typical purity-yield trade-off of classical batch chromatography can be surmounted by continuous processes for polishing applications. In the context of continuous manufacturing, different but complementary chromatographic columns or devices are typically combined to improve overall process performance and avoid unnecessary product storage. In the following, these various processes, their performances compared with batch processing and resulting product quality are discussed based on a review of the literature. Based on various examples of applications, primarily monoclonal antibody production processes, conclusions are drawn about the future of these continuous-manufacturing technologies. Copyright © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

PubMed

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation). Copyright © 2017. Published by Elsevier GmbH.

A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Özer, Özgen; Güneri, Tamer; York, Peter

2013-02-01

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the quality target product profiles (QTPPs) using the historical data and risk assessment method failure mode and effect analysis (FMEA). Compendial and in-house specifications were selected as QTPPs for ramipril tablets. CPPs that affected the product and process were used to establish an experimental design. The results thus obtained can be used to facilitate definition of the design space using tools such as design of experiments (DoE), the response surface method (RSM) and artificial neural networks (ANNs). The project was aimed at discovering hidden knowledge associated with the manufacture of ramipril tablets using a range of artificial intelligence-based software, with the intention of establishing a multi-dimensional design space that ensures consistent product quality. At the end of the study, a design space was developed based on the study data and specifications, and a new formulation was optimized. On the basis of this formulation, a new laboratory batch formulation was prepared and tested. It was confirmed that the explored formulation was within the design space.

Phenotyping the quality of complex medium components by simple online-monitored shake flask experiments.

PubMed

Diederichs, Sylvia; Korona, Anna; Staaden, Antje; Kroutil, Wolfgang; Honda, Kohsuke; Ohtake, Hisao; Büchs, Jochen

2014-11-07

Media containing yeast extracts and other complex raw materials are widely used for the cultivation of microorganisms. However, variations in the specific nutrient composition can occur, due to differences in the complex raw material ingredients and in the production of these components. These lot-to-lot variations can affect growth rate, product yield and product quality in laboratory investigations and biopharmaceutical production processes. In the FDA's Process Analytical Technology (PAT) initiative, the control and assessment of the quality of critical raw materials is one key aspect to maintain product quality and consistency. In this study, the Respiration Activity Monitoring System (RAMOS) was used to evaluate the impact of different yeast extracts and commercial complex auto-induction medium lots on metabolic activity and product yield of four recombinant Escherichia coli variants encoding different enzymes. Under non-induced conditions, the oxygen transfer rate (OTR) of E. coli was not affected by a variation of the supplemented yeast extract lot. The comparison of E. coli cultivations under induced conditions exhibited tremendous differences in OTR profiles and volumetric activity for all investigated yeast extract lots of different suppliers as well as lots of the same supplier independent of the E. coli variant. Cultivation in the commercial auto-induction medium lots revealed the same reproducible variations. In cultivations with parallel offline analysis, the highest volumetric activity was found at different cultivation times. Only by online monitoring of the cultures, a distinct cultivation phase (e.g. glycerol depletion) could be detected and chosen for comparable and reproducible offline analysis of the yield of functional product. This work proves that cultivations conducted in complex media may be prone to significant variation in final product quality and quantity if the quality of the raw material for medium preparation is not thoroughly checked. In this study, the RAMOS technique enabled a reliable and reproducible screening and phenotyping of complex raw material lots by online measurement of the respiration activity. Consequently, complex raw material lots can efficiently be assessed if the distinct effects on culture behavior and final product quality and quantity are visualized.

A Controlled Agitation Process for Improving Quality of Canned Green Beans during Agitation Thermal Processing.

PubMed

Singh, Anika; Pratap Singh, Anubhav; Ramaswamy, Hosahalli S

2016-06-01

This work introduces the concept of a controlled agitation thermal process to reduce quality damage in liquid-particulate products during agitation thermal processing. Reciprocating agitation thermal processing (RA-TP) was used as the agitation thermal process. In order to reduce the impact of agitation, a new concept of "stopping agitations after sufficient development of cold-spot temperature" was proposed. Green beans were processed in No. 2 (307×409) cans filled with liquids of various consistency (0% to 2% CMC) at various frequencies (1 to 3 Hz) of RA-TP using a full-factorial design and heat penetration results were collected. Corresponding operator's process time to impart a 10-min process lethality (Fo ) and agitation time (AT) were calculated using heat penetration results. Accordingly, products were processed again by stopping agitations as per 3 agitation regimes, namely; full time agitation, equilibration time agitation, and partial time agitation. Processed products were photographed and tested for visual quality, color, texture, breakage of green beans, turbidity, and percentage of insoluble solids in can liquid. Results showed that stopping agitations after sufficient development of cold-spot temperatures is an effective way of reducing product damages caused by agitation (for example, breakage of beans and its leaching into liquid). Agitations till one-log temperature difference gave best color, texture and visual product quality for low-viscosity liquid-particulate mixture and extended agitations till equilibration time was best for high-viscosity products. Thus, it was shown that a controlled agitation thermal process is more effective in obtaining high product quality as compared to a regular agitation thermal process. © 2016 Institute of Food Technologists®

Combining metabolic and process engineering strategies to improve recombinant glycoprotein production and quality.

PubMed

Karengera, Eric; Durocher, Yves; De Crescenzo, Gregory; Henry, Olivier

2017-11-01

Increasing recombinant protein production while ensuring a high and consistent protein quality remains a challenge in mammalian cell culture process development. In this work, we combined a nutrient substitution approach with a metabolic engineering strategy that improves glucose utilization efficiency. This combination allowed us to tackle both lactate and ammonia accumulation and investigate on potential synergistic effects on protein production and quality. To this end, HEK293 cells overexpressing the pyruvate yeast carboxylase (PYC2) and their parental cells, both stably producing the therapeutic glycoprotein interferon α2b (IFNα2b), were cultured in media deprived of glutamine but containing chosen substitutes. Among the tested substitutes, pyruvate led to the best improvement in growth (integral of viable cell density) for both cell lines in batch cultures, whereas the culture of PYC2 cells without neither glutamine nor any substitute displayed surprisingly enhanced IFNα2b production. The drastic reduction in both lactate and ammonia in the cultures translated into extended high viability conditions and an increase in recombinant protein titer by up to 47% for the parental cells and the PYC2 cells. Product characterization performed by surface plasmon resonance biosensing using Sambucus nigra (SNA) lectin revealed that the increase in yield was however accompanied by a reduction in the degree of sialylation of the product. Supplementing cultures with glycosylation precursors and a cofactor were effective at counterbalancing the lack of glutamine and allowed improvement in IFNα2b quality as evaluated by lectin affinity. Our study provides a strategy to reconcile protein productivity and quality and highlights the advantages of PYC2-overexpressing cells in glutamine-free conditions.

Application of a quality by design approach to the cell culture process of monoclonal antibody production, resulting in the establishment of a design space.

PubMed

Nagashima, Hiroaki; Watari, Akiko; Shinoda, Yasuharu; Okamoto, Hiroshi; Takuma, Shinya

2013-12-01

This case study describes the application of Quality by Design elements to the process of culturing Chinese hamster ovary cells in the production of a monoclonal antibody. All steps in the cell culture process and all process parameters in each step were identified by using a cause-and-effect diagram. Prospective risk assessment using failure mode and effects analysis identified the following four potential critical process parameters in the production culture step: initial viable cell density, culture duration, pH, and temperature. These parameters and lot-to-lot variability in raw material were then evaluated by process characterization utilizing a design of experiments approach consisting of a face-centered central composite design integrated with a full factorial design. Process characterization was conducted using a scaled down model that had been qualified by comparison with large-scale production data. Multivariate regression analysis was used to establish statistical prediction models for performance indicators and quality attributes; with these, we constructed contour plots and conducted Monte Carlo simulation to clarify the design space. The statistical analyses, especially for raw materials, identified set point values, which were most robust with respect to the lot-to-lot variability of raw materials while keeping the product quality within the acceptance criteria. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.

PubMed

Selen, Arzu; Dickinson, Paul A; Müllertz, Anette; Crison, John R; Mistry, Hitesh B; Cruañes, Maria T; Martinez, Marilyn N; Lennernäs, Hans; Wigal, Tim L; Swinney, David C; Polli, James E; Serajuddin, Abu T M; Cook, Jack A; Dressman, Jennifer B

2014-11-01

The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development and performance by using therapy-driven target drug delivery profiles as a framework to achieve the desired therapeutic outcome. Hence, clinical relevance is directly built into early formulation development. Biopharmaceutics tools are used to identify and address potential challenges to optimize the drug product for patient benefit. For illustration, BioRAM is applied to four relatively common therapy-driven drug delivery scenarios: rapid therapeutic onset, multiphasic delivery, delayed therapeutic onset, and maintenance of target exposure. BioRAM considers the therapeutic target with the drug substance characteristics and enables collection of critical knowledge for development of a dosage form that can perform consistently for meeting the patient's needs. Accordingly, the key factors are identified and in vitro, in vivo, and in silico modeling and simulation techniques are used to elucidate the optimal drug delivery rate and pattern. BioRAM enables (1) feasibility assessment for the dosage form, (2) development and conduct of appropriate "learning and confirming" studies, (3) transparency in decision-making, (4) assurance of drug product quality during lifecycle management, and (5) development of robust linkages between the desired clinical outcome and the necessary product quality attributes for inclusion in the quality target product profile. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Bacteriophages in dairy products: pros and cons.

PubMed

Mc Grath, Stephen; Fitzgerald, Gerald F; van Sinderen, Douwe

2007-04-01

Since the time bacteriophages were first identified as a major cause of fermentation failure in the dairy industry, researchers have been struggling to develop strategies to exclude them from the dairy environment. Over 70 years of research has led to huge improvements in the consistency and quality of fermented dairy products, while also facilitating an appreciation of the beneficial properties of bacteriophages with respect to dairy product development. With specific reference to Lactococcus lactis and cheese production, this review outlines some recently reported novel methods aimed at limiting the bacteriophage infection as well as highlighting some beneficial aspects of bacteriophage activity.

Continuation of Global NO2 and SO2 Monitoring with Suomi NPP OMPS

NASA Astrophysics Data System (ADS)

Yang, K.; Zhang, H.; Wang, J.; Ge, C.; Wang, Y.

2017-12-01

We have produced high-quality NO2 and SO2 standard products (named NMNO2 and NMSO2 respectively) from the SNPP OMPS-NM daily global observations. These OMPS standard products have been archived and publicly released at NASA Goddard Earth Sciences Data and Information Services Center (https://daac.gsfc.nasa.gov/information/news/595e9675624016d1af392c73/omps-nm-no- 2-and-so-2-l-2-data-products-released). Analyses and comparisons have demonstrated that the qualities of these OMPS standard products match or surpass those of the corresponding OMI products, enabling the continuity and extension of these two key standard Earth System Data Records (ESDRs) that begun with NASA's EOS Aura mission using the SNPP observations. In this presentation, we summarize the new techniques and algorithm advances that improve the accuracy and consistency of these ESDRs from satellite observations, and highlight the regional changes in NO2 and SO2 detected from half a decade of SNPP OMPS observations.

Quantification of the impact of endometriosis symptoms on health-related quality of life and work productivity.

PubMed

Fourquet, Jessica; Báez, Lorna; Figueroa, Michelle; Iriarte, R Iván; Flores, Idhaliz

2011-07-01

To quantify the impact of endometriosis-related symptoms on physical and mental health status, health-related quality of life, and work-related aspects (absenteeism, presenteeism, work productivity, and activity impairment). Cross-sectional quantitative study. Academic and research institution. Women (n = 193) with self-reported surgically diagnosed endometriosis from the Endometriosis Patient Registry at Ponce School of Medicine and Health Sciences (PSMHS). Anonymous questionnaire divided into three sections consisting of questions from the Patient Health Survey (SF-12), the Endometriosis Health Profile (EHP-5), and the Work Productivity and Activity Impairment Survey (WPAI). Quantification of impact of endometriosis symptoms on physical and mental health status, health-related quality of life, absenteeism, presenteeism, work productivity, and activity impairment. Patients had SF-12 scores denoting statistically significant disability in the physical and mental health components. They also reported an average of 7.41 hours (approximately one working day) of work time lost during the week when the symptoms are worse. In addition, the WPAI scores showed a high impact on work-related domains: 13% of average loss in work time (absenteeism), 65% of work impaired (presenteeism), 64% of loss in efficiency levels (work productivity loss), and 60% of daily activities perturbed (activity impairment). Endometriosis symptoms such as chronic, incapacitating pelvic pain and infertility negatively and substantially impact the physical and mental health status, health-related quality of life, and productivity at work of women. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Separation of pigment formulations by high-performance thin-layer chromatography with automated multiple development.

PubMed

Stiefel, Constanze; Dietzel, Sylvia; Endress, Marc; Morlock, Gertrud E

2016-09-02

Food packaging is designed to provide sufficient protection for the respective filling, legally binding information for the consumers like nutritional facts or filling information, and an attractive appearance to promote the sale. For quality and safety of the package, a regular quality control of the used printing materials is necessary to get consistently good print results, to avoid migration of undesired ink components into the food and to identify potentially faulty ink batches. Analytical approaches, however, have hardly been considered for quality assurance so far due to the lack of robust, suitable methods for the analysis of rarely soluble pigment formulations. Thus, a simple and generic high-performance thin-layer chromatography (HPTLC) method for the separation of different colored pigment formulations was developed on HPTLC plates silica gel 60 by automated multiple development. The gradient system provided a sharp resolution for differently soluble pigment constituents like additives and coating materials. The results of multi-detection allowed a first assignment of the differently detectable bands to particular chemical substance classes (e.g., lipophilic components), enabled the comparison of different commercially available pigment batches and revealed substantial variations in the composition of the batches. Hyphenation of HPTLC with high resolution mass spectrometry and infrared spectroscopy allowed the characterization of single unknown pigment constituents, which may partly be responsible for known quality problems during printing. The newly developed, precise and selective HPTLC method can be used as part of routine quality control for both, incoming pigment batches and monitoring of internal pigment production processes, to secure a consistent pigment composition resulting in consistent ink quality, a faultless print image and safe products. Hyphenation of HPTLC with the A. fischeri bioassay gave first information on the bioactivity or rather on the toxicological potential of different compounds of the pigment formulations. The results of the bioassay might be helpful to choose pigment compositions that provide both, a high printing quality but at the same time guarantee a high consumer safety, especially in regard to smaller pigment components, which tend to migrate through the packaging. Copyright © 2016 Elsevier B.V. All rights reserved.

Spacelab Data Processing Facility (SLDPF) quality assurance expert systems development

NASA Technical Reports Server (NTRS)

Kelly, Angelita C.; Basile, Lisa; Ames, Troy; Watson, Janice; Dallam, William

1987-01-01

Spacelab Data Processing Facility (SLDPF) expert system prototypes were developed to assist in the quality assurance of Spacelab and/or Attached Shuttle Payload (ASP) processed telemetry data. The SLDPF functions include the capturing, quality monitoring, processing, accounting, and forwarding of mission data to various user facilities. Prototypes for the two SLDPF functional elements, the Spacelab Output Processing System and the Spacelab Input Processing Element, are described. The prototypes have produced beneficial results including an increase in analyst productivity, a decrease in the burden of tedious analyses, the consistent evaluation of data, and the providing of concise historical records.

Spacelab Data Processing Facility (SLDPF) quality assurance expert systems development

NASA Technical Reports Server (NTRS)

Kelly, Angelita C.; Basile, Lisa; Ames, Troy; Watson, Janice; Dallam, William

1987-01-01

Spacelab Data Processing Facility (SLDPF) expert system prototypes have been developed to assist in the quality assurance of Spacelab and/or Attached Shuttle Payload (ASP) processed telemetry data. SLDPF functions include the capturing, quality monitoring, processing, accounting, and forwarding of mission data to various user facilities. Prototypes for the two SLDPF functional elements, the Spacelab Output Processing System and the Spacelab Input Processing Element, are described. The prototypes have produced beneficial results including an increase in analyst productivity, a decrease in the burden of tedious analyses, the consistent evaluation of data, and the providing of concise historical records.

Starter cultures for kimchi fermentation.

PubMed

Lee, Mo-Eun; Jang, Ja-Young; Lee, Jong-Hee; Park, Hae-Woong; Choi, Hak-Jong; Kim, Tae-Woon

2015-05-01

Kimchi is a traditional Korean vegetable product that is naturally fermented by various microorganisms present in the raw materials. Among these microorganisms, lactic acid bacteria dominate the fermentation process. Natural fermentation with unsterilized raw materials leads to the growth of various lactic acid bacteria, resulting in variations in the taste and quality of kimchi, which may make it difficult to produce industrial-scale kimchi with consistent quality. The use of starter cultures has been considered as an alternative for the industrial production of standardized kimchi, and recent trends suggest that the demand for starter cultures is on the rise. However, several factors should be carefully considered for the successful application of starter cultures for kimchi fermentation. In this review, we summarize recent studies on kimchi starter cultures, describe practical problems in the application of industrial-scale kimchi production, and discuss the directions for further studies.

Out-of-the-Box Marketing Strategies.

ERIC Educational Resources Information Center

Smith, Joanna Warren

1997-01-01

The new definition of camp includes year-round camp programs for a variety of populations at multiple sites. Developing a marketing strategy involves creating a mission statement that is unique, publishing a year-round marketing strategy, delivering a consistent quality product, and getting people to talk about camp. Sidebar lists elements of how…

High Tech Training at Arthur Andersen and Co.

ERIC Educational Resources Information Center

Dennis, Verl E.

1984-01-01

Discusses Arthur Andersen and Company's reasons for using high technology in job training, including its ability to improve productivity, provide training on demand, reduce training costs, and keep educational quality consistent. A Life Cycle Model which is used to integrate high technology into this accounting company's educational programs is…

Low-inductance bus lines

NASA Technical Reports Server (NTRS)

Kernick, A.

1977-01-01

Laminated bus strips and bifilar litz cable connectors for high-power rectifiers, thrisistors, and transistors provide low inductance and eliminate electromagnetic interference in high-power circuits. These techniques offer significant cost advantages because of ease of assembly and consistent high quality of product. Effectiveness makes general usage in static power conversion likely.

Food Preparation. Michigan School Food Service Training Manual.

ERIC Educational Resources Information Center

Michigan State Univ., East Lansing. Cooperative Extension Service.

This training manual on food preparation consists of 23 detailed lessons, ranging from an orientation to quality food production and the use and advantages of standardized recipes for bakery ingredients to the making of various desserts. Detailed definitions of words related to food preparation and innumerable handouts with titles like…

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2010 CFR

2010-04-01

... monitoring required under subpart E; (4) Conducting any required material review and making any required disposition decision; (5) Approving or rejecting any reprocessing; (6) Determining whether all in-process... and to determine that the product is consistent with your purchase order. ...

Offline modeling for product quality prediction of mineral processing using modeling error PDF shaping and entropy minimization.

PubMed

Ding, Jinliang; Chai, Tianyou; Wang, Hong

2011-03-01

This paper presents a novel offline modeling for product quality prediction of mineral processing which consists of a number of unit processes in series. The prediction of the product quality of the whole mineral process (i.e., the mixed concentrate grade) plays an important role and the establishment of its predictive model is a key issue for the plantwide optimization. For this purpose, a hybrid modeling approach of the mixed concentrate grade prediction is proposed, which consists of a linear model and a nonlinear model. The least-squares support vector machine is adopted to establish the nonlinear model. The inputs of the predictive model are the performance indices of each unit process, while the output is the mixed concentrate grade. In this paper, the model parameter selection is transformed into the shape control of the probability density function (PDF) of the modeling error. In this context, both the PDF-control-based and minimum-entropy-based model parameter selection approaches are proposed. Indeed, this is the first time that the PDF shape control idea is used to deal with system modeling, where the key idea is to turn model parameters so that either the modeling error PDF is controlled to follow a target PDF or the modeling error entropy is minimized. The experimental results using the real plant data and the comparison of the two approaches are discussed. The results show the effectiveness of the proposed approaches.

Development of a biotechnological process for the production of high quality linen fibers.

PubMed

Valladares Juárez, Ana Gabriela; Rost, Gernot; Heitmann, Uwe; Heger, Egon; Müller, Rudolf

2011-10-01

A novel biotechnological process for the production of high-quality flax fibers was developed. In this process, decorticated fibers from green flax were washed with 0.5% soda solution and treated with the pectinolytic strain Geobacillus thermoglucosidasius PB94A. Before drying the fibers, they were treated with the textile softener Adulcinol BUN. If the fibers contained contaminant shives, a bleaching step with hydrogen peroxide was performed before the softener treatment. In experiments where fibers were treated by the new process, and in which the bacterial solutions were reused seven times, the fiber quality was similar in all batches. The resolution of the treated fibers was 2.7 ± 0.4 and the fineness was 11.1 ± 1.1 dtex, while the starting material had a resolution of 7.3 and a fineness of 37 dtex. The new biotechnological treatment eliminates the weather-associated risks of the traditional fiber retting completely and produces consistently high-quality fibers that can be used to produce fine linen yarns.

CARINA TCO2 data in the Atlantic Ocean

NASA Astrophysics Data System (ADS)

Pierrot, D.; Brown, P.; van Heuven, S.; Tanhua, T.; Schuster, U.; Wanninkhof, R.; Key, R. M.

2010-01-01

Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 cruises in the Arctic, Atlantic and Southern Ocean have been retrieved and merged in a new data base: the CARINA (CARbon IN the Atlantic) Project. These data have gone through rigorous quality control (QC) procedures to assure the highest possible quality and consistency. Secondary quality control, which involved objective study of data in order to quantify systematic differences in the reported values, was performed for the pertinent parameters in the CARINA data base. Systematic biases in the data have been corrected in the data products. The products are three merged data files with measured, adjusted and interpolated data of all cruises for each of the three CARINA regions (Arctic, Atlantic and Southern Ocean). Ninety-eight cruises were conducted in the "Atlantic" defined as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30° S. Here we report the details of the secondary QC which was done on the total dissolved inorganic carbon (TCO2) data and the adjustments that were applied to yield the final data product in the Atlantic. Procedures of quality control - including crossover analysis between stations and inversion analysis of all crossover data - are briefly described. Adjustments were applied to TCO2 measurements for 17 of the cruises in the Atlantic Ocean region. With these adjustments, the CARINA data base is consistent both internally as well as with GLODAP data, an oceanographic data set based on the WOCE Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, regional oceanic carbon inventories, uptake rates and model validation.

Evaluation of Environmental Quality Productive Ecosystem Guayas (Ecuador).

NASA Astrophysics Data System (ADS)

Pozo, Wilson; Pardo, Francisco; Sanfeliu, Teófilo; Carrera, Gloria; Jordan, Manuel; Bech, Jaume; Roca, Núria

2015-04-01

Natural resources are deteriorating very rapidly in the Gulf of Guayaquil and the area of influence in the Guayas Basin due to human activity. Specific problems are generated by the mismanagement of the aquaculture industry affecting the traditional agricultural sectors: rice, banana, sugarcane, cocoa, coffee, and soya also studied, and by human and industrial settlements. The development of industrial activities such as aquaculture (shrimp building for shrimp farming in ponds) and agriculture, have increasingly contributed to the generation of waste, degrading and potentially toxic elements in high concentrations, which can have adverse effects on organisms in the ecosystems, in the health of the population and damage the ecological and environmental balance. The productive Guayas ecosystem, consists of three interrelated ecosystems, the Gulf of Guayaquil, the Guayas River estuary and the Guayas Basin buffer. The objective of this study was to evaluate the environmental quality of the productive Guayas ecosystem (Ecuador), through operational and specific objectives: 1) Draw up the transition coastal zone in the Gulf of Guayaquil, 2) Set temporal spatial variability of soil salinity in wetlands rice, Lower Guayas Basin, 3) evaluate the heavy metals in wetland rice in the Lower Basin of Guayas. The physical and chemical parameters of the soils have been studied. These are indicators of environmental quality. The multivariate statistical method showed the relations of similarities and dissimilarities between variables and parameter studies as stable. Moreover, the boundaries of coastal transition areas, temporal spatial variability of soil salinity and heavy metals in rice cultivation in the Lower Basin of Guayas were researched. The sequential studies included and discussed represent a broad framework of fundamental issues that has been valued as a basic component of the productive Guayas ecosystem. They are determinants of the environmental quality of the Guayas productive ecosystem. Keyword: Evaluation, Environmental Quality, Productive Ecosystem

High Speed Video Applications In The Pharmaceutical Industry

NASA Astrophysics Data System (ADS)

Stapley, David

1985-02-01

The pursuit of quality is essential in the development and production of drugs. The pursuit of excellence is relentless, a never ending search. In the pharmaceutical industry, we all know and apply wide-ranging techniques to assure quality production. We all know that in reality none of these techniques are perfect for all situations. We have all experienced, the damaged foil, blister or tube, the missing leaflet, the 'hard to read' batch code. We are all aware of the need to supplement the traditional techniques of fault finding. This paper shows how high speed video systems can be applied to fully automated filling and packaging operations as a tool to aid the company's drive for high quality and productivity. The range of products involved totals some 350 in approximately 3,000 pack variants, encompassing creams, ointments, lotions, capsules, tablets, parenteral and sterile antibiotics. Pharmaceutical production demands diligence at all stages, with optimum use of the techniques offered by the latest technology. Figure 1 shows typical stages of pharmaceutical production in which quality must be assured, and highlights those stages where the use of high speed video systems have proved of value to date. The use of high speed video systems begins with the very first use of machine and materials: commissioning and validation, (the term used for determining that a process is capable of consistently producing the requisite quality) and continues to support inprocess monitoring, throughout the life of the plant. The activity of validation in the packaging environment is particularly in need of a tool to see the nature of high speed faults, no matter how infrequently they occur, so that informed changes can be made precisely and rapidly. The prime use of this tool is to ensure that machines are less sensitive to minor variations in component characteristics.

Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.

PubMed

Selen, Arzu; Cruañes, Maria T; Müllertz, Anette; Dickinson, Paul A; Cook, Jack A; Polli, James E; Kesisoglou, Filippos; Crison, John; Johnson, Kevin C; Muirhead, Gordon T; Schofield, Timothy; Tsong, Yi

2010-09-01

A biopharmaceutics and Quality by Design (QbD) conference was held on June 10-12, 2009 in Rockville, Maryland, USA to provide a forum and identify approaches for enhancing product quality for patient benefit. Presentations concerned the current biopharmaceutical toolbox (i.e., in vitro, in silico, pre-clinical, in vivo, and statistical approaches), as well as case studies, and reflections on new paradigms. Plenary and breakout session discussions evaluated the current state and envisioned a future state that more effectively integrates QbD and biopharmaceutics. Breakout groups discussed the following four topics: Integrating Biopharmaceutical Assessment into the QbD Paradigm, Predictive Statistical Tools, Predictive Mechanistic Tools, and Predictive Analytical Tools. Nine priority areas, further described in this report, were identified for advancing integration of biopharmaceutics and support a more fundamentally based, integrated approach to setting product dissolution/release acceptance criteria. Collaboration among a broad range of disciplines and fostering a knowledge sharing environment that places the patient's needs as the focus of drug development, consistent with science- and risk-based spirit of QbD, were identified as key components of the path forward.

Advanced Manufacturing Systems in Food Processing and Packaging Industry

NASA Astrophysics Data System (ADS)

Shafie Sani, Mohd; Aziz, Faieza Abdul

2013-06-01

In this paper, several advanced manufacturing systems in food processing and packaging industry are reviewed, including: biodegradable smart packaging and Nano composites, advanced automation control system consists of fieldbus technology, distributed control system and food safety inspection features. The main purpose of current technology in food processing and packaging industry is discussed due to major concern on efficiency of the plant process, productivity, quality, as well as safety. These application were chosen because they are robust, flexible, reconfigurable, preserve the quality of the food, and efficient.

Changes in Rice Grain Quality of Indica and Japonica Type Varieties Released in China from 2000 to 2014.

PubMed

Feng, Fan; Li, Yajun; Qin, Xiaoliang; Liao, Yuncheng; Siddique, Kadambot H M

2017-01-01

China is the first country to use heterosis successfully for commercial rice production. This study compared the main quality characteristics (head rice rate, chalky rice rate, chalkiness degree, gel consistency, amylose content, and length-to-width ratio) of 635 rice varieties (not including upland and glutinous rice) released from 2000 to 2014 to establish the quality status and offer suggestions for future rice breeding for grain quality in China. In the past 15 years, grain quality in japonica rice and indica hybrid rice has improved. In japonica rice, inbred varieties have increased head rice rates and decreased chalkiness degree over time, while hybrid rice varieties have decreased chalky rice rates and chalkiness degree. In indica hybrid rice, the chalkiness degree and amylose contents have decreased and gel consistency has increased. Improvements in grain quality in indica inbred rice have been limited, with some increases in head rice rate and decreases in chalky rice rate and amylose content. From 2010 to 2014, the percentage of indica varieties meeting the Grade III national standard of rice quality for different quality traits was low, especially for chalky rice rate and chalkiness degree. Japonica varieties have more superior grain quality than indica rice in terms of higher head rice rates and gel consistency, lower chalky rice rates and chalkiness degree, and lower amylose contents, which may explain why the Chinese prefer japonica rice. The japonica rice varieties, both hybrid and inbred, had similar grain qualities, but this varied in indica rice with the hybrid varieties having higher grain quality than inbred varieties due to significantly better head rice rates and lower chalkiness degree. For better quality rice in future, the chalky rice rate and chalkiness degree should be improved in japonica rice along with most of the quality traits in indica rice.

Fingerprint analysis of Ginkgo biloba leaves and related health foods by high-performance liquid chromatography/electrospray ionization-mass spectrometry.

PubMed

Song, Jiajia; Fang, Guozhen; Zhang, Yan; Deng, Qiliang; Wang, Shuo

2010-01-01

A fingerprint analysis method was developed for Ginkgo biloba leaves and was successfully used for quality evaluation of related health foods by HPLC with electrospray ionization MS. Fifteen samples of G. biloba leaves, which were collected from 15 different locations in China, were analyzed and identified in this study. By both peak analysis and similarity analysis of the fingerprint chromatograms, variation of constituents was easily observed in the leaves from different sources. By comparison with batches of authentic leaves, the authenticity, and quality consistency of related health foods in different matrixes were effectively estimated. It is important to mention that studying a wide range of authentic leaves from various habitats made the quality evaluation of commercial products more convincing and reasonable. The fingerprint-based strategy of the developed method should provide improved QC of G. biloba leaves and products.

A systematic approach to evaluate parameter consistency in the inlet stream of source separated biowaste composting facilities: A case study in Colombia.

PubMed

Oviedo-Ocaña, E R; Torres-Lozada, P; Marmolejo-Rebellon, L F; Torres-López, W A; Dominguez, I; Komilis, D; Sánchez, A

2017-04-01

Biowaste is commonly the largest fraction of municipal solid waste (MSW) in developing countries. Although composting is an effective method to treat source separated biowaste (SSB), there are certain limitations in terms of operation, partly due to insufficient control to the variability of SSB quality, which affects process kinetics and product quality. This study assesses the variability of the SSB physicochemical quality in a composting facility located in a small town of Colombia, in which SSB collection was performed twice a week. Likewise, the influence of the SSB physicochemical variability on the variability of compost parameters was assessed. Parametric and non-parametric tests (i.e. Student's t-test and the Mann-Whitney test) showed no significant differences in the quality parameters of SSB among collection days, and therefore, it was unnecessary to establish specific operation and maintenance regulations for each collection day. Significant variability was found in eight of the twelve quality parameters analyzed in the inlet stream, with corresponding coefficients of variation (CV) higher than 23%. The CVs for the eight parameters analyzed in the final compost (i.e. pH, moisture, total organic carbon, total nitrogen, C/N ratio, total phosphorus, total potassium and ash) ranged from 9.6% to 49.4%, with significant variations in five of those parameters (CV>20%). The above indicate that variability in the inlet stream can affect the variability of the end-product. Results suggest the need to consider variability of the inlet stream in the performance of composting facilities to achieve a compost of consistent quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

FDA perspective on specifications for biotechnology products--from IND to PLA.

PubMed

Murano, G

1997-01-01

Quality standards are obligatory throughout development, approval and post-marketing phases of biotechnology-derived products, thus assuring product identity, purity, and potency/strength. The process of developing and setting specifications should be based on sound science and should represent a logical progression of actions based on the use of experiential data spanning manufacturing process validation, consistency in production, and characterization of relevant product properties/attributes, by multiple analytical means. This interactive process occurs in phases, varying in rigour. It is best described as encompassing a framework which starts with the implementation of realistic/practical operational quality limits, progressing to the establishment/adoption of more stringent specifications. The historical database is generated from preclinical, toxicology and early clinical lots. This supports the clinical development programme which, as it progresses, allows for further assay method validation/refinement, adoption/addition due to relevant or newly recognized product attributes or rejection due to irrelevance. In the next phase, (licensing/approval) specifications are set through extended experience and validation of both the preparative and analytical processes, to include availability of suitable reference standards and extensive product characterization throughout its proposed dating period. Subsequent to product approval, the incremental database of test results serves as a natural continuum for further evolving/refining specifications. While there is considerable latitude in the kinds of testing modalities finally adopted to establish product quality on a routine basis, for both drugs and drug products, it is important that the selection takes into consideration relevant (significant) product characteristics that appropriately reflect on identity, purity and potency.

Quality-Controlled Small-Scale Production of a Well-Defined Bacteriophage Cocktail for Use in Human Clinical Trials

PubMed Central

Merabishvili, Maya; Pirnay, Jean-Paul; Verbeken, Gilbert; Chanishvili, Nina; Tediashvili, Marina; Lashkhi, Nino; Glonti, Thea; Krylov, Victor; Mast, Jan; Van Parys, Luc; Lavigne, Rob; Volckaert, Guido; Mattheus, Wesley; Verween, Gunther; De Corte, Peter; Rose, Thomas; Jennes, Serge; Zizi, Martin; De Vos, Daniel; Vaneechoutte, Mario

2009-01-01

We describe the small-scale, laboratory-based, production and quality control of a cocktail, consisting of exclusively lytic bacteriophages, designed for the treatment of Pseudomonas aeruginosa and Staphylococcus aureus infections in burn wound patients. Based on succesive selection rounds three bacteriophages were retained from an initial pool of 82 P. aeruginosa and 8 S. aureus bacteriophages, specific for prevalent P. aeruginosa and S. aureus strains in the Burn Centre of the Queen Astrid Military Hospital in Brussels, Belgium. This cocktail, consisting of P. aeruginosa phages 14/1 (Myoviridae) and PNM (Podoviridae) and S. aureus phage ISP (Myoviridae) was produced and purified of endotoxin. Quality control included Stability (shelf life), determination of pyrogenicity, sterility and cytotoxicity, confirmation of the absence of temperate bacteriophages and transmission electron microscopy-based confirmation of the presence of the expected virion morphologic particles as well as of their specific interaction with the target bacteria. Bacteriophage genome and proteome analysis confirmed the lytic nature of the bacteriophages, the absence of toxin-coding genes and showed that the selected phages 14/1, PNM and ISP are close relatives of respectively F8, φKMV and phage G1. The bacteriophage cocktail is currently being evaluated in a pilot clinical study cleared by a leading Medical Ethical Committee. PMID:19300511

Evaluating the hydrological consistency of evaporation products using satellite-based gravity and rainfall data

NASA Astrophysics Data System (ADS)

López, Oliver; Houborg, Rasmus; McCabe, Matthew Francis

2017-01-01

Advances in space-based observations have provided the capacity to develop regional- to global-scale estimates of evaporation, offering insights into this key component of the hydrological cycle. However, the evaluation of large-scale evaporation retrievals is not a straightforward task. While a number of studies have intercompared a range of these evaporation products by examining the variance amongst them, or by comparison of pixel-scale retrievals against ground-based observations, there is a need to explore more appropriate techniques to comprehensively evaluate remote-sensing-based estimates. One possible approach is to establish the level of product agreement between related hydrological components: for instance, how well do evaporation patterns and response match with precipitation or water storage changes? To assess the suitability of this consistency-based approach for evaluating evaporation products, we focused our investigation on four globally distributed basins in arid and semi-arid environments, comprising the Colorado River basin, Niger River basin, Aral Sea basin, and Lake Eyre basin. In an effort to assess retrieval quality, three satellite-based global evaporation products based on different methodologies and input data, including CSIRO-PML, the MODIS Global Evapotranspiration product (MOD16), and Global Land Evaporation: the Amsterdam Methodology (GLEAM), were evaluated against rainfall data from the Global Precipitation Climatology Project (GPCP) along with Gravity Recovery and Climate Experiment (GRACE) water storage anomalies. To ensure a fair comparison, we evaluated consistency using a degree correlation approach after transforming both evaporation and precipitation data into spherical harmonics. Overall we found no persistent hydrological consistency in these dryland environments. Indeed, the degree correlation showed oscillating values between periods of low and high water storage changes, with a phase difference of about 2-3 months. Interestingly, after imposing a simple lag in GRACE data to account for delayed surface runoff or baseflow components, an improved match in terms of degree correlation was observed in the Niger River basin. Significant improvements to the degree correlations (from ˜ 0 to about 0.6) were also found in the Colorado River basin for both the CSIRO-PML and GLEAM products, while MOD16 showed only half of that improvement. In other basins, the variability in the temporal pattern of degree correlations remained considerable and hindered any clear differentiation between the evaporation products. Even so, it was found that a constant lag of 2 months provided a better fit compared to other alternatives, including a zero lag. From a product assessment perspective, no significant or persistent advantage could be discerned across any of the three evaporation products in terms of a sustained hydrological consistency with precipitation and water storage anomaly data. As a result, our analysis has implications in terms of the confidence that can be placed in independent retrievals of the hydrological cycle, raises questions on inter-product quality, and highlights the need for additional techniques to evaluate large-scale products.

Enrichment of Animal Diets with Essential Oils—A Great Perspective on Improving Animal Performance and Quality Characteristics of the Derived Products

PubMed Central

Simitzis, Panagiotis E.

2017-01-01

Food industry operates in a competitive market and is continually facing challenges to retain or even increase its market share. Consistent high-quality animal products are required to maintain consumer confidence and consumption. Enrichment of foods with bioactive compounds such as the essential oils appears to improve quality characteristics of the derived products and protects consumers against oxidation and bacterial spoilage effects. Synthetic additives are nowadays questioned due to their suspected carcinogenic potential, and therefore extensive research has been undertaken to identify safe and efficient alternatives. Aromatic plants and their respective essential oils belong to natural products and are generally used in pig, poultry, rabbit and ruminant nutrition. The inclusion of essential oils in livestock diets is nowadays becoming a common practice, since dietary supplementation has been proven a simple and convenient strategy to effectively inhibit the oxidative reactions or microbial spoilage at their localized sites. A wide range of essential oils contain bioactive compounds that have the potential to act as multifunctional feed supplements for animals including effects on growth performance, digestive system, pathogenic bacterial growth and lipid oxidation. However, further studies are needed to clarify their exact action and establish their regular use in animal production. PMID:28930250

Validation of a 30-year-old process for the manufacture of L-asparaginase from Erwinia chrysanthemi.

PubMed

Gervais, David; Allison, Nigel; Jennings, Alan; Jones, Shane; Marks, Trevor

2013-04-01

A 30-year-old manufacturing process for the biologic product L-asparaginase from the plant pathogen Erwinia chrysanthemi was rigorously qualified and validated, with a high level of agreement between validation data and the 6-year process database. L-Asparaginase exists in its native state as a tetrameric protein and is used as a chemotherapeutic agent in the treatment regimen for Acute Lymphoblastic Leukaemia (ALL). The manufacturing process involves fermentation of the production organism, extraction and purification of the L-asparaginase to make drug substance (DS), and finally formulation and lyophilisation to generate drug product (DP). The extensive manufacturing experience with the product was used to establish ranges for all process parameters and product quality attributes. The product and in-process intermediates were rigorously characterised, and new assays, such as size-exclusion and reversed-phase UPLC, were developed, validated, and used to analyse several pre-validation batches. Finally, three prospective process validation batches were manufactured and product quality data generated using both the existing and the new analytical methods. These data demonstrated the process to be robust, highly reproducible and consistent, and the validation was successful, contributing to the granting of an FDA product license in November, 2011.

Assessment of the emissions and air quality impacts of biomass and biogas use in California.

PubMed

Carreras-Sospedra, Marc; Williams, Robert; Dabdub, Donald

2016-02-01

It is estimated that there is sufficient in-state "technically" recoverable biomass to support nearly 4000 MW of bioelectricity generation capacity. This study assesses the emissions of greenhouse gases and air pollutants and resulting air quality impacts of new and existing bioenergy capacity throughout the state of California, focusing on feedstocks and advanced technologies utilizing biomass resources predominant in each region. The options for bioresources include the production of bioelectricity and renewable natural gas (NG). Emissions of criteria pollutants and greenhouse gases are quantified for a set of scenarios that span the emission factors for power generation and the use of renewable natural gas for vehicle fueling. Emissions are input to the Community Multiscale Air Quality (CMAQ) model to predict regional and statewide temporal air quality impacts from the biopower scenarios. With current technology and at the emission levels of current installations, maximum bioelectricity production could increase nitrogen oxide (NOx) emissions by 10% in 2020, which would cause increases in ozone and particulate matter concentrations in large areas of California. Technology upgrades would achieve the lowest criteria pollutant emissions. Conversion of biomass to compressed NG (CNG) for vehicles would achieve comparable emission reductions of criteria pollutants and minimize emissions of greenhouse gases (GHG). Air quality modeling of biomass scenarios suggest that applying technological changes and emission controls would minimize the air quality impacts of bioelectricity generation. And a shift from bioelectricity production to CNG production for vehicles would reduce air quality impacts further. From a co-benefits standpoint, CNG production for vehicles appears to provide the best benefits in terms of GHG emissions and air quality. This investigation provides a consistent analysis of air quality impacts and greenhouse gas emissions for scenarios examining increased biomass use. Further work involving economic assessment, seasonal or annual emissions and air quality modeling, and potential exposure analysis would help inform policy makers and industry with respect to further development and direction of biomass policy and bioenergy technology alternatives needed to meet energy and environmental goals in California.

Application of NIR hyperspectral imaging for post-consumer polyolefins recycling

NASA Astrophysics Data System (ADS)

Serranti, Silvia; Gargiulo, Aldo; Bonifazi, Giuseppe

2012-06-01

An efficient large-scale recycling approach of particulate solid wastes is always accomplished according to the quality of the materials fed to the recycling plant and/or to any possible continuous and reliable control of the different streams inside the processing plants. Processing technologies addressed to recover plastics need to be extremely powerful, since they must be relatively simple to be cost-effective, but also accurate enough to create high-purity products and able to valorize a substantial fraction of the plastic waste materials into useful products of consistent quality in order to be economical. On the other hand, the potential market for such technologies is large and the boost of environmental regulations, and the oil price increase, has made many industries interested both in "general purpose" waste sorting technologies, as well as in developing more specialized sensing devices and/or inspection logics for a better quality assessment of plastic products. In this perspective recycling strategies have to be developed taking into account some specific aspects as i) mixtures complexity: the valuable material has to be extracted from the residue, ii) overall production: the profitability of plastic can be achieved only with mass production and iii) costs: low-cost sorting processes are required. In this paper new analytical strategies, based on hyperspectral imaging in the near infrared field (1000-1700 nm), have been investigated and set up in order to define sorting and/or quality control logics that could be profitably applied, at industrial plant level, for polyolefins recycling.

Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products

PubMed Central

Zhao, Yuan; Stepto, Hannah; Schneider, Christian K

2017-01-01

Gene therapy is a rapidly evolving field. So far, there have been >2,400 gene therapy products in clinical trials and four products on the market. A prerequisite for producing gene therapy products is ensuring their quality and safety. This requires appropriately controlled and standardized production and testing procedures that result in consistent safety and efficacy. Assuring the quality and safety of lentivirus-based gene therapy products in particular presents a great challenge because they are cell-based multigene products that include viral and therapeutic proteins as well as modified cells. In addition to the continuous refinement of a product, changes in production sites and manufacturing processes have become more and more common, posing challenges to developers regarding reproducibility and comparability of results. This paper discusses the concept of developing a first World Health Organization International Standard, suitable for the standardization of assays and enabling comparison of cross-trial and cross-manufacturing results for this important vector platform. The standard will be expected to optimize the development of gene therapy medicinal products, which is especially important, given the usually orphan nature of the diseases to be treated, naturally hampering reproducibility and comparability of results. PMID:28747142

Results from CrIS/ATMS Obtained Using an "AIRS Version-6 Like" Retrieval Algorithm

NASA Technical Reports Server (NTRS)

Susskind, Joel; Kouvaris, Louis; Iredell, Lena

2015-01-01

A main objective of AIRS/AMSU on EOS is to provide accurate sounding products that are used to generate climate data sets. Suomi NPP carries CrIS/ATMS that were designed as follow-ons to AIRS/AMSU. Our objective is to generate a long term climate data set of products derived from CrIS/ATMS to serve as a continuation of the AIRS/AMSU products. We have modified an improved version of the operational AIRS Version-6 retrieval algorithm for use with CrIS/ATMS. CrIS/ATMS products are of very good quality, and are comparable to, and consistent with, those of AIRS.

Physical quality characteristics of the microwave-dried breadfruit powders due to different processing conditions

NASA Astrophysics Data System (ADS)

Taruna, I.; Hakim, A. L.; Sutarsi

2018-03-01

Production of breadfruit powder has been an option to make easy its uses in various food processing. Accordingly, there is a need recently to apply advanced drying method, i.e. microwave drying, for improving quality since conventional methods produced highly variable product quality and required longer process. The present work was aimed to study the effect of microwave power and grinding time on physical quality of breadfruit powders. The experiment was done initially by drying breadfruit slices in a microwave dryer at power level of 420, 540, and 720 W and then grinding for 3, 5, and 7 min to get powdery product of less than 80 mesh. The physical quality of breadfruit powders were measured in terms of fineness modulus (FM), average particle size (D), whiteness (WI), total color difference (ΔE), water absorption (Wa), oil absorption (La), bulk density (ρb) and consistency gel (Gc). The results showed that physical quality of powders and its ranged-values included the FM (2.08-2.62), D (0.44-0.68 mm), WI (75.2-77.9), ΔE (7.4-10.5), Wa (5.5-6.2 ml/g), La (0.7-0.9 ml/g), ρb (0.62-0.70 g/cm3) and Gc (41.3-46.8 mm). The experiment revealed that variation of microwave power and grinding time affected significantly the quality of the breadfruit powders. However, microwave power was more dominant factor to affect quality of breadfruit powder in comparison to the grinding time.

Quality of omeprazole purchased via the Internet and personally imported into Japan: comparison with products sampled in other Asian countries.

PubMed

Rahman, Mohammad Sofiqur; Yoshida, Naoko; Sugiura, Sakura; Tsuboi, Hirohito; Keila, Tep; Kiet, Heng Bun; Zin, Theingi; Tanimoto, Tsuyoshi; Kimura, Kazuko

2018-03-01

To evaluate the quality of omeprazole personally imported into Japan via the Internet and to compare the quality of these samples with previously collected samples from two other Asian countries. The samples were evaluated by observation, authenticity investigation and pharmacopoeial quality analysis. Quality comparison of some selected samples was carried out by dissolution profiling, Raman spectroscopy and principle component analysis (PCA). Observation of the Internet sites and samples revealed some discrepancies including the delivery of a wrong sample and the selling of omeprazole without a prescription, although it is a prescription medicine. Among the 28 samples analysed, all passed the identification test, 26 (93%) passed the quantity and content uniformity tests and all passed the dissolution test. Dissolution profiling confirmed that all the personally imported omeprazole samples remained intact in the acid medium. On the other hand, six samples from two of the same manufacturers, previously collected during surveys in Cambodia and Myanmar, frequently showed premature omeprazole release in acid. Raman spectroscopy and PCA showed significant variation between omeprazole formulations in personally imported samples and the samples from Cambodia and Myanmar. Our results indicate that the pharmaceutical quality of omeprazole purchased through the Internet was sufficient, as determined by pharmacopeial tests. However, omeprazole formulations distributed in different market segments by the same manufacturers were of diverse quality. Measures are needed to ensure consistent quality of products and to prevent entry of substandard products into the legitimate supply chain. © 2018 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

Radio Frequency Scanning and Simulation of Oriented Strand Board Material Property

NASA Astrophysics Data System (ADS)

Liu, Xiaojian; Zhang, Jilei; Steele, Philip. H.; Donohoe, J. Patrick

2008-02-01

Oriented strandboard (OSB) is a wood composite product with the largest market share in U.S. residential and commercial construction. Wood specific gravity (SG) and moisture content (MC) play an important role in the OSB manufacturing process. They are the two of the critical variables that manufacturers are required to monitor, locate, and control in order to produce a product with consistent quality. In this study, radio frequency scanning nondestructive evaluation (NDE) technologies evaluated the local area MC and SG of OSB panels following panel production by hot pressing. A finite element software simulation tool was used to optimize the sensor geometry and for investigating the interaction between electromagnetic field and wood dielectric properties. Our results indicate the RF scanning response is closely correlated to the MC and SG variations in OSB panels. Radio frequency NDE appears to have potential as an effective method for insuring OSB panel quality during manufacturing.

Introduction to the application of QbD principles for the development of monoclonal antibodies.

PubMed

Finkler, Christof; Krummen, Lynne

2016-09-01

Quality by Design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter introduces a publication series on the application of Quality by Design for biopharmaceuticals, with a focus on the development of recombinant monoclonal antibodies. The development of and overview on the QbD concept applied by Roche and Genentech is described and essential QbD elements are presented. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

A 100-Year Review: Sensory analysis of milk.

PubMed

Schiano, A N; Harwood, W S; Drake, M A

2017-12-01

Evaluation of the sensory characteristics of food products has been, and will continue to be, the ultimate method for evaluating product quality. Sensory quality is a parameter that can be evaluated only by humans and consists of a series of tests or tools that can be applied objectively or subjectively within the constructs of carefully selected testing procedures and parameters. Depending on the chosen test, evaluators are able to probe areas of interest that are intrinsic product attributes (e.g., flavor profiles and off-flavors) as well as extrinsic measures (e.g., market penetration and consumer perception). This review outlines the literature pertaining to relevant testing procedures and studies of the history of sensory analysis of fluid milk. In addition, evaluation methods outside of traditional sensory techniques and future outlooks on the subject of sensory analysis of fluid milk are explored and presented. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Role of litter turnover in soil quality in tropical degraded lands of Colombia.

PubMed

León, Juan D; Osorio, Nelson W

2014-01-01

Land degradation is the result of soil mismanagement that reduces soil productivity and environmental services. An alternative to improve degraded soils through reactivation of biogeochemical nutrient cycles (via litter production and decomposition) is the establishment of active restoration models using new forestry plantations, agroforestry, and silvopastoral systems. On the other hand, passive models of restoration consist of promoting natural successional processes with native plants. The objective in this review is to discuss the role of litter production and decomposition as a key strategy to reactivate biogeochemical nutrient cycles and thus improve soil quality in degraded land of the tropics. For this purpose the results of different projects of land restoration in Colombia are presented based on the dynamics of litter production, nutrient content, and decomposition. The results indicate that in only 6-13 years it is possible to detect soil properties improvements due to litter fall and decomposition. Despite that, low soil nutrient availability, particularly of N and P, seems to be major constraint to reclamation of these fragile ecosystems.

Fingerprint analysis and quality consistency evaluation of flavonoid compounds for fermented Guava leaf by combining high-performance liquid chromatography time-of-flight electrospray ionization mass spectrometry and chemometric methods.

PubMed

Wang, Lu; Tian, Xiaofei; Wei, Wenhao; Chen, Gong; Wu, Zhenqiang

2016-10-01

Guava leaves are used in traditional herbal teas as antidiabetic therapies. Flavonoids are the main active of Guava leaves and have many physiological functions. However, the flavonoid compositions and activities of Guava leaves could change due to microbial fermentation. A high-performance liquid chromatography time-of-flight electrospray ionization mass spectrometry method was applied to identify the varieties of the flavonoids in Guava leaves before and after fermentation. High-performance liquid chromatography, hierarchical cluster analysis and principal component analysis were used to quantitatively determine the changes in flavonoid compositions and evaluate the consistency and quality of Guava leaves. Monascus anka Saccharomyces cerevisiae fermented Guava leaves contained 2.32- and 4.06-fold more total flavonoids and quercetin, respectively, than natural Guava leaves. The flavonoid compounds of the natural Guava leaves had similarities ranging from 0.837 to 0.927. The flavonoid compounds from the Monascus anka S. cerevisiae fermented Guava leaves had similarities higher than 0.993. This indicated that the quality consistency of the fermented Guava leaves was better than that of the natural Guava leaves. High-performance liquid chromatography fingerprinting and chemometric analysis are promising methods for evaluating the degree of fermentation of Guava leaves based on quality consistency, which could be used in assessing flavonoid compounds for the production of fermented Guava leaves. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Integrated LC-MS/MS Analytical Systems and Physical Inspection for the Analysis of a Botanical Herbal Preparation.

PubMed

Lai, Kuan-Ming; Cheng, Yung-Yi; Tsai, Tung-Hu

2015-06-09

The herbal decoction process is generally inconvenient and unpleasant. To avoid using herbal medicine decoctions, various high-quality industrial and pharmaceutical herbal decoction products have been used in clinical applications for more than ten years in Taiwan. However, the consistency and standardization of the quality of these herbal medicines are goals that remain to be achieved. The aim of study was to develop a validated liquid chromatography-tandem electrospray ionization mass spectrometry (LC-MS/MS) method to determine the biomarkers astragaloside I, astragaloside IV, formononetin, cinnamic acid, paeoniflorin and gingerol in the herbal preparation known as Huangqi-Guizhi-Wuwu (HGW). To investigate the physical quality of HGW, methods such as scanning electron microscopy, light microscopy with Congo red and potassium iodine staining, solubility measurements, swelling power tests, and crude fiber analysis were used to identify additives in commercial pharmaceutical products. The optimal LC-MS/MS multiple reaction-monitoring system included a gradient program using 5 mM ammonium acetate buffer with 0.05% formic acid/methanol. The results demonstrate deviations in biomarker content across different brands. In addition to the herbal extract, starch and excipients in the pharmaceutical granule, and crushed crude herb powder was added to the pharmaceutical products to increase their herbal ingredient content. In conclusion, a rigorous examination should be performed to certify the quality of the herbal products.

Effects of NaCl Replacement with Gamma-Aminobutyric acid (GABA) on the Quality Characteristics and Sensorial Properties of Model Meat Products

PubMed Central

Chun, Ji-Yeon; Cho, Hyung-Yong; Min, Sang-Gi

2014-01-01

This study investigated the effects of γ-aminobutylic acid (GABA) on the quality and sensorial properties of both the GABA/NaCl complex and model meat products. GABA/NaCl complex was prepared by spray-drying, and the surface dimensions, morphology, rheology, and saltiness were characterized. For model meat products, pork patties were prepared by replacing NaCl with GABA. For characteristics of the complex, increasing GABA concentration increased the surface dimensions of the complex. However, GABA did not affect the rheological properties of solutions containing the complex. The addition of 2% GABA exhibited significantly higher saltiness than the control (no GABA treatment). In the case of pork patties, sensory testing indicated that the addition of GABA decreased the saltiness intensity. Both the intensity of juiciness and tenderness of patties containing GABA also scored lower than the control, based on the NaCl reduction. These results were consistent with the quality characteristics (cooking loss and texture profile analysis). Nevertheless, overall acceptability of the pork patties showed that up to 1.5%, patties containing GABA did not significantly differ from the control. Consequently, the results indicated that GABA has a potential application in meat products, but also manifested a deterioration of quality by the NaCl reduction, which warrants further exploration. PMID:26761294

The effect of pre-treatment and modified atmosphere packaging on contents of phenolic compounds and sensory and microbiological quality of shredded celeriac.

PubMed

Radziejewska-Kubzdela, Elżbieta; Czapski, Janusz; Czaczyk, Katarzyna; Biegańska-Marecik, Róża

2014-04-01

The aim of this study was to determine the effect of washing (4 °C, 120 s) or soaking (4 °C, 600 s) of shredded celeriac in tap water on changes in contents of phenolic compounds, including furanocoumarins, and sensory and microbiological quality during 12 days of storage. The product was packaged in air or modified atmosphere containing 2/10/88 kPa O2/CO2/N2. The applied pre-treatment consisting of washing or soaking of shredded celeriac in water resulted in decreases in 8-methoxypsoralen content by approximately 50 and 70% respectively and phenolic content by 30% compared with samples that were not subjected to pre-treatment. During storage of shredded celeriac, a further significant (P ≤ 0.05) reduction in phenolic compounds and an approximately 2.5-fold increase in the total content of furanocoumarins were found. The application of modified atmosphere packaging had a significant effect on the maintenance of good sensory and microbiological quality of the tested product. Modified atmosphere packaging of shredded celeriac not subjected to pre-treatment made it possible to obtain a product with good sensory and microbiological quality and the highest content of phenolic compounds. The level of furanocoumarins recorded in the tested product does not constitute a health hazard. © 2013 Society of Chemical Industry.

Soils and nutrition: A forest nursery perspective

Treesearch

Russell D. Briggs

2008-01-01

A brief review of the published proceedings from meetings of nursery managers over the past 30 years reveals a high level of consistency with respect to topics of interest from year to year. Seedling quality, defined as seedling capacity to effectively compete after outplanting, has been the unifying theme. Production issues, including collection, storage, and sowing...

The water quality and quantity effects of biofuel operations in pine plantations of the southeastern USA

Treesearch

J. Nettles; M. Youssef; J. Cacho; J. Grace; Z. Leggett; E. Sucre

2011-01-01

Working alongside operational trials, a comprehensive research programme was developed to evaluate sustainability, life-cycle analysis, soil productivity, wildlife, and water resource impacts. The hydrology field studies consist of three sets of forested watersheds, each with mid-rotation pine reference, switchgrass (Panicum virgatum) interplanted, typical...

Progress in Brewing Science and Beer Production.

PubMed

Bamforth, C W

2017-06-07

The brewing of beer is an ancient biotechnology, the unit processes of which have not changed in hundreds of years. Equally, scientific study within the brewing industry not only has ensured that modern beer making is highly controlled, leading to highly consistent, high-quality, healthful beverages, but also has informed many other fermentation-based industries.

Cartographic standards to improve maps produced by the Forest Inventory and Analysis program

Treesearch

Charles H. (Hobie) Perry; Mark D. Nelson

2009-01-01

The Forest Service, U.S. Department of Agriculture's Forest Inventory and Analysis (FIA) program is incorporating an increasing number of cartographic products in reports, publications, and presentations. To create greater quality and consistency within the national FIA program, a Geospatial Standards team developed cartographic design standards for FIA map...

The Global Ocean Data Analysis Project version 2 (GLODAPv2) - an internally consistent data product for the world ocean

NASA Astrophysics Data System (ADS)

Olsen, Are; Key, Robert M.; van Heuven, Steven; Lauvset, Siv K.; Velo, Anton; Lin, Xiaohua; Schirnick, Carsten; Kozyr, Alex; Tanhua, Toste; Hoppema, Mario; Jutterström, Sara; Steinfeldt, Reiner; Jeansson, Emil; Ishii, Masao; Pérez, Fiz F.; Suzuki, Toru

2016-08-01

Version 2 of the Global Ocean Data Analysis Project (GLODAPv2) data product is composed of data from 724 scientific cruises covering the global ocean. It includes data assembled during the previous efforts GLODAPv1.1 (Global Ocean Data Analysis Project version 1.1) in 2004, CARINA (CARbon IN the Atlantic) in 2009/2010, and PACIFICA (PACIFic ocean Interior CArbon) in 2013, as well as data from an additional 168 cruises. Data for 12 core variables (salinity, oxygen, nitrate, silicate, phosphate, dissolved inorganic carbon, total alkalinity, pH, CFC-11, CFC-12, CFC-113, and CCl4) have been subjected to extensive quality control, including systematic evaluation of bias. The data are available in two formats: (i) as submitted but updated to WOCE exchange format and (ii) as a merged and internally consistent data product. In the latter, adjustments have been applied to remove significant biases, respecting occurrences of any known or likely time trends or variations. Adjustments applied by previous efforts were re-evaluated. Hence, GLODAPv2 is not a simple merging of previous products with some new data added but a unique, internally consistent data product. This compiled and adjusted data product is believed to be consistent to better than 0.005 in salinity, 1 % in oxygen, 2 % in nitrate, 2 % in silicate, 2 % in phosphate, 4 µmol kg-1 in dissolved inorganic carbon, 6 µmol kg-1 in total alkalinity, 0.005 in pH, and 5 % for the halogenated transient tracers.The original data and their documentation and doi codes are available at the Carbon Dioxide Information Analysis Center (http://cdiac.ornl.gov/oceans/GLODAPv2/). This site also provides access to the calibrated data product, which is provided as a single global file or four regional ones - the Arctic, Atlantic, Indian, and Pacific oceans - under the doi:10.3334/CDIAC/OTG.NDP093_GLODAPv2. The product files also include significant ancillary and approximated data. These were obtained by interpolation of, or calculation from, measured data. This paper documents the GLODAPv2 methods and products and includes a broad overview of the secondary quality control results. The magnitude of and reasoning behind each adjustment is available on a per-cruise and per-variable basis in the online Adjustment Table.

Evaluation of Coptidis Rhizoma-Euodiae Fructus couple and Zuojin products based on HPLC fingerprint chromatogram and simultaneous determination of main bioactive constituents.

PubMed

Gao, Xin; Yang, Xiu-Wei; Marriott, Philip J

2013-11-01

Coptidis Rhizoma-Euodiae Fructus couple (CEC) is a classic traditional Chinese medicine preparation consisting of Coptidis Rhizoma and Euodiae Fructus at the ratio of 6:1, and used to treat gastro-intestinal disorders. Alkaloids are the main bioactive component. This research provides comprehensive analysis information for the quality control of CEC. To develop a high-performance liquid chromatography-diode array detection fingerprint for chemical composition characteristics of CEC and its products. The samples were separated with a Gemini C18 column by using gradient elution with water-formic acid (100:0.03) and acetonitrile as mobile phase. Flow rate was 1.0 mL/min and detection wavelength was 250 nm. Similarity analysis and principal component analysis (PCA) were employed to evaluate quality consistencies of analytes. Mean chromatograms and correlation coefficients of analytes were calculated by the software "Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine". Fingerprint chromatogram comparison determined 20 representative general fingerprint peaks, and the fingerprint chromatogram resemblances are all better than 0.988. Consistent results were obtained to show that CEC and its related samples could be successfully divided into three groups. Contribution plots generated by PCA were performed to interpret differences among the sample groups while peaks which significantly contributed to classification were identified. Seven bioactive constituents in the samples were verified by quantitative analysis. The chromatographic fingerprint with similarity evaluation and PCA assay combined with quantification of seven compounds could be utilized as a quality control method for the herbal couple.

Nutritional limitations to increased production on pasture-based systems.

PubMed

Kolver, Eric S

2003-05-01

The constraints to high levels of milk production imposed by a high-quality-pasture diet, and development of feeding strategies to overcome these limitations, were examined by modelling the nutritional status of New Zealand Friesian and North American Holstein-Friesian dairy cows grazing high-quality pasture. The Cornell Net Carbohydrate and Protein System (CNCPS) was used to predict sensitivity of milk production to a 10% change in the composition of pasture nutrients. The rate at which fibre and protein were degraded in the rumen and the value given to effective fibre and lignin content significantly affected the supply of metabolisable energy and protein, and the profile of amino acid supply. The first limiting factor in milk production when only high-quality pasture was fed was metabolisable energy supply, while specific amino acids, particularly methionine and lysine, limited milk production when > 20 g/kg diet consisted of a grain supplement. Compared with cows fed a total mixed ration in confinement, North American Holstein-Friesians grazing all pasture produced less milk (29.6 v. 44.1 kg/d). Of the difference in milk production 61% could be attributed to a lower DM intake (19 kg/d v. 23.4 kg/d). Predictions using the CNCPS indicated that supply of metabolisable energy was the first-limiting factor for milk production from high-quality pasture (251 g crude protein (N x 6.25)/kg, 432 g neutral-detergent fibre/kg, 77% in vitro DM digestibility), rather than metabolisable protein or amino acids. In addition, these nutritional limitations imposed by pasture diets will be greater for dairy cow genotypes that have not been selected for high performance within a pasture system.

DUACS: Toward High Resolution Sea Level Products

NASA Astrophysics Data System (ADS)

Faugere, Y.; Gerald, D.; Ubelmann, C.; Claire, D.; Pujol, M. I.; Antoine, D.; Desjonqueres, J. D.; Picot, N.

2016-12-01

The DUACS system produces, as part of the CNES/SALP project, and the Copernicus Marine Environment and Monitoring Service, high quality multimission altimetry Sea Level products for oceanographic applications, climate forecasting centers, geophysic and biology communities... These products consist in directly usable and easy to manipulate Level 3 (along-track cross-calibrated SLA) and Level 4 products (multiple sensors merged as maps or time series) and are available in global and regional version (Mediterranean Sea, Arctic, European Shelves …).The quality of the products is today limited by the altimeter technology "Low Resolution Mode" (LRM), and the lack of available observations. The launch of 2 new satellites in 2016, Jason-3 and Sentinel-3A, opens new perspectives. Using the global Synthetic Aperture Radar mode (SARM) coverage of S3A and optimizing the LRM altimeter processing (retracking, editing, ...) will allow us to fully exploit the fine-scale content of the altimetric missions. Thanks to this increase of real time altimetry observations we will also be able to improve Level-4 products by combining these new Level-3 products and new mapping methodology, such as dynamic interpolation. Finally these improvements will benefit to downstream products : geostrophic currents, Lagrangian products, eddy atlas… Overcoming all these challenges will provide major upgrades of Sea Level products to better fulfill user needs.

Time and Temperature Conditions during Product Flow and Sensory Quality of Potato Salad Prepared in a Conventional Foodservice System.

DTIC Science & Technology

1983-01-01

potentially hazardous food requiring refrigeration should be cooled rapidly to an internal temperature of 450F or below so that the cooling period...does not exceed four hours; (c) potentially hazardous food to be served chilled should be kept at an internal temperature of 450F or below during...display and service (HEW, 1978). Potentially hazardous food - any food that consists in whole or in part of milk or milk products, eggs, meat, poultry

Analysis of the quality of image data acquired by the LANDSAT-4 thematic mapper and multispectral scanners

NASA Technical Reports Server (NTRS)

Colwell, R. N. (Principal Investigator)

1983-01-01

The three types of LANDSAT 4 film products generally accessible to the user community were analyzed and attempts were made to acquire a data set consisting of a variety of TM and MSS image products for the Sacramento and San Francisco Bay Area test sites. On request, the EDC developed an interim TM analytical film by using a leaser beam recorder to produce black and white masters from which natural and false color composites were created.

Physicochemical interactions in solid dosage forms.

PubMed

Narang, Ajit S; Desai, Divyakant; Badawy, Sherif

2012-10-01

Complete characterization and mechanistic understanding of physicochemical interactions in solid dosage forms are not only important for consistent manufacturability, stability, and bioavailability of the drug product, but are also expected under the quality-by-design paradigm of drug development. Lack of this understanding can impact successful and timely development, scale-up, and commercial manufacture of dosage forms. This article highlights the stability and bioavailability implications of physicochemical interactions in dosage forms citing a couple of examples where such interactions necessitated the recall of commercial drug products.

Design of penicillin fermentation process simulation system

NASA Astrophysics Data System (ADS)

Qi, Xiaoyu; Yuan, Zhonghu; Qi, Xiaoxuan; Zhang, Wenqi

2011-10-01

Real-time monitoring for batch process attracts increasing attention. It can ensure safety and provide products with consistent quality. The design of simulation system of batch process fault diagnosis is of great significance. In this paper, penicillin fermentation, a typical non-linear, dynamic, multi-stage batch production process, is taken as the research object. A visual human-machine interactive simulation software system based on Windows operation system is developed. The simulation system can provide an effective platform for the research of batch process fault diagnosis.

Analysis and interpretation of water-quality trends in major U.S. rivers, 1974-81

USGS Publications Warehouse

Smith, Richard A.; Alexander, Richard B.; Wolman, M. Gordon

1987-01-01

Water-quality records from two nationwide sampling networks are now of sufficient length to permit nationally consistent analysis of long-term water-quality trends at more than 300 locations on major U.S. rivers. Observed trends in 24 water-quality measures for the period 1974--81 provide evidence of both improvement and deterioration in stream quality during a time of major changes in atmospheric and terrestrial influences on surface waters. Particularly noteworthy are widespread decreases in lead and fecal bacteria concentrations and widespread increases in nitrate, arsenic, and cadmium concentrations. Changes in municipal waste treatment, leaded-gasoline consumption, highway-salt use, and nitrogen-fertilizer application, and regionally variable trends in coal production and combustion during the period, appear to be reflected in water-quality changes. There is evidence that atmospheric deposition of a variety of substances has played a surprisingly large role in water-quality changes.

The cleanroom case study in the Software Engineering Laboratory: Project description and early analysis

NASA Technical Reports Server (NTRS)

Green, Scott; Kouchakdjian, Ara; Basili, Victor; Weidow, David

1990-01-01

This case study analyzes the application of the cleanroom software development methodology to the development of production software at the NASA/Goddard Space Flight Center. The cleanroom methodology emphasizes human discipline in program verification to produce reliable software products that are right the first time. Preliminary analysis of the cleanroom case study shows that the method can be applied successfully in the FDD environment and may increase staff productivity and product quality. Compared to typical Software Engineering Laboratory (SEL) activities, there is evidence of lower failure rates, a more complete and consistent set of inline code documentation, a different distribution of phase effort activity, and a different growth profile in terms of lines of code developed. The major goals of the study were to: (1) assess the process used in the SEL cleanroom model with respect to team structure, team activities, and effort distribution; (2) analyze the products of the SEL cleanroom model and determine the impact on measures of interest, including reliability, productivity, overall life-cycle cost, and software quality; and (3) analyze the residual products in the application of the SEL cleanroom model, such as fault distribution, error characteristics, system growth, and computer usage.

Taming wild yeast: potential of conventional and nonconventional yeasts in industrial fermentations.

PubMed

Steensels, Jan; Verstrepen, Kevin J

2014-01-01

Yeasts are the main driving force behind several industrial food fermentation processes, including the production of beer, wine, sake, bread, and chocolate. Historically, these processes developed from uncontrolled, spontaneous fermentation reactions that rely on a complex mixture of microbes present in the environment. Because such spontaneous processes are generally inconsistent and inefficient and often lead to the formation of off-flavors, most of today's industrial production utilizes defined starter cultures, often consisting of a specific domesticated strain of Saccharomyces cerevisiae, S. bayanus, or S. pastorianus. Although this practice greatly improved process consistency, efficiency, and overall quality, it also limited the sensorial complexity of the end product. In this review, we discuss how Saccharomyces yeasts were domesticated to become the main workhorse of food fermentations, and we investigate the potential and selection of nonconventional yeasts that are often found in spontaneous fermentations, such as Brettanomyces, Hanseniaspora, and Pichia spp.

Improving Access to MODIS Biophysical Science Products for NACP Investigators

NASA Technical Reports Server (NTRS)

Wolfe, Robert E.; Gao, Feng; Morisette, Jeffrey T.; Ederer, Gregory A.; Pedelty, Jeffrey A.

2007-01-01

MODIS 4 NACP is a NASA-funded project supporting the North American Carbon Program (NACP). The purpose of this Advancing Collaborative Connections for Earth-Sun System Science (ACCESS) project is to provide researchers with Moderate Resolution Imaging Spectroradiometer (MODIS) biophysical data products that are custom tailored for use in NACP model studies. Standard MODIS biophysical products provide used to improve our understanding on the climate and ecosystem changes. However, direct uses of the MODIS biophysical parameters are constrained by retrieval quality and cloud contamination. Another challenge that NACP users face is acquiring MODIS data in formats and at spatial-temporal resolutions consistent with other data sets they use. We have been working closely with key NACP users to tailor the MODIS products to fit their needs. First, we provide new temporally smoothed and spatially continuous MODIS biophysical data sets. Second, we are distributing MODIS data at suitable spatial-temporal resolutions and in formats consistent with other data integration into model studies.

Biomanufacturing process analytical technology (PAT) application for downstream processing: Using dissolved oxygen as an indicator of product quality for a protein refolding reaction.

PubMed

Pizarro, Shelly A; Dinges, Rachel; Adams, Rachel; Sanchez, Ailen; Winter, Charles

2009-10-01

Process analytical technology (PAT) is an initiative from the US FDA combining analytical and statistical tools to improve manufacturing operations and ensure regulatory compliance. This work describes the use of a continuous monitoring system for a protein refolding reaction to provide consistency in product quality and process performance across batches. A small-scale bioreactor (3 L) is used to understand the impact of aeration for refolding recombinant human vascular endothelial growth factor (rhVEGF) in a reducing environment. A reverse-phase HPLC assay is used to assess product quality. The goal in understanding the oxygen needs of the reaction and its impact to quality, is to make a product that is efficiently refolded to its native and active form with minimum oxidative degradation from batch to batch. Because this refolding process is heavily dependent on oxygen, the % dissolved oxygen (DO) profile is explored as a PAT tool to regulate process performance at commercial manufacturing scale. A dynamic gassing out approach using constant mass transfer (k(L)a) is used for scale-up of the aeration parameters to manufacturing scale tanks (2,000 L, 15,000 L). The resulting DO profiles of the refolding reaction show similar trends across scales and these are analyzed using rpHPLC. The desired product quality attributes are then achieved through alternating air and nitrogen sparging triggered by changes in the monitored DO profile. This approach mitigates the impact of differences in equipment or feedstock components between runs, and is directly inline with the key goal of PAT to "actively manage process variability using a knowledge-based approach." (c) 2009 Wiley Periodicals, Inc.

Euro-Maps 3D- A Transnational, High-Resolution Digital Surface Model For Europe

NASA Astrophysics Data System (ADS)

Uttenthaler, A.; Barner, F.; Hass, T.; Makiola, J.; d'Angelo, P.; Reinartz, P.; Carl, S.; Steiner, K.

2013-12-01

Euro-Maps 3D is a homogeneous 5 m spaced digital surface model (DSM) semi-automatically derived by Euromap from 2.5 m in-flight stereo data provided by the Indian IRS-P5 Cartosat-1 satellite. This new and innovative product has been developed in close co- operation with the Remote Sensing Technology Institute (IMF) of the German Aerospace Center (DLR) and is being jointly exploited. The very detailed and accurate representation of the surface is achieved by using a sophisticated and well adapted algorithm implemented on the basis of the Semi-Global Matching approach. In addition, the final product includes detailed flanking information consisting of several pixel-based quality and traceability layers also including an ortho layer. The product is believed to provide maximum accuracy and transparency. The DSM product meets and exceeds HRE80 qualification standards. The DSM product will be made available transnational in a homogeneous quality for most parts of Europe, North Africa and Turkey by Euromap step-by-step. Other areas around the world are processed on demand.

Housing Quality and Access to Material and Learning Resources within the Home Environment in Developing Countries

PubMed Central

Bradley, Robert H.; Putnick, Diane L.

2011-01-01

This study examined home environment conditions (housing quality, material resources, formal and informal learning materials) and their relations with the Human Development Index (HDI) in 28 developing countries. Home environment conditions in these countries varied widely. The quality of housing and availability of material resources at home were consistently tied to HDI; the availability of formal and informal learning materials little less so. Gross domestic product (GDP) tended to show a stronger independent relation with housing quality and material resources than life expectancy and education. Formal learning resources were independently related to the GDP and education indices, and informal learning resources were not independently related to any constituent indices of the overall HDI. PMID:22277008

Review: DNA Barcoding and Chromatography Fingerprints for the Authentication of Botanicals in Herbal Medicinal Products

PubMed Central

2017-01-01

In the last two decades, there has been a tremendous increase in the global use of herbal medicinal products (HMPs) due to their claimed health benefits. This has led to increase in their demand and consequently, also, resulted in massive adulteration. This is due to the fact that most of the traditional methods cannot identify closely related species in a process product form. Therefore the urgent need for simple and rapid identification methods resulted in the discovery of a novel technique. DNA barcoding is a process that uses short DNA sequence from the standard genome for species identification. This technique is reliable and is not affected by external factors such as climates, age, or plant part. The difficulties in isolation of DNA of high quality in addition to other factors are among the challenges encountered using the DNA barcoding in the authentication of HMP. These limitations indicated that using DNA barcoding alone may ineffectively authenticate the HMP. Therefore, the combination of DNA barcoding with chromatographic fingerprint, a popular and generally accepted technique for the assessment and quality control of HMP, will offer an efficient solution to effectively evaluate the authenticity and quality consistency of HMP. Detailed and quality information about the main composition of the HMPs will help to ascertain their efficacy and safety as these are very important for quality control. PMID:28536641

Investigation of stability, consistency, and oil oxidation of emulsion filled gel prepared by inulin and rice bran oil using ultrasonic radiation.

PubMed

Nourbehesht, Newsha; Shekarchizadeh, Hajar; Soltanizadeh, Nafiseh

2018-04-01

Inulin, rice bran oil and rosemary essential oil were used to produce high quality emulsion filled gel (EFG) using ultrasonic radiation. Response surface methodology was used to investigate the effects of oil content, inulin content and power of ultrasound on the stability and consistency of prepared EFG. The process conditions were optimized by conducting experiments at five different levels. Second order polynomial response surface equations were developed indicating the effect of variables on EFG stability and consistency. The oil content of 18%; inulin content of 44.6%; and power of ultrasound of 256 W were found to be the optimum conditions to achieve the best EFG stability and consistency. Microstructure and rheological properties of prepared EFG were investigated. Oil oxidation as a result of using ultrasonic radiation was also investigated. The increase of oxidation products and the decrease of total phenolic compounds as well as radical scavenging activity of antioxidant compounds showed the damaging effect of ultrasound on the oil quality of EFG. Copyright © 2017 Elsevier B.V. All rights reserved.

Design and validation of a consistent and reproducible manufacture process for the production of clinical-grade bone marrow-derived multipotent mesenchymal stromal cells.

PubMed

Codinach, Margarita; Blanco, Margarita; Ortega, Isabel; Lloret, Mireia; Reales, Laura; Coca, Maria Isabel; Torrents, Sílvia; Doral, Manel; Oliver-Vila, Irene; Requena-Montero, Miriam; Vives, Joaquim; Garcia-López, Joan

2016-09-01

Multipotent mesenchymal stromal cells (MSC) have achieved a notable prominence in the field of regenerative medicine, despite the lack of common standards in the production processes and suitable quality controls compatible with Good Manufacturing Practice (GMP). Herein we describe the design of a bioprocess for bone marrow (BM)-derived MSC isolation and expansion, its validation and production of 48 consecutive batches for clinical use. BM samples were collected from the iliac crest of patients for autologous therapy. Manufacturing procedures included: (i) isolation of nucleated cells (NC) by automated density-gradient centrifugation and plating; (ii) trypsinization and expansion of secondary cultures; and (iii) harvest and formulation of a suspension containing 40 ± 10 × 10(6) viable cells. Quality controls were defined as: (i) cell count and viability assessment; (ii) immunophenotype; and (iii) sterility tests, Mycoplasma detection, endotoxin test and Gram staining. A 3-week manufacturing bioprocess was first designed and then validated in 3 consecutive mock productions, prior to producing 48 batches of BM-MSC for clinical use. Validation included the assessment of MSC identity and genetic stability. Regarding production, 139.0 ± 17.8 mL of BM containing 2.53 ± 0.92 × 10(9) viable NC were used as starting material, yielding 38.8 ± 5.3 × 10(6) viable cells in the final product. Surface antigen expression was consistent with the expected phenotype for MSC, displaying high levels of CD73, CD90 and CD105, lack of expression of CD31 and CD45 and low levels of HLA-DR. Tests for sterility, Mycoplasma, Gram staining and endotoxin had negative results in all cases. Herein we demonstrated the establishment of a feasible, consistent and reproducible bioprocess for the production of safe BM-derived MSC for clinical use. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

The Global Ocean Data Analysis Project version 2 (GLODAPv2) – an internally consistent data product for the world ocean

DOE PAGES

Olsen, Are; Key, Robert M.; van Heuven, Steven; ...

2016-08-15

Version 2 of the Global Ocean Data Analysis Project (GLODAPv2) data product is composed of data from 724 scientific cruises covering the global ocean. It includes data assembled during the previous efforts GLODAPv1.1 (Global Ocean Data Analysis Project version 1.1) in 2004, CARINA (CARbon IN the Atlantic) in 2009/2010, and PACIFICA (PACIFic ocean Interior CArbon) in 2013, as well as data from an additional 168 cruises. Data for 12 core variables (salinity, oxygen, nitrate, silicate, phosphate, dissolved inorganic carbon, total alkalinity, pH, CFC-11, CFC-12, CFC-113, and CCl 4) have been subjected to extensive quality control, including systematic evaluation of bias.more » The data are available in two formats: (i) as submitted but updated to WOCE exchange format and (ii) as a merged and internally consistent data product. In the latter, adjustments have been applied to remove significant biases, respecting occurrences of any known or likely time trends or variations. Adjustments applied by previous efforts were re-evaluated. Hence, GLODAPv2 is not a simple merging of previous products with some new data added but a unique, internally consistent data product. In conclusion, this compiled and adjusted data product is believed to be consistent to better than 0.005 in salinity, 1 % in oxygen, 2 % in nitrate, 2 % in silicate, 2 % in phosphate, 4 µmol kg -1 in dissolved inorganic carbon, 6 µmol kg -1 in total alkalinity, 0.005 in pH, and 5 % for the halogenated transient tracers.« less

The Global Ocean Data Analysis Project version 2 (GLODAPv2) – an internally consistent data product for the world ocean

DOE Office of Scientific and Technical Information (OSTI.GOV)

Olsen, Are; Key, Robert M.; van Heuven, Steven

Version 2 of the Global Ocean Data Analysis Project (GLODAPv2) data product is composed of data from 724 scientific cruises covering the global ocean. It includes data assembled during the previous efforts GLODAPv1.1 (Global Ocean Data Analysis Project version 1.1) in 2004, CARINA (CARbon IN the Atlantic) in 2009/2010, and PACIFICA (PACIFic ocean Interior CArbon) in 2013, as well as data from an additional 168 cruises. Data for 12 core variables (salinity, oxygen, nitrate, silicate, phosphate, dissolved inorganic carbon, total alkalinity, pH, CFC-11, CFC-12, CFC-113, and CCl 4) have been subjected to extensive quality control, including systematic evaluation of bias.more » The data are available in two formats: (i) as submitted but updated to WOCE exchange format and (ii) as a merged and internally consistent data product. In the latter, adjustments have been applied to remove significant biases, respecting occurrences of any known or likely time trends or variations. Adjustments applied by previous efforts were re-evaluated. Hence, GLODAPv2 is not a simple merging of previous products with some new data added but a unique, internally consistent data product. In conclusion, this compiled and adjusted data product is believed to be consistent to better than 0.005 in salinity, 1 % in oxygen, 2 % in nitrate, 2 % in silicate, 2 % in phosphate, 4 µmol kg -1 in dissolved inorganic carbon, 6 µmol kg -1 in total alkalinity, 0.005 in pH, and 5 % for the halogenated transient tracers.« less

Extraneous agents testing for substrates of avian origin and viral vaccines for poultry: current provisions and proposals for future approaches.

PubMed

Jungbäck, Carmen; Motitschke, Andreas

2010-05-01

In the 1970s the European Pharmacopoeia (Ph. Eur.) established the first requirements for testing starting materials for vaccines and the vaccines themselves. These requirements also cover testing for freedom from extraneous agents of specific pathogen free (SPF) chicken flocks, the embryonated eggs derived from them and viral vaccines for poultry. This was the first common European approach initiated by the Ph. Eur. as an institution of the Council of Europe and it was the beginning of building a scientific basis for vaccine quality. In the following years, the increasingly detailed requirements concerning viral purity also impacted viral vaccines for poultry, SPF chicken flocks and the embryonated eggs derived from them. The core of these requirements is formed by the list of extraneous agents that must be tested for and the accepted test methods. In the early 1990s and in 2004, the next steps were taken towards the harmonization of quality regulations for the production and testing of veterinary immunological products, this time at the level of the European Community. With the first step, good manufacturing practices (GMP) and good laboratory practices (GLP) were introduced, ensuring more consistent production, validation of production procedures and testing. The next step introduced the risk assessment, which covers the evaluation of the quality of production and control. The intention of these efforts is to contribute to the quality, safety and purity of the products placed on the market. It makes sense that, based on the outcome of the risk-evaluation, a reduction of in-process and final product testing may be called for in certain cases. However, despite the fact that the quality of the starting materials and vaccines has been increased over the years, the provisions of the Ph. Eur. have not been adjusted. Progress made by the manufacturers of starting materials and vaccines with respect to increasing the quality of their products should be recognised. This review gives an analysis of the current provisions of the Ph. Eur. and makes some proposals on how the requirements concerning the testing of extraneous agents could be modified to take into consideration the increase in quality that has been achieved over the past few decades. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

Genetic dissection of sorghum grain quality traits using diverse and segregating populations.

PubMed

Boyles, Richard E; Pfeiffer, Brian K; Cooper, Elizabeth A; Rauh, Bradley L; Zielinski, Kelsey J; Myers, Matthew T; Brenton, Zachary; Rooney, William L; Kresovich, Stephen

2017-04-01

Coordinated association and linkage mapping identified 25 grain quality QTLs in multiple environments, and fine mapping of the Wx locus supports the use of high-density genetic markers in linkage mapping. There is a wide range of end-use products made from cereal grains, and these products often demand different grain characteristics. Fortunately, cereal crop species including sorghum [Sorghum bicolor (L.) Moench] contain high phenotypic variation for traits influencing grain quality. Identifying genetic variants underlying this phenotypic variation allows plant breeders to develop genotypes with grain attributes optimized for their intended usage. Multiple sorghum mapping populations were rigorously phenotyped across two environments (SC Coastal Plain and Central TX) in 2 years for five major grain quality traits: amylose, starch, crude protein, crude fat, and gross energy. Coordinated association and linkage mapping revealed several robust QTLs that make prime targets to improve grain quality for food, feed, and fuel products. Although the amylose QTL interval spanned many megabases, the marker with greatest significance was located just 12 kb from waxy (Wx), the primary gene regulating amylose production in cereal grains. This suggests higher resolution mapping in recombinant inbred line (RIL) populations can be obtained when genotyped at a high marker density. The major QTL for crude fat content, identified in both a RIL population and grain sorghum diversity panel, encompassed the DGAT1 locus, a critical gene involved in maize lipid biosynthesis. Another QTL on chromosome 1 was consistently mapped in both RIL populations for multiple grain quality traits including starch, crude protein, and gross energy. Collectively, these genetic regions offer excellent opportunities to manipulate grain composition and set up future studies for gene validation.

Validation of projective mapping as potential sensory screening tool for application by the honeybush herbal tea industry.

PubMed

Moelich, Erika Ilette; Muller, Magdalena; Joubert, Elizabeth; Næs, Tormod; Kidd, Martin

2017-09-01

Honeybush herbal tea is produced from the endemic South African Cyclopia species. Plant material subjected to a high-temperature oxidation step ("fermentation") forms the bulk of production. Production lags behind demand forcing tea merchants to use blends of available material to supply local and international markets. The distinct differences in the sensory profiles of the herbal tea produced from the different Cyclopia species require that special care is given to blending to ensure a consistent, high quality product. Although conventional descriptive sensory analysis (DSA) is highly effective in providing a detailed sensory profile of herbal tea infusions, industry requires a method that is more time- and cost-effective. Recent advances in sensory science have led to the development of rapid profiling methodologies. The question is whether projective mapping can successfully be used for the sensory characterisation of herbal tea infusions. Trained assessors performed global and partial projective mapping to determine the validity of this technique for the sensory characterisation of infusions of five Cyclopia species. Similar product configurations were obtained when comparing results of DSA and global and partial projective mapping. Comparison of replicate sessions showed RV coefficients >0.8. A similarity index, based on multifactor analysis, was calculated to determine assessor repeatability. Global projective mapping, demonstrated to be a valid method for providing a broad sensory characterisation of Cyclopia species, is thus suitable as a rapid quality control method of honeybush infusions. Its application by the honeybush industry could improve the consistency of the sensory profile of blended products. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nursing home consumer complaints and their potential role in assessing quality of care.

PubMed

Stevenson, David G

2005-02-01

State survey agencies collect and investigate consumer complaints for care in nursing homes and other health care settings. Complaint investigations play a key role in quality assurance, because they can respond to concerns of consumers and families. This study uses 5 years of nursing home complaints data from Massachusetts (1998-2002) to investigate whether complaints might be used to assess nursing home quality of care. The investigator matches facility-level complaints data with On-Line Survey Certification and Reporting (OSCAR) data and Minimum Data Set Quality Indicator (MDS QI) data to evaluate the association between consumer complaints, facility and resident characteristics, and other nursing home quality measures. Consumer complaints varied across facility characteristics in ways consistent with the nursing home quality literature. Complaints were consistently and significantly associated with survey deficiencies, the presence of a serious survey deficiency, and nurse aide staffing. Complaints were not significantly associated with nurse staffing, and associations with 6 MDS QIs were mixed. The number of complaints was significantly predictive of survey deficiencies identified at the subsequent inspection. Nursing home consumer complaints provide a supplemental tool with which to differentiate nursing homes on quality. Despite limitations, complaints data have potential strengths when used in combination with other quality measures. The potential of using consumer complaints to assess nursing home quality of care should be evaluated in states beyond Massachusetts. Evaluating consumer complaints also might be a productive area of inquiry for other health care settings such as hospitals and home health agencies.

Automated quality control in a file-based broadcasting workflow

NASA Astrophysics Data System (ADS)

Zhang, Lina

2014-04-01

Benefit from the development of information and internet technologies, television broadcasting is transforming from inefficient tape-based production and distribution to integrated file-based workflows. However, no matter how many changes have took place, successful broadcasting still depends on the ability to deliver a consistent high quality signal to the audiences. After the transition from tape to file, traditional methods of manual quality control (QC) become inadequate, subjective, and inefficient. Based on China Central Television's full file-based workflow in the new site, this paper introduces an automated quality control test system for accurate detection of hidden troubles in media contents. It discusses the system framework and workflow control when the automated QC is added. It puts forward a QC criterion and brings forth a QC software followed this criterion. It also does some experiments on QC speed by adopting parallel processing and distributed computing. The performance of the test system shows that the adoption of automated QC can make the production effective and efficient, and help the station to achieve a competitive advantage in the media market.

Redox agents and N-ethylmaleimide affect protein polymerization during laboratory scale dry pasta production and cooking.

PubMed

Bruneel, Charlotte; Buggenhout, Joke; Lagrain, Bert; Brijs, Kristof; Delcour, Jan A

2016-04-01

Durum wheat (Triticum durum Desf.) semolina gluten proteins consist of monomeric gliadin and polymeric glutenin and determine the quality of pasta products made therefrom. During pasta drying, glutenin starts polymerizing already below 60 °C (65% relative humidity (RH)), whereas gliadin only is incorporated in the protein network at temperatures exceeding 68 °C (68% RH) through thiol (SH)/disulfide (SS) exchange reactions. Removal of free SH groups in glutenin by adding 2.3 μmol KBrO3 or KIO3 per g dry matter semolina protein (g protein) or 13.8 μmol N-ethylmaleimide/g protein reduces gliadin-glutenin cross-linking during pasta drying and/or cooking and yields cooked pasta of high quality. Introducing free SH groups by adding 13.8 μmol glutathione/g protein increases gliadin-glutenin cross-linking during pasta processing, resulting in cooked pasta of lower quality. We hypothesize that too much gliadin incorporation in the glutenin network during pasta processing tightens the protein network and results in lower cooking quality. Copyright © 2015 Elsevier Ltd. All rights reserved.

Beyond image quality: designing engaging interactions with digital products

NASA Astrophysics Data System (ADS)

de Ridder, Huib; Rozendaal, Marco C.

2008-02-01

Ubiquitous computing (or Ambient Intelligence) promises a world in which information is available anytime anywhere and with which humans can interact in a natural, multimodal way. In such world, perceptual image quality remains an important criterion since most information will be displayed visually, but other criteria such as enjoyment, fun, engagement and hedonic quality are emerging. This paper deals with engagement, the intrinsically enjoyable readiness to put more effort into exploring and/or using a product than strictly required, thus attracting and keeping user's attention for a longer period of time. The impact of the experienced richness of an interface, both visually and degree of possible manipulations, was investigated in a series of experiments employing game-like user interfaces. This resulted in the extension of an existing conceptual framework relating engagement to richness by means of two intermediating variables, namely experienced challenge and sense of control. Predictions from this revised framework are evaluated against results of an earlier experiment assessing the ergonomic and hedonic qualities of interactive media. Test material consisted of interactive CD-ROM's containing presentations of three companies for future customers.

Strength and stiffness assessment of standing trees using a nondestructive stress wave technique.

Treesearch

Xiping Wang; Robert J. Ross; Michael McClellan; R. James Barbour; John R. Erickson; John W. Forsman; Gary D. McGinnis

Natureas engineering of wood through genetics, stand conditions, and environment creates wide variability in wood as a material, which in turn introduces difficulties in wood processing and utilization. Manufacturers sometimes find it difficult to consistently process wood into quality products because of its wide range of properties. The primary objective of this...

Forest seedling production in Israel

Treesearch

Nir Atzmon; David Brand

2002-01-01

Afforestation and reforestation in Israel are done on marginal lands, which consist of poor and shallow soils, with precipitation ranging from 650 mm in the north down to 200 mm in the south. Therefore, seedling quality is of great concern. All forest seedlings planted in Israel are produced by three forest nurseries which belong to the Forest Authority of Israel....

Negotiating the Context of Online In-Service Training: "Expert" and "Non-Expert" Footings

ERIC Educational Resources Information Center

Nilsen, Mona

2010-01-01

This paper focuses on how people working in the Swedish food production industry engage in in-service training by means of computer-mediated communication. The empirical material consists of archived chat log files from a course concerning quality assurance and food safety hazards control in the preparation and handling of foodstuff. Drawing on…

Performance Evaluation and Quality Validation System for Optical Gas Imaging Cameras that Visualize Fugitive Hydrocarbon Gas Emissions

EPA Science Inventory

A U.S. EPA team, consisting of the Office of Research and Development and Region 6 (Dallas) and Region 8 (Denver), deployed passive-diffusive sorbent tubes as part of a method evaluation study around one oil and natural gas production pad in both the Barnett Shale Basin in Texas ...

Design-Driven Innovation as Seen in a Worldwide Values-Based Curriculum

ERIC Educational Resources Information Center

Hadlock, Camey Andersen; McDonald, Jason K.

2014-01-01

While instructional design's technological roots have given it many approaches for process and product improvement, in most cases designers still rely on instructional forms that do not allow them to develop instruction of a quality consistent with that expressed by the field's visionary leaders. As a result, often the teachers and students using…

Strategies of performance self-monitoring in automotive production.

PubMed

Faye, Hélène; Falzon, Pierre

2009-09-01

Production in the automotive industry, based on assembly line work, is now characterized by lean manufacturing and customization. This results in greater flexibility and increased quality demands, including worker performance self-monitoring. The objectives of this study are to refine the concept of performance self-monitoring and to characterize the strategies developed by operators to achieve it. Data were collected based on the method of individual auto-confrontation, consisting of two steps: eleven assembly-line operators of a French automotive company were individually observed and video-taped while they were working; an interview then allowed each operator to discuss his/her activity based on the video-tape. This study expands the concept of performance self-monitoring by highlighting three types of strategies directly oriented toward quality: prevention, feedback control and control action strategies.

Quantity and/or Quality? The Importance of Publishing Many Papers

PubMed Central

van den Besselaar, Peter

2016-01-01

Do highly productive researchers have significantly higher probability to produce top cited papers? Or do high productive researchers mainly produce a sea of irrelevant papers—in other words do we find a diminishing marginal result from productivity? The answer on these questions is important, as it may help to answer the question of whether the increased competition and increased use of indicators for research evaluation and accountability focus has perverse effects or not. We use a Swedish author disambiguated dataset consisting of 48.000 researchers and their WoS-publications during the period of 2008–2011 with citations until 2014 to investigate the relation between productivity and production of highly cited papers. As the analysis shows, quantity does make a difference. PMID:27870854

Data collection automation and total quality management: case studies in the health-service industry.

PubMed

Smith, Alan D; Offodile, O Felix

2008-01-01

The limitations, immeasurable, and seemly unquantifiable aspects of the healthcare service industry, make it imperative that quality assurance programs include total quality management (TQM) and automatic identification and data capture (AIDC)-related technologies. Most of standards used in TQM and AIDC require data, to measure improvement and achieve standardization. Major difference between managing a service firm and managing a product-manufacturing firm is the difficulty of achieving consistently high quality. Examination of two different healthcare service providers in the Pittsburgh, Pennsylvania area offers different views as to the implementation and practice of total quality management techniques and AIDC integration. Since the healthcare service industry must take into account its high customization needs, there are positive steps to make the hospital structure itself more patient friendly and quality related; hence improving its heath-marketing strategies to the general public.

[JUSTIFICATION OF USING EQUIVALENCE OF THE INDICES OF QUALITY, SAFETY, AND EFFICACY IN DEVELOPING BIOANALOGS].

PubMed

Niyazov, R R; Goryachev, D V; Gavrishina, E V; Romodanovskii, D P; Dranitsyna, M A

2015-01-01

We describe general principles of demonstrating biosimilarity, as well as selecting the biosimilarity margins. Any change in the structure of a biological molecule can modify its functional activity. Therefore, therapeutic equivalence between a biosimilar product and the corresponding reference product cannot be demonstrated using a single criterion. To demonstrate biosimilarity between two medicinal products, their various characteristics have to be evaluated which may, directly or indirectly, justify that clinically significant differences are absent. Insufficient understanding of 6ritical quality attributes brings a risk for the biosimilar product developer. This will either increase the number of non-clinical and clinical tests and trials needed or will result in awareness that the manufacturing process needs to be improved at the late stages of development, after investing significant resources in the development process. At the same time, the specification of the biological medicinal product cannot solely ensure safety and efficacy thereof. Properly characterized and controlled manufacturing process, which ensures consistency in its attributes not adequately controlled in specifications but influencing safety and efficacy profiles and showing their relevance in non-clinical tests and clinical trials, is an additional quality assurance factor. Justification of all development strategy details, including biosimilarity margins, has to be provided each time when the development process is initiated or when proceeding to the next steps. All problems encountered by the developer have to be resolved in close communication with the regulatory authority. In order to increase the quality of investigation and developer's adherence to good practices, clinical trial results should be published in detail.

Recycling of inorganic nutrients for hydroponic crop production following incineration of inedible biomass.

PubMed

Bubenheim, D L; Wignarajah, K

1997-01-01

The goal of resource recovery in a regenerative life support system is maintenance of product quality to sure support of reliable and predictable levels of life support function performance by the crop plant component. Further, these systems must be maintained over extended periods of time, requiring maintenance of nutrient solutions to avoid toxicity and deficiencies. The focus of this study was to determine the suitability of the ash product following incineration of inedible biomass as a source of inorganic nutrients for hydroponic crop production. Inedible wheat biomass was incinerated and ash quality characterized. The incinerator ash was dissolved in adequate nitric acid to establish a consistent nitrogen concentration is all nutrient solution treatments. Four experimental nutrient treatments were included: control, ash only, ash supplemented to match the control treatment, and ash only quality formulated with reagent grade chemicals. When nutrient solutions were formulated using only ash following incineration of inedible biomass, a balance in solution is established representing elemental retention following incineration and nutrient proportions present in the original biomass. The resulting solution is not identical to the control. This imbalance resulted in a suppression of crop growth. When the ash is supplemented with reagent grade chemicals to establish the same balance as in the control--growth is identical to the control. The ash appears to carry no phytotoxic materials. Growth in solution formulated with reagent grade chemicals but matching the quality of the ash only treatment resulted in similar growth to that of the ash only treatment. The ash product resulting from incineration of inedible biomass appears to be a suitable form for recycle of inorganic nutrients to crop production.

Strengthening radiopharmacy practice in IAEA Member States.

PubMed

Duatti, Adriano; Bhonsle, Uday

2013-05-01

Radiopharmaceuticals are essential components of nuclear medicine procedures. Without radiopharmaceuticals nuclear medicine procedures cannot be performed. Therefore it could be said that 'No radiopharmaceutical-no nuclear medicine.' A good radiopharmacy practice supports nuclear medicine activities by producing radiopharmaceuticals that are safe and are of the required quality in a consistent way. As with any medicinal product, radiopharmaceuticals are required to be produced under carefully controlled conditions and are tested for their quality, prior to the administration to patients, using validated standard operating procedures. These procedures are based on the principles of Good Manufacturing Practice (GMP). The GMP principles are based on scientific knowledge and applicable regulatory requirements and guidance related to radiopharmaceutical productions and use. The International Atomic Energy Agency (IAEA) is committed to promote, in the Member States (MS), a rational and practical approach for the implementation of GMP for compounding or manufacturing of diagnostic or therapeutic radiopharmaceuticals. To pursue this goal the IAEA has developed various mechanisms and collaborations with individual experts in the field and with relevant national and international institutions or organizations. IAEA's activities in promoting radiopharmaceutical science include commissioning expert advice in the form of publications on radiopharmaceutical production, quality control and usage, producing technical guidance on production and regulatory aspects related to new radiopharmaceuticals, creating guidance documentation for self or internal audits of radiopharmaceutical production facilities, producing guidance on implementation of Quality Management System and GMP in radiopharmacy, assisting in creation of specific radiopharmaceutical monographs for the International Pharmacopoeia, and developing radiopharmacy-related human resource capabilities in MS through individual and regional training courses and education programs. IAEA strongly supports development of clinical nuclear medicine services by assisting MS in setting up reliable Radiopharmaceutical production facilities for single photon emission computed tomography, positron emission tomography, and for therapeutic applications. Copyright © 2013 Elsevier Inc. All rights reserved.

Consumers' attitudes towards GM Free products in a European Region. The case of the Prefecture of Drama-Kavala-Xanthi in Greece.

PubMed

Tsourgiannis, L; Karasavvoglou, A; Florou, G

2011-10-01

This study aims to identify the factors that affect consumers purchasing behaviour towards food products that are free from Genetic Modified Organism (GM Free) in a European Region and more precisely in the Prefecture of Drama-Kavala-Xanthi. Field interviews conducted in a random selected sample consisted of 337 consumers in the cities of Drama, Kavala, Xanthi, in November and December of 2009. Principal components analysis (PCA) was conducted in order to identify the factors that affect people in preferring consuming products that are GM Free. The factors that influence people in the study area to buy GM Free products are: (a) products' certification as GM Free or organic products, (b) interest about the protection of the environment and nutrition value, (c) marketing issues, and (d) price and quality. Furthermore, cluster and discriminant analysis identified two groups of consumers: (a) those are influenced by the product price, quality and marketing aspects and (b) those are interested in product's certification and environmental protection. Non parametric statistical bivariate techniques were performed to profile the identified groups of consumers regarding their personal characteristics and some other factors affecting their buying behaviour. Copyright © 2011. Published by Elsevier Ltd.

Hybrid modeling as a QbD/PAT tool in process development: an industrial E. coli case study.

PubMed

von Stosch, Moritz; Hamelink, Jan-Martijn; Oliveira, Rui

2016-05-01

Process understanding is emphasized in the process analytical technology initiative and the quality by design paradigm to be essential for manufacturing of biopharmaceutical products with consistent high quality. A typical approach to developing a process understanding is applying a combination of design of experiments with statistical data analysis. Hybrid semi-parametric modeling is investigated as an alternative method to pure statistical data analysis. The hybrid model framework provides flexibility to select model complexity based on available data and knowledge. Here, a parametric dynamic bioreactor model is integrated with a nonparametric artificial neural network that describes biomass and product formation rates as function of varied fed-batch fermentation conditions for high cell density heterologous protein production with E. coli. Our model can accurately describe biomass growth and product formation across variations in induction temperature, pH and feed rates. The model indicates that while product expression rate is a function of early induction phase conditions, it is negatively impacted as productivity increases. This could correspond with physiological changes due to cytoplasmic product accumulation. Due to the dynamic nature of the model, rational process timing decisions can be made and the impact of temporal variations in process parameters on product formation and process performance can be assessed, which is central for process understanding.

Application of a water quality model in the White Cart water catchment, Glasgow, UK.

PubMed

Liu, S; Tucker, P; Mansell, M; Hursthouse, A

2003-03-01

Water quality models of urban systems have previously focused on point source (sewerage system) inputs. Little attention has been given to diffuse inputs and research into diffuse pollution has been largely confined to agriculture sources. This paper reports on new research that is aimed at integrating diffuse inputs into an urban water quality model. An integrated model is introduced that is made up of four modules: hydrology, contaminant point sources, nutrient cycling and leaching. The hydrology module, T&T consists of a TOPMODEL (a TOPography-based hydrological MODEL), which simulates runoff from pervious areas and a two-tank model, which simulates runoff from impervious urban areas. Linked into the two-tank model, the contaminant point source module simulates the overflow from the sewerage system in heavy rain. The widely known SOILN (SOIL Nitrate model) is the basis of nitrogen cycle module. Finally, the leaching module consists of two functions: the production function and the transfer function. The production function is based on SLIM (Solute Leaching Intermediate Model) while the transfer function is based on the 'flushing hypothesis' which postulates a relationship between contaminant concentrations in the receiving water course and the extent to which the catchment is saturated. This paper outlines the modelling methodology and the model structures that have been developed. An application of this model in the White Cart catchment (Glasgow) is also included.

A first-generation software product line for data acquisition systems in astronomy

NASA Astrophysics Data System (ADS)

López-Ruiz, J. C.; Heradio, Rubén; Cerrada Somolinos, José Antonio; Coz Fernandez, José Ramón; López Ramos, Pablo

2008-07-01

This article presents a case study on developing a software product line for data acquisition systems in astronomy based on the Exemplar Driven Development methodology and the Exemplar Flexibilization Language tool. The main strategies to build the software product line are based on the domain commonality and variability, the incremental scope and the use of existing artifacts. It consists on a lean methodology with little impact on the organization, suitable for small projects, which reduces product line start-up time. Software Product Lines focuses on creating a family of products instead of individual products. This approach has spectacular benefits on reducing the time to market, maintaining the know-how, reducing the development costs and increasing the quality of new products. The maintenance of the products is also enhanced since all the data acquisition systems share the same product line architecture.

Rare earth element-enriched yeast improved egg production and egg quality in laying hens in the late period of peak egg production.

PubMed

Cai, L; Nyachoti, C M; Hancock, J D; Lee, J Y; Kim, Y H; Lee, D H; Kim, I H

2016-06-01

The objective of this study was to determine the effects of rare earth element-enriched yeast (RY) on egg production, coefficient of total tract apparent digestibility (CTTAD), egg quality, excreta gas emission and excreta microbiota of laying hens. A total of 216 ISA brown laying hens of 52 weeks of age were used in a 5-week feeding trial and data were collected every week. Birds were randomly allotted to three dietary treatments each with six replicates and 12 hens per replicate. Each cage (38 cm width × 50 cm length × 40 cm height) contained one hen. Treatments consisted of corn-soya bean meal-based diet supplemented with 0, 500 or 1000 mg/kg of RY. From weeks 55 to 56, inclusion of RY linearly increased (p < 0.05) egg production. The CTTAD of nitrogen was increased (linear, p < 0.05) with increasing dietary level of RY. In week 55, yolk height and Haugh units were increased linearly (p < 0.05) with increasing dietary RY content. However, no significant effects were observed in terms of excreta emissions and excreta microbiota in laying hens. In conclusion, dietary supplementation with RY improved egg production and CTTAD of nitrogen and slightly improved egg quality in laying hens of the late period of peak egg production. Journal of Animal Physiology and Animal Nutrition © 2015 Blackwell Verlag GmbH.

Breeding Strategy To Generate Robust Yeast Starter Cultures for Cocoa Pulp Fermentations

PubMed Central

Meersman, Esther; Steensels, Jan; Paulus, Tinneke; Struyf, Nore; Saels, Veerle; Mathawan, Melissa; Koffi, Jean; Vrancken, Gino

2015-01-01

Cocoa pulp fermentation is a spontaneous process during which the natural microbiota present at cocoa farms is allowed to ferment the pulp surrounding cocoa beans. Because such spontaneous fermentations are inconsistent and contribute to product variability, there is growing interest in a microbial starter culture that could be used to inoculate cocoa pulp fermentations. Previous studies have revealed that many different fungi are recovered from different batches of spontaneous cocoa pulp fermentations, whereas the variation in the prokaryotic microbiome is much more limited. In this study, therefore, we aimed to develop a suitable yeast starter culture that is able to outcompete wild contaminants and consistently produce high-quality chocolate. Starting from specifically selected Saccharomyces cerevisiae strains, we developed robust hybrids with characteristics that allow them to efficiently ferment cocoa pulp, including improved temperature tolerance and fermentation capacity. We conducted several laboratory and field trials to show that these new hybrids often outperform their parental strains and are able to dominate spontaneous pilot scale fermentations, which results in much more consistent microbial profiles. Moreover, analysis of the resulting chocolate showed that some of the cocoa batches that were fermented with specific starter cultures yielded superior chocolate. Taken together, these results describe the development of robust yeast starter cultures for cocoa pulp fermentations that can contribute to improving the consistency and quality of commercial chocolate production. PMID:26150457

Breeding Strategy To Generate Robust Yeast Starter Cultures for Cocoa Pulp Fermentations.

PubMed

Meersman, Esther; Steensels, Jan; Paulus, Tinneke; Struyf, Nore; Saels, Veerle; Mathawan, Melissa; Koffi, Jean; Vrancken, Gino; Verstrepen, Kevin J

2015-09-01

Cocoa pulp fermentation is a spontaneous process during which the natural microbiota present at cocoa farms is allowed to ferment the pulp surrounding cocoa beans. Because such spontaneous fermentations are inconsistent and contribute to product variability, there is growing interest in a microbial starter culture that could be used to inoculate cocoa pulp fermentations. Previous studies have revealed that many different fungi are recovered from different batches of spontaneous cocoa pulp fermentations, whereas the variation in the prokaryotic microbiome is much more limited. In this study, therefore, we aimed to develop a suitable yeast starter culture that is able to outcompete wild contaminants and consistently produce high-quality chocolate. Starting from specifically selected Saccharomyces cerevisiae strains, we developed robust hybrids with characteristics that allow them to efficiently ferment cocoa pulp, including improved temperature tolerance and fermentation capacity. We conducted several laboratory and field trials to show that these new hybrids often outperform their parental strains and are able to dominate spontaneous pilot scale fermentations, which results in much more consistent microbial profiles. Moreover, analysis of the resulting chocolate showed that some of the cocoa batches that were fermented with specific starter cultures yielded superior chocolate. Taken together, these results describe the development of robust yeast starter cultures for cocoa pulp fermentations that can contribute to improving the consistency and quality of commercial chocolate production. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Phase I of The National Beef Quality Audit-2011: quantifying willingness-to-pay, best-worst scaling, and current status of quality characteristics in different beef industry marketing sectors.

PubMed

Igo, J L; VanOverbeke, D L; Woerner, D R; Tatum, J D; Pendell, D L; Vedral, L L; Mafi, G G; Moore, M C; McKeith, R O; Gray, G D; Griffin, D B; Hale, D S; Savell, J W; Belk, K E

2013-04-01

The National Beef Quality Audit (NBQA)-2011 benchmarked the current status of and assessed progress being made toward quality and consistency of U.S. cattle, carcasses, and beef products after the completion of the first NBQA in 1991. Unlike previous NBQA, objectives of the 2011 Phase I study were to determine how each beef market sector defined 7 quality categories, estimate willingness-to-pay (WTP) for the same quality categories by market sector, and establish a best-worst (B/W) scaling for the quality categories. Structured face-to-face interviews were conducted and responses were recorded using dynamic routing software over an 11-mo period (February to December 2011) with decision makers in each of the following beef market sectors: Feeders (n = 59), Packers (n = 26), Food Service, Distribution, and Further Processors (n = 48), Retailers (n = 30), and Government and Allied Industries (n = 47). All respondents participated in a structured interview consisting of WTP and B/W questions that were tied to 7 quality categories and then were asked to "define" each of the 7 categories in terms of what the category meant to them, resulting in completely unbiased results. The 7 quality categories were a) how and where the cattle were raised, b) lean, fat, and bone, c) weight and size, d) cattle genetics, e) visual characteristics, f) food safety, and g) eating satisfaction. Overall, "food safety" and "eating satisfaction" were the categories of greatest and second most importance, respectively, to all beef market sectors except for Feeders. Feeders ranked "how and where the cattle were raised" and "weight and size" as the most important and second most important, respectively. Overall, "how and where the cattle were raised" had the greatest odds of being considered a nonnegotiable requirement before the raw material for each sector would be considered for purchase and was statistically more important (P < 0.05) as a requirement for purchase than all other categories except "food safety." When all market sectors were considered, "eating satisfaction" was shown to generate the greatest average WTP percentage premium (11.1%), but that WTP premium value only differed statistically (P < 0.05) from "weight and size" (8.8%). Most notably, when a sector said that "food safety" was a nonnegotiable requirement, no sector was willing to purchase the product at a discounted price if the "food safety" of the product could not be assured.

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar.

PubMed

Kim, Seokkyun; Song, Jinsu; Park, Seungkyu; Ham, Sunyoung; Paek, Kyungyeol; Kang, Minjung; Chae, Yunjung; Seo, Heewon; Kim, Hyung-Chan; Flores, Michael

A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019. For lots with expiry dates up to July 2018, a high degree of consistency was observed for all the tested properties. However, among the lots expiring in August 2018 or later, a downward drift was observed in %afucose (G0+G1+G2). Furthermore, the upward drift of %high mannose (M5+M6) was observed in the lots with expiry dates from June 2019 to December 2019. As a result, the combination of %afucose and %high mannose showed 2 marked drifts in the lots with expiry dates from August 2018 to December 2019, which was supported by the similar trend of biologic data, such as FcγRIIIa binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Considering that ADCC is one of the clinically relevant mechanisms of action for trastuzumab, the levels of %afucose and %high mannose should be tightly monitored as critical quality attributes for biosimilar development of trastuzumab.

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

PubMed Central

Kim, Seokkyun; Song, Jinsu; Park, Seungkyu; Ham, Sunyoung; Paek, Kyungyeol; Kang, Minjung; Chae, Yunjung; Seo, Heewon; Kim, Hyung-Chan; Flores, Michael

2017-01-01

ABSTRACT A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019. For lots with expiry dates up to July 2018, a high degree of consistency was observed for all the tested properties. However, among the lots expiring in August 2018 or later, a downward drift was observed in %afucose (G0+G1+G2). Furthermore, the upward drift of %high mannose (M5+M6) was observed in the lots with expiry dates from June 2019 to December 2019. As a result, the combination of %afucose and %high mannose showed 2 marked drifts in the lots with expiry dates from August 2018 to December 2019, which was supported by the similar trend of biologic data, such as FcγRIIIa binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Considering that ADCC is one of the clinically relevant mechanisms of action for trastuzumab, the levels of %afucose and %high mannose should be tightly monitored as critical quality attributes for biosimilar development of trastuzumab. PMID:28296619

Factors influencing the quality of Myrmecia pilosula (Jack Jumper) ant venom for use in in vitro and in vivo diagnoses of allergen sensitization and in allergen immunotherapy.

PubMed

Wanandy, T; Dwyer, H E; McLean, L; Davies, N W; Nichols, D; Gueven, N; Brown, S G A; Wiese, M D

2017-11-01

Allergen immunotherapy uses pharmaceutical preparations derived from naturally occurring source materials, which contain water-soluble allergenic components responsible for allergic reactions. The success of in vivo and in vitro diagnoses in allergen sensitization and allergen immunotherapy largely depends on the quality, composition and uniformity of allergenic materials used to produce the active ingredients, and the formulation employed to prepare finished products. We aimed to examine the factors influencing batch-to-batch consistency of Jack Jumper (Myrmecia pilosula) ant venom (JJAV) in the form of active pharmaceutical ingredient (AI) and informed whether factors such as temperature, artificial light and container materials influence the quality of JJAV AIs. We also aimed to establish handling and storage requirements of JJAV AIs to ensure preservation of allergenic activities during usage in the diagnosis of allergen sensitization and in allergen immunotherapy. The quality and consistency of JJAV AIs were analysed using a combination of bicinchoninic acid assay for total protein quantification, HPLC-UV for JJAV allergen peptides quantification, ELISA inhibition for total allergenic potency, SDS-PAGE, AU-PAGE and immunoblot for qualitative assessment of JJAV components, and Limulus Amebocyte Lysate assay for the quantification of endotoxin concentration. API-ZYM and Zymogram assays were used to probe the presence of enzymatic activities in JJAV. Pharmaceutical-grade JJAV for allergen immunotherapy has good batch-to-batch consistency. Temporary storage at 4°C and light exposure do not affect the quality of JJAV. Exposure to temperature above 40°C degrades high MW allergens in JJAV. Vials containing JJAV must be stored frozen and in upright position during long-term storage. We have identified factors, which can influence the quality and consistency of JJAV AIs, and provided a framework for appropriate handling, transporting and storage of JJAV to be used for the diagnosis of allergen sensitization and in AIT. © 2017 John Wiley & Sons Ltd.

ASAS Centennial Paper: Impact of animal science research on United States goat production and predictions for the future.

PubMed

Sahlu, T; Dawson, L J; Gipson, T A; Hart, S P; Merkel, R C; Puchala, R; Wang, Z; Zeng, S; Goetsch, A L

2009-01-01

Goat research in the United States has increased but at a rate less than that in production. Research on goat meat includes nutritional quality, packaging, color, sensory characteristics, and preslaughter management. Goat skins have value for leather, but quality of goat leather has not been extensively studied. Research in the production, quality, antibiotic residues, and sensory characteristics of goat milk and its products has aided development of the US dairy goat industry. Limited progress has been made in genetic improvement of milk or meat production. There is need to explore applications of genomics and proteomics and improve consistency in texture and functionality of goat cheeses. New goat meat and milk products are needed to increase demand and meet the diverse tastes of the American public. Despite research progress in control of mohair and cashmere growth, erratic prices and sale of raw materials have contributed to further declines in US production. Innovative and cooperative ventures are needed for profit sharing up to the consumer level. Internal parasites pose the greatest challenge to goat production in humid areas largely because of anthelmintic resistance. Study of alternative controls is required, including immunity enhancement via nutrition, vaccination, pasture management such as co-grazing with cattle, and genetic resistance. Similarly, the importance of health management is increasing related in part to a lack of effective vaccines for many diseases. Nutrition research should address requirements for vitamins and minerals, efficiencies of protein utilization, adjusting energy requirements for nutritional plane, acclimatization, and grazing conditions, feed intake prediction, and management practices for rapid-growth production systems. Moreover, efficient technology transfer methods are needed to disseminate current knowledge and that gained in future research.

Application of Optical Coherence Tomography Freeze-Drying Microscopy for Designing Lyophilization Process and Its Impact on Process Efficiency and Product Quality.

PubMed

Korang-Yeboah, Maxwell; Srinivasan, Charudharshini; Siddiqui, Akhtar; Awotwe-Otoo, David; Cruz, Celia N; Muhammad, Ashraf

2018-01-01

Optical coherence tomography freeze-drying microscopy (OCT-FDM) is a novel technique that allows the three-dimensional imaging of a drug product during the entire lyophilization process. OCT-FDM consists of a single-vial freeze dryer (SVFD) affixed with an optical coherence tomography (OCT) imaging system. Unlike the conventional techniques, such as modulated differential scanning calorimetry (mDSC) and light transmission freeze-drying microscopy, used for predicting the product collapse temperature (Tc), the OCT-FDM approach seeks to mimic the actual product and process conditions during the lyophilization process. However, there is limited understanding on the application of this emerging technique to the design of the lyophilization process. In this study, we investigated the suitability of OCT-FDM technique in designing a lyophilization process. Moreover, we compared the product quality attributes of the resulting lyophilized product manufactured using Tc, a critical process control parameter, as determined by OCT-FDM versus as estimated by mDSC. OCT-FDM analysis revealed the absence of collapse even for the low protein concentration (5 mg/ml) and low solid content formulation (1%w/v) studied. This was confirmed by lab scale lyophilization. In addition, lyophilization cycles designed using Tc values obtained from OCT-FDM were more efficient with higher sublimation rate and mass flux than the conventional cycles, since drying was conducted at higher shelf temperature. Finally, the quality attributes of the products lyophilized using Tc determined by OCT-FDM and mDSC were similar, and product shrinkage and cracks were observed in all the batches of freeze-dried products irrespective of the technique employed in predicting Tc.

Ethnopedology and soil quality of bamboo (Bambusa sp.) based agroforestry system.

PubMed

Arun Jyoti, Nath; Lal, Rattan; Das, Ashesh Kumar

2015-07-15

It is widely recognized that farmers' hold important knowledge of folk soil classification for agricultural land for its uses, yet little has been studied for traditional agroforestry systems. This article explores the ethnopedology of bamboo (Bambusa sp.) based agroforestry system in North East India, and establishes the relationship of soil quality index (SQI) with bamboo productivity. The study revealed four basic folk soil (mati) types: kalo (black soil), lal (red soil), pathal (stony soil) and balu (sandy soil). Of these, lal mati soil was the most predominant soil type (~ 40%) in bamboo-based agroforestry system. Soil physio-chemical parameters were studied to validate the farmers' soil hierarchal classification and also to correlate with productivity of the bamboo stand. Farmers' hierarchal folk soil classification was consistent with the laboratory scientific analysis. Culm production (i.e. measure of productivity of bamboo) was the highest (27culmsclump(-1)) in kalo mati (black soil) and the lowest (19culmsclump(-1)) in balu mati (sandy soil). Linear correlation of individual soil quality parameter with bamboo productivity explained 16 to 49% of the variability. A multiple correlation of the best fitted linear soil quality parameter (soil organic carbon or SOC, water holding capacity or WHC, total nitrogen) with productivity improved explanatory power to 53%. Development of SQI from ten relevant soil quality parameters and its correlation with bamboo productivity explained the 64% of the variation and therefore, suggest SQI as the best determinant of bamboo yield. Data presented indicate that the kalo mati (black soil) is sustainable or sustainable with high input. However, the other three folk soil types (red, stony and sandy soil) are also sustainable but for other land uses. Therefore, ethnopedological studies may move beyond routine laboratory analysis and incorporate SQI for assessing the sustainability of land uses managed by the farmers'. Additional research is required to incorporate principal component analysis for improving the SQI and site potential assessment. It is also important to evaluate the minimum data set (MDS) required for SQI and productivity assessment in agroforestry systems. Copyright © 2015 Elsevier B.V. All rights reserved.

Improving production efficiency in the presence of genotype by environment interactions in pig genomic selection breeding programmes.

PubMed

Nirea, K G; Meuwissen, T H E

2017-04-01

We simulated a genomic selection pig breeding schemes containing nucleus and production herds to improve feed efficiency of production pigs that were cross-breed. Elite nucleus herds had access to high-quality feed, and production herds were fed low-quality feed. Feed efficiency in the nucleus herds had a heritability of 0.3 and 0.25 in the production herds. It was assumed the genetic relationships between feed efficiency in the nucleus and production were low (r g  = 0.2), medium (r g  = 0.5) and high (r g  = 0.8). In our alternative breeding schemes, different proportion of production animals were recorded for feed efficiency and genotyped with high-density panel of genetic markers. Genomic breeding value of the selection candidates for feed efficiency was estimated based on three different approaches. In one approach, genomic breeding value was estimated including nucleus animals in the reference population. In the second approach, the reference population was containing a mixture of nucleus and production animals. In the third approach, the reference population was only consisting of production herds. Using a mixture reference population, we generated 40-115% more genetic gain in the production environment as compared to only using nucleus reference population that were fed high-quality feed sources when the production animals were offspring of the nucleus animals. When the production animals were grand offspring of the nucleus animals, 43-104% more genetic gain was generated. Similarly, a higher genetic gain generated in the production environment when mixed reference population was used as compared to only using production animals. This was up to 19 and 14% when the production animals were offspring and grand offspring of nucleus animals, respectively. Therefore, in genomic selection pig breeding programmes, feed efficiency traits could be improved by properly designing the reference population. © 2016 Blackwell Verlag GmbH.

Intercomparison and validation of MODIS and GLASS leaf area index (LAI) products over mountain areas: A case study in southwestern China

NASA Astrophysics Data System (ADS)

Jin, Huaan; Li, Ainong; Bian, Jinhu; Nan, Xi; Zhao, Wei; Zhang, Zhengjian; Yin, Gaofei

2017-03-01

The validation study of leaf area index (LAI) products over rugged surfaces not only gives additional insights into data quality of LAI products, but deepens understanding of uncertainties regarding land surface process models depended on LAI data over complex terrain. This study evaluated the performance of MODIS and GLASS LAI products using the intercomparison and direct validation methods over southwestern China. The spatio-temporal consistencies, such as the spatial distributions of LAI products and their statistical relationship as a function of topographic indices, time, and vegetation types, respectively, were investigated through intercomparison between MODIS and GLASS products during the period 2011-2013. The accuracies and change ranges of these two products were evaluated against available LAI reference maps over 10 sampling regions which standed for typical vegetation types and topographic gradients in southwestern China. The results show that GLASS LAI exhibits higher percentage of good quality data (i.e. successful retrievals) and smoother temporal profiles than MODIS LAI. The percentage of successful retrievals for MODIS and GLASS is vulnerable to topographic indices, especially to relief amplitude. Besides, the two products do not capture seasonal dynamics of crop, especially in spring over heterogeneously hilly regions. The yearly mean LAI differences between MODIS and GLASS are within ±0.5 for 64.70% of the total retrieval pixels over southwestern China. The spatial distribution of mean differences and temporal profiles of these two products are inclined to be dominated by vegetation types other than topographic indices. The spatial and temporal consistency of these two products is good over most area of grasses/cereal crops; however, it is poor for evergreen broadleaf forest. MODIS presents more reliable change range of LAI than GLASS through comparison with fine resolution reference maps over most of sampling regions. The accuracies of direct validation are obtained for GLASS LAI (r = 0.35, RMSE = 1.72, mean bias = -0.71) and MODIS LAI (r = 0.49, RMSE = 1.75, mean bias = -0.67). GLASS performs similarly to MODIS, but may be marginally inferior to MODIS based on our direct validation results. The validation experience demonstrates the necessity and importance of topographic consideration for LAI estimation over mountain areas. Considerable attention will be paid to the improvements of surface reflectance, retrieval algorithm and land cover types so as to enhance the quality of LAI products in topographically complex terrain.

Precision oncology using a limited number of cells: optimization of whole genome amplification products for sequencing applications.

PubMed

Sho, Shonan; Court, Colin M; Winograd, Paul; Lee, Sangjun; Hou, Shuang; Graeber, Thomas G; Tseng, Hsian-Rong; Tomlinson, James S

2017-07-01

Sequencing analysis of circulating tumor cells (CTCs) enables "liquid biopsy" to guide precision oncology strategies. However, this requires low-template whole genome amplification (WGA) that is prone to errors and biases from uneven amplifications. Currently, quality control (QC) methods for WGA products, as well as the number of CTCs needed for reliable downstream sequencing, remain poorly defined. We sought to define strategies for selecting and generating optimal WGA products from low-template input as it relates to their potential applications in precision oncology strategies. Single pancreatic cancer cells (HPAF-II) were isolated using laser microdissection. WGA was performed using multiple displacement amplification (MDA), multiple annealing and looping based amplification (MALBAC) and PicoPLEX. Quality of amplified DNA products were assessed using a multiplex/RT-qPCR based method that evaluates for 8-cancer related genes and QC-scores were assigned. We utilized this scoring system to assess the impact of de novo modifications to the WGA protocol. WGA products were subjected to Sanger sequencing, array comparative genomic hybridization (aCGH) and next generation sequencing (NGS) to evaluate their performances in respective downstream analyses providing validation of the QC-score. Single-cell WGA products exhibited a significant sample-to-sample variability in amplified DNA quality as assessed by our 8-gene QC assay. Single-cell WGA products that passed the pre-analysis QC had lower amplification bias and improved aCGH/NGS performance metrics when compared to single-cell WGA products that failed the QC. Increasing the number of cellular input resulted in improved QC-scores overall, but a resultant WGA product that consistently passed the QC step required a starting cellular input of at least 20-cells. Our modified-WGA protocol effectively reduced this number, achieving reproducible high-quality WGA products from ≥5-cells as a starting template. A starting cellular input of 5 to 10-cells amplified using the modified-WGA achieved aCGH and NGS results that closely matched that of unamplified, batch genomic DNA. The modified-WGA protocol coupled with the 8-gene QC serve as an effective strategy to enhance the quality of low-template WGA reactions. Furthermore, a threshold number of 5-10 cells are likely needed for a reliable WGA reaction and product with high fidelity to the original starting template.

Novel wine yeast with mutations in YAP1 that produce less acetic acid during fermentation.

PubMed

Cordente, Antonio G; Cordero-Bueso, Gustavo; Pretorius, Isak S; Curtin, Christopher D

2013-02-01

Acetic acid, a byproduct formed during yeast alcoholic fermentation, is the main component of volatile acidity (VA). When present in high concentrations in wine, acetic acid imparts an undesirable 'vinegary' character that results in a significant reduction in quality and sales. Previously, it has been shown that saké yeast strains resistant to the antifungal cerulenin produce significantly lower levels of VA. In this study, we used a classical mutagenesis method to isolate a series of cerulenin-resistant strains, derived from a commercial diploid wine yeast. Four of the selected strains showed a consistent low-VA production phenotype after small-scale fermentation of different white and red grape musts. Specific mutations in YAP1, a gene encoding a transcription factor required for oxidative stress tolerance, were found in three of the four low-VA strains. When integrated into the genome of a haploid wine strain, the mutated YAP1 alleles partially reproduced the low-VA production phenotype of the diploid cerulenin-resistant strains, suggesting that YAP1 might play a role in (regulating) acetic acid production during fermentation. This study offers prospects for the development of low-VA wine yeast starter strains that could assist winemakers in their effort to consistently produce wine to definable quality specifications. © 2012 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd. All rights reserved.

Influence of irrigation during the growth stage on yield and quality in mango (Mangifera indica L)

PubMed Central

Wei, Junya; Liu, Guoyin; Liu, Debing; Chen, Yeyuan

2017-01-01

Although being one of the few drought-tolerant plants, mango trees are irrigated to ensure optimum and consistent productivity in China. In order to better understand the effects of soil water content on mango yield and fruit quality at fruit growth stage, irrigation experiments were investigated and the object was to determine the soil water content criteria at which growth and quality of mango would be optimal based on soil water measured by RHD-JS water-saving irrigation system through micro-sprinkling irrigation. Five soil water content treatments (relative to the percentage of field water capacity) for irrigation (T1:79%-82%, T2:75%-78%, T3:71%-74%, T4: 65%-70%, T5:63%-66%) were compared in 2013. Amount of applied irrigation water for different treatments varied from 2.93m3 to 1.08 m3. The results showed that mango fruit production and quality at fruit growth stage were significantly affected under different irrigation water amounts. Variation in soil water content not only had effects on fruit size, but also on fruit yield. The highest fruit yield and irrigation water use efficiency were obtained from the T4 treatment. Irrigation water amount also affected fruit quality parameters like fruit total soluble solids, soluble sugar, starch, titratable acid and vitamin C content. Comprehensive evaluation of the effect of indexs of correlation on irrigation treatment by subordinate function showed that when the soil moisture content were controlled at about 65–70% of the field water moisture capacity, water demand in the growth and development of mango could be ensured, and maximum production efficiency of irrigation and the best quality of fruit could be achieved. In conclusion, treatment T4 was the optimum irrigation schedule for growing mango, thus achieving efficient production of mango in consideration of the compromise among mango yield, fruit quality and water use efficiency. PMID:28384647

Influence of irrigation during the growth stage on yield and quality in mango (Mangifera indica L).

PubMed

Wei, Junya; Liu, Guoyin; Liu, Debing; Chen, Yeyuan

2017-01-01

Although being one of the few drought-tolerant plants, mango trees are irrigated to ensure optimum and consistent productivity in China. In order to better understand the effects of soil water content on mango yield and fruit quality at fruit growth stage, irrigation experiments were investigated and the object was to determine the soil water content criteria at which growth and quality of mango would be optimal based on soil water measured by RHD-JS water-saving irrigation system through micro-sprinkling irrigation. Five soil water content treatments (relative to the percentage of field water capacity) for irrigation (T1:79%-82%, T2:75%-78%, T3:71%-74%, T4: 65%-70%, T5:63%-66%) were compared in 2013. Amount of applied irrigation water for different treatments varied from 2.93m3 to 1.08 m3. The results showed that mango fruit production and quality at fruit growth stage were significantly affected under different irrigation water amounts. Variation in soil water content not only had effects on fruit size, but also on fruit yield. The highest fruit yield and irrigation water use efficiency were obtained from the T4 treatment. Irrigation water amount also affected fruit quality parameters like fruit total soluble solids, soluble sugar, starch, titratable acid and vitamin C content. Comprehensive evaluation of the effect of indexs of correlation on irrigation treatment by subordinate function showed that when the soil moisture content were controlled at about 65-70% of the field water moisture capacity, water demand in the growth and development of mango could be ensured, and maximum production efficiency of irrigation and the best quality of fruit could be achieved. In conclusion, treatment T4 was the optimum irrigation schedule for growing mango, thus achieving efficient production of mango in consideration of the compromise among mango yield, fruit quality and water use efficiency.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space.

PubMed

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Main object of this quality risk management (QRM) study is to provide a sophisticated "robust and rugged" Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. THIS STUDY IS PRINCIPALLY FOCUSING ON THOROUGH MECHANISTIC UNDERSTANDING OF THE FBP BY WHICH IT IS DEVELOPED AND SCALED UP WITH A KNOWLEDGE OF THE CRITICAL RISKS INVOLVED IN MANUFACTURING PROCESS ANALYZED BY RISK ASSESSMENT TOOLS LIKE: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space

PubMed Central

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Introduction: Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Materials and Methods: Main object of this quality risk management (QRM) study is to provide a sophisticated “robust and rugged” Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. Results and Conclusion: This study is principally focusing on thorough mechanistic understanding of the FBP by which it is developed and scaled up with a knowledge of the critical risks involved in manufacturing process analyzed by risk assessment tools like: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale. PMID:23799202

Managing a closed-loop supply chain inventory system with learning effects

NASA Astrophysics Data System (ADS)

Jauhari, Wakhid Ahmad; Dwicahyani, Anindya Rachma; Hendaryani, Oktiviandri; Kurdhi, Nughthoh Arfawi

2018-02-01

In this paper, we propose a closed-loop supply chain model consisting of a retailer and a manufacturer. We intend to investigate the impact of learning in regular production, remanufacturing and reworking. The customer demand is assumed deterministic and will be satisfied from both regular production and remanufacturing process. The return rate of used items depends on quality. We propose a mathematical model with the objective is to maximize the joint total profit by simultaneously determining the length of ordering cycle for the retailer and the number of regular production and remanufacturing cycle. The algorithm is suggested for finding the optimal solution. A numerical example is presented to illustrate the application of using a proposed model. The results show that the integrated model performs better in reducing total cost compared to the independent model. The total cost is most affected by the changes in the values of unit production cost and acceptable quality level. In addition, the changes in the defective items proportion and the fraction of holding costs significantly influence the retailer's ordering period.

Role of Litter Turnover in Soil Quality in Tropical Degraded Lands of Colombia

PubMed Central

León, Juan D.; Osorio, Nelson W.

2014-01-01

Land degradation is the result of soil mismanagement that reduces soil productivity and environmental services. An alternative to improve degraded soils through reactivation of biogeochemical nutrient cycles (via litter production and decomposition) is the establishment of active restoration models using new forestry plantations, agroforestry, and silvopastoral systems. On the other hand, passive models of restoration consist of promoting natural successional processes with native plants. The objective in this review is to discuss the role of litter production and decomposition as a key strategy to reactivate biogeochemical nutrient cycles and thus improve soil quality in degraded land of the tropics. For this purpose the results of different projects of land restoration in Colombia are presented based on the dynamics of litter production, nutrient content, and decomposition. The results indicate that in only 6–13 years it is possible to detect soil properties improvements due to litter fall and decomposition. Despite that, low soil nutrient availability, particularly of N and P, seems to be major constraint to reclamation of these fragile ecosystems. PMID:24696656

NCCDS configuration management process improvement

NASA Technical Reports Server (NTRS)

Shay, Kathy

1993-01-01

By concentrating on defining and improving specific Configuration Management (CM) functions, processes, procedures, personnel selection/development, and tools, internal and external customers received improved CM services. Job performance within the section increased in both satisfaction and output. Participation in achieving major improvements has led to the delivery of consistent quality CM products as well as significant decreases in every measured CM metrics category.

Quality, Social Justice and Accountability in Education Worldwide. BCES Conference Books, Volume 13. Number 1

ERIC Educational Resources Information Center

Popov, Nikolay, Ed.; Wolhuter, Charl, Ed.; Ermenc, Klara Skubic, Ed.; Hilton, Gillian, Ed.; Ogunleye, James, Ed.; Niemczyk, Ewelina, Ed.

2015-01-01

The Annual International Conference of the Bulgarian Comparative Education Society is now running in its thirteenth year. From its modest beginnings thirteen years ago, to its impressive size today, a tradition has been the production of a conference book, consistently launched on the first day of the conference each year. This year, Volume 13 of…

Dividing Practices: Preservice Teacher Quality Assessment and the (Re)production of Relations between General and Special Education

ERIC Educational Resources Information Center

Pugach, Marleen C.; Peck, Charles

2016-01-01

Promoting the education of children with disabilities in general education classrooms has been a clear and consistent goal of federal education policy since the enactment of the Individuals With Disabilities Education Act (IDEA) over forty years ago. However, among the many challenges to achieving this goal, one of the most persistent has been the…

Mekong Land Cover Dasboard: Regional Land Cover Mointoring Systems

NASA Astrophysics Data System (ADS)

Saah, D. S.; Towashiraporn, P.; Aekakkararungroj, A.; Phongsapan, K.; Triepke, J.; Maus, P.; Tenneson, K.; Cutter, P. G.; Ganz, D.; Anderson, E.

2016-12-01

SERVIR-Mekong, a USAID-NASA partnership, helps decision makers in the Lower Mekong Region utilize GIS and Remote Sensing information to inform climate related activities. In 2015, SERVIR-Mekong conducted a geospatial needs assessment for the Lower Mekong countries which included individual country consultations. The team found that many countries were dependent on land cover and land use maps for land resource planning, quantifying ecosystem services, including resilience to climate change, biodiversity conservation, and other critical social issues. Many of the Lower Mekong countries have developed national scale land cover maps derived in part from remote sensing products and geospatial technologies. However, updates are infrequent and classification systems do not always meet the needs of key user groups. In addition, data products stop at political boundaries and are often not accessible making the data unusable across country boundaries and with resource management partners. Many of these countries rely on global land cover products to fill the gaps of their national efforts, compromising consistency between data and policies. These gaps in national efforts can be filled by a flexible regional land cover monitoring system that is co-developed by regional partners with the specific intention of meeting national transboundary needs, for example including consistent forest definitions in transboundary watersheds. Based on these facts, key regional stakeholders identified a need for a land cover monitoring system that will produce frequent, high quality land cover maps using a consistent regional classification scheme that is compatible with national country needs. SERVIR-Mekong is currently developing a solution that leverages recent developments in remote sensing science and technology, such as Google Earth Engine (GEE), and working together with production partners to develop a system that will use a common set of input data sources to generate high-quality regional land cover maps on a regular basis that are consistent and continuous across the landscape. The system is being designed to facilitate improved policy, planning, and decision making by a wide range of users (such as government agencies, local community groups, non-profit organizations, and the private sector).

Analysis of the isoprene chemistry observed during the New England Air Quality Study (NEAQS) 2002 intensive experiment

NASA Astrophysics Data System (ADS)

Roberts, James M.; Marchewka, Mathew; Bertman, Steven B.; Goldan, Paul; Kuster, William; de Gouw, Joost; Warneke, Carsten; Williams, Eric; Lerner, Brian; Murphy, Paul; Apel, Eric; Fehsenfeld, Fred C.

2006-12-01

Isoprene and its first and second generation photochemical products, methyl vinyl ketone (MVK), methacrolein (MACR), and peroxymethacrylic nitric anhydride (MPAN), were measured off the coast of New England during the 2002 New England Air Quality Study (NEAQS) on board the NOAA Research Vessel Ronald H. Brown. The results of these measurements were analyzed using a simple sequential reaction model that has been used previously to examine regional oxidant chemistry. The highest isoprene impact was observed in air masses that had passed over an area of high isoprene emission WSW of Boston. The relative concentrations of isoprene and its first generation products show that the photochemistry is consistently "older" than the isoprene photochemistry observed at continental sites. The sequential reaction model was also applied to the aldehyde-PANs (Peroxycarboxylic nitric anhydride) system, and the resulting PPN (peroxypropionic nitric anhydride)/propanal and PAN (peroxyacetic nitric anhydride)/acetaldehyde relationships were consistent with additional sources of PAN in this environment, e.g., isoprene photochemistry. This isoprene source was estimated to result in approximately 1.6 to 4 times more PAN in this environment relative to that produced from anthropogenic VOCs (volatile organic compounds) alone.

Evaluation of the Sensor Data Record from the Nadir Instruments of the Ozone Mapping Profiler Suite (OMPS)

NASA Technical Reports Server (NTRS)

Wu, Xiangqian; Liu, Quanhua; Zeng, Jian; Grotenhuis, Michael; Qian, Haifeng; Caponi, Maria; Flynn, Larry; Jaross, Glen; Sen, Bhaswar; Buss, Richard H., Jr.;

Identification of milling and baking quality QTL in multiple soft wheat mapping populations.

PubMed

Cabrera, Antonio; Guttieri, Mary; Smith, Nathan; Souza, Edward; Sturbaum, Anne; Hua, Duc; Griffey, Carl; Barnett, Marla; Murphy, Paul; Ohm, Herb; Uphaus, Jim; Sorrells, Mark; Heffner, Elliot; Brown-Guedira, Gina; Van Sanford, David; Sneller, Clay

2015-11-01

Two mapping approaches were use to identify and validate milling and baking quality QTL in soft wheat. Two LG were consistently found important for multiple traits and we recommend the use marker-assisted selection on specific markers reported here. Wheat-derived food products require a range of characteristics. Identification and understanding of the genetic components controlling end-use quality of wheat is important for crop improvement. We assessed the underlying genetics controlling specific milling and baking quality parameters of soft wheat including flour yield, softness equivalent, flour protein, sucrose, sodium carbonate, water absorption and lactic acid, solvent retention capacities in a diversity panel and five bi-parental mapping populations. The populations were genotyped with SSR and DArT markers, with markers specific for the 1BL.1RS translocation and sucrose synthase gene. Association analysis and composite interval mapping were performed to identify quantitative trait loci (QTL). High heritability was observed for each of the traits evaluated, trait correlations were consistent over populations, and transgressive segregants were common in all bi-parental populations. A total of 26 regions were identified as potential QTL in the diversity panel and 74 QTL were identified across all five bi-parental mapping populations. Collinearity of QTL from chromosomes 1B and 2B was observed across mapping populations and was consistent with results from the association analysis in the diversity panel. Multiple regression analysis showed the importance of the two 1B and 2B regions and marker-assisted selection for the favorable alleles at these regions should improve quality.

Improved quantification of important beer quality parameters based on nonlinear calibration methods applied to FT-MIR spectra.

PubMed

Cernuda, Carlos; Lughofer, Edwin; Klein, Helmut; Forster, Clemens; Pawliczek, Marcin; Brandstetter, Markus

2017-01-01

During the production process of beer, it is of utmost importance to guarantee a high consistency of the beer quality. For instance, the bitterness is an essential quality parameter which has to be controlled within the specifications at the beginning of the production process in the unfermented beer (wort) as well as in final products such as beer and beer mix beverages. Nowadays, analytical techniques for quality control in beer production are mainly based on manual supervision, i.e., samples are taken from the process and analyzed in the laboratory. This typically requires significant lab technicians efforts for only a small fraction of samples to be analyzed, which leads to significant costs for beer breweries and companies. Fourier transform mid-infrared (FT-MIR) spectroscopy was used in combination with nonlinear multivariate calibration techniques to overcome (i) the time consuming off-line analyses in beer production and (ii) already known limitations of standard linear chemometric methods, like partial least squares (PLS), for important quality parameters Speers et al. (J I Brewing. 2003;109(3):229-235), Zhang et al. (J I Brewing. 2012;118(4):361-367) such as bitterness, citric acid, total acids, free amino nitrogen, final attenuation, or foam stability. The calibration models are established with enhanced nonlinear techniques based (i) on a new piece-wise linear version of PLS by employing fuzzy rules for local partitioning the latent variable space and (ii) on extensions of support vector regression variants (-PLSSVR and ν-PLSSVR), for overcoming high computation times in high-dimensional problems and time-intensive and inappropriate settings of the kernel parameters. Furthermore, we introduce a new model selection scheme based on bagged ensembles in order to improve robustness and thus predictive quality of the final models. The approaches are tested on real-world calibration data sets for wort and beer mix beverages, and successfully compared to linear methods, showing a clear out-performance in most cases and being able to meet the model quality requirements defined by the experts at the beer company. Figure Workflow for calibration of non-Linear model ensembles from FT-MIR spectra in beer production .

Global Ocean Data Quality Assessment of SARAL/AltiKa GDR products

NASA Astrophysics Data System (ADS)

Picot, Nicolas; Prandi, Pierre; desjonqueres, jean-damien

2015-04-01

The SARAL mission was successfully launched on February, 5th 2013 and cycle 1 started a few days later on March 14th. For more than 2 years, the Ka-band altimeter and dual frequency radiometer on board have been collecting high quality ocean topography measurements. Within the first months of the mission, a first patch (P1) was developed to correct some small anomalies detected in the products and to account for in-flight calibration data. At the beginning of year 2014, a second patch (P2) was produced (applied from cycle 10 pass 407 on OGDR data and from pass 566 on IGDR data) and the all GDR produced before this were reprocessed in order to deliver a consistent dataset to users. This new version of the products provides, among other changes, important improvements regarding radiometer data processing, sea-state bias and wind speed. Since the beginning of the mission, data quality assessment of OGDR, IGDR and GDR data has been routinely performed at CNES and CLS (as part of the CNES SALP project). We will present the main results of the data quality assessment over ocean based on SARAL/AltiKa GDR data reprocessed using the homogeneous P2 version. The main data quality metrics presented will include: Data availability and validity, Monitoring of the main altimeter and radiometer parameters and comparisons to other altimeter missions such as OSTM/Jason-2, Mission performance through mono-mission crossovers analysis, Investigation of inter-mission biases and large-scale regional differences from multi-mission crossovers between SARAL and Jason-2. Monitoring of the global mean SLA and comparison to Jason-2 Finally, we will present the new product version standard that is currently under development on CNES side.

Implementation of hazard analysis and critical control point (HACCP) in dried anchovy production process

NASA Astrophysics Data System (ADS)

Citraresmi, A. D. P.; Wahyuni, E. E.

2018-03-01

The aim of this study was to inspect the implementation of Hazard Analysis and Critical Control Point (HACCP) for identification and prevention of potential hazards in the production process of dried anchovy at PT. Kelola Mina Laut (KML), Lobuk unit, Sumenep. Cold storage process is needed in each anchovy processing step in order to maintain its physical and chemical condition. In addition, the implementation of quality assurance system should be undertaken to maintain product quality. The research was conducted using a survey method, by following the whole process of making anchovy from the receiving raw materials to the packaging of final product. The method of data analysis used was descriptive analysis method. Implementation of HACCP at PT. KML, Lobuk unit, Sumenep was conducted by applying Pre Requisite Programs (PRP) and preparation stage consisting of 5 initial stages and 7 principles of HACCP. The results showed that CCP was found in boiling process flow with significant hazard of Listeria monocytogenesis bacteria and final sorting process with significant hazard of foreign material contamination in the product. Actions taken were controlling boiling temperature of 100 – 105°C for 3 - 5 minutes and training for sorting process employees.

Elements of the quality management in the materials' industry

NASA Astrophysics Data System (ADS)

Ioana, Adrian; Semenescu, Augustin; Costoiu, Mihnea; Marcu, Dragoş

2017-12-01

The criteria function concept consists of transforming the criteria function (CF) in a quality-economical matrix math MQE. The levels of prescribing the criteria function was obtained by using a composition algorithm for three vectors: T¯ vector - technical parameters' vector (ti); Ē vector - economical parameters' vector (ej) and P¯ vector - weight vector (p1). For each product or service, the area of the circle represents the value of its sales. The BCG Matrix thus offers a very useful map of the organization's service strengths and weaknesses, at least in terms of current profitability, as well as the likely cash flows.

Avian artificial insemination and semen preservation

USGS Publications Warehouse

Gee, G.F.; Risser, Arthur C.; Todd, Frank S.

1983-01-01

Summary: Artificial insemination is a practical propagation tool that has been successful with a variety of birds. Cooperative, massage, and electroejaculation and modifications of these three basic methods of semen collection are described for a variety of birds. Semen color and consistency and sperm number, moti!ity, and morphology, as discussed, are useful indicators of semen quality, but the most reliable test of semen quality is the production of fertile eggs. Successful cryogenic preservation of avian semen with DMSO or glycerol as the cryoprotectant has been possible. Although the methods for preservation require special equipment, use of frozen semen requires only simple insemination supplies

Multivariate statistical process control in product quality review assessment - A case study.

PubMed

Kharbach, M; Cherrah, Y; Vander Heyden, Y; Bouklouze, A

2017-11-01

According to the Food and Drug Administration and the European Good Manufacturing Practices (GMP) guidelines, Annual Product Review (APR) is a mandatory requirement in GMP. It consists of evaluating a large collection of qualitative or quantitative data in order to verify the consistency of an existing process. According to the Code of Federal Regulation Part 11 (21 CFR 211.180), all finished products should be reviewed annually for the quality standards to determine the need of any change in specification or manufacturing of drug products. Conventional Statistical Process Control (SPC) evaluates the pharmaceutical production process by examining only the effect of a single factor at the time using a Shewhart's chart. It neglects to take into account the interaction between the variables. In order to overcome this issue, Multivariate Statistical Process Control (MSPC) can be used. Our case study concerns an APR assessment, where 164 historical batches containing six active ingredients, manufactured in Morocco, were collected during one year. Each batch has been checked by assaying the six active ingredients by High Performance Liquid Chromatography according to European Pharmacopoeia monographs. The data matrix was evaluated both by SPC and MSPC. The SPC indicated that all batches are under control, while the MSPC, based on Principal Component Analysis (PCA), for the data being either autoscaled or robust scaled, showed four and seven batches, respectively, out of the Hotelling T 2 95% ellipse. Also, an improvement of the capability of the process is observed without the most extreme batches. The MSPC can be used for monitoring subtle changes in the manufacturing process during an APR assessment. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Integrated continuous processing of proteins expressed as inclusion bodies: GCSF as a case study.

PubMed

Kateja, Nikhil; Agarwal, Harshit; Hebbi, Vishwanath; Rathore, Anurag S

2017-07-01

Affordability of biopharmaceuticals continues to be a challenge, particularly in developing economies. This has fuelled advancements in manufacturing that can offer higher productivity and better economics without sacrificing product quality in the form of an integrated continuous manufacturing platform. While platform processes for monoclonal antibodies have existed for more than a decade, development of an integrated continuous manufacturing process for bacterial proteins has received relatively scant attention. In this study, we propose an end-to-end integrated continuous downstream process (from inclusion bodies to unformulated drug substance) for a therapeutic protein expressed in Escherichia coli as inclusion body. The final process consisted of a continuous refolding in a coiled flow inverter reactor directly coupled to a three-column periodic counter-current chromatography for capture of the product followed by a three-column con-current chromatography for polishing. The continuous bioprocessing train was run uninterrupted for 26 h to demonstrate its capability and the resulting output was analyzed for the various critical quality attributes, namely product purity (>99%), high molecular weight impurities (<0.5%), host cell proteins (<100 ppm), and host cell DNA (<10 ppb). All attributes were found to be consistent over the period of operation. The developed assembly offers smaller facility footprint, higher productivity, fewer hold steps, and significantly higher equipment and resin utilization. The complexities of process integration in the context of continuous processing have been highlighted. We hope that the study presented here will promote development of highly efficient, universal, end-to-end, fully continuous platforms for manufacturing of biotherapeutics. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 33:998-1009, 2017. © 2016 American Institute of Chemical Engineers.

US Topo Maps 2014: Program updates and research

USGS Publications Warehouse

Fishburn, Kristin A.

2014-01-01

The U. S. Geological Survey (USGS) US Topo map program is now in year two of its second three-year update cycle. Since the program was launched in 2009, the product and the production system tools and processes have undergone enhancements that have made the US Topo maps a popular success story. Research and development continues with structural and content product enhancements, streamlined and more fully automated workflows, and the evaluation of a GIS-friendly US Topo GIS Packet. In addition, change detection methodologies are under evaluation to further streamline product maintenance and minimize resource expenditures for production in the future. The US Topo map program will continue to evolve in the years to come, providing traditional map users and Geographic Information System (GIS) analysts alike with a convenient, freely available product incorporating nationally consistent data that are quality assured to high standards.

Evaluation of Heavy-Chain C-Terminal Deletion on Product Quality and Pharmacokinetics of Monoclonal Antibodies.

PubMed

Jiang, Guoying; Yu, Christopher; Yadav, Daniela B; Hu, Zhilan; Amurao, Annamarie; Duenas, Eileen; Wong, Marc; Iverson, Mark; Zheng, Kai; Lam, Xanthe; Chen, Jia; Vega, Roxanne; Ulufatu, Sheila; Leddy, Cecilia; Davis, Helen; Shen, Amy; Wong, Pin Y; Harris, Reed; Wang, Y John; Li, Dongwei

2016-07-01

Due to their potential influence on stability, pharmacokinetics, and product consistency, antibody charge variants have attracted considerable attention in the biotechnology industry. Subtle to significant differences in the level of charge variants and new charge variants under various cell culture conditions are often observed during routine manufacturing or process changes and pose a challenge when demonstrating product comparability. To explore potential solutions to control charge heterogeneity, monoclonal antibodies (mAbs) with native, wild-type C-termini, and mutants with C-terminal deletions of either lysine or lysine and glycine were constructed, expressed, purified, and characterized in vitro and in vivo. Analytical and physiological characterization demonstrated that the mAb mutants had greatly reduced levels of basic variants without decreasing antibody biologic activity, structural stability, pharmacokinetics, or subcutaneous bioavailability in rats. This study provides a possible solution to mitigate mAb heterogeneity in C-terminal processing, improve batch-to-batch consistency, and facilitate the comparability study during process changes. Published by Elsevier Inc.

Helping people change: the magic of motivation.

PubMed

Jameson, Cathy

2003-01-01

The consensus of the data and of the interviewed doctors was that the five most profound motivators of people in the workplace today are as follows: (1) Achievement of work well done; (2) Personal pride and satisfaction in being a part of quality treatment and excellent care of patients; (3) Continuing education; (4) Equitable compensation; (5) Respect, responsibility, and appreciation. When asked how important motivation is to the productivity of her practice, Dr. Stelly closes by saying, "Motivation is the most critical factor in productivity. Motivation is the key. If everyone is on the same page and if the doctor and key team members can continue to motivate and encourage others, then the sky is the limit. The key is to keep everyone goal-oriented, unified, and excited about the possibilities. Then you are going to have a team of consistent, long-term employees, you don't have turnover and with that kind of consistency, you are going to have increased productivity."

Quality Management in Astronomical Software and Data Systems

NASA Astrophysics Data System (ADS)

Radziwill, N. M.

2007-10-01

As the demand for more sophisticated facilities increases, the complexity of the technical and organizational challenges faced by operational space- and ground-based telescopes also increases. In many organizations, funding tends not to be proportional to this trend, and steps must be taken to cultivate a lean environment in both development and operations to consistently do more with less. To facilitate this transition, an organization must be aware of how it can meet quality-related goals, such as reducing variation, improving productivity of people and systems, streamlining processes, ensuring compliance with requirements (scientific, organizational, project, or regulatory), and increasing user satisfaction. Several organizations are already on this path. Quality-based techniques for the efficient, effective development of new telescope facilities and maintenance of existing facilities are described.

Automated Production of Movies on a Cluster of Computers

NASA Technical Reports Server (NTRS)

Nail, Jasper; Le, Duong; Nail, William L.; Nail, William

2008-01-01

A method of accelerating and facilitating production of video and film motion-picture products, and software and generic designs of computer hardware to implement the method, are undergoing development. The method provides for automation of most of the tedious and repetitive tasks involved in editing and otherwise processing raw digitized imagery into final motion-picture products. The method was conceived to satisfy requirements, in industrial and scientific testing, for rapid processing of multiple streams of simultaneously captured raw video imagery into documentation in the form of edited video imagery and video derived data products for technical review and analysis. In the production of such video technical documentation, unlike in production of motion-picture products for entertainment, (1) it is often necessary to produce multiple video derived data products, (2) there are usually no second chances to repeat acquisition of raw imagery, (3) it is often desired to produce final products within minutes rather than hours, days, or months, and (4) consistency and quality, rather than aesthetics, are the primary criteria for judging the products. In the present method, the workflow has both serial and parallel aspects: processing can begin before all the raw imagery has been acquired, each video stream can be subjected to different stages of processing simultaneously on different computers that may be grouped into one or more cluster(s), and the final product may consist of multiple video streams. Results of processing on different computers are shared, so that workers can collaborate effectively.

The effect of gender, age and product type on the origin induced food product experience among young consumers in Finland.

PubMed

Kumpulainen, Tommi; Vainio, Annukka; Sandell, Mari; Hopia, Anu

2018-04-01

Locally produced and sourced food products are gaining popularity among consumers. The effect of the expectations induced by the origin of the food was studied with 1491 consumers in two separate studies among different age groups. In order to test the consumer response to the product origin neutral, domestic, and local conditions were used. Consumers evaluated the product's pleasantness, their probability to choose it, the overall quality, and their willingness to pay. To gather information on whether the phenomenon was consistent, independent from the product category, three different types of products were tested (meat, bread, and vegetables). Our results show that a closer origin does not necessarily produce a positive response, but that there are several moderating factors such as gender, age, and product type. Female university students responded equally to domestic and local origins in the case of bread, but for meat products, only those of local origin induced a positive reaction. In this study population, the male respondents only reacted to a local origin in the case of bread, while domestic meat products provided similar results to local origins. Among young men consumers in the 7th-9th grades responded to the local origin of vegetables positively, while others among the youngest consumers, the origin did not induce a significant effect. The results indicate that even when the product is not appealing itself, locality can still increase the perceived quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

Agent-based station for on-line diagnostics by self-adaptive laser Doppler vibrometry

NASA Astrophysics Data System (ADS)

Serafini, S.; Paone, N.; Castellini, P.

2013-12-01

A self-adaptive diagnostic system based on laser vibrometry is proposed for quality control of mechanical defects by vibration testing; it is developed for appliances at the end of an assembly line, but its characteristics are generally suited for testing most types of electromechanical products. It consists of a laser Doppler vibrometer, equipped with scanning mirrors and a camera, which implements self-adaptive bahaviour for optimizing the measurement. The system is conceived as a Quality Control Agent (QCA) and it is part of a Multi Agent System that supervises all the production line. The QCA behaviour is defined so to minimize measurement uncertainty during the on-line tests and to compensate target mis-positioning under guidance of a vision system. Best measurement conditions are reached by maximizing the amplitude of the optical Doppler beat signal (signal quality) and consequently minimize uncertainty. In this paper, the optimization strategy for measurement enhancement achieved by the down-hill algorithm (Nelder-Mead algorithm) and its effect on signal quality improvement is discussed. Tests on a washing machine in controlled operating conditions allow to evaluate the efficacy of the method; significant reduction of noise on vibration velocity spectra is observed. Results from on-line tests are presented, which demonstrate the potential of the system for industrial quality control.

An assessment model for quality management

NASA Astrophysics Data System (ADS)

Völcker, Chr.; Cass, A.; Dorling, A.; Zilioli, P.; Secchi, P.

2002-07-01

SYNSPACE together with InterSPICE and Alenia Spazio is developing an assessment method to determine the capability of an organisation in the area of quality management. The method, sponsored by the European Space Agency (ESA), is called S9kS (SPiCE- 9000 for SPACE). S9kS is based on ISO 9001:2000 with additions from the quality standards issued by the European Committee for Space Standardization (ECSS) and ISO 15504 - Process Assessments. The result is a reference model that supports the expansion of the generic process assessment framework provided by ISO 15504 to nonsoftware areas. In order to be compliant with ISO 15504, requirements from ISO 9001 and ECSS-Q-20 and Q-20-09 have been turned into process definitions in terms of Purpose and Outcomes, supported by a list of detailed indicators such as Practices, Work Products and Work Product Characteristics. In coordination with this project, the capability dimension of ISO 15504 has been revised to be consistent with ISO 9001. As contributions from ISO 9001 and the space quality assurance standards are separable, the stripped down version S9k offers organisations in all industries an assessment model based solely on ISO 9001, and is therefore interesting to all organisations, which intend to improve their quality management system based on ISO 9001.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Expectations and perceptions of clients concerning the quality of care provided at a Brazilian hospital facility.

PubMed

Mendes, Isabel Amélia Costa; Trevizan, Maria Auxiliadora; de Godoy, Simone; Nogueira, Paula Cristina; Ventura, Carla Aparecida Arena; Furlan, Claudia Elizangela Bis

2018-02-01

To identify the expectations and perceptions of clients concerning the quality of hospital care provided to them and their respective companions at a private Brazilian hospital using SERVQUAL. The SERVQUAL questionnaire can provide information concerning expectations and perceptions of clients. In addition, it is able to identify the participation of frontline employees and how they contribute to the organization's end product (service delivery). In total, 172 inpatients for surgical reasons answered the SERVQUAL questionnaire. It consists of 23 pairs of statements, 22 of which are distributed into the dimensions of tangibles, reliability, responsiveness, assurance and empathy. Statement 23 refers to the overall quality of care. Exploratory analysis, internal consistency (Cronbach's alpha) and the kappa Coefficient were calculated using the Statistical Package for Social Sciences and SAS 9.2. Ethical approval was obtained from the Institutional Review Board at the Hospital das Clínicas at the University of São Paulo at Ribeirao Preto Medical School. Most participants had a bachelor's degree and were over than 60years old. Cronbach's alpha coefficients indicated good internal consistency (α=0.93) and high levels of agreement were observed (91.10%). The SERVQUAL questionnaire was sensitive to items in each dimension for which clients' perceptions surpassed their expectations. The continuous quality assessment of health services is mandatory for nursing leadership. The nursing leadership can further explore the SERVQUAL with a view to better attending to the clients' expectations. Copyright © 2017. Published by Elsevier Inc.

Housing quality and access to material and learning resources within the home environment in developing countries.

PubMed

Bradley, Robert H; Putnick, Diane L

2012-01-01

This study examined home environment conditions (housing quality, material resources, formal and informal learning materials) and their relations with the Human Development Index (HDI) in 28 developing countries. Home environment conditions in these countries varied widely. The quality of housing and availability of material resources at home were consistently tied to HDI; the availability of formal and informal learning materials a little less so. Gross domestic product (GDP) tended to show a stronger independent relation with housing quality and material resources than life expectancy and education. Formal learning resources were independently related to the GDP and education indices, and informal learning resources were not independently related to any constituent indices of the overall HDI. © 2012 The Authors. Child Development © 2012 Society for Research in Child Development, Inc.

Par-baked Bread Technology: Formulation and Process Studies to Improve Quality.

PubMed

Almeida, Eveline Lopes; Steel, Caroline Joy; Chang, Yoon Kil

2016-01-01

Extending the shelf-life of bakery products has been an important requirement resulting from the mechanization of this industry and the need to increase the distance for the distribution of final products, caused by the increase in production and consumer demand. Technologies based on the interruption of the breadmaking process represent an alternative to overcome product staling and microbiological deterioration. The production of par-baked breads is one of these technologies. It consists of baking the bread in two stages, and due to the possibility of retarding the second stage, it can be said that the bread can always be offered fresh to the consumer. The technology inserts logistics as part of the production process and creates the "hot point" concept, these being the locations where the bread is finalized, such as in the consumers' homes or sales locations. In this work, a review of the papers published on this subject was carried out, and aspects related to both the formulation and the process were considered. This technology still faces a few challenges, such as solving bread quality problems that appear due to process modifications, and these will also be considered. The market for these breads has grown rapidly and the bakery industry searches innovations related to par-baked bread technology.

Application of target costing in machining

NASA Astrophysics Data System (ADS)

Gopalakrishnan, Bhaskaran; Kokatnur, Ameet; Gupta, Deepak P.

2004-11-01

In today's intensely competitive and highly volatile business environment, consistent development of low cost and high quality products meeting the functionality requirements is a key to a company's survival. Companies continuously strive to reduce the costs while still producing quality products to stay ahead in the competition. Many companies have turned to target costing to achieve this objective. Target costing is a structured approach to determine the cost at which a proposed product, meeting the quality and functionality requirements, must be produced in order to generate the desired profits. It subtracts the desired profit margin from the company's selling price to establish the manufacturing cost of the product. Extensive literature review revealed that companies in automotive, electronic and process industries have reaped the benefits of target costing. However target costing approach has not been applied in the machining industry, but other techniques based on Geometric Programming, Goal Programming, and Lagrange Multiplier have been proposed for application in this industry. These models follow a forward approach, by first selecting a set of machining parameters, and then determining the machining cost. Hence in this study we have developed an algorithm to apply the concepts of target costing, which is a backward approach that selects the machining parameters based on the required machining costs, and is therefore more suitable for practical applications in process improvement and cost reduction. A target costing model was developed for turning operation and was successfully validated using practical data.

Quantification of the Impact of Endometriosis Symptoms on Health Related Quality of Life and Work Productivity

PubMed Central

Fourquet, Jessica; Báez, Lorna; Figueroa, Michelle; Iriarte, R. Iván; Flores, Idhaliz

2011-01-01

OBJECTIVE To quantify the impact of endometriosis-related symptoms on physical and mental health status, health-related quality of life (HRQoL), and work-related aspects (absenteeism, presenteeism, work productivity, activity impairment). DESIGN Cross-sectional quantitative study. SETTING Academic and research institution. PATIENT(S) Women (n=193) with self-reported surgically diagnosed endometriosis from the Endometriosis Patient Registry at Ponce School of Medicine and Health Sciences (PSMHS). INTERVENTION(S) Patients completed an anonymous questionnaire divided into three sections consisting of questions from the Patient Health Survey (SF-12®), the Endometriosis Health Profile (EHP-5), and the Work Productivity and Activity Impairment Survey (WPAI). MAIN OUTCOME MEASURE(S) Impact of endometriosis symptoms on physical and mental health status, health-related quality of life (HRQoL), absenteeism, presenteeism, work productivity and activity impairment was quantified. RESULTS Patients had SF-12 scores denoting significant disability in the phyisical and mental health components. They also reported an average of 7.41 hrs (approximately one working day) of work time loss during the week the symptoms are worse. In addition, WPAI scores show high impact on work-related domains: 13% of average loss in work time (absenteeism), 65% of their work was impaired (presenteeism), 64% loss in efficiency levels (work productivity loss), and 60% of daily activities perturbed (activity impairment). CONCLUSION Endometriosis symptoms such as chronic, incapacitating pelvic pain and infertility negatively and substantially impact the physical and mental health status, HRQoL, and productivity at work of patients with endometriosis. PMID:21621771

[Handbook for the preparation of evidence-based documents. Tools derived from scientific knowledge].

PubMed

Carrión-Camacho, M R; Martínez-Brocca, M A; Paneque-Sánchez-Toscano, I; Valencia-Martín, R; Palomino-García, A; Muñoz-Durán, C; Tamayo-López, M J; González-Eiris-Delgado, C; Otero-Candelera, R; Ortega-Ruiz, F; Sobrino-Márquez, J M; Jiménez-García-Bóveda, R; Fernández-Quero, M; Campos-Pareja, A M

2013-01-01

This handbook is intended to be an accessible, easy-to-consult guide to help professionals produce or adapt Evidence-Based Documents. Such documents will help standardize both clinical practice and decision-making, the quality always being monitored in such a way that established references are complied with. Evidence-Based Health Care Committee, a member of "Virgen del Rocío" University Hospital quality structure, proposed the preparation of a handbook to produce Evidence-Based Documents including: a description of products, characteristics, qualities, uses, methodology of production, and application scope of every one of them. The handbook consists of seven Evidence-Based tools, one chapter on critical analysis methodology of scientific literature, one chapter with internet resources, and some appendices with different assessment tools. This Handbook provides general practitioners with a great opportunity to improve quality and as a guideline to standardize clinical healthcare, and managers with a strategy to promote and encourage the development of documents in an effort to reduce clinical practice variability, as well as giving patients the opportunity of taking part in planning their own care. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

Burden of reduced work productivity among people with chronic knee pain: a systematic review.

PubMed

Agaliotis, Maria; Mackey, Martin G; Jan, Stephen; Fransen, Marlene

2014-09-01

The aims of this systematic review were to determine the prevalence of reduced work productivity among people with chronic knee pain as well as specifically categorise determinants of work productivity losses into individual, disease and work-related factors, conduct an evaluation of study methodological quality and present a best-evidence synthesis. We searched the literature using combinations of key words such as knee pain, knee osteoarthritis, absenteeism (days taken off work) and presenteeism (reduced productivity while at work) for observational studies published in English. Methodological quality appraisal and a best-evidence synthesis were used to pool the study findings. The studies were conducted exclusively in high income countries of North America, Western Europe and Hong Kong. 17 studies were included in the review, 10 measuring absenteeism and six measuring presenteeism. Of the 10 studies reporting absenteeism, seven found a 12-month absenteeism prevalence ranging from 5% to 22%. Only two studies evaluated presenteeism prevalence and reported a range from 66% to 71%. Using best-evidence synthesis: three high quality cohort studies and three cross-sectional studies provided strong evidence that knee pain or knee osteoarthritis was associated with absenteeism; two high quality cross-sectional studies and one cohort study provided limited evidence for an association with presenteeism; one cross-sectional study provided limited evidence for an association among age, high job demands and low coworker support and absenteeism among nurses with knee pain. No studies examined individual or work-related factors associated with presenteeism. A number of high quality studies consistently demonstrated that chronic knee pain or knee osteoarthritis is associated with absenteeism. However, data are lacking regarding presenteeism and individual or work-related risk factors for reduced work productivity among older workers with chronic knee pain. PROSPERO registry number: CRD42013004137. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Development of a multichannel hyperspectral imaging probe for food property and quality assessment

NASA Astrophysics Data System (ADS)

Huang, Yuping; Lu, Renfu; Chen, Kunjie

2017-05-01

This paper reports on the development, calibration and evaluation of a new multipurpose, multichannel hyperspectral imaging probe for property and quality assessment of food products. The new multichannel probe consists of a 910 μm fiber as a point light source and 30 light receiving fibers of three sizes (i.e., 50 μm, 105 μm and 200 μm) arranged in a special pattern to enhance signal acquisitions over the spatial distances of up to 36 mm. The multichannel probe allows simultaneous acquisition of 30 spatially-resolved reflectance spectra of food samples with either flat or curved surface over the spectral region of 550-1,650 nm. The measured reflectance spectra can be used for estimating the optical scattering and absorption properties of food samples, as well as for assessing the tissues of the samples at different depths. Several calibration procedures that are unique to this probe were carried out; they included linearity calibrations for each channel of the hyperspectral imaging system to ensure consistent linear responses of individual channels, and spectral response calibrations of individual channels for each fiber size group and between the three groups of different size fibers. Finally, applications of this new multichannel probe were demonstrated through the optical property measurement of liquid model samples and tomatoes of different maturity levels. The multichannel probe offers new capabilities for optical property measurement and quality detection of food and agricultural products.

Evaluation of quality of kefir from milk obtained from goats supplemented with a diet rich in bioactive compounds.

PubMed

Cais-Sokolińska, Dorota; Pikul, Jan; Wójtowski, Jacek; Danków, Romualda; Teichert, Joanna; Czyżak-Runowska, Grażyna; Bagnicka, Emilia

2015-04-01

The composition of bioactive components in dairy products depends on their content in raw milk and the processing conditions. The experimental material consisted of the milk of dairy goats supplemented with 120 g d(-1) per head of false flax cake. The aim of the study was to evaluate the quality of kefir produced from goat's milk with a higher content of bioactive components resulting from supplementation of the goats' diet with false flax cake. The administration of false flax cake to goats had a positive effect on the fatty acid profile of the raw milk, causing an increase in the proportion of polyunsaturated fatty acids (PUFA), including conjugated linoleic acid (CLA) and n-3 fatty acids. Their increased percentage was detected in the kefir after production as well as after storage. The processing value of the harvested milk did not differ from the qualitative characteristics of milk from goats of the control group. Increasing the proportion of bioactive components in goat's milk did not result in changes in the acidity, texture, colour, flavour, aroma or consistency of the kefir obtained. Milk and kefir obtained after the administration of false flax cake to goats contain bioactive components (PUFA including CLA, n-3 and monoenic trans fatty acids) in significant amounts. Kefir from experimental goat's milk did not differ in quality from kefir made from the milk of the control group. © 2014 Society of Chemical Industry.

Effects of goat milk or milk replacer diet on meat quality and fat composition of suckling goat kids.

PubMed

Bañón, S; Vila, R; Price, A; Ferrandini, E; Garrido, M D

2006-02-01

The effects of a diet with goat milk "GM" or milk replacer "MR" on the meat quality and fat composition of suckling Murciano-Granadina kids were studied. MR consisted of powdered skimmed milk, coconut oil and fat, and cereal products and by-products. Raw meat quality (moisture, protein, lipids, ash, collagen, cholesterol, haem pigments, CIELab colour, pH and water retention capacity), fatty acid "FA" composition and eating quality of cooked meat (odour, flavour and texture) were determined. Diet had only a slight effect on raw meat quality but had a pronounced effect on fatty acid composition and eating quality of cooked meat. MR diet increased the water/protein proportion in the muscle. The saturated/unsaturated FA ratio in GM and MR fat was 0.94 and 2.27, respectively. The major FA in GM and MR fat were C16:0 and C18:1, respectively. Short-chain C4-C12 hardly accumulated in the adipose tissue of suckling kid, increasing the relative percentages of C14-C20. This effect was more pronounced in MR fat, due to the fact that MR contained more short-chain fatty acids than GM. MR diet gave cooked meat a more intense characteristic goat meat odour and flavour, more tenderness and more juiciness than the natural suckling diet. This fact could be related to differences in meat and fat composition.

Effects of feeding fatty acid calcium and the interaction of forage quality on production performance and biochemical indexes in early lactation cow.

PubMed

Hu, Z Y; Yin, Z Y; Lin, X Y; Yan, Z G; Wang, Z H

2015-10-01

Multiparous early lactation Holstein cows (n = 16) were used in a randomized complete block design to determine the effects of feeding fatty acid calcium and the interaction of forage quality on production performance and biochemical indexes in early lactation cow. Treatments were as follows: (i) feeding low-quality forage without supplying fatty acid calcium (Diet A), (ii) feeding low-quality forage with supplying 400 g fatty acid calcium (Diet B), (iii) feeding high-quality forage without supplying fatty acid calcium (Diet C) and (iv) feeding high-quality forage with supplying 400 g fatty acid calcium. This experiment consisted 30 days. The milk and blood samples were collected in the last day of the trail. Intakes were recorded in the last 2 days of the trail. Supplementation of fatty acid calcium decreased significantly dry matter intake (DMI) (p < 0.01). Addition fatty acid calcium decreased milk protein percentage (p < 0.01) and milk SNF percentage (p < 0.01), but increased MUN (p < 0.05). Supplemented fatty acid decreased concentration of blood BHBA (p < 0.05), but increased TG, NEFA, glucagon, GLP-1, CCK, leptin, ApoA-IV, serotonin and MSH concentration in blood, the CCK concentration and feed intake showed a significant negative correlation (p < 0.05). Journal of Animal Physiology and Animal Nutrition © 2015 Blackwell Verlag GmbH.

The GeoEye Satellite Constellation

NASA Technical Reports Server (NTRS)

Dial, Gene; Cole, Aaron; Lutes, James; McKune, John; Martinez, Mike; Rao, R. S.; Taylor, Martin

2007-01-01

The GeoEye Constellation consists of: a) IKONOS and OrbView-3 for high resolution; b) GeoEye with higher resolution 1Q2007; c) RESOUCESAT-1 for global crop assessment; d) OrbView-2 for ocean research and fish. IKONOS performance in 2005 included stable image quality, radiometry and geometric accuracy. reliability is 80% to 2008. Demonstrated capacity for high-volume, quick-response collection and production.

EOS MLS Science Data Processing System: A Description of Architecture and Capabilities

NASA Technical Reports Server (NTRS)

Cuddy, David T.; Echeverri, Mark D.; Wagner, Paul A.; Hanzel, Audrey T.; Fuller, Ryan A.

2006-01-01

This paper describes the architecture and capabilities of the Science Data Processing System (SDPS) for the EOS MLS. The SDPS consists of two major components--the Science Computing Facility and the Science Investigator-led Processing System. The Science Computing Facility provides the facilities for the EOS MLS Science Team to perform the functions of scientific algorithm development, processing software development, quality control of data products, and scientific analyses. The Science Investigator-led Processing System processes and reprocesses the science data for the entire mission and delivers the data products to the Science Computing Facility and to the Goddard Space Flight Center Earth Science Distributed Active Archive Center, which archives and distributes the standard science products.

Third-Party Evaluation: A Review of Dietary Supplements Dispensed by Military Treatment Facilities From 2007 to 2011.

PubMed

Jones, Donnamaria R; Kasper, Korey B; Deuster, Patricia A

2015-07-01

Third-party certification/verification of dietary supplements (DS), although not mainstream, is one way to help ensure high-quality products. In the medical setting, physicians may prescribe DS to correct a deficiency or improve a health care outcome, and they want products of a certain standard of quality, free of adulteration/contamination. We reviewed DS dispensed from all Department of Defense military treatment facilities over a 5-year period to determine which products had been third-party reviewed and certified/verified. By using product name, manufacturer, and/or National Drug Codes, we examined product listings on the websites of three independent-evaluating organizations. Over 1.5 million dietary supplement prescriptions consisting of 753 different products were dispensed from 2007 through 2011. Less than 3.6% of the products examined were third-party certified/verified by any of the three most well-known evaluation organizations: 19 were verified by United States Pharmacopeial Convention; 9 products were reviewed and 8 certified by ConsumerLab; and none of the products were certified by NSF International. Most DS dispensed by military treatment facilities are not reviewed by a third party. This is not unexpected, as third party certification is not yet mainstream. However, one way to reduce potential hazards and exposure to unsafe products is to encourage use of supplements that have third-party certification/verification. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Consistent ozone-induced decreases in pasture forage quality across several grassland types and consequences for UK lamb production.

PubMed

Hayes, Felicity; Mills, Gina; Jones, Laurence; Abbott, John; Ashmore, Mike; Barnes, Jeremy; Neil Cape, J; Coyle, Mhairi; Peacock, Simon; Rintoul, Naomi; Toet, Sylvia; Wedlich, Kerstin; Wyness, Kirsten

2016-02-01

In this study we have demonstrated that rising background ozone has the potential to reduce grassland forage quality and explored the implications for livestock production. We analysed pasture samples from seven ozone exposure experiments comprising mesotrophic, calcareous, haymeadow and sanddune unimproved grasslands conducted in open-top chambers, solardomes and a field release system. Across all grassland types, there were significant increases in acid detergent fibre, crude fibre and lignin content with increasing ozone concentration, resulting in decreased pasture quality in terms of the metabolisable energy content of the vegetation. We derived a dose-response function for metabolisable energy of the grassland with ozone concentration, applicable to a range of grassland types, and used this to predict effects on pasture quality of UK vegetation at 1 km resolution using modelled ozone data for 2007 and for predicted higher average ozone concentrations in 2020. This showed a potential total reduction in lamb production in the UK of approximately 4% in 2020 compared to 2007. The largest impacts were in geographical areas of modest ozone increases between the two years, but where large numbers of lambs were present. For an individual farmer working to a very small cost margin this could represent a large reduction in profit, both in regions where the impacts per lamb and those where the impacts per km(2) of grazing land are largest. In the short term farmers could adapt their lamb management in response to changed forage quality by additional supplementary feed of high metabolisable energy content. Nationally this increase in annual additional feed in 2020 compared to 2007 would be 2,166 tonnes (an increase of 0.7%). Of added concern are the longer-term consequences of continual deterioration of pasture quality and the implications for changes in farming practices to compensate for potential reductions in livestock production capacity. Copyright © 2015 Elsevier B.V. All rights reserved.

A novel approach to support formulation design on twin screw wet granulation technology: Understanding the impact of overarching excipient properties on drug product quality attributes.

PubMed

Willecke, N; Szepes, A; Wunderlich, M; Remon, J P; Vervaet, C; De Beer, T

2018-04-21

The overall objective of this work is to understand how excipient characteristics influence the drug product quality attributes and process performance of a continuous twin screw wet granulation process. The knowledge gained in this study is intended to be used for Quality by Design (QbD)-based formulation design and formulation optimization. Three principal components which represent the overarching properties of 8 selected pharmaceutical fillers were used as factors, whereas factors 4 and 5 represented binder type and binder concentration in a design of experiments (DoE). The majority of process parameters were kept constant to minimize their influence on the granule and drug product quality. 27 DoE batches consisting of binary filler/binder mixtures were processed via continuous twin screw wet granulation followed by tablet compression. Multiple linear regression models were built providing understanding of the impact of filler and binder properties on granule and tablet quality attributes (i.e. 16 DoE responses). The impact of fillers on the granule and tablet responses was more dominant compared to the impact of binder type and concentration. The filler properties had a relevant effect on granule characteristics, such as particle size, friability and specific surface area. Binder type and concentration revealed a relevant influence on granule flowability and friability as well as on the compactability (required compression force during tableting to obtain target hardness). In order to evaluate the DoE models' validity, a verification of the DoE models was performed with new formulations (i.e. a new combination of filler, binder type and binder concentration) which were initially not included in the dataset used to build the DoE models. The combined PCA (principle component analysis)/DoE approach allowed to link the excipient properties with the drug product quality attributes. Copyright © 2018 Elsevier B.V. All rights reserved.

Read Code Quality Assurance

PubMed Central

Schulz, Erich; Barrett, James W.; Price, Colin

1998-01-01

As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131

Read Code quality assurance: from simple syntax to semantic stability.

PubMed

Schulz, E B; Barrett, J W; Price, C

1998-01-01

As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with "business rules" declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short.

Clinically lean; "cutting the crap".

PubMed

Caldwell, G

2012-01-01

Proponents of Lean Philosophy believe that successful businesses must reduce waste in working time and resources to a minimum, and maximise their use in productive work. The productive work of the Acute Medical Unit is to provide effective clinical management to a daily cohort of acutely ill patients. Many Clinicians are cynical about Lean. In this article, Dr Caldwell discusses how many clinicians complain of too much crap in the workplace, which gets in the way of swift, safe high quality clinical care. He argues that "Cutting the Crap" in the Acute Medical Unit is entirely consistent with Lean approaches to management of complex systems.

First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 3: Porcine islet product manufacturing and release testing criteria.

PubMed

Rayat, Gina R; Gazda, Lawrence S; Hawthorne, Wayne J; Hering, Bernhard J; Hosking, Peter; Matsumoto, Shinichi; Rajotte, Ray V

2016-01-01

In the 2009 IXA consensus, the requirements for the quality and control of manufacturing of porcine islet products were based on the U.S. regulatory framework where the porcine islet products fall within the definition of somatic cell therapy under the statutory authority of the U.S. Food and Drug Administration (FDA). In addition, porcine islet products require pre-market approval as a biologic product under the Public Health Services Act and they meet the definition of a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Thus, they are subject to applicable provisions of the law and as such, control of manufacturing as well as reproducibility and consistency of porcine islet products, safety of porcine islet products, and characterization of porcine islet products must be met before proceeding to clinical trials. In terms of control of manufacturing as well as reproducibility and consistency of porcine islet products, the manufacturing facility must be in compliance with current Good Manufacturing Practices (cGMP) guidelines appropriate for the initiation of Phase 1/2 clinical trials. Sponsors intending to conduct a Phase 1/2 trial of islet xenotransplantation products must be able to demonstrate the safety of the product through the establishment of particular quality assurance and quality control procedures. All materials (including animal source and pancreas) used in the manufacturing process of the porcine islet products must be free of adventitious agents. The final porcine islet product must undergo tests for the presence of these adventitious agents including sterility, mycoplasma (if they are cultured), and endotoxin. Assessments of the final product must include the safety specifications mentioned above even if the results are not available until after release as these data would be useful for patient diagnosis and treatment if necessary. In addition, a plan of action must be in place for patient notification and treatment in case the sterility culture results are positive. In terms of the characterization of porcine islet products and product release criteria, the information on the porcine islet products should be acquired from a sample of the final product to be used for transplantation and must include the morphology of the islets, specific identity, purity, viability, and potency of the product. In addition, information on the quantity of the islet products should also be provided in a standardized fashion and this should be in terms of islet equivalents and/or cell numbers. The current consensus was created to provide guidelines that manufacturing facilities may find helpful in the manufacture of and the release criteria for porcine islet products including encapsulated islets and combined islet products. Our intent with the above recommendations is to provide a framework for individual porcine islet manufacturing facilities to ensure a high level of safety for the initiation of Phase 1/2 clinical trials on porcine islet xenotransplantation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Characterizing LEDAPS surface reflectance products by comparisons with AERONET, field spectrometer, and MODIS data

USGS Publications Warehouse

Maiersperger, Tom; Scaramuzza, Pat; Leigh, Larry; Shrestha, S.; Gallo, Kevin; Jenkerson, Calli B.; Dwyer, John L.

2013-01-01

This study provides a baseline quality check on provisional Landsat Surface Reflectance (SR) products as generated by the U.S. Geological Survey (USGS) Earth Resources Observation and Science (EROS) Center using Landsat Ecosystem Disturbance Adaptive Processing System (LEDAPS) software. Characterization of the Landsat SR products leveraged comparisons between aerosol optical thickness derived from LEDAPS and measured by Aerosol Robotic Network (AERONET), as well as reflectance correlations with field spectrometer and Moderate Resolution Imaging Spectroradiometer (MODIS) data. Results consistently indicated similarity between LEDAPS and alternative data products in longer wavelengths over vegetated areas with no adjacent water, while less reliable performance was observed in shorter wavelengths and sparsely vegetated areas. This study demonstrates the strengths and weaknesses of the atmospheric correction methodology used in LEDAPS, confirming its successful implementation to generate Landsat SR products.

Error-Free Software

NASA Technical Reports Server (NTRS)

1989-01-01

001 is an integrated tool suited for automatically developing ultra reliable models, simulations and software systems. Developed and marketed by Hamilton Technologies, Inc. (HTI), it has been applied in engineering, manufacturing, banking and software tools development. The software provides the ability to simplify the complex. A system developed with 001 can be a prototype or fully developed with production quality code. It is free of interface errors, consistent, logically complete and has no data or control flow errors. Systems can be designed, developed and maintained with maximum productivity. Margaret Hamilton, President of Hamilton Technologies, also directed the research and development of USE.IT, an earlier product which was the first computer aided software engineering product in the industry to concentrate on automatically supporting the development of an ultrareliable system throughout its life cycle. Both products originated in NASA technology developed under a Johnson Space Center contract.

A Natural Experiment: Using Immersive Technologies to Study the Impact of "All-Natural" Labeling on Perceived Food Quality, Nutritional Content, and Liking.

PubMed

Liu, Rebecca; Hooker, Neal H; Parasidis, Efthimios; Simons, Christopher T

2017-03-01

The "all-natural" label is used extensively in the United States. At many point-of-purchase locations, employed servers provide food samples and call out specific label information to influence consumers' purchase decisions. Despite these ubiquitous practices, it is unclear what information is conveyed to consumers by the all-natural label or how it impacts judgments of perceived food quality, nutritional content, and acceptance. We used a novel approach incorporating immersive technology to simulate a virtual in-store sampling scenario where consumers were asked by a server to evaluate identical products with only one being labeled all-natural. Another condition evaluated the impact of the in-store server additionally emphasizing the all-natural status of one sample. Results indicated the all-natural label significantly improved consumer's perception of product quality and nutritional content, but not liking or willingness to pay, when compared to the regular sample. With the simple emphasis of the all-natural claim by the in-store server, these differences in quality and nutritional content became even more pronounced, and willingness to pay increased significantly by an average of 8%. These results indicate that in a virtual setting consistent with making food purchases, an all-natural front-of-pack label improves consumer perceptions of product quality and nutritional content. In addition, information conveyed to consumers by employed servers has a further, substantial impact on these variables suggesting that consumers are highly susceptible to social influence at the point of purchase. © 2017 Institute of Food Technologists®.

Characterizing potential water quality impacts from soils treated with dust suppressants.

PubMed

Beighley, R Edward; He, Yiping; Valdes, Julio R

2009-01-01

Two separate laboratory experiment series, surface runoff and steady-state seepage, were performed to determine if dust suppressant products can be applied to soils with an expected minimal to no negative impact on water quality. The experiments were designed to mimic arid field conditions and used two soils (clayey and sandy) and six different dust suppressants. The two experiments consisted of: (i) simulated rainfall (intensities of 18, 33, or 61 mm h(-1)) and associated runoff from soil trays at a surface slope of 33%; and (ii) steady-state, constant head seepage through soil columns. Both experiment series involved two product application scenarios and three application ages (i.e., to account for degradation effects) for a total of 126 surface runoff and 80 column experiments. One composite effluent sample was collected from each experiment and analyzed for pH, electrical conductivity, total suspended solids (TSS), total dissolved solids, dissolved oxygen, total organic carbon, nitrate, nitrite, and phosphate. Paired t tests at 1 and 5% levels of significance and project specific data quality objectives are used to compare water quality parameters from treated and untreated soils. Overall, the results from this laboratory scale study suggest that the studied dust suppressants have minimal potential for adverse impacts to selected water quality parameters. The primary impacts were increased TSS for two synthetic products from the surface runoff experiments on both soils. The increase in TSS was not expected based on previous studies and may be attributed to this study's focus on simulating real-world soil agitation/movement at an active construction site subjected to rough grading.

Results from raw milk microbiological tests do not predict the shelf-life performance of commercially pasteurized fluid milk.

PubMed

Martin, N H; Ranieri, M L; Murphy, S C; Ralyea, R D; Wiedmann, M; Boor, K J

2011-03-01

Analytical tools that accurately predict the performance of raw milk following its manufacture into commercial food products are of economic interest to the dairy industry. To evaluate the ability of currently applied raw milk microbiological tests to predict the quality of commercially pasteurized fluid milk products, samples of raw milk and 2% fat pasteurized milk were obtained from 4 New York State fluid milk processors for a 1-yr period. Raw milk samples were examined using a variety of tests commonly applied to raw milk, including somatic cell count, standard plate count, psychrotrophic bacteria count, ropy milk test, coliform count, preliminary incubation count, laboratory pasteurization count, and spore pasteurization count. Differential and selective media were used to identify groups of bacteria present in raw milk. Pasteurized milk samples were held at 6°C for 21 d and evaluated for standard plate count, coliform count, and sensory quality throughout shelf-life. Bacterial isolates from select raw and pasteurized milk tests were identified using 16S ribosomal DNA sequencing. Linear regression analysis of raw milk test results versus results reflecting pasteurized milk quality consistently showed low R(2) values (<0.45); the majority of R(2) values were <0.25, indicating small relationship between the results from the raw milk tests and results from tests used to evaluate pasteurized milk quality. Our findings suggest the need for new raw milk tests that measure the specific biological barriers that limit shelf-life and quality of fluid milk products. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Acceptance Probability (P a) Analysis for Process Validation Lifecycle Stages.

PubMed

Alsmeyer, Daniel; Pazhayattil, Ajay; Chen, Shu; Munaretto, Francesco; Hye, Maksuda; Sanghvi, Pradeep

2016-04-01

This paper introduces an innovative statistical approach towards understanding how variation impacts the acceptance criteria of quality attributes. Because of more complex stage-wise acceptance criteria, traditional process capability measures are inadequate for general application in the pharmaceutical industry. The probability of acceptance concept provides a clear measure, derived from specific acceptance criteria for each quality attribute. In line with the 2011 FDA Guidance, this approach systematically evaluates data and scientifically establishes evidence that a process is capable of consistently delivering quality product. The probability of acceptance provides a direct and readily understandable indication of product risk. As with traditional capability indices, the acceptance probability approach assumes that underlying data distributions are normal. The computational solutions for dosage uniformity and dissolution acceptance criteria are readily applicable. For dosage uniformity, the expected AV range may be determined using the s lo and s hi values along with the worst case estimates of the mean. This approach permits a risk-based assessment of future batch performance of the critical quality attributes. The concept is also readily applicable to sterile/non sterile liquid dose products. Quality attributes such as deliverable volume and assay per spray have stage-wise acceptance that can be converted into an acceptance probability. Accepted statistical guidelines indicate processes with C pk > 1.33 as performing well within statistical control and those with C pk < 1.0 as "incapable" (1). A C pk > 1.33 is associated with a centered process that will statistically produce less than 63 defective units per million. This is equivalent to an acceptance probability of >99.99%.

Implementation of quality systems by Mexican exporters of processed meat.

PubMed

Maldonado-Siman, E; Bernal-Alcántara, R; Cadena-Meneses, J A; Altamirano-Cárdenas, J R; Martinez-Hernández, P A

2014-12-01

Requirements of hazard analysis and critical control points (HACCP) are becoming essential for international trade in food commodities as a safety assurance component. This research reports the level of the adoption of ISO 9000 and the HACCP system by Federal Inspection Type (TIF) pork-exporting enterprises. Implementation and operating costs are reported as well as the benefits involved in this food industry process. In Mexico, there are 97 companies classified as TIF enterprises, and 22 are registered as exporters of processed pork with the National Services for Safety and Quality and Animal Health of the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food. Surveys were administered to 22 companies, with a 95.2% response rate. Enterprise characteristics were evaluated, as well as their operating activities. Fieldwork consisted of administering structured questionnaires to TIF exporters. All the surveyed enterprises had implemented HACCP, whereas the ISO 9000 regulation was applied in only 30%. Of total production, 75% is exported to 13 countries, and 25% goes to the Mexican market niche. Results indicate that the main factors for adopting HACCP are related to accessibility to international markets, improving quality, and reducing product quality audits by customers. The results also indicated that staff training was the most important issue. Microbiological testing was the highest cost of the operation. The main benefits reported were related to better access to international markets and a considerable reduction in microbial counts. This study shows the willingness of Mexican pork processors to implement food safety protocols for producing safe and quality products to compete in the international food trade.

Effects of training to implement new tools and working methods to reduce knee load in floor layers.

PubMed

Jensen, Lilli Kirkeskov; Friche, Claus

2007-09-01

The purpose was to measure the effect of a participatory ergonomics implementation strategy consisting of information, education, and facilitation on the use of new tools and working methods in the floor laying trade. Floor layers (n=292) were trained in using new working methods. The effects were evaluated by using questionnaires, interviews, and assessments of quality and productivity. Following the training, 43% had used the new working methods weekly/daily compared to 11% before. There was a reduction in the degree of self-reported pain in the knees among the floor layers using the new working methods weekly or daily compared to those using them never or occasionally. The musculoskeletal complaints did not increase from any other region and the quality and the productivity of the work were not decreased. This indicates that within a 3-months perspective the implementation strategy succeeded.

A research factory for polymer microdevices: muFac

NASA Astrophysics Data System (ADS)

Anthony, Brian W.; Hardt, David E.; Hale, Melinda; Zarrouati, Nadege

2010-02-01

As part of our research on the manufacturing science of micron scale polymer-based devices, an automated production cell has been developed to explore its use in a volume manufacturing environment. This "micro-factory" allows the testing of models and hardware that have resulted from research on material characterization and simulation, tooling and equipment design and control, and process control and metrology. More importantly it has allowed us to identify the problems that exist between and within unit-processes. This paper details our efforts to produce basic micro-fluidic products in high volume at acceptable production rates and quality levels. The device chosen for our first product is a simple binary micromixer with 40×50 micron channel cross section manufactured by embossing of PMMA. The processes in the cell include laser cutting and drilling, hot embossing, thermal bonding and high-speed inspection of the components. Our goal is to create a "lights-out" factory that can make long production runs (e.g. an 8 hour shift) at high rates (Takt time of less than 3 minutes) with consistent quality. This contrasts with device foundries where prototypes in limited quantities but with high variety are the goal. Accordingly, rate and yield are dominant factors in this work, along with the need for precise material handling strategies. Production data will be presented to include process run charts, sampled functional testing of the products and measures of the overall system throughput.

Relationship between productivity, quality and musculoskeletal disorder risk among deboning workers in a Chilean salmon industry.

PubMed

Ilardi, Juan S

2012-01-01

The purpose of this ergonomic investigation is to establish a relationship between quality, productivity and risk of musculoskeletal disorder (MSD) in manual bone-removal process in the salmon fish industry. The method consists in a follow up study of 14 workers in a lane that processes salmon steak. Time between each steak (work cycle), quality of the steak's meat through inspection of deepness and length of the gapping generated by the manual bone-removal process and risk for musculoskeletal disorders through OCRA method were considered for this study. IMC and musculoskeletal Nordic Questionnaire of Kourinka were applied to the workers evaluated. Fourteen women worker's completed the evaluation, age 37.67 ± 8.1, with 65.27 ± 34.41 months of experience, with an IMC of 27.18 ± 3.87 (1.52 ± 0.057 meters of height) at the time of the evaluation. Time for deboning per steak averaged 38 ± 14 seconds with 68.33 ± 14.79 steaks per hour per worker. In quality terms, 74% of the steaks were qualified as "premium steaks" and 26% as "grade or industrial" (lower category and cheapest price). OCRA index for the right hand average 13.79 ± 4.59 and 3.59 ± 0.41 for the left hand. From Nordic questionnaire 80% of the workers manifested musculoskeletal symptoms in the right hand/wrist, followed up by shoulder with 60% of the workers and arm/elbow with over 50%. There was no statistically significant relationship between productivity and quality of the steak after manual bone removal process and between quality and MSD risk. However, there was a statistically significant relationship between productivity and MSD risk (p<0.05). Discussion around the results allows to see complementary results that did have strong correlation between MSD risk and the presence of lower grade salmon steaks and between areas that present musculoskeletal symptoms (MSS) and the intensity of the MSS (p<0.05). The results showed that further research is needed to validate these relationships, due to the increasing demands of health-care services from this productive sector, considering its importance for this region.

Machine vision based quality inspection of flat glass products

NASA Astrophysics Data System (ADS)

Zauner, G.; Schagerl, M.

2014-03-01

This application paper presents a machine vision solution for the quality inspection of flat glass products. A contact image sensor (CIS) is used to generate digital images of the glass surfaces. The presented machine vision based quality inspection at the end of the production line aims to classify five different glass defect types. The defect images are usually characterized by very little `image structure', i.e. homogeneous regions without distinct image texture. Additionally, these defect images usually consist of only a few pixels. At the same time the appearance of certain defect classes can be very diverse (e.g. water drops). We used simple state-of-the-art image features like histogram-based features (std. deviation, curtosis, skewness), geometric features (form factor/elongation, eccentricity, Hu-moments) and texture features (grey level run length matrix, co-occurrence matrix) to extract defect information. The main contribution of this work now lies in the systematic evaluation of various machine learning algorithms to identify appropriate classification approaches for this specific class of images. In this way, the following machine learning algorithms were compared: decision tree (J48), random forest, JRip rules, naive Bayes, Support Vector Machine (multi class), neural network (multilayer perceptron) and k-Nearest Neighbour. We used a representative image database of 2300 defect images and applied cross validation for evaluation purposes.

High power parallel ultrashort pulse laser processing

NASA Astrophysics Data System (ADS)

Gillner, Arnold; Gretzki, Patrick; Büsing, Lasse

2016-03-01

The class of ultra-short-pulse (USP) laser sources are used, whenever high precession and high quality material processing is demanded. These laser sources deliver pulse duration in the range of ps to fs and are characterized with high peak intensities leading to a direct vaporization of the material with a minimum thermal damage. With the availability of industrial laser source with an average power of up to 1000W, the main challenge consist of the effective energy distribution and disposition. Using lasers with high repetition rates in the MHz region can cause thermal issues like overheating, melt production and low ablation quality. In this paper, we will discuss different approaches for multibeam processing for utilization of high pulse energies. The combination of diffractive optics and conventional galvometer scanner can be used for high throughput laser ablation, but are limited in the optical qualities. We will show which applications can benefit from this hybrid optic and which improvements in productivity are expected. In addition, the optical limitations of the system will be compiled, in order to evaluate the suitability of this approach for any given application.

Crystal and Particle Engineering Strategies for Improving Powder Compression and Flow Properties to Enable Continuous Tablet Manufacturing by Direct Compression.

PubMed

Chattoraj, Sayantan; Sun, Changquan Calvin

2018-04-01

Continuous manufacturing of tablets has many advantages, including batch size flexibility, demand-adaptive scale up or scale down, consistent product quality, small operational foot print, and increased manufacturing efficiency. Simplicity makes direct compression the most suitable process for continuous tablet manufacturing. However, deficiencies in powder flow and compression of active pharmaceutical ingredients (APIs) limit the range of drug loading that can routinely be considered for direct compression. For the widespread adoption of continuous direct compression, effective API engineering strategies to address power flow and compression problems are needed. Appropriate implementation of these strategies would facilitate the design of high-quality robust drug products, as stipulated by the Quality-by-Design framework. Here, several crystal and particle engineering strategies for improving powder flow and compression properties are summarized. The focus is on the underlying materials science, which is the foundation for effective API engineering to enable successful continuous manufacturing by the direct compression process. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

The MODIS Aerosol Algorithm: Critical Evaluation and Plans for Collection 6

NASA Technical Reports Server (NTRS)

Remer, Lorraine

2010-01-01

For ten years the MODIS aerosol algorithm has been applied to measured MODIS radiances to produce a continuous set of aerosol products, over land and ocean. The MODIS aerosol products are widely used by the scientific and applied science communities for variety of purposes that span operational air quality forecasting in estimates o[ clear-sky direct radiative effects over ocean and aerosol-cloud interactions. The products undergo continual evaluation, including self-consistency checks and comparisons with highly accurate ground-based instruments. The result of these evaluation exercises is a quantitative understanding of the strengths and weaknesses of the retrieval, where and when the products are accurate and the situations where and when accuracy degrades. We intend 10 present results of the most recent critical evaluations including the first comparison of the over ocean products against the shipboard aerosol optical depth measurements of the Marine Aerosol Network (MAN), the demonstration of the lack of sensitivity to size parameter in the over land products and identification of residual problems and regional issues. While the current data set is undergoing evaluation, we are preparing for the next data processing, labeled Collection 6. Collection 6 will include transparent Quality Flags, a 3 km aerosol product and the 500m resolution cloud mask used within the aerosol n:bicvu|. These new products and adjustments to algorithm assumptions should provide users with more options and greater control, as they adapt the product for their own purposes.

Monitoring and long-term assessment of the Mediterranean Sea physical state

NASA Astrophysics Data System (ADS)

Simoncelli, Simona; Fratianni, Claudia; Clementi, Emanuela; Drudi, Massimiliano; Pistoia, Jenny; Grandi, Alessandro; Del Rosso, Damiano

2017-04-01

The near real time monitoring and long-term assessment of the physical state of the ocean are crucial for the wide CMEMS user community providing a continuous and up to date overview of key indicators computed from operational analysis and reanalysis datasets. This constitutes an operational warning system on particular events, stimulating the research towards a deeper understanding of them and consequently increasing CMEMS products uptake. Ocean Monitoring Indicators (OMIs) of some Essential Ocean Variables have been identified and developed by the Mediterranean Monitoring and Forecasting Centre (MED-MFC) under the umbrella of the CMEMS MYP WG (Multi Year Products Working Group). These OMIs have been operationally implemented starting from the physical reanalysis products and then they have been applied to the operational analyses product. Sea surface temperature, salinity, height as well as heat, water and momentum fluxes at the air-sea interface have been operationally implemented since the reanalysis system development as a real time monitoring of the data production. Their consistency analysis against available observational products or budget values recognized in literature guarantees the high quality of the numerical dataset. The results of the reanalysis validation procedures are yearly published in the QUality Information Document since 2014 available through the CMEMS catalogue (http://marine.copernicus.eu), together with the yearly dataset extension. New OMIs of the winter mixed layer depth, the eddy kinetic energy and the heat content will be presented, in particular we will analyze their time evolution and trends starting from 1987, then we will focus on the recent time period 2013-2016 when reanalysis and analyses datasets overlap to show their consistency beside their different system implementation (i.e. atmospheric forcing, wave coupling, nesting). At the end the focus will be on 2016 sea state and circulation of the Mediterranean Sea and its anomaly with respect to the climatological fields to early detect the 2016 peculiarities.

Advances in the control of wine spoilage by Zygosaccharomyces and Dekkera/Brettanomyces.

PubMed

Zuehlke, J M; Petrova, B; Edwards, C G

2013-01-01

Understanding the characteristics of yeast spoilage, as well as the available control technologies, is vital to producing consistent, high-quality wine. Zygosaccharomyces bailii contamination may result in refermentation and CO2 production in sweet wines or grape juice concentrate, whereas Brettanomyces bruxellensis spoilage often contributes off-odors and flavors to red wines. Early detection of these yeasts by selective/differential media or genetic methods is important to minimize potential spoilage. More established methods of microbial control include sulfur dioxide, dimethyl dicarbonate, and filtration. Current research is focused on the use of chitosan, pulsed electric fields, low electric current, and ultrasonics as means to protect wine quality.

Metatranscriptomics reveals temperature-driven functional changes in microbiome impacting cheese maturation rate

PubMed Central

De Filippis, Francesca; Genovese, Alessandro; Ferranti, Pasquale; Gilbert, Jack A.; Ercolini, Danilo

2016-01-01

Traditional cheeses harbour complex microbial consortia that play an important role in shaping typical sensorial properties. However, the microbial metabolism is considered difficult to control. Microbial community succession and the related gene expression were analysed during ripening of a traditional Italian cheese, identifying parameters that could be modified to accelerate ripening. Afterwards, we modulated ripening conditions and observed consistent changes in microbial community structure and function. We provide concrete evidence of the essential contribution of non-starter lactic acid bacteria in ripening-related activities. An increase in the ripening temperature promoted the expression of genes related to proteolysis, lipolysis and amino acid/lipid catabolism and significantly increases the cheese maturation rate. Moreover, temperature-promoted microbial metabolisms were consistent with the metabolomic profiles of proteins and volatile organic compounds in the cheese. The results clearly indicate how processing-driven microbiome responses can be modulated in order to optimize production efficiency and product quality. PMID:26911915

Advanced composite elevator for Boeing 727 aircraft, volume 2

NASA Technical Reports Server (NTRS)

Chovil, D. V.; Grant, W. D.; Jamison, E. S.; Syder, H.; Desper, O. E.; Harvey, S. T.; Mccarty, J. E.

1980-01-01

Preliminary design activity consisted of developing and analyzing alternate design concepts and selecting the optimum elevator configuration. This included trade studies in which durability, inspectability, producibility, repairability, and customer acceptance were evaluated. Preliminary development efforts consisted of evaluating and selecting material, identifying ancillary structural development test requirements, and defining full scale ground and flight test requirements necessary to obtain Federal Aviation Administration (FAA) certification. After selection of the optimum elevator configuration, detail design was begun and included basic configuration design improvements resulting from manufacturing verification hardware, the ancillary test program, weight analysis, and structural analysis. Detail and assembly tools were designed and fabricated to support a full-scope production program, rather than a limited run. The producibility development programs were used to verify tooling approaches, fabrication processes, and inspection methods for the production mode. Quality parts were readily fabricated and assembled with a minimum rejection rate, using prior inspection methods.

Digital contract approach for consistent and predictable multimedia information delivery in electronic commerce

NASA Astrophysics Data System (ADS)

Konana, Prabhudev; Gupta, Alok; Whinston, Andrew B.

1997-01-01

A pure 'technological' solution to network quality problems is incomplete since any benefits from new technologies are offset by the demand from exponentially growing electronic commerce ad data-intensive applications. SInce an economic paradigm is implicit in electronic commerce, we propose a 'market-system' approach to improve quality of service. Quality of service for digital products takes on a different meaning since users view quality of service differently and value information differently. We propose a framework for electronic commerce that is based on an economic paradigm and mass-customization, and works as a wide-area distributed management system. In our framework, surrogate-servers act as intermediaries between information provides and end- users, and arrange for consistent and predictable information delivery through 'digital contracts.' These contracts are negotiated and priced based on economic principles. Surrogate servers pre-fetched, through replication, information from many different servers and consolidate based on demand expectations. In order to recognize users' requirements and process requests accordingly, real-time databases are central to our framework. We also propose that multimedia information be separated into slowly changing and rapidly changing data streams to improve response time requirements. Surrogate- servers perform the tasks of integration of these data streams that is transparent to end-users.

Validation and Temporal Analysis of Lai and Fapar Products Derived from Medium Resolution Sensor

NASA Astrophysics Data System (ADS)

Claverie, M.; Vermote, E. F.; Baret, F.; Weiss, M.; Hagolle, O.; Demarez, V.

2012-12-01

Leaf Area Index (LAI) and Fraction of Absorbed Photosynthetically Active Radiation (FAPAR) have been defined as Essential Climate Variables. Many Earth surface monitoring applications are based on global estimation combined with a relatively high frequency. The medium spatial resolution sensors (MRS), such as SPOT-VGT, MODIS or MERIS, have been widely used to provide land surface products (mainly LAI and FAPAR) to the scientific community. These products require quality assessment and consistency. However, due to consistency of the ground measurements spatial sampling, the medium resolution is not appropriate for direct validation with in situ measurements sampling. It is thus more adequate to use high spatial resolution sensors which can integrate the spatial variability. The recent availability of combined high spatial (8 m) and temporal resolutions (daily) Formosat-2 data allows to evaluate the accuracy and the temporal consistency of medium resolution sensors products. In this study, we proposed to validate MRS products over a cropland area and to analyze their spatial and temporal consistency. As a matter of fact, this study belongs to the Stage 2 of the validation, as defined by the Land Product Validation sub-group of the Earth Observation Satellites. Reference maps, derived from the aggregation of Formosat-2 data (acquired during the 2006-2010 period over croplands in southwest of France), were compared with (i) two existing global biophysical variables products (GEOV1/VGT and MODIS-15 coll. 5), and (ii) a new product (MODdaily) derived from the inversion of PROSAIL radiative transfer model (EMMAH, INRA Avignon) applied on MODIS BRDF-corrected daily reflectance. Their uncertainty was calculated with 105 LAI and FAPAR reference maps, which uncertainties (22 % for LAI and 12% for FAPAR) were evaluated with in situ measurements performed over maize, sunflower and soybean. Inter-comparison of coarse resolution (0.05°) products showed that LAI and FAPAR have consistent phenology (Figure). The GEOLAND-2 showed the smoothest time series due to a 30-day composite, while MODdaily noise was satisfactory (<12%). The RMSE of LAI calculated for the period 2006-2010 were 0.46 for GEOV1/VGT, 0.19 for MODIS-15 and 0.16 for MODdaily. A significant overestimation (bias=0.43) of the LAI peak were observed for GEOV1/VGT products, while MOD-15 showed a small underestimation (bias=-0.14) of highest LAI. Finally, over a larger area (a quarter of France) covered by cropland, grassland and forest, the products displayed a good spatial consistency.; LAI 2006-2010 time-series of a coarse resolution pixel of cropland (extent in upper-left corner). Products are compared to Formosat-2 reference maps.

Courageous leaders. The integral force behind organizational excellence.

PubMed

Snyder, N H

1995-01-01

For more than a decade, Total Quality Management (TQM) has been used as a powerful instrument in shaping the competitive strategies of businesses, and producing quality products and services has become the credo of firms trying to defend or expand their markets. During this time, we have come to realize that without effective leadership no quality program can succeed. That is why the quality guru, W. Edwards Deming, refused to work in any organization unless he could begin with the CEO. That is why the first criterion examined for the Malcolm Baldridge National Quality Award is leadership. Focusing on quality will not guarantee success in today's rapidly changing markets. Increasingly discriminating consumers have come to expect quality in the products and services they buy, and businesses that fail to deliver it will not survive. In a very real sense, quality performance is the price you must pay simply to play the game. But consumers want more, and satisfying their expectations will determine tomorrow's winners and losers. Building organizations capable of producing superior results that consistently meet the needs of customers is the responsibility of leaders. For this reason, leaders are more important today than they have ever been before. Leaders in successful businesses must show the way for their employees by nurturing "cultures" that encourage and reward superior performance and by exhibiting personal characteristics that inspire excellence. Great leaders possess three crucial characteristics--vision, strong values and beliefs, and the courage to do the job despite seemingly insurmountable obstacles. These characteristics make the difference between excellence and "business as usual."

[Quality assurance and quality improvement. Personal experiences and intentions].

PubMed

Roche, B G; Sommer, C

1995-01-01

In may 1994 we were selected by the surgical Swiss association to make a study about quality in USA. During our travel we visited 3 types of institutions: Hospitals, National Institute of standard and Technology, Industry, Johnson & Johnson. We appreciate to compare 2 types of quality programs: Quality Assurance (QA) and Continuous Quality Improvement (CQI). In traditional healthcare circles, QA is the process established to meet external regulatory requirements and to assure that patient care is consistent with established standards. In a modern quality terms, QA outside of healthcare means designing a product or service, as well as controlling its production, so well that quality is inevitable. The ideas of W. Edward Deming is that there is never improvement just by inspection. He developed a theory based on 14 principles. A productive work is accomplished through processes. Understanding the variability of processes is a key to improve quality. Quality management sees each person in an organisation as part of one or more processes. The job of every worker is to receive the work of others, add value to that work, and supply it to the next person in the process. This is called the triple role the workers as customer, processor, and supplier. The main source of quality defects is problems in the process. The old assumption is that quality fails when people do the right thing wrong; the new assumption is that, more often, quality failures arise when people do the wrong think right. Exhortation, incentives and discipline of workers are unlikely to improve quality. If quality is failing when people do their jobs as designed, then exhorting them to do better is managerial nonsense. Modern quality theory is customer focused. Customers are identified internally and externally. The modern approach to quality is thoroughly grounded in scientific and statistical thinking. Like in medicine, the symptom is a defect in quality. The therapist of process must perform diagnostic test, formulate hypotheses of cause, test those hypotheses, apply remedies, and assess the effect of remedies. Total employee involvement is critical. A power comes from enabling all employees to become involved in quality improvement. A great advantage of CQI is the prevention orientation of the concept. The CQI permeated a collegial approach, people learn how to work together to improve. CQI is a time consuming procedure. During our travel we learned the definition of quality as the customer satisfaction. To build a CQI concept in employed time but all employed are involved in quality improvement. Applying CQI we could be able to refuse Quality control programs.

Ballistic Testing for Interceptor Body Armor Inserts Needs Improvement

DTIC Science & Technology

2011-08-01

030, “Ballistic Testing and Product Quality Surveillance for the Interceptor Body Armor - Vest Components Need Improvement,” January 3, 2011. This...Body Armor Ballistic Inserts Interceptor Body Armor (IBA) is a modular body armor system that consists of an outer tactical vest , ballistic inserts...altitude tests was because the ceramic ballistic inserts are solid structures that are not sensitive to reduced pressure and moisture. PM SEQ offered no

Public Reporting and Demand Rationing: Evidence from the Nursing Home Industry.

PubMed

He, Daifeng; Konetzka, R Tamara

2015-11-01

This paper examines an under-explored unintended consequence of public reporting: the potential for demand rationing. Public reporting, although intended to increase consumer access to high-quality products, may have provided the perverse incentive for high-quality providers facing fixed capacity and administrative pricing to avoid less profitable types of residents. Using data from the nursing home industry before and after the implementation of the public reporting system in 2002, we find that high-quality nursing homes facing capacity constraints reduced admissions of less profitable Medicaid residents while increasing the more profitable Medicare and private-pay admissions, relative to low-quality nursing homes facing no capacity constraints. These effects, although small in magnitude, are consistent with provider rationing of demand on the basis of profitability and underscore the important role of institutional details in designing effective public reporting systems for regulated industries. Copyright © 2014 John Wiley & Sons, Ltd.

Application-ready expedited MODIS data for operational land surface monitoring of vegetation condition

USGS Publications Warehouse

Brown, Jesslyn; Howard, Daniel M.; Wylie, Bruce K.; Friesz, Aaron M.; Ji, Lei; Gacke, Carolyn

2015-01-01

Monitoring systems benefit from high temporal frequency image data collected from the Moderate Resolution Imaging Spectroradiometer (MODIS) system. Because of near-daily global coverage, MODIS data are beneficial to applications that require timely information about vegetation condition related to drought, flooding, or fire danger. Rapid satellite data streams in operational applications have clear benefits for monitoring vegetation, especially when information can be delivered as fast as changing surface conditions. An “expedited” processing system called “eMODIS” operated by the U.S. Geological Survey provides rapid MODIS surface reflectance data to operational applications in less than 24 h offering tailored, consistently-processed information products that complement standard MODIS products. We assessed eMODIS quality and consistency by comparing to standard MODIS data. Only land data with known high quality were analyzed in a central U.S. study area. When compared to standard MODIS (MOD/MYD09Q1), the eMODIS Normalized Difference Vegetation Index (NDVI) maintained a strong, significant relationship to standard MODIS NDVI, whether from morning (Terra) or afternoon (Aqua) orbits. The Aqua eMODIS data were more prone to noise than the Terra data, likely due to differences in the internal cloud mask used in MOD/MYD09Q1 or compositing rules. Post-processing temporal smoothing decreased noise in eMODIS data.

Cibachrome testing. [photographic processing and printing materials

NASA Technical Reports Server (NTRS)

Weinstein, M. S.

1974-01-01

The use of Cibachrome products as a solution to problems encountered when contact printing Kodak film type SO-397 onto Kodak Ektrachrome color reversal paper type 1993 is investigated. A roll of aerial imagery consisting of Kodak film types SO-397 and 2443 was contact printed onto Cibachrome and Kodak materials and compared in terms of color quality, resolution, cost, and compatibility with existing equipment and techniques. Objective measurements are given in terms of resolution and sensitometric response. Comparison prints and transparencies were viewed and ranked according to overall quality and aesthetic appeal. It is recommended that Cibachrome Print material be used in place of Kodak Ektachrome paper because it is more easily processed, the cost is equivalent, and it provides improved resolution, color quality, and image fade resistance.

[A new scale for the assessment of the quality of hospitality services].

PubMed

Varela Mallou, Jesús; Prat Santaolària, Remei; Voces López, Carmen; Rial Boubeta, Antonio

2006-02-01

In the last 20 years the services sector has experienced a highly significant growth, being currently one of the most important economic sectors in our country. Inside the touristic sector, a strong competence has being experienced among the lodging and restoration establishments. In a scenario characterized by competitiveness, the bet for quality represents a difficult competitive advantage to surpass (García-Buedes, 2001). The objective of this study is to carry out an approach to the evaluation of the perceived quality of the restaurants. As a result of bibliographic revision, and also a first approach of a qualitative nature, we started from a scale of 31 items that included 5 dimensions: access, personal, service, product and installations. The results obtained applying the questionnaire to more than 2400 clients of 180 establishments of Santiago de Compostela and region, by means of structured interviews, confirmed that not all these dimensions had the same importance as predictors of customer satisfaction. Specifically, the product emerges as the most important dimension. Likewise, the elimination of the dimension service and a more exhaustive selection of the items, based on psychometric criteria, has permitted to define a brief scale, consisting of only 15 items, which makes it very attractive as a management tool. The final scale proposed to evaluate the perceived quality in the restaurant sector includes four fundamental and non-independent dimensions. These are, ordered by importance: product, personal, installations and access.

Here the data: the new FLUXNET collection and the future for model-data integration

NASA Astrophysics Data System (ADS)

Papale, D.; Pastorello, G.; Trotta, C.; Chu, H.; Canfora, E.; Agarwal, D.; Baldocchi, D. D.; Torn, M. S.

2016-12-01

Seven years after the release of the LaThuile FLUXNET database, widely used in synthesis activities and model-data fusion exercises, a new FLUXNET collection has been released (FLUXNET 2015 - http://fluxnet.fluxdata.org) with the aim to increase the quality of the measurements and provide high quality standardized data obtained by a new processing pipeline. The new FLUXNET collection includes also sites with timeseries of 20 years of continuous carbon and energy fluxes, opening new opportunities in their use in the context of models parameterization and validation. The main characteristics of the FLUXNET 2015 dataset are the uncertainty quantification, the multiple products (e.g. partitioning in photosynthesis and ecosystem respiration) that allow consistency analysis for each site, and new long term downscaled meteorological data provided with the data. Feedbacks from new users, in particular from the modelling communities, are crucial to further improve the quality of the products and move in the direction of a coherent integration across multi-disciplinary communities. In this presentation, the new FLUXNET2015 dataset will be explained and explored, with particular focus on the meaning of the different products and variables, their potentiality but also their limitations. The future development of the dataset will be discussed, with the role of the regional networks and the ongoing efforts to provide new and advanced services such a near real time data provision and a completely open access policy to high quality standardized measurements of GHGs exchanges and additional ecological quantities.

Applied Technology on Influence of Humic Substances on Fertilizer, Water-use Efficiency and Soil Health

NASA Astrophysics Data System (ADS)

Seyedbagheri, Mir

2017-04-01

In continuation of over 35 years of on-farm studies on soil organic matter from different humates (functional carbon) and compost, I have documented quantitative improvements in soil health and water-use efficiency. The ability of soil organic matter to bind water has become an important theme for research in past years. Research trials were established to evaluate the efficacy of different commercial functional carbon products derived from Leonardite (highly oxidized lignite) in crop production. In each of these trials, functional carbon (Humic and Fulvic acids) products were used in a randomized complete block design. The use of humic substances creates strong organo-mineral complexes (aggregation), chelation, as well as enhanced buffering capacities. We evaluated data from 3 fields and compared the results. Our observation and field demonstrations indicated there was a marked increase in water retention. Data from humic acid (HA) trials showed that different cropping systems responded differently to different products in relation to yield and quality. The functional carbon products used in the study seemed to enhance fertilizer and water-use efficiency by increasing complexation, chelation and buffering. The consistent use of good quality functional carbons in our replicated plots resulted in a yield increase from 6% to 30% over several decades.

[Staff accreditation in parenteral nutrition production in hospital pharmacy].

PubMed

Vrignaud, S; Le Pêcheur, V; Jouan, G; Valy, S; Clerc, M-A

2016-09-01

This work aims to provide staff accreditation methodology to harmonize and secure practices for parenteral nutrition bags preparation. The methodology used in the present study is inspired from project management and quality approach. Existing training supports were used to produce accreditation procedure and evaluation supports. We first defined abilities levels, from level 1, corresponding to accredited learning agent to level 3, corresponding to expert accredited agent. Elements assessed for accreditation are: clothing assessment either by practices audit or by microbiologic test, test bags preparation and handling assessment, bag production to assess aseptic filling for both manual or automatized method, practices audit, number of days of production, and non-conformity following. At Angers Hospital, in 2014, production staff is composed of 12 agents. Staff accreditation reveals that 2 agents achieve level 3, 8 agents achieve level 2 and 2 agents are level 1. We noted that non-conformity decreased as accreditation took place from 81 in 2009 to 0 in 2014. To date, there is no incident due to parenteral bag produced by Angers hospital for neonatal resuscitation children. Such a consistent study is essential to insure a secured nutrition parenteral production. This also provides a satisfying quality care for patients. Copyright © 2016 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

[Effects of rice-duck mutualistic organic farming on rice quality in the Yellow River Delta, China.

PubMed

Wang, Jian Lin; Li, Jie; Cao, Yuan Yuan

2016-07-01

Three cultivation models including rice-duck mutualistic, manual weeding and conventional rice farming were designed in the Yellow River Delta area to study the effects on rice milling quality, appearance quality, cooking and eating quality, and sanitation quality. The results showed that compared to conventional rice farming, the rice-duckmutualistic treatment increased grain width and brown rice rate, milled rice rate, head rice rate and reduced the chalkiness. This was mainly due to the increase of panicle numbers and grain mass and the decrease of the inferior grains. Due to the application of organic manure, the gel consistency increased, amylose and protein contents decreased, and the rice taste improved under rice-duck mutualistic and manual weeding cultivation treatments. As no chemical fertilizers and pesticides were applied under rice-duck mutualistic and manual weeding treatments, pesticide residues were greatly reduced or even not detected. Rice duck farming could improve the quality of rice and protect the environment, which would be a good ecological technology for high quality rice production.

Chromatographic molecular weight measurements for heparin, its fragments and fractions, and other glycosaminoglycans.

PubMed

Mulloy, Barbara; Hogwood, John

2015-01-01

Glycosaminoglycan samples are usually polydisperse, consisting of molecules with differing length and differing sequence. Methods for measuring the molecular weight of heparin have been developed to assure the quality and consistency of heparin products for medicinal use, and these methods can be applied in other laboratory contexts. In the method described here, high-performance gel permeation chromatography is calibrated using appropriate heparin molecular weight markers or a single broad standard calibrant, and used to characterize the molecular weight distribution of polydisperse samples or the peak molecular weight of monodisperse, or approximately monodisperse, heparin fractions. The same technology can be adapted for use with other glycosaminoglycans.

Evaluation and Validation of Updated MODIS C6 and VIIRS LAI/FPAR

NASA Astrophysics Data System (ADS)

Yan, K.; Park, T.; Chen, C.; Yang, B.; Yan, G.; Knyazikhin, Y.; Myneni, R. B.; CHOI, S.

2015-12-01

Leaf Area Index (LAI) and Fraction of Photosynthetically Active Radiation (0.4-0.7 μm) absorbed by vegetation (FPAR) play a key role in characterizing vegetation canopy functioning and energy absorption capacity. With radiative transfer realization, MODIS onboard NASA EOS Terra and Aqua satellites has provided globally continuous LAI/FPAR since 2000 and continuously updated the products with better quality. And NPP VIIRS shows the measurement capability to extend high-quality LAI/FPAR time series data records as a successor of MODIS. The primary objectives of this study are 1) to evaluate and validate newly updated MODIS Collection 6 (C6) LAI/FPAR product which has finer resolution (500m) and improved biome type input, and 2) to examine and adjust VIIRS LAI/FPAR algorithm for continuity with MODIS'. For MODIS C6 investigation, we basically measure the spatial coverage (i.e., main radiative transfer algorithm execution), continuity and consistency with Collection 5 (C5), and accuracy with field measured LAI/FPAR. And we also validate C6 LAI/FPAR via comparing other possible global LAI/FPAR products (e.g., GLASS and CYCLOPES) and capturing co-varying seasonal signatures with climatic variables (e.g., temperature and precipitation). For VIIRS evaluation and adjustment, we first quantify possible difference between C5 and MODIS heritage based VIIRS LAI/FPAR. Then based on the radiative transfer theory of canopy spectral invariants, we find VIIRS- and biome-specific configurable parameters (single scattering albedo and uncertainty). These two practices for MODIS C6 and VIIRS LAI/FPAR products clearly suggest that (a) MODIS C6 has better coverage and accuracy than C5, (b) C6 shows consistent spatiotemporal pattern with C5, (c) VIIRS has the potential for producing MODIS-like global LAI/FPAR Earth System Data Records.

Lubricant based determination of design space for continuously manufactured high dose paracetamol tablets.

PubMed

Taipale-Kovalainen, Krista; Karttunen, Anssi-Pekka; Ketolainen, Jarkko; Korhonen, Ossi

2018-03-30

The objective of this study was to devise robust and stable continuous manufacturing process settings, by exploring the design space after an investigation of the lubrication-based parameters influencing the continuous direct compression tableting of high dose paracetamol tablets. Experimental design was used to generate a structured study plan which involved 19 runs. The formulation variables studied were the type of lubricant (magnesium stearate or stearic acid) and its concentration (0.5, 1.0 and 1.5%). Process variables were total production feed rate (5, 10.5 and 16kg/h), mixer speed rpm (500, 850 and 1200rpm), and mixer inlet port for lubricant (A or B). The continuous direct compression tableting line consisted of loss-in-weight feeders, a continuous mixer and a tablet press. The Quality Target Product Profile (QTPP) was defined for the final product, as the flowability of powder blends (2.5s), tablet strength (147N), dissolution in 2.5min (90%) and ejection force (425N). A design space was identified which fulfilled all the requirements of QTPP. The type and concentration of lubricant exerted the greatest influence on the design space. For example, stearic acid increased the tablet strength. Interestingly, the studied process parameters had only a very minor effect on the quality of the final product and the design space. It is concluded that the continuous direct compression tableting process itself is insensitive and can cope with changes in lubrication, whereas formulation parameters exert a major influence on the end product quality. Copyright © 2017 Elsevier B.V. All rights reserved.

Beef and pork packing industries.

PubMed

MacDonald, James M

2003-07-01

A remarkable transformation of the meatpacking industry occurred in the last 25 years. That transformation consolidated the industry into one that could deliver large volumes of meat at low costs. Slaughter plants grew much larger and realized economies of scale from their size, and operations within plants were rationalized to emphasize the delivery of a small set of consistent major products (boxed beef, cut-up pork, and by-products) to retailers, wholesalers, and other processors. Similar developments occurred in livestock feeding whereby the industry realized significant cost reductions by consolidating production in very large cattle feedlots and hog farms. Gains from scale have largely been met (absent the development of new technologies that are not yet on the horizon); therefore, we are unlikely to see similar shifts in plant sizes in the next 25 years. The major forces affecting meatpacking and livestock feeding in the near future are more likely to revolve around tighter coordination among livestock production, meatpacking, wholesaling, and retailing. Although much of the recent response to food safety concerns took the form of investments in equipment, testing, and training within meatpacking plants, packers and retailers are likely to focus more on assurance of livestock production quality and methods in the future. Such assurance can be met through vertical integration or through a greater reliance on tightly drawn contracts; producers who attempt to provide the assurance while still selling through cash markets will need to develop paper trails of testing and quality assurance that will move through the marketing chain with livestock. Similarly, because of likely increased future demand for meats of assured consumer qualities, such as organically grown products or branded meat products with very specific traits, producers will likely need to provide similar indicators of assurance throughout the marketing chain. Finally, the funding offered through federal environmental assistance programs such as the USDA's Environmental Quality Incentives Program along with related regulations governing waste management will likely lead to greater control over livestock production practices by investors, financiers, integrators, and packers through contractual design. Shifts toward tighter vertical coordination will force continuing changes in traditional ways of doing business in livestock production and in meatpacking. In turn, public policy discussions and corporate strategies in meatpacking are likely to focus continuing attention on the particulars of contract design: how to meet consumers', retailers', and regulators' requirements for quality assurance while ensuring efficient low-cost production without retarding competition in the industry.

Programmable diffractive optic for multi-beam processing: applications and limitations

NASA Astrophysics Data System (ADS)

Gretzki, Patrick; Gillner, Arnold

2017-08-01

In the field of laser ablation, especially in the field of micro-structuring, the current challenge is the improvement of productivity. While many applications, e.g. surface fictionalization and structuring, drilling and thin film ablation, use relatively low pulse energies, industrial laser sources provide considerably higher average powers and pulse energies. The main challenge consist of the effective energy distribution and depositions. There are essential two complementary approaches for the up-scaling of (ultra) short pulse laser processes: Higher repetition frequency or higher pulse energies. Using lasers with high repetition rates in the MHz region can cause thermal issues like overheating, melt production and low ablation quality. In this paper we pursuit the second approach by using diffractive optics for parallel processing. We will discuss, which technologies can be used and which applications will benefit from the multi-beam approach and which increase in productivity can be expected. Additionally we will show, which quality attributes can be used to rate the performance of a diffractive optic and and which limitations and restrictions this technology has.

A retrospective investigation of energy efficiency standards: Policies may have accelerated long term declines in appliance costs

DOE PAGES

Van Buskirk, R. D.; Kantner, C. L. S.; Gerke, B. F.; ...

2014-11-14

We perform a retrospective investigation of multi-decade trends in price and life-cycle cost (LCC) for home appliances in periods with and without energy efficiency (EE) standards and labeling polices. In contrast to the classical picture of the impact of efficiency standards, the introduction and updating of appliance standards is not associated with a long-term increase in purchase price; rather, quality-adjusted prices undergo a continued or accelerated long-term decline. In addition, long term trends in appliance LCCs—which include operating costs—consistently show an accelerated long term decline with EE policies. We also show that the incremental price of efficiency improvements has declinedmore » faster than the baseline product price for selected products. These observations are inconsistent with a view of EE standards that supposes a perfectly competitive market with static supply costs. These results suggest that EE policies may be associated with other forces at play, such as innovation and learning-by-doing in appliance production and design, that can affect long term trends in quality-adjusted prices and LCCs.« less

Effects of environmental change on agriculture, nutrition and health: A framework with a focus on fruits and vegetables

PubMed Central

Tuomisto, Hanna L.; Scheelbeek, Pauline F.D.; Chalabi, Zaid; Green, Rosemary; Smith, Richard D.; Haines, Andy; Dangour, Alan D.

2017-01-01

Environmental changes are likely to affect agricultural production over the next  decades. The interactions between environmental change, agricultural yields and crop quality, and the critical pathways to future diets and health outcomes are largely undefined. There are currently no quantitative models to test the impact of multiple environmental changes on nutrition and health outcomes. Using an interdisciplinary approach, we developed a framework to link the multiple interactions between environmental change, agricultural productivity and crop quality, population-level food availability, dietary intake and health outcomes, with a specific focus on fruits and vegetables. The main components of the framework consist of: i) socio-economic and societal factors, ii) environmental change stressors, iii) interventions and policies, iv) food system activities, v) food and nutrition security, and vi) health and well-being outcomes. The framework, based on currently available evidence, provides an overview of the multidimensional and complex interactions with feedback between environmental change, production of fruits and vegetables, diets and health, and forms the analytical basis for future modelling and scenario testing. PMID:29511740

Continuous immobilized yeast reactor system for complete beer fermentation using spent grains and corncobs as carrier materials.

PubMed

Brányik, Tomás; Silva, Daniel P; Vicente, António A; Lehnert, Radek; e Silva, João B Almeida; Dostálek, Pavel; Teixeira, José A

2006-12-01

Despite extensive research carried out in the last few decades, continuous beer fermentation has not yet managed to outperform the traditional batch technology. An industrial breakthrough in favour of continuous brewing using immobilized yeast could be expected only on achievement of the following process characteristics: simple design, low investment costs, flexible operation, effective process control and good product quality. The application of cheap carrier materials of by-product origin could significantly lower the investment costs of continuous fermentation systems. This work deals with a complete continuous beer fermentation system consisting of a main fermentation reactor (gas-lift) and a maturation reactor (packed-bed) containing yeast immobilized on spent grains and corncobs, respectively. The suitability of cheap carrier materials for long-term continuous brewing was proved. It was found that by fine tuning of process parameters (residence time, aeration) it was possible to adjust the flavour profile of the final product. Consumers considered the continuously fermented beer to be of a regular quality. Analytical and sensorial profiles of both continuously and batch fermented beers were compared.

Marketing Strategy Analysis for Small and Medium Scale Business Enterprise (SMEs) for Home Industry Furniture in Leilem, the Regency of Minahasa

NASA Astrophysics Data System (ADS)

Pangemanan, S. A.; Walukow, I. M.

2018-01-01

Leilem is a small village located in Minahasa Regency. This village is well known for furniture products made of Timber. Eventhough the village has been producing various furniture products with high quality since many decades ago, it has not been able to compete with other new entries such furniture from Java, Synthetic Ratan, Plywood and plastic based furniture. The monotonous design and the finishing works done on the furniture have been some of the major issues in the decline of home furniture. The research explores problems and challenges faced by the furniture home Industry. It will also aim at identifying the internal and external factors that prevent the home industry to compete and survive. In the end the research will develop the strategic positioning of the home industry in the midst of competition. The research methodology employs descriptive analysis in which data are collected through observation, interview, and questionnaire. This methodology is combined with IFE (Internal Factor Evaluation) and EFE (External Factor Evaluation) Matrix, SPACE Matrix and SWOT Analysis and QSPM (Quantitative Strategic Planning Matrix). The sample is 66 business people, of 823 craftsmen who are working in this business. The result shows this home industry is very competitive in terms of consistency, but in terms of promotion, product quality, price, product diversification, design training of furniture, management and economic scale, it is lagging behind. The home industry should be able to develop marketing networking, improve design and product quality, promotion and cost control, product diversification and these can only be done by intensive training in managing business and investment.

Tactical Approaches for Making a Successful Satellite Passive Microwave ESDR

NASA Astrophysics Data System (ADS)

Hardman, M.; Brodzik, M. J.; Gotberg, J.; Long, D. G.; Paget, A. C.

2014-12-01

Our NASA MEaSUREs project is producing a new, enhanced resolution gridded Earth System Data Record for the entire satellite passive microwave (SMMR, SSM/I-SSMIS and AMSR-E) time series. Our project goals are twofold: to produce a well-documented, consistently processed, high-quality historical record at higher spatial resolutions than have previously been available, and to transition the production software to the NSIDC DAAC for ongoing processing after our project completion. In support of these goals, our distributed team at BYU and NSIDC faces project coordination challenges to produce a high-quality data set that our user community will accept as a replacement for the currently available historical versions of these data. We work closely with our DAAC liaison on format specifications, data and metadata plans, and project progress. In order for the user community to understand and support our project, we have solicited a team of Early Adopters who are reviewing and evaluating a prototype version of the data. Early Adopter feedback will be critical input to our final data content and format decisions. For algorithm transparency and accountability, we have released an Algorithm Theoretical Basis Document (ATBD) and detailed supporting technical documentation, with rationale for all algorithm implementation decisions. For distributed team management, we are using collaborative tools for software revision control and issue tracking. For reliably transitioning a research-quality image reconstruction software system to production-quality software suitable for use at the DAAC, we have adopted continuous integration methods for running automated regression testing. Our presentation will summarize bothadvantages and challenges of each of these tactics in ensuring production of a successful ESDR and an enduring production software system.

Extra-virgin olive oil: are consumers provided with the sensory quality they want? A hedonic price model with sensory attributes.

PubMed

Cavallo, Carla; Caracciolo, Francesco; Cicia, Gianni; Del Giudice, Teresa

2018-03-01

Over the years, niche-differentiation strategies and food policies have pushed quality standards of European extra-virgin olive oil towards a product that has a sensory profile consisting of fruity, bitter and pungent notes, with such oils having excellent healthy features. However, it is unclear whether typical consumers are ready for a richer and more complex sensory profile than the neutral one historically found on the market. This potential discrepancy is investigated in the present study aiiming to determine whether current demand is able to appreciate this path of quality enhancement. Implicit prices for each and every attribute of extra-virgin olive oil with a focus on sensory characteristics were investigated using a hedonic price model. Although confirming the importance of origin and terroir for extra-virgin olive oil, the results of the present study strongly confirm the discrepancy between what is currently valued on the market and what novel supply trends are trying to achieve in terms of the sensory properties of such products. Increasing consumer awareness about the direct link between the health quality of oils and their sensory profile appears to be necessary to make quality enhancement programs more successful on the market and hence more effective for companies. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Trends in groundwater quality in principal aquifers of the United States, 1988-2012

USGS Publications Warehouse

Lindsey, Bruce D.; Rupert, Michael G.

2014-01-01

The U.S. Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program analyzed trends in groundwater quality throughout the nation for the sampling period of 1988-2012. Trends were determined for networks (sets of wells routinely monitored by the USGS) for a subset of constituents by statistical analysis of paired water-quality measurements collected on a near-decadal time scale. The data set for chloride, dissolved solids, and nitrate consisted of 1,511 wells in 67 networks, whereas the data set for methyl tert-butyl ether (MTBE) consisted of 1, 013 wells in 46 networks. The 25 principal aquifers represented by these networks account for about 75 percent of withdrawals of groundwater used for drinking-water supply for the nation. Statistically significant changes in chloride, dissolved-solids, or nitrate concentrations were found in many well networks over a decadal period. Concentrations increased significantly in 48 percent of networks for chloride, 42 percent of networks for dissolved solids, and 21 percent of networks for nitrate. Chloride, dissolved solids, and nitrate concentrations decreased significantly in 3, 3, and 10 percent of the networks, respectively. The magnitude of change in concentrations was typically small in most networks; however, the magnitude of change in networks with statistically significant increases was typically much larger than the magnitude of change in networks with statistically significant decreases. The largest increases of chloride concentrations were in urban areas in the northeastern and north central United States. The largest increases of nitrate concentrations were in networks in agricultural areas. Statistical analysis showed 42 or the 46 networks had no statistically significant changes in MTBE concentrations. The four networks with statistically significant changes in MTBE concentrations were in the northeastern United States, where MTBE was widely used. Two networks had increasing concentrations, and two networks had decreasing concentrations. Production and use of MTBE peaked in about 2000 and has been effectively banned in many areas since about 2006. The two networks that had increasing concentrations were sampled for the second time close to the peak of MTBE production, whereas the two networks that had decreasing concentrations were sampled for the second time 10 years after the peak of MTBE production.

HPTLC Fingerprint Analysis: A Quality Control for Authentication of Herbal Phytochemicals

NASA Astrophysics Data System (ADS)

Ram, Mauji; Abdin, M. Z.; Khan, M. A.; Jha, Prabhakar

Authentication and consistent quality are the basic requirement for Indian traditional medicine (TIM), Chinese traditional herbal medicine (TCHM), and their commercial products, regardless of the kind of research conducted to modernize the TIM and TCHM. The complexities of TIM and TCHM challenge the current official quality control mode, for which only a few biochemical markers were selected for identification and quantitative assay. Referring too many unknown factors existed in TIM and TCHM, it is impossible and unnecessary to pinpoint qualitatively and quantitatively every single component contained in the herbal drug. Chromatographic fingerprint is a rational option to meet the need for more effective and powerful quality assessment to TIM and TCHM. The optimized chromatographic fingerprint is not only an alternative analytical tool for authentication, but also an approach to express the various pattern of chemical ingredients distribution in the herbal drugs and preserve such "database" for further multifaced sustainable studies. Analytical separation techniques, for example, high-performance liquid chromatography (HPLC), gas chromatography (GC) and mass spectrometry (MS) were among the most popular methods of choice used for quality control of raw material and finished herbal product. Fingerprint analysis approach using high-performance thin-layer chromatography (HPTLC) has become the most potent tool for quality control of herbal medicines because of its simplicity and reliability. It can serve as a tool for identification, authentication, and quality control of herbal drugs. In this chapter, attempts are being made to expand the use of HPTLC and at the same time create interest among prospective researcher in herbal analysis. The developed method can be used as a quality control tool for rapid authentication from a wide variety of herbal samples. Some examples demonstrated the role of fingerprinting in quality control and assessment.

A Transparent and Transferable Framework for Tracking Quality Information in Large Datasets

PubMed Central

Smith, Derek E.; Metzger, Stefan; Taylor, Jeffrey R.

2014-01-01

The ability to evaluate the validity of data is essential to any investigation, and manual “eyes on” assessments of data quality have dominated in the past. Yet, as the size of collected data continues to increase, so does the effort required to assess their quality. This challenge is of particular concern for networks that automate their data collection, and has resulted in the automation of many quality assurance and quality control analyses. Unfortunately, the interpretation of the resulting data quality flags can become quite challenging with large data sets. We have developed a framework to summarize data quality information and facilitate interpretation by the user. Our framework consists of first compiling data quality information and then presenting it through 2 separate mechanisms; a quality report and a quality summary. The quality report presents the results of specific quality analyses as they relate to individual observations, while the quality summary takes a spatial or temporal aggregate of each quality analysis and provides a summary of the results. Included in the quality summary is a final quality flag, which further condenses data quality information to assess whether a data product is valid or not. This framework has the added flexibility to allow “eyes on” information on data quality to be incorporated for many data types. Furthermore, this framework can aid problem tracking and resolution, should sensor or system malfunctions arise. PMID:25379884

QUALITY OF WOOD PELLETS PRODUCED IN BRITISH COLUMBIA FOR EXPORT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tumuluru, J.S.; Sokhansanj, Shahabaddine; Lim, C. Jim

2010-11-01

Wood pellet production and its use for heat and power production are increasing worldwide. The quality of export pellets has to consistently meet certain specifications as stipulated by the larger buyers, such as power utilities or as specified by the standards used for the non-industrial bag market. No specific data is available regarding the quality of export pellets to Europe. To develop a set of baseline data, wood pellets were sampled at an export terminal in Vancouver, British Columbia, Canada. The sampling period was 18 months in 2007-2008 when pellets were transferred from storage bins to the ocean vessels. Themore » sampling frequency was once every 1.5 to 2 months for a total of 9 loading/shipping events. The physical properties of the wood pellets measured were moisture content in the range of 3.5% to 6.5%, bulk density from 728 to 808 kg/m3, durability from 97% to 99%, fines content from 0.03% to 0.87%, calorific value as is from 17 to almost 18 MJ/kg, and ash content from 0.26% to 0.93%.The diameter and length were in the range of 6.4 to 6.5 mm and 14.0 to 19.0 mm, respectively. All of these values met the published non-industrial European grades (CEN) and the grades specified by the Pellet Fuel Institute for the United States for the bag market. The measured values for wood pellet properties were consistent except the ash content values decreased over the test period.« less

Quality of Wood Pellets Produced in British Columbia for Export

DOE Office of Scientific and Technical Information (OSTI.GOV)

J. S. Tumuluru; S. Sokhansanj; C. J. Lim

2010-11-01

Wood pellet production and its use for heat and power production are increasing worldwide. The quality of export pellets has to consistently meet certain specifications as stipulated by the larger buyers, such as power utilities or as specified by the standards used for the non-industrial bag market. No specific data is available regarding the quality of export pellets to Europe. To develop a set of baseline data, wood pellets were sampled at an export terminal in Vancouver, British Columbia, Canada. The sampling period was 18 months in 2007-2008 when pellets were transferred from storage bins to the ocean vessels. Themore » sampling frequency was once every 1.5 to 2 months for a total of 9 loading/shipping events. The physical properties of the wood pellets measured were moisture content in the range of 3.5% to 6.5%, bulk density from 728 to 808 kg/m3, durability from 97% to 99%, fines content from 0.03% to 0.87%, calorific value as is from 17 to almost 18 MJ/kg, and ash content from 0.26% to 0.93%.The diameter and length were in the range of 6.4 to 6.5 mm and 14.0 to 19.0 mm, respectively. All of these values met the published non-industrial European grades (CEN) and the grades specified by the Pellet Fuel Institute for the United States for the bag market. The measured values for wood pellet properties were consistent except the ash content values decreased over the test period.« less

Evaluation of Aquarius Version-5 Sea Surface Salinity on various spatial and temporal scales

NASA Astrophysics Data System (ADS)

Lee, T.

2017-12-01

Sea surface salinity (SSS) products from Aquarius have had three public releases with progressive improvement in data quality: Versions 2, 3, and 4, with the last one being released in October 2015. A systematic assessment of the Version-4, Level-3 Aquarius SSS product was performed on various spatial and temporal scales by comparing it with gridded Argo products (Lee 2016, Geophys. Res. Lett.). The comparison showed that the consistency of Aquarius Version-4 SSS with gridded Argo products is comparable to that between two different gridded Argo products. However, significant seasonal biases remain in high-latitude oceans. Further improvements are being made by the Aquarius team. Aquarius Version 5.0 SSS is scheduled to be released in October 2017 as the final version of the Aquarius Project. This presentation provides a similar evaluation of Version-5 SSS as reported by Lee (2016) and contrast it with the current Version-4 SSS.

Examining the sources of variability in cell culture media used for biopharmaceutical production.

PubMed

McGillicuddy, Nicola; Floris, Patrick; Albrecht, Simone; Bones, Jonathan

2018-01-01

Raw materials, in particular cell culture media, represent a significant source of variability to biopharmaceutical manufacturing processes that can detrimentally affect cellular growth, viability and specific productivity or alter the quality profile of the expressed therapeutic protein. The continual expansion of the biopharmaceutical industry is creating an increasing demand on the production and supply chain consistency for cell culture media, especially as companies embrace intensive continuous processing. Here, we provide a historical perspective regarding the transition from serum containing to serum-free media, the development of chemically-defined cell culture media for biopharmaceutical production using industrial scale bioprocesses and review production mechanisms for liquid and powder culture media. An overview and critique of analytical approaches used for the characterisation of cell culture media and the identification of root causes of variability are also provided, including in-depth liquid phase separations, mass spectrometry and spectroscopic methods.

Detection and quantification of beef and pork materials in meat products by duplex droplet digital PCR.

PubMed

Cai, Yicun; He, Yuping; Lv, Rong; Chen, Hongchao; Wang, Qiang; Pan, Liangwen

2017-01-01

Meat products often consist of meat from multiple animal species, and inaccurate food product adulteration and mislabeling can negatively affect consumers. Therefore, a cost-effective and reliable method for identification and quantification of animal species in meat products is required. In this study, we developed a duplex droplet digital PCR (dddPCR) detection and quantification system to simultaneously identify and quantify the source of meat in samples containing a mixture of beef (Bos taurus) and pork (Sus scrofa) in a single digital PCR reaction tube. Mixed meat samples of known composition were used to test the accuracy and applicability of this method. The limit of detection (LOD) and the limit of quantification (LOQ) of this detection and quantification system were also identified. We conclude that our dddPCR detection and quantification system is suitable for quality control and routine analyses of meat products.

[Quality assurance in interventional cardiology].

PubMed

Gülker, H

2009-10-01

Quality assurance in clinical studies aiming at approval of pharmaceutical products is submitted to strict rules, controls and auditing regulations. Comparative instruments to ensure quality in diagnostic and therapeutic procedures are not available in interventional cardiology, likewise in other fields of cardiovascular medicine. Quality assurance simply consists of "quality registers" with basic data not externally controlled. Based on the experiences of clinical studies and their long history of standardization it is assumed that these data may be severely flawed thus being inappropriate to set standards for diagnostic and therapeutic strategies. The precondition for quality assurance are quality data. In invasive coronary angiography and intervention medical indications, the decision making process interventional versus surgical revascularization, technical performance and after - care are essential aspects affecting quality of diagnostics and therapy. Quality data are externally controlled data. To collect quality data an appropriate infrastructure is a necessary precondition which is not existent. For an appropriate infrastructure investments have to be done both to build up as well as to sustain the necessary preconditions. As long as there are no infrastructure and no investments there will be no "quality data". There exist simply registers of data which are not proved to be a basis for significant assurance and enhancement in quality in interventional coronary cardiology. Georg Thieme Verlag KG Stuttgart, New York.

Effects of stimulus duration and vowel quality in cross-linguistic categorical perception of pitch directions

PubMed Central

Zhu, Yiqing; Wayland, Ratree

2017-01-01

We investigated categorical perception of rising and falling pitch contours by tonal and non-tonal listeners. Specifically, we determined minimum durations needed to perceive both contours and compared to those of production, how stimuli duration affects their perception, whether there is an intrinsic F0 effect, and how first language background, duration, directions of pitch and vowel quality interact with each other. Continua of fundamental frequency on different vowels with 9 duration values were created for identification and discrimination tasks. Less time is generally needed to effectively perceive a pitch direction than to produce it. Overall, tonal listeners’ perception is more categorical than non-tonal listeners. Stimuli duration plays a critical role for both groups, but tonal listeners showed a stronger duration effect, and may benefit more from the extra time in longer stimuli for context-coding, consistent with the multistore model of categorical perception. Within a certain range of semitones, tonal listeners also required shorter stimulus duration to perceive pitch direction changes than non-tonal listeners. Finally, vowel quality plays a limited role and only interacts with duration in perceiving falling pitch directions. These findings further our understanding on models of categorical perception, the relationship between speech perception and production, and the interaction between the perception of tones and vowel quality. PMID:28671991

The mycobiota of the production environments of traditional Norwegian salted and dried mutton (pinnekjøtt).

PubMed

Schirmer, Bjørn C T; Wiik-Nielsen, Jannicke; Skaar, Ida

2018-07-02

In 2013, mould growth on Norwegian ready-to-sell pinnekjøtt (dried and cured lamb ribs) lead to the withdrawal of 200 tons of the product. The aim of this study was to identify the mycobiota at two Norwegian production sites and determine which species present the highest risk for reduced product quality and safety. A total of 485 samples from 2014, 2015 and 2016 were analysed for Penicillium and Aspergillus species. Both production sites showed a persistent mycobiota that remained stable over three seasons. Samples from site A were dominated by P. solitum while samples from site B were equally dominated by P. solitum, P. brevicompactum/bialowiezense and P. nordicum. The presence of P. nordicum was concentrated in one area of the production site where long-time stored hams were produced, but P. nordicum was also found sporadically in other parts of the site. Product samples taken from products with visible mould growth were at both sites dominated by P. solitum, highlighting its importance for product quality. P. nordicum was found frequently in the long-time stored hams, indicating a food safety risk of these products. However, P. nordicum was rarely isolated from pinnekjøtt. Aspergillus spp. were isolated from both sites at all samplings; however, there were no Aspergillus isolated from products, and no sites were repeatedly tested positive for identical species, indicating that Aspergillus is not a part of the persistent mycobiota, but enters the site sporadically. In conclusion, the study showed that a stable mycobiota consisting of few Penicillium species dominated the products and production environments of pinnekjøtt. Copyright © 2018 Elsevier B.V. All rights reserved.

Cell-Based Therapies for Joint Disease in Veterinary Medicine: What We Have Learned and What We Need to Know

PubMed Central

Bogers, Sophie Helen

2018-01-01

Biological cell-based therapies for the treatment of joint disease in veterinary patients include autologous-conditioned serum, platelet-rich plasma, and expanded or non-expanded mesenchymal stem cell products. This narrative review outlines the processing and known mechanism of action of these therapies and reviews current preclinical and clinical efficacy in joint disease in the context of the processing type and study design. The significance of variation for biological activity and consequently regulatory approval is also discussed. There is significant variation in study outcomes for canine and equine cell-based products derived from whole blood or stem cell sources such as adipose and bone marrow. Variation can be attributed to altering bio-composition due to factors including preparation technique and source. In addition, study design factors like selection of cases with early vs. late stage osteoarthritis (OA), or with intra-articular soft tissue injury, influence outcome variation. In this under-regulated field, variation raises concerns for product safety, consistency, and efficacy. Cell-based therapies used for OA meet the Food and Drug Administration’s (FDA’s) definition of a drug; however, researchers must consider their approach to veterinary cell-based research to meet future regulatory demands. This review explains the USA’s FDA guidelines as an example pathway for cell-based therapies to demonstrate safety, effectiveness, and manufacturing consistency. An understanding of the variation in production consistency, effectiveness, and regulatory concerns is essential for practitioners and researchers to determine what products are indicated for the treatment of joint disease and tactics to improve the quality of future research. PMID:29713634

An empirical evaluation of software quality assurance practices and challenges in a developing country: a comparison of Nigeria and Turkey.

PubMed

Sowunmi, Olaperi Yeside; Misra, Sanjay; Fernandez-Sanz, Luis; Crawford, Broderick; Soto, Ricardo

2016-01-01

The importance of quality assurance in the software development process cannot be overemphasized because its adoption results in high reliability and easy maintenance of the software system and other software products. Software quality assurance includes different activities such as quality control, quality management, quality standards, quality planning, process standardization and improvement amongst others. The aim of this work is to further investigate the software quality assurance practices of practitioners in Nigeria. While our previous work covered areas on quality planning, adherence to standardized processes and the inherent challenges, this work has been extended to include quality control, software process improvement and international quality standard organization membership. It also makes comparison based on a similar study carried out in Turkey. The goal is to generate more robust findings that can properly support decision making by the software community. The qualitative research approach, specifically, the use of questionnaire research instruments was applied to acquire data from software practitioners. In addition to the previous results, it was observed that quality assurance practices are quite neglected and this can be the cause of low patronage. Moreover, software practitioners are neither aware of international standards organizations or the required process improvement techniques; as such their claimed standards are not aligned to those of accredited bodies, and are only limited to their local experience and knowledge, which makes it questionable. The comparison with Turkey also yielded similar findings, making the results typical of developing countries. The research instrument used was tested for internal consistency using the Cronbach's alpha, and it was proved reliable. For the software industry in developing countries to grow strong and be a viable source of external revenue, software assurance practices have to be taken seriously because its effect is evident in the final product. Moreover, quality frameworks and tools which require minimum time and cost are highly needed in these countries.

Air Quality Research and Applications Using AURA OMi Data

NASA Technical Reports Server (NTRS)

Bhartia, P.K.; Gleason, J.F.; Torres, O.; Levelt, P.; Liu, X.; Ziemke, J.; Chandra, S.; Krotkov, N.

2007-01-01

The Ozone Monitoring Instrument (OMI) on EOS Aura is a new generation of satellite remote sensing instrument designed to measure trace gas and aerosol absorption at the UV and blue wavelengths. These measurements are made globally at urban scale resolution with no inter-orbital gaps that make them potentially very useful for air quality research, such as the determination of the sources and processes that affect global and regional air quality, and to develop applications such as air quality forecast. However, the use of satellite data for such applications is not as straight forward as satellite data have been for stratospheric research. There is a need for close interaction between the satellite product developers, in-situ measurement programs, and the air quality research community to overcome some of the inherent difficulties in interpreting data from satellite-based remote sensing instruments. In this talk we will discuss the challenges and opportunities in using OMI products for air quality research and applications. A key conclusion of this work is that to realize the full potential of OMI measurements it will be necessary to combine OMI data with data from instruments such as MLS, MODIS, AIRS, and CALIPSO that are currently flying in the "A-train" satellite constellation. In addition similar data taken by satellites crossing the earth at different local times than the A-train (e.g., the recently MetOp satellite) would need to be processed in a consistent manner to study diurnal variability, and to capture the effects on air quality of rapidly changing events such as wild fires.

Image quality specification and maintenance for airborne SAR

NASA Astrophysics Data System (ADS)

Clinard, Mark S.

2004-08-01

Specification, verification, and maintenance of image quality over the lifecycle of an operational airborne SAR begin with the specification for the system itself. Verification of image quality-oriented specification compliance can be enhanced by including a specification requirement that a vendor provide appropriate imagery at the various phases of the system life cycle. The nature and content of the imagery appropriate for each stage of the process depends on the nature of the test, the economics of collection, and the availability of techniques to extract the desired information from the data. At the earliest lifecycle stages, Concept and Technology Development (CTD) and System Development and Demonstration (SDD), the test set could include simulated imagery to demonstrate the mathematical and engineering concepts being implemented thus allowing demonstration of compliance, in part, through simulation. For Initial Operational Test and Evaluation (IOT&E), imagery collected from precisely instrumented test ranges and targets of opportunity consisting of a priori or a posteriori ground-truthed cultural and natural features are of value to the analysis of product quality compliance. Regular monitoring of image quality is possible using operational imagery and automated metrics; more precise measurements can be performed with imagery of instrumented scenes, when available. A survey of image quality measurement techniques is presented along with a discussion of the challenges of managing an airborne SAR program with the scarce resources of time, money, and ground-truthed data. Recommendations are provided that should allow an improvement in the product quality specification and maintenance process with a minimal increase in resource demands on the customer, the vendor, the operational personnel, and the asset itself.

Soil indigenous knowledge in North Central Namibia

NASA Astrophysics Data System (ADS)

Prudat, Brice; Bloemertz, Lena; Kuhn, Nikolaus J.

2016-04-01

Mapping and classifying soils is part of an important learning process to improve soil management practices, soil quality and increase productivity. In order to assess soil quality improvement related to an ongoing land reform in North-Central Namibia, the characteristics that determine soil quality in the local land use context were determined in this study. To do so, we collated the indigenous soil knowledge in North-Central Namibia where the Ovakwanyama cultivate pearl millet for centuries. Local soil groups are defined mostly based on their productivity potential, which varies depending on the rainfall pattern. The morphological criteria used by the farmers to differentiate the soil groups (colour, consistence) were supported by a conventional analysis of soil physical and chemical properties. Now, they can be used to develop a soil quality assessment toolbox adapted to the regional use. The characteristics of the tool box do not directly indicate soil quality, but refer to local soils groups. The quality of these groups is relatively homogenous at the local scale. Our results show that understanding of indigenous soil knowledge has great potential to improve soil quality assessment with regards to land use. The integration of this knowledge with the conventional soil analysis improves the local meaning of such a "scientific" assessment and thus facilitates dialog between farmers and agronomists, but also scientists working in different regions of the world, but in similar conditions. Overall, the integration of indigenous knowledge in international classification systems (e.g. WRB) as attempted in this study has thus a major potential to improve soil mapping in the local context.

Production and quality of clinical practice guidelines in Argentina (1994–2004): a cross-sectional study

PubMed Central

Esandi, María Eugenia; Ortiz, Zulma; Chapman, Evelina; Dieguez, Marcelo García; Mejía, Raúl; Bernztein, Ricardo

2008-01-01

Background In the last decades, a sustained increment of Clinical Practice Guidelines (CPG) production in the world has been accompanied by a growing concern about their quality. Many studies related to quality assessment of guidelines produced in High Income Countries were published; however, evidence on this topic is scarce in Low and Middle Income Countries (LMIC). The objectives of this research were: a) to describe guideline production in Argentina at different levels of the health system (macro, meso and micro) from 1994 to 2004; and b) to assess their quality by using the AGREE instrument. Methods A cross-sectional study was undertaken to describe guidelines production in Argentina between 1994 and 2004. CPG were identified through Internet and electronic databases (MEDLINE and LILACS). Explicit inclusion and exclusion criteria were used to select guidelines. Each CPG was independently assessed by two reviewers using the AGREE instrument. Domain scores were calculated as recommended by the AGREE Collaboration. The internal consistency of each domain was evaluated using Cronbach's alpha and inter-observer agreement by the Intraclass Correlation Coefficient (ICC). Results A total amount of 431 potential CPG were identified, but only 144 were considered CPG. At the end, 101 CPG were included for further assessment. Median standardized score for each domain were: scope = 39%; stakeholder involvement = 13%; rigour of development = 10%; clarity = 42%; applicability = 6%; editorial independence = 0%. Only 22 CPG were recommended with modifications by both appraisers. ICC and Cronbach's alpha for each domain were in all cases moderate or high (greater than 0.40), except for editorial independence. Conclusion This study has systematically employed the AGREE instrument for the critical assessment of guidelines produced in a LMIC. Guideline development and diffusion in Argentina from 1994 to 2004 shows a constant increment, although quality of reporting did not improve; moreover, in some aspects it seemed to decline. Much room for improvement of the guideline development process was found at all levels of the health system. PMID:18851739

Automation and quality assurance of the production cycle

NASA Astrophysics Data System (ADS)

Hajdu, L.; Didenko, L.; Lauret, J.

2010-04-01

Processing datasets on the order of tens of terabytes is an onerous task, faced by production coordinators everywhere. Users solicit data productions and, especially for simulation data, the vast amount of parameters (and sometime incomplete requests) point at the need for a tracking, control and archiving all requests made so a coordinated handling could be made by the production team. With the advent of grid computing the parallel processing power has increased but traceability has also become increasing problematic due to the heterogeneous nature of Grids. Any one of a number of components may fail invalidating the job or execution flow in various stages of completion and re-submission of a few of the multitude of jobs (keeping the entire dataset production consistency) a difficult and tedious process. From the definition of the workflow to its execution, there is a strong need for validation, tracking, monitoring and reporting of problems. To ease the process of requesting production workflow, STAR has implemented several components addressing the full workflow consistency. A Web based online submission request module, implemented using Drupal's Content Management System API, enforces ahead that all parameters are described in advance in a uniform fashion. Upon submission, all jobs are independently tracked and (sometime experiment-specific) discrepancies are detected and recorded providing detailed information on where/how/when the job failed. Aggregate information on success and failure are also provided in near real-time.

Evaluation of three growing media substrates for western larch seedling production at the USDA Forest Service Coeur d'Alene Nursery

Treesearch

Anthony S. Davis; Kent Eggleston; Jeremy R. Pinto; R. Kasten Dumroese

2009-01-01

In response to concerns regarding growing media substrate costs, and the impact of growing media on seedling quality, we evaluated three peat-based growing media substrates at the USDA Forest Service Coeur d'Alene Nursery in Idaho. Current medium consists of 80:20 peat:fresh Douglas-fir sawdust (v:v). Two other substrates, 75:25 peat:fine screened Douglas-fir bark...

Latest framework to improve vital signs.

PubMed

Baillie, Jonathan

2009-08-01

Greater consistency in NHS signage, coupled with the assurance of a high quality, competitively-priced range of signage and wayfinding products and services, are among the benefits promised to estates and facilities teams UK-wide following the NHS Purchasing and Supply Agency's (NHS PASA) recent launch of a new pan-Government signage framework agreement. Jonathan Baillie reports, and talks to several signage suppliers appointed to the framework about their expertise, skills and recent experience.

[Ecological regionalization of national cotton fiber quality in China using GGE biplot analysis method].

PubMed

Xu, Nai Yin; Jin, Shi Qiao; Li, Jian

2017-01-01

The distinctive regional characteristics of cotton fiber quality in the major cotton-producing areas in China enhance the textile use efficiency of raw cotton yarn by improving fiber quality through ecological regionalization. The "environment vs. trait" GGE biplot analysis method was adopted to explore the interaction between conventional cotton sub-regions and cotton fiber quality traits based on the datasets collected from the national cotton regional trials from 2011 to 2015. The results showed that the major cotton-producing area in China were divided into four fiber quality ecological regions, namely, the "high fiber quality ecological region", the "low micronaire ecological region", the "high fiber strength and micronaire ecological region", and the "moderate fiber quality ecological region". The high fiber quality ecological region was characterized by harmonious development of cotton fiber length, strength, micronaire value and the highest spinning consistency index, and located in the conventional cotton regions in the upper and lower reaches of Yangtze River Valley. The low micronaire value ecological region composed of the northern and south Xinjiang cotton regions was characterized by low micronaire value, relatively lower fiber strength, and relatively high spinning consistency index performance. The high fiber strength and micronaire value ecological region covered the middle reaches of Yangtze River Valley, Nanxiang Basin and Huaibei Plain, and was prominently characterized by high strength and micronaire value, and moderate performance of other traits. The moderate fiber quality ecological region included North China Plain and Loess Plateau cotton growing regions in the Yellow River Valley, and was characterized by moderate or lower performances of all fiber quality traits. This study effectively applied "environment vs. trait" GGE biplot to regionalize cotton fiber quality, which provided a helpful reference for the regiona-lized cotton growing regions in terms of optimal raw fiber production for textile industry, and gave a good example for the implementation of similar ecological regionalization of other crops as well.

Can Real-Time Data Also Be Climate Quality?

NASA Astrophysics Data System (ADS)

Brewer, M.; Wentz, F. J.

2015-12-01

GMI, AMSR-2 and WindSat herald a new era of highly accurate and timely microwave data products. Traditionally, there has been a large divide between real-time and re-analysis data products. What if these completely separate processing systems could be merged? Through advanced modeling and physically based algorithms, Remote Sensing Systems (RSS) has narrowed the gap between real-time and research-quality. Satellite microwave ocean products have proven useful for a wide array of timely Earth science applications. Through cloud SST capabilities have enormously benefited tropical cyclone forecasting and day to day fisheries management, to name a few. Oceanic wind vectors enhance operational safety of shipping and recreational boating. Atmospheric rivers are of import to many human endeavors, as are cloud cover and knowledge of precipitation events. Some activities benefit from both climate and real-time operational data used in conjunction. RSS has been consistently improving microwave Earth Science Data Records (ESDRs) for several decades, while making near real-time data publicly available for semi-operational use. These data streams have often been produced in 2 stages: near real-time, followed by research quality final files. Over the years, we have seen this time delay shrink from months or weeks to mere hours. As well, we have seen the quality of near real-time data improve to the point where the distinction starts to blur. We continue to work towards better and faster RFI filtering, adaptive algorithms and improved real-time validation statistics for earlier detection of problems. Can it be possible to produce climate quality data in real-time, and what would the advantages be? We will try to answer these questions…

The bacteriological quality of different brands of bottled water available to consumers in Ile-Ife, south-western Nigeria.

PubMed

Igbeneghu, Oluwatoyin A; Lamikanra, Adebayo

2014-11-28

The upsurge in the demand for bottled water has prompted the interest of many manufacturers in the production of bottled water and very many water bottling companies are therefore involved in its production. These range from large scale multinational companies to medium scale business enterprises, institutional and government business investment companies as well as small scale entrepreneurs. There is however little information on the comparative quality of bottled water brands produced by different classes of water bottling companies in Nigeria. This study was undertaken to determine the bacteriological quality of brands of bottled water available to consumers in Ile-Ife. Forty-three samples of bottled water comprising of three batches each of thirteen bottled water brands and two batches of two brands were purchased and analyzed for total bacterial count, presence of coliform and the presence of other bacterial indicators of drinking water quality. Only 67.4% of the water samples representing the products of 10 companies or 66.7% of the brands had heterotrophic counts within the acceptable limits. Coliforms present in 100 ml of water were detected in 26.7% of the bottled water brands. Other indicator organisms detected included Staphylococci isolated from 27.9% of the samples (33.3% of the brands) and specifically Staphylococcus aureus found in four brands constituting 14% of the samples. Pseudomonas strains were consistently detected in consecutive batches of three brands of the water samples. Bottled water samples produced by the large scale multinational producers were of acceptable bacteriological quality unlike those produced by most small companies. There is need for a greater control of water bottling processes carried out by commercial bottled water producers in Nigeria.

Temperature-induced impacts on groundwater quality and arsenic mobility in anoxic aquifer sediments used for both drinking water and shallow geothermal energy production.

PubMed

Bonte, Matthijs; van Breukelen, Boris M; Stuyfzand, Pieter J

2013-09-15

Aquifers used for the production of drinking water are increasingly being used for the generation of shallow geothermal energy. This causes temperature perturbations far beyond the natural variations in aquifers and the effects of these temperature variations on groundwater quality, in particular trace elements, have not been investigated. Here, we report the results of column experiments to assess the impacts of temperature variations (5°C, 11°C, 25°C and 60°C) on groundwater quality in anoxic reactive unconsolidated sandy sediments derived from an aquifer system widely used for drinking water production in the Netherlands. Our results showed that at 5 °C no effects on water quality were observed compared to the reference of 11°C (in situ temperature). At 25°C, As concentrations were significantly increased and at 60 °C, significant increases were observed pH and DOC, P, K, Si, As, Mo, V, B, and F concentrations. These elements should therefore be considered for water quality monitoring programs of shallow geothermal energy projects. No consistent temperature effects were observed on Na, Ca, Mg, Sr, Fe, Mn, Al, Ba, Co, Cu, Ni, Pb, Zn, Eu, Ho, Sb, Sc, Yb, Ga, La, and Th concentrations, all of which were present in the sediment. The temperature-induced chemical effects were probably caused by (incongruent) dissolution of silicate minerals (K and Si), desorption from, and potentially reductive dissolution of, iron oxides (As, B, Mo, V, and possibly P and DOC), and mineralisation of sedimentary organic matter (DOC and P). Copyright © 2013 Elsevier Ltd. All rights reserved.

Experience of ALCOA-KOFEM with MHD induction stirrer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Petho, S.

1996-10-01

Every ingot cast shop makes an effort to reduce the costs and to increase the productivity. The MHD stirrer is an adequate tool to achieve a more economical production. The electromagnetic stirrer accelerates the melting rate of the charge, reduces the metal loss and improves the consistency of ingot quality. The Ingot Business Unit of ALCOA-KOFEM operates seven melting furnaces. Each furnace is equipped with a POTOK type MHD induction stirrer in order to achieve a more profitable melting operation. Magnetohydrodynamic stirrers were installed between 1988 and 1990 on melting furnaces ranging in capacity from 25 to 60 tons ofmore » molten metal.« less

Quality Assessment of Landsat Surface Reflectance Products Using MODIS Data

NASA Technical Reports Server (NTRS)

Feng, Min; Huang, Chengquan; Channan, Saurabh; Vermote, Eric; Masek, Jeffrey G.; Townshend, John R.

2012-01-01

Surface reflectance adjusted for atmospheric effects is a primary input for land cover change detection and for developing many higher level surface geophysical parameters. With the development of automated atmospheric correction algorithms, it is now feasible to produce large quantities of surface reflectance products using Landsat images. Validation of these products requires in situ measurements, which either do not exist or are difficult to obtain for most Landsat images. The surface reflectance products derived using data acquired by the Moderate Resolution Imaging Spectroradiometer (MODIS), however, have been validated more comprehensively. Because the MODIS on the Terra platform and the Landsat 7 are only half an hour apart following the same orbit, and each of the 6 Landsat spectral bands overlaps with a MODIS band, good agreements between MODIS and Landsat surface reflectance values can be considered indicators of the reliability of the Landsat products, while disagreements may suggest potential quality problems that need to be further investigated. Here we develop a system called Landsat-MODIS Consistency Checking System (LMCCS). This system automatically matches Landsat data with MODIS observations acquired on the same date over the same locations and uses them to calculate a set of agreement metrics. To maximize its portability, Java and open-source libraries were used in developing this system, and object-oriented programming (OOP) principles were followed to make it more flexible for future expansion. As a highly automated system designed to run as a stand-alone package or as a component of other Landsat data processing systems, this system can be used to assess the quality of essentially every Landsat surface reflectance image where spatially and temporally matching MODIS data are available. The effectiveness of this system was demonstrated using it to assess preliminary surface reflectance products derived using the Global Land Survey (GLS) Landsat images for the 2000 epoch. As surface reflectance likely will be a standard product for future Landsat missions, the approach developed in this study can be adapted as an operational quality assessment system for those missions.

A screening mammography program. Staying alive and making it work.

PubMed

Monsees, B S; Destouet, J M

1992-01-01

The success of a mammography screening program requires thorough planning. A dependably high volume and a streamlined efficient operation are essential to survival of the program. Factors that warrant consideration prior to designing such a program include the following: Distinction between screening and diagnostic mammography examinations. Selection of a site that will meet the needs of the community and yet provide a consistently high volume. Low examination cost for screening mammography coupled with a detailed financial analysis and reappraisal on an ongoing basis. A customized marketing program that incorporates methods to increase awareness, compliance, and utilization by women and referring physicians. Well-trained, efficient, and dedicated personnel. An operation that is designed for rapid throughput and expeditious patient flow. An efficient plan for film handling, interpretation, reporting, and storage. Timely communication of examination results. A reliable mechanism for follow-up evaluation and outcome data collection. Establishment of a consistent and reliable quality assurance program and the production of high quality mammograms.

Uniqueness and Overlap: Characteristics and Longitudinal Correlates of Native Chinese Children’s Writing in English as a Foreign Language

PubMed Central

Zhang, Juan; McBride-Chang, Catherine; Wagner, Richard K.; Chan, Shingfong

2015-01-01

Longitudinal predictors of writing composition in Chinese and English written by the same 153 Hong Kong nine-year-old children were tested, and their production errors within the English essays across ten categories, focusing on punctuation, spelling, and grammar, were compared to errors made by ninety American nine-year-olds writing on the same topic. The correlation between quality of the compositions in Chinese and English was .53. In stepwise regression analyses examining early predictors at ages between five and nine years, tasks of speed or fluency were consistently uniquely associated with Chinese writing composition; measures of English vocabulary knowledge, word reading, or both were consistently uniquely associated with English writing quality. Compared to the American children, Chinese children’s writing reflected significantly higher proportions of errors in all grammatical categories but did not differ in punctuation or spelling. Findings underscore both similarities and differences in writing at different levels across languages. PMID:25729319

A Method of Retrospective Computerized System Validation for Drug Manufacturing Software Considering Modifications

NASA Astrophysics Data System (ADS)

Takahashi, Masakazu; Fukue, Yoshinori

This paper proposes a Retrospective Computerized System Validation (RCSV) method for Drug Manufacturing Software (DMSW) that relates to drug production considering software modification. Because DMSW that is used for quality management and facility control affects big impact to quality of drugs, regulatory agency required proofs of adequacy for DMSW's functions and performance based on developed documents and test results. Especially, the work that explains adequacy for previously developed DMSW based on existing documents and operational records is called RCSV. When modifying RCSV conducted DMSW, it was difficult to secure consistency between developed documents and test results for modified DMSW parts and existing documents and operational records for non-modified DMSW parts. This made conducting RCSV difficult. In this paper, we proposed (a) definition of documents architecture, (b) definition of descriptive items and levels in the documents, (c) management of design information using database, (d) exhaustive testing, and (e) integrated RCSV procedure. As a result, we could conduct adequate RCSV securing consistency.

Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center.

PubMed

Sather, Mike R; Parsons, Sherry; Boardman, Kathy D; Warren, Stuart R; Davis-Karim, Anne; Griffin, Kevin; Betterton, Jane A; Jones, Mark S; Johnson, Stanley H; Vertrees, Julia E; Hickey, Jan H; Salazar, Thelma P; Huang, Grant D

2018-03-01

This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES) that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA) Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management) to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, continued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.

Landsat 8 Remote Sensing Reflectance (Rrs) Products: Evaluations, Intercomparisons, and Enhancements

NASA Technical Reports Server (NTRS)

Pahlevan, Nima; Schott, John R.; Franz, Bryan A.; Zibordi, Giuseppe; Markham, Brian; Bailey, Sean; Schaaf, Crystal B.; Ondrusek, Michael; Greb, Steven; Strait, Christopher M.

2017-01-01

The Operational Land Imager (OLI) onboard Landsat-8 is generating high-quality aquatic science products, the most critical of which is the remote sensing reflectance (Rrs), defined as the ratio of water-leaving radiance to the total downwelling irradiance just above water. The quality of the Rrs products has not, however, been extensively assessed. This manuscript provides a comprehensive evaluation of Level-1B, i.e., top of atmosphere reflectance, and Rrs products available from OLI imagery under near-ideal atmospheric conditions in moderately turbid waters. The procedure includes a) evaluations of the Rrs products at sites included in the Ocean Color component of the Aerosol Robotic Network (AERONET-OC), b) intercomparisons and cross-calibrations against other ocean color products, and c) optimizations of vicarious calibration gains across the entire OLI observing swath. Results indicate that the near-infrared and shortwave infrared (NIR-SWIR) band combinations yield the most robust and stable Rrs retrievals in moderately turbid waters. Intercomparisons against products derived from the Visible Infrared Imaging Radiometer Suite (VIIRS) and the Moderate Resolution Imaging Spectroradiometer onboard the Aqua platform (MODISA) indicate slight across-track non-uniformities (<1%) associated with OLI scenes in the blue bands. In both product domains (TOA and Rrs), on average, the OLI products were found larger in radiometric responses in the blue channels. Following the implementation of updated vicarious calibration gains and accounting for across-track non-uniformities, matchup analyses using independent in-situ validation data confirmed improvements in Rrs products. These findings further support high-fidelity OLI-derived aquatic science products in terms of both demonstrating a robust atmospheric correction method and providing consistent products across OLI's imaging swath.

Integrating Theory and Practice: Applying the Quality Improvement Paradigm to Product Line Engineering

NASA Technical Reports Server (NTRS)

Stark, Michael; Hennessy, Joseph F. (Technical Monitor)

2002-01-01

My assertion is that not only are product lines a relevant research topic, but that the tools used by empirical software engineering researchers can address observed practical problems. Our experience at NASA has been there are often externally proposed solutions available, but that we have had difficulties applying them in our particular context. We have also focused on return on investment issues when evaluating product lines, and while these are important, one can not attain objective data on success or failure until several applications from a product family have been deployed. The use of the Quality Improvement Paradigm (QIP) can address these issues: (1) Planning an adoption path from an organization's current state to a product line approach; (2) Constructing a development process to fit the organization's adoption path; (3) Evaluation of product line development processes as the project is being developed. The QIP consists of the following six steps: (1) Characterize the project and its environment; (2) Set quantifiable goals for successful project performance; (3) Choose the appropriate process models, supporting methods, and tools for the project; (4) Execute the process, analyze interim results, and provide real-time feedback for corrective action; (5) Analyze the results of completed projects and recommend improvements; and (6) Package the lessons learned as updated and refined process models. A figure shows the QIP in detail. The iterative nature of the QIP supports an incremental development approach to product lines, and the project learning and feedback provide the necessary early evaluations.

AirNow Information Management System - Global Earth Observation System of Systems Data Processor for Real-Time Air Quality Data Products

NASA Astrophysics Data System (ADS)

Haderman, M.; Dye, T. S.; White, J. E.; Dickerson, P.; Pasch, A. N.; Miller, D. S.; Chan, A. C.

2012-12-01

Built upon the success of the U.S. Environmental Protection Agency's (EPA) AirNow program (www.AirNow.gov), the AirNow-International (AirNow-I) system contains an enhanced suite of software programs that process and quality control real-time air quality and environmental data and distribute customized maps, files, and data feeds. The goals of the AirNow-I program are similar to those of the successful U.S. program and include fostering the exchange of environmental data; making advances in air quality knowledge and applications; and building a community of people, organizations, and decision makers in environmental management. In 2010, Shanghai became the first city in China to run this state-of-the-art air quality data management and notification system. AirNow-I consists of a suite of modules (software programs and schedulers) centered on a database. One such module is the Information Management System (IMS), which can automatically produce maps and other data products through the use of GIS software to provide the most current air quality information to the public. Developed with Global Earth Observation System of Systems (GEOSS) interoperability in mind, IMS is based on non-proprietary standards, with preference to formal international standards. The system depends on data and information providers accepting and implementing a set of interoperability arrangements, including technical specifications for collecting, processing, storing, and disseminating shared data, metadata, and products. In particular, the specifications include standards for service-oriented architecture and web-based interfaces, such as a web mapping service (WMS), web coverage service (WCS), web feature service (WFS), sensor web services, and Really Simple Syndication (RSS) feeds. IMS is flexible, open, redundant, and modular. It also allows the merging of data grids to create complex grids that show comprehensive air quality conditions. For example, the AirNow Satellite Data Processor (ASDP) was recently developed to merge PM2.5 estimates from National Aeronautics and Space Administration (NASA) satellite data and AirNow observational data, creating more precise maps and gridded data products for under-monitored areas. The ASDP can easily incorporate other data feeds, including fire and smoke locations, to build enhanced real-time air quality data products. In this presentation, we provide an overview of the features and functions of IMS, an explanation of how data moves through IMS, the rationale of the system architecture, and highlights of the ASDP as an example of the modularity and scalability of IMS.

Recirculation of reverse osmosis concentrate in lab-scale anaerobic and aerobic landfill simulation reactors.

PubMed

Morello, Luca; Cossu, Raffaello; Raga, Roberto; Pivato, Alberto; Lavagnolo, Maria Cristina

2016-10-01

Leachate treatment is a major issue in the context of landfill management, particularly in view of the consistent changes manifested over time in the quality and quantity of leachate produced, linked to both waste and landfill characteristics, which renders the procedure technically difficult and expensive. Leachate recirculation may afford a series of potential advantages, including improvement of leachate quality, enhancement of gas production, acceleration of biochemical processes, control of moisture content, as well as nutrients and microbe migration within the landfill. Recirculation of the products of leachate treatment, such as reverse osmosis (RO) concentrate, is a less common practice, with widespread controversy relating to its suitability, potential impacts on landfill management and future gaseous and leachable emissions. Scientific literature provides the results of only a few full-scale applications of concentrate recirculation. In some cases, an increase of COD and ammonium nitrogen in leachate was observed, coupled with an increase of salinity; which, additionally, might negatively affect performance of the RO plant itself. In other cases, not only did leachate production not increase significantly but the characteristics of leachate extracted from the well closest to the re-injection point also remained unchanged. This paper presents the results of lab-scale tests conducted in landfill simulation reactors, in which the effects of injection of municipal solid waste (MSW) landfill leachate RO concentrate were evaluated. Six reactors were managed with different weekly concentrate inputs, under both anaerobic and aerobic conditions, with the aim of investigating the short and long-term effects of this practice on landfill emissions. Lab-scale tests resulted in a more reliable identification of compound accumulation and kinetic changes than full-scale applications, further enhancing the development of a mass balance in which gaseous emissions and waste characteristics were also taken into consideration. Results showed that RO concentrate recirculation did not produce consistent changes in COD emissions and methane production. Simultaneously, ammonium ion showed a consistent increase in leachate (more than 25%) in anaerobic reactors, free ammonia gaseous emissions doubled with concentrate injection, while chloride resulted accumulated inside the reactor. Copyright © 2016 Elsevier Ltd. All rights reserved.

GEOLAND2 global LAI, FAPAR Essential Climate Variables for terrestrial carbon modeling: principles and validation

NASA Astrophysics Data System (ADS)

Baret, F.; Weiss, M.; Lacaze, R.; Camacho, F.; Smets, B.; Pacholczyk, P.; Makhmara, H.

2010-12-01

LAI and fAPAR are recognized as Essential Climate Variables providing key information for the understanding and modeling of canopy functioning. Global remote sensing observations at medium resolution are routinely acquired since the 80’s mainly with AVHRR, SEAWIFS, VEGETATION, MODIS and MERIS sensors. Several operational products have been derived and provide global maps of LAI and fAPAR at daily to monthly time steps. Inter-comparison between MODIS, CYCLOPES, GLOBCARBON and JRC-FAPAR products showed generally consistent seasonality, while large differences in magnitude and smoothness may be observed. One of the objectives of the GEOLAND2 European project is to develop such core products to be used in a range of application services including the carbon monitoring. Rather than generating an additional product from scratch, the version 1 of GEOLAND2 products was capitalizing on the existing products by combining them to retain their pros and limit their cons. For these reasons, MODIS and CYCLOPES products were selected since they both include LAI and fAPAR while having relatively close temporal sampling intervals (8 to 10 days). GLOBCARBON products were not used here because of the too long monthly time step inducing large uncertainties in the seasonality description. JRC-FAPAR was not selected as well to preserve better consistency between LAI and fAPAR products. MODIS and CYCLOPES products were then linearly combined to take advantage of the good performances of CYCLOPES products for low to medium values of LAI and fAPAR while benefiting from the better MODIS performances for the highest LAI values. A training database representative of the global variability of vegetation type and conditions was thus built. A back-propagation neural network was then calibrated to estimate the new LAI and fAPAR products from VEGETATION preprocessed observations. Similarly, the vegetation cover fraction (fCover) was also derived by scaling the original CYCLOPES fCover products. Validation results achieved following the principles proposed by CEOS-LPV show that the new product called GEOV1 behaves as expected with good performances over the whole range of LAI and fAPAR in a temporally smooth and spatially consistent manner. These products will be processed and delivered by VITO in near real time at 1 km spatial resolution and 10 days frequency using a pre-operational production quality tracking system. The entire VEGETATION archive, from 1999 will be processed to provide a consistent time series over both VEGETATION sensors at the same spatial and temporal sampling. A climatology of products computed over the VEGETATION period will be also delivered at the same spatial and temporal sampling, showing average values, between year variability and possible trends over the decade. Finally, the VEGETATION derived time series starting back to 1999 will be completed with consistent products at 4 km spatial resolution derived from the NOAA/AVHRR series to cover the 1981-2010 period.

Container-content compatibility studies: a pharmaceutical team's integrated approach.

PubMed

Laschi, Alda; Sehnal, Natacha; Alarcon, Antoine; Barcelo, Beatrice; Caire-Maurisier, François; Delaire, Myriam; Feuilloley, Marc; Genot, Stéphanie; Lacaze, Catherine; Pisarik, Luc; Smati, Christophe

2009-01-01

Container-content compatibility studies are required as part of the submission of a new product market authorization file or for a change relating to the primary product-contact packaging. Many regulatory publications and guidances are available in the USA, Europe, and Japan. However these publications and guidances are not sufficiently precise enough to allow for consistent interpretation and implementation of the technical requirements. A working group has been formed by the French Society of Pharmaceutical Science and Technology (SFSTP) in order to propose guidance for container-content interaction studies that meet both European and US requirements, and allows consistent and standardized information to be presented by the industry to the regulators. When a pharmaceutical drug product remains in prolonged contact with a material, the two critical points to consider are the drug product's quality and safety. A pharmaceutical evaluation of the container-content relationship should be done based on the knowledge of the contact material (e.g., type, physicochemical properties), its manufacturing processes (e.g., the type of sterilization that could potentially alter the interactions), and the formulation components involved in contact with this material (e.g., physicochemical properties, pharmaceutical presentation, route of administration). Quality is evaluated using the stability study performed on the product. Safety is partially evaluated with the stability study and is analyzed in conjunction with toxicity testing, specifically with cytotoxicity testing. The toxicity aspect is the key point of the container-content compatibility study and of patient safety. Migration tests are conducted when an interaction is suspected, or found based on previous results, to identify the component responsible for this interaction and to help select a new material if needed. Therefore, such tests are perhaps not the best ones to use for the purpose of safety evaluation. Consequently, a decision tree based mainly on the toxicity aspect is proposed in order to support the pharmaceutical companies' container-content interaction approach and filing.

[Physical fingerprint for quality control of traditional Chinese medicine extract powders].

PubMed

Zhang, Yi; Xu, Bing; Sun, Fei; Wang, Xin; Zhang, Na; Shi, Xin-Yuan; Qiao, Yan-Jiang

2016-06-01

The physical properties of both raw materials and excipients are closely correlated with the quality of traditional Chinese medicine preparations in oral solid dosage forms. In this paper, based on the concept of the chemical fingerprint for quality control of traditional Chinese medicine products, the method of physical fingerprint for quality evaluation of traditional Chinese medicine extract powders was proposed. This novel physical fingerprint was built by the radar map, and consisted of five primary indexes (i.e. stackablity, homogeneity, flowability, compressibility and stability) and 12 secondary indexes (i.e. bulk density, tap density, particle size<50 μm percentage, relative homogeneity index, hausner ratio, angle of repose, powder flow time, inter-particle porosity, Carr index, cohesion index, loss on drying, hygroscopicity). Panax notoginseng saponins (PNS) extract was taken for an example. This paper introduced the application of physical fingerprint in the evaluation of source-to-source and batch-to-batch quality consistence of PNS extract powders. Moreover, the physical fingerprint of PNS was built by calculating the index of parameters, the index of parametric profile and the index of good compressibility, in order to successfully predict the compressibility of the PNS extract powder and relevant formulations containing PNS extract powder and conventional pharmaceutical excipients. The results demonstrated that the proposed method could not only provide new insights into the development and process control of traditional Chinese medicine solid dosage forms. Copyright© by the Chinese Pharmaceutical Association.

Analysis of consumer behavior in decision making of purchasing ornamental freshwater fish (case of study at ornamental freshwater fish market at Peta Street, Bandung)

NASA Astrophysics Data System (ADS)

Gumilar, I.; Rizal, A.; Sriati; Setiawan Putra, R.

2018-04-01

This research aim was to analyzed process of decision making of purchasing ornamental freshwater fish at Peta Street, Bandung City and Analyzed what factors are driving consumers to buy freshwater fish Peta Street. The method used in this research is case study with rating scale and rank spearman analysis. The sampling technique is the accidental random sampling method consist of 30 respondents. The consumer’s decision making process consist of five stages, namely the recognition of needs, information searching, alternative evaluation, process of purchasing, and the evaluation of results. The results showed that at the stage of recognition of needs the motivation of purchasing freshwater fish because respondents are very fond of ornamental freshwater fish, at the stage of information search, the information sources are from the print media and friends or neighborhood. At the stage of alternative evaluation, the reason consumers buy ornamental freshwater fish because the quality of good products. The stage of purchasing decision process consumers bought 1-5 fish with frequency of purchase 1 time per month. The evaluation of results of post-purchasing consumers feel very satisfied with the fish products and the price is very affordable. To observe the factors that influence purchasing motivation of consumers, spearman rank test is the method. The results showed that the quality and price of the product are the factors that most influence the purchase decision of ornamental freshwater fish with the range of student-t value 3,968 and 2,107.

The influence of farmland pollution on the quality and safety of agricultural products

NASA Astrophysics Data System (ADS)

Ma, Z. L.; Li, L. Y.; Ye, C.; Lin, X. Y.; B, C.; Wei

2018-02-01

The quality and safety of agricultural products is not only a major livelihood issues for people’s health, but also the main barriers to international trade of agricultural products nowadays. The soil is the foundation to the production of agricultural products and the guarantee of agricultural development. The farmland soil quality is directly related to the quality and safety of agricultural products. Our country’s soil has been polluted by a series of pollution, Such as the excessive discharge of industrial wastes, the encroachment of household waste, and the unreasonable use of pesticides and fertilizers. Soil degradation is a serious threat to the quality and safety of agricultural products, so eliminating soil degradation is the fundamental way out for quality and safety of agricultural products. By analyzing problems of the quality and safety of agricultural products in our country, and exploring the farmland soil influence on the quality and safety of agricultural products. This article provides a reference for improving the control level of quality and safety of agricultural products and the farmland soil quality.

Studies and Application of the Platform for Synergies among Tobacco Enterprises in Tobacco Leaf Threshing and Redrying

NASA Astrophysics Data System (ADS)

Xu, Xiao-Shuang; Wang, Hong-Lv

2018-03-01

Departing from the formulas of cigarette products, synergized business framework is established on the basis of cross-enterprise synergies for tobacco leaf threshing and redrying through the introduction of batch management, remote quality data sharing and consistent processes, among others. Functions of the business framework are achieved and a platform for synergies is erected by applying IOT, cross-enterprise system integration and big data processing technologies, resulting in a new pattern for intensive interaction and synergies between China Tobacco Zhejiang (CTZ) and tobacco redrying plants for more delicate management of the redrying process, more interactive information flows and more stable tobacco strip quality.

Enhancing wind erosion monitoring and assessment for U.S. rangelands

USGS Publications Warehouse

Webb, Nicholas P.; Van Zee, Justin W.; Karl, Jason W.; Herrick, Jeffrey E.; Courtright, Ericha M.; Billings, Benjamin J.; Boyd, Robert C.; Chappell, Adrian; Duniway, Michael C.; Derner, Justin D.; Hand, Jenny L.; Kachergis, Emily; McCord, Sarah E.; Newingham, Beth A.; Pierson, Frederick B.; Steiner, Jean L.; Tatarko, John; Tedela, Negussie H.; Toledo, David; Van Pelt, R. Scott

2017-01-01

On the GroundWind erosion is a major resource concern for rangeland managers because it can impact soil health, ecosystem structure and function, hydrologic processes, agricultural production, and air quality.Despite its significance, little is known about which landscapes are eroding, by how much, and when.The National Wind Erosion Research Network was established in 2014 to develop tools for monitoring and assessing wind erosion and dust emissions across the United States.The Network, currently consisting of 13 sites, creates opportunities to enhance existing rangeland soil, vegetation, and air quality monitoring programs.Decision-support tools developed by the Network will improve the prediction and management of wind erosion across rangeland ecosystems.

Assessment of the Impacts of Rice Cropping through a Soil Quality Index

NASA Astrophysics Data System (ADS)

Sione, S. M.; Wilson, M. G.; Paz González, A.

2012-04-01

In Entre Ríos (Argentina), rice cultivation is carried out mainly in Vertisols. Several factors, such as the use of sodium bicarbonate waters for irrigation, the excessive tillage required, and the lack of proper planning for land use, mainly regarding the crop sequence, cause serious impacts on the soil and have an effect on sustainable agriculture. Thus, the development of methodologies to detect these impacts has become a priority. The aim of this study was to standardize soil quality indicators (SQI) and integrate them into an index to evaluate the impacts of the rice production system on soil, at the farm scale. The study was conducted in farms of the traditional rice cultivation area of Entre Ríos province, Argentina. We evaluated a minimum data set consisting of six indicators: structural stability and percolation, total organic matter content (TOM), exchangeable sodium content (ESC), electrical conductivity of saturation extract (ECe) and reaction of the soil (pH). From a database from 75 production lots, we determined the reference values, i.e. limits to ensure the maintenance of long-term productivity and the allowable thresholds for each indicator. The indicators were standardized and integrated into a soil quality index. Five ranges of soil quality were established: very low, low, moderate, high and very high, depending on the values assigned to each SQI. This index allowed differentiating the impact of different crop sequences and showed that the increased participation of rice crop in the rotation resulted in a deterioration of the soil structure due to the decrease in the TOM and to the cumulative increase in ESC caused by the sodium bicarbonate water used for irrigation. Soil management strategies should aim to increase TOM values and to reduce the input of sodium to the exchange complex. A rotation with 50% to 60% of pasture and 40 to 50% of agriculture with a participation of rice lower than 20 to 25% would allow the sustainability of the production system. The use of the so called SQI, i.e. soil quality index, for rice crop production will allow generating early warning of degradation and thus adopting recovery measures.

Potential for use of environmental factors in urban planning

NASA Astrophysics Data System (ADS)

Teixeira da Silva, Ricardo; van der Ploeg, Martine; van Delden, Hedwig; Fleskens, Luuk

2016-04-01

Projections for population growth estimate, on top of the current 7.4 billion world population, an increase of 2 billion people for the next 40 years. It is also projected that 66 per cent of the world population in 2050 will live in urban areas. To accommodate the urban population growth cities are changing continuously land cover to urban areas. Such changes are a threat for natural resources and food production systems stability and capability to provide food and other functions. However, little has been done concerning a rational soil management for food production in urban and peri-urban areas. This study focuses on the assessment of soil lost due to urban expansion and discusses the potential loss regarding the quality of the soil for food production and environmental functions. It is relevant to increase the knowledge on the role of soils in peri-urban areas and in the interaction of physical, environmental and social factors. The methodology consists of assessing the soil quality in and around urban and peri-urban areas. It focuses particularly on the physical properties and the environmental factors, for two periods of time and account the potential losses due to urban expansion. This project is on-going, therefore current advances will be presented and will look for a discussion on the contribution of soil quality for decision-making and land management in urban and peri-urban areas.

A review on optimization production and upgrading biogas through CO2 removal using various techniques.

PubMed

Andriani, Dian; Wresta, Arini; Atmaja, Tinton Dwi; Saepudin, Aep

2014-02-01

Biogas from anaerobic digestion of organic materials is a renewable energy resource that consists mainly of CH4 and CO2. Trace components that are often present in biogas are water vapor, hydrogen sulfide, siloxanes, hydrocarbons, ammonia, oxygen, carbon monoxide, and nitrogen. Considering the biogas is a clean and renewable form of energy that could well substitute the conventional source of energy (fossil fuels), the optimization of this type of energy becomes substantial. Various optimization techniques in biogas production process had been developed, including pretreatment, biotechnological approaches, co-digestion as well as the use of serial digester. For some application, the certain purity degree of biogas is needed. The presence of CO2 and other trace components in biogas could affect engine performance adversely. Reducing CO2 content will significantly upgrade the quality of biogas and enhancing the calorific value. Upgrading is generally performed in order to meet the standards for use as vehicle fuel or for injection in the natural gas grid. Different methods for biogas upgrading are used. They differ in functioning, the necessary quality conditions of the incoming gas, and the efficiency. Biogas can be purified from CO2 using pressure swing adsorption, membrane separation, physical or chemical CO2 absorption. This paper reviews the various techniques, which could be used to optimize the biogas production as well as to upgrade the biogas quality.

Development of an analysis tool for cloud base height and visibility

NASA Astrophysics Data System (ADS)

Umdasch, Sarah; Reinhold, Steinacker; Manfred, Dorninger; Markus, Kerschbaum; Wolfgang, Pöttschacher

2014-05-01

The meteorological variables cloud base height (CBH) and horizontal atmospheric visibility (VIS) at surface level are of vital importance for safety and effectiveness in aviation. Around 20% of all civil aviation accidents in the USA from 2003 to 2007 were due to weather related causes, around 18% of which were owing to decreased visibility or ceiling (main CBH). The aim of this study is to develop a system generating quality-controlled gridded analyses of the two parameters based on the integration of various kinds of observational data. Upon completion, the tool is planned to provide guidance for nowcasting during take-off and landing as well as for flights operated under visual flight rules. Primary input data consists of manual as well as instrumental observation of CBH and VIS. In Austria, restructuring of part of the standard meteorological stations from human observation to automatic measurement of VIS and CBH is currently in progress. As ancillary data, satellite derived products can add 2-dimensional information, e.g. Cloud Type by NWC SAF (Nowcasting Satellite Application Facilities) MSG (Meteosat Second Generation). Other useful available data are meteorological surface measurements (in particular of temperature, humidity, wind and precipitation), radiosonde, radar and high resolution topography data. A one-year data set is used to study the spatial and weather-dependent representativeness of the CBH and VIS measurements. The VERA (Vienna Enhanced Resolution Analysis) system of the Institute of Meteorology and Geophysics of the University of Vienna provides the framework for the analysis development. Its integrated "Fingerprint" technique allows the insertion of empirical prior knowledge and ancillary information in the form of spatial patterns. Prior to the analysis, a quality control of input data is performed. For CBH and VIS, quality control can consist of internal consistency checks between different data sources. The possibility of two-dimensional consistency checks has to be explored. First results in the development of quality control features and fingerprints will be shown.

LANDFIRE Remap: A New National Baseline Product Suite

NASA Astrophysics Data System (ADS)

Dockter, D.; Peterson, B.; Picotte, J. J.; Long, J.; Tolk, B.; Callahan, K.; Davidson, A.; Earnhardt, T.

2017-12-01

LANDFIRE, also known as the Landscape Fire and Resource Management Planning Tools Program, is a vegetation, fire, and fuel characteristic data creation program managed by both the U.S. Department of Agriculture Forest Service and the U.S. Department of the Interior with involvement from The Nature Conservancy. LANDFIRE represents the first and only complete, nationally consistent collection of over 20 geo-spatial layers (e.g., vegetation type and structure, fuels, fire regimes), databases, and ecological models that can be used across multiple disciplines to support cross-boundary planning, management, and operations across all lands of the United States and insular areas. Since 2004, LANDFIRE has produced comprehensive, consistent, and scientifically based suites of mapped products and associated databases for the United States and affiliated territories. These products depict the nation's major ecosystems and wildlife habitats. Over a decade has passed since the development of the first LANDFIRE base map, and an overhaul of the data products, i.e., a "Remap", is needed to maintain their functionality and relevance. To prepare for Remap production LANDFIRE has invested in a prototyping phase that focused on exploring various input data sources and new modeling and mapping techniques. While still grounded in a solid base consisting of Landsat imagery and high-quality field observations, the prototyping efforts explored different image compositing techniques, the integration of lidar data, modeling approaches as well as other factors that will inform Remap production. Several of these various research efforts are highlighted here and are currently being integrated into an end-to-end data processing flow that will drive the Remap production. The current Remap prototype effort has focused on several study areas throughout CONUS, with additional studies anticipated for Alaska, Hawaii and the territories. The LANDFIRE Remap effort is expected to take three to four years, with production commencing in northwestern CONUS.

Reducing the societal burden of depression: a review of economic costs, quality of care and effects of treatment.

PubMed

Donohue, Julie M; Pincus, Harold Alan

2007-01-01

Depression is a highly prevalent condition that results in substantial functional impairment. Advocates have attempted in recent years to make the 'business case' for investing in quality improvement efforts in depression care, particularly in primary care settings. The business case suggests that the costs of depression treatment may be offset by gains in worker productivity and/or reductions in other healthcare spending. In this paper, we review the evidence in support of this argument for improving the quality of depression treatment. We examined the impact of depression on two of the primary drivers of the societal burden of depression: healthcare utilisation and worker productivity. Depression leads to higher healthcare utilisation and spending, most of which is not the result of depression treatment costs. Depression is also a leading cause of absenteeism and reduced productivity at work. It is clear that the economic burden of depression is substantial; however, critical gaps in the literature remain and need to be addressed. For instance, we do not know the economic burden of untreated and/or inappropriately treated versus appropriately treated depression. There remain considerable problems with access to and quality of depression treatment. Progress has been made in terms of access to care, but quality of care is seldom consistent with national treatment guidelines. A wide range of effective treatments and care programmes for depression are available, yet rigorously tested clinical models to improve depression care have not been widely adopted by healthcare systems. Barriers to improving depression care exist at the patient, healthcare provider, practice, plan and purchaser levels, and may be both economic and non-economic. Studies evaluating interventions to improve the quality of depression treatment have found that the cost per QALY associated with improved depression care ranges from a low of 2519 US dollars to a high of 49,500 US dollars. We conclude from our review of the literature that effective treatment of depression is cost effective, but that evidence of a medical or productivity cost offset for depression treatment remains equivocal, and this points to the need for further research in this area.

Measurement bias detection with Kronecker product restricted models for multivariate longitudinal data: an illustration with health-related quality of life data from thirteen measurement occasions

PubMed Central

Verdam, Mathilde G. E.; Oort, Frans J.

2014-01-01

Highlights Application of Kronecker product to construct parsimonious structural equation models for multivariate longitudinal data. A method for the investigation of measurement bias with Kronecker product restricted models. Application of these methods to health-related quality of life data from bone metastasis patients, collected at 13 consecutive measurement occasions. The use of curves to facilitate substantive interpretation of apparent measurement bias. Assessment of change in common factor means, after accounting for apparent measurement bias. Longitudinal measurement invariance is usually investigated with a longitudinal factor model (LFM). However, with multiple measurement occasions, the number of parameters to be estimated increases with a multiple of the number of measurement occasions. To guard against too low ratios of numbers of subjects and numbers of parameters, we can use Kronecker product restrictions to model the multivariate longitudinal structure of the data. These restrictions can be imposed on all parameter matrices, including measurement invariance restrictions on factor loadings and intercepts. The resulting models are parsimonious and have attractive interpretation, but require different methods for the investigation of measurement bias. Specifically, additional parameter matrices are introduced to accommodate possible violations of measurement invariance. These additional matrices consist of measurement bias parameters that are either fixed at zero or free to be estimated. In cases of measurement bias, it is also possible to model the bias over time, e.g., with linear or non-linear curves. Measurement bias detection with Kronecker product restricted models will be illustrated with multivariate longitudinal data from 682 bone metastasis patients whose health-related quality of life (HRQL) was measured at 13 consecutive weeks. PMID:25295016

Measurement bias detection with Kronecker product restricted models for multivariate longitudinal data: an illustration with health-related quality of life data from thirteen measurement occasions.

PubMed

Verdam, Mathilde G E; Oort, Frans J

2014-01-01

Application of Kronecker product to construct parsimonious structural equation models for multivariate longitudinal data.A method for the investigation of measurement bias with Kronecker product restricted models.Application of these methods to health-related quality of life data from bone metastasis patients, collected at 13 consecutive measurement occasions.The use of curves to facilitate substantive interpretation of apparent measurement bias.Assessment of change in common factor means, after accounting for apparent measurement bias.Longitudinal measurement invariance is usually investigated with a longitudinal factor model (LFM). However, with multiple measurement occasions, the number of parameters to be estimated increases with a multiple of the number of measurement occasions. To guard against too low ratios of numbers of subjects and numbers of parameters, we can use Kronecker product restrictions to model the multivariate longitudinal structure of the data. These restrictions can be imposed on all parameter matrices, including measurement invariance restrictions on factor loadings and intercepts. The resulting models are parsimonious and have attractive interpretation, but require different methods for the investigation of measurement bias. Specifically, additional parameter matrices are introduced to accommodate possible violations of measurement invariance. These additional matrices consist of measurement bias parameters that are either fixed at zero or free to be estimated. In cases of measurement bias, it is also possible to model the bias over time, e.g., with linear or non-linear curves. Measurement bias detection with Kronecker product restricted models will be illustrated with multivariate longitudinal data from 682 bone metastasis patients whose health-related quality of life (HRQL) was measured at 13 consecutive weeks.

Traceability from a US perspective.

PubMed

Smith, G C; Tatum, J D; Belk, K E; Scanga, J A; Grandin, T; Sofos, J N

2005-09-01

Traceability of a food consists of development of "an information trail that follows the food product's physical trail". Internationally, the US is lagging behind many countries in developing traceability systems for food in general and especially for livestock, poultry and their products. The US food industry is developing, implementing and maintaining traceability systems designed to improve food supply management, facilitate traceback for food safety and quality, and differentiate and market foods with subtle or undetectable quality attributes. Traceability, for livestock, poultry and meat, in its broadest context, can, could, or will eventually be used: (1) to ascertain origin and ownership, and to deter theft and misrepresentation, of animals and meat; (2) for surveillance, control and eradication of foreign animal diseases; (3) for biosecurity protection of the national livestock population; (4) for compliance with requirements of international customers; (5) for compliance with country-of-origin labeling requirements; (6) for improvement of supply-side management, distribution/delivery systems and inventory controls; (7) to facilitate value-based marketing; (8) to facilitate value-added marketing; (9) to isolate the source and extent of quality-control and food-safety problems; and (10) to minimize product recalls and make crisis management protocols more effective. Domestically and internationally, it has now become essential that producers, packers, processors, wholesalers, exporters and retailers assure that livestock, poultry and meat are identified, that record-keeping assures traceability through all or parts of the complete life-cycle, and that, in some cases, the source, the production-practices and/or the process of generating final products, can be verified. At issue, as the US develops traceback capabilities, will be the breadth, depth and precision of its specific traceability systems.

High throughput electrospinning of high-quality nanofibers via an aluminum disk spinneret

NASA Astrophysics Data System (ADS)

Zheng, Guokuo

In this work, a simple and efficient needleless high throughput electrospinning process using an aluminum disk spinneret with 24 holes is described. Electrospun mats produced by this setup consisted of fine fibers (nano-sized) of the highest quality while the productivity (yield) was many times that obtained from conventional single-needle electrospinning. The goal was to produce scaled-up amounts of the same or better quality nanofibers under variable concentration, voltage, and the working distance than those produced with the single needle lab setting. The fiber mats produced were either polymer or ceramic (such as molybdenum trioxide nanofibers). Through experimentation the optimum process conditions were defined to be: 24 kilovolt, a distance to collector of 15cm. More diluted solutions resulted in smaller diameter fibers. Comparing the morphologies of the nanofibers of MoO3 produced by both the traditional and the high throughput set up it was found that they were very similar. Moreover, the nanofibers production rate is nearly 10 times than that of traditional needle electrospinning. Thus, the high throughput process has the potential to become an industrial nanomanufacturing process and the materials processed by it may be used as filtration devices, in tissue engineering, and as sensors.

Fabrication, Quality Assurance, and Quality Control for PROSPECT Detector Component Production

NASA Astrophysics Data System (ADS)

Gustafson, Ian; Prospect (The Precision Reactor Oscillation; Spectrum Experiment) Collaboration

2017-09-01

The Precision Reactor Oscillation and Spectrum Experiment (PROSPECT) is an electron antineutrino (νe) detector intended to make a precision measurement of the 235U neutrino spectrum and to search for the possible existence of sterile neutrinos with a mass splitting of Δm2 on the order of 1 eV2 . As a short baseline detector, PROSPECT will be located less than 10 meters from the High Flux Isotope Reactor at Oak Ridge National Laboratory. As PROSPECT intends to search for baseline-dependent oscillations, physical segmentation is needed to better measure the interaction position. PROSPECT will therefore be a segmented detector in two dimensions, thereby improving position measurements. PROSPECT will be segmented into 154 (11×14) 1.2-meter long rectangular tubes, using optical separators. Each separator will consist of a carbon fiber core, laminated with optical reflector (to increase light collection) and Teflon (to ensure compatibility with the scintillator). These optical separators will be held in place via strings of 3D printed PLA rods called `pinwheels.' This poster discusses the fabrication and quality assurance (QA) procedures used in the production of both the PROSPECT optical separators and pinwheels. For the PROSPECT collaboration.

Fly Ash: From Cradle to Grave

USGS Publications Warehouse

Ellis, Margaret S.; Affolter, Ronald H.

2007-01-01

The Energy Resources Program of the U.S. Geological Survey promotes and supports coal research to improve the understanding of the coal endowment of the United States. This results in geologically based, non-biased energy information products for policy and decision makers, land and resource managers, other federal and state agencies, the domestic energy industry, foreign governments, nongovernmental groups, academia, and other scientists. A more integrated approach to our coal quality work involves what we call a 'cradle to grave' approach. These types of studies focus not on just one aspect of the coal but rather on how or where different quality parameters form and (or) occur and what happens to them through the mining, production, transport, utilization and waste disposal process. An extensive suite of coal quality analyses, mineralogical, petrology, and leaching investigations are determined on samples taken from the different phases of the coal utilization process. This report consists of a tutorial that was given on June 10, 2007 at the 32nd International Technical Conference on Coal Utilization & Fuel Systems, The Power of Coal, Clearwater Coal Conference in Clearwater, Florida, USA. This tutorial covers how these studies are conducted and the importance of providing improved, comprehensive, science-based data sets for policy and decision makers.

Fabrication of high aspect ratio nanopillars and micro/nano combined structures with hydrophobic surface characteristics by injection molding

NASA Astrophysics Data System (ADS)

Zhou, Mingyong; Xiong, Xiang; Jiang, Bingyan; Weng, Can

2018-01-01

Polymer products with micro/nano-structures have excellent mechanical and optical properties, chemical resistance, and other advantages. Injection molding is one of the most potential techniques to fabricate polymer products with micro/nano-structures artificially in large numbers. In this study, a surface approach to fabricate high aspect ratio nanopillars and micro/nano combined structures was presented. Mold insert with micropillar arrays and nanopillars on its surface was prepared by combing anodic aluminum oxide (AAO) template and etched plate. Anti-sticking modification was done on the template to realize a better demolding quality. The influences of mold temperature and polymer material on the final replication quality were investigated. The results showed that the final replication quality of high aspect ratio nanopillars was greatly improved as compared with the unprocessed template. Polymer with low elongation at break was not suitable to fabricate structures with high aspect ratio via injection molding. For polypropylene surface, the experimental results of static contact angles were almost consistent with Cassie-Baxter equation. When the mold temperature reached 178 °C, hair-like polycarbonate nanopillars were observed, resulting in an excellent hydrophobic characteristic.

Lizard threat display handicaps endurance.

PubMed Central

Brandt, Y

2003-01-01

Honest-signalling theory asserts that threat displays reliably advertise attributes that influence fighting success. Endurance, as measured by treadmill performance, predicts the outcome of agonistic interactions among lizards. If threat displays in lizards function to advertise endurance capacity then variation in threat displays should correlate with endurance. I tested this prediction for the duration of threat posturing in male side-blotched lizards (Uta stansburiana) and examined whether threat displays act as quality handicaps, reliable signals that expend the attribute that is advertised. Individual variation in the duration of threat posturing correlated with endurance, while an experimental reduction of endurance diminished the duration of threat posturing. As expected of a quality handicap, endurance fell below baseline after display production. A restriction of aerobic metabolism can account for this effect. In threat posturing, lateral compression of the thorax may interfere with respiration or with circulation, limiting aerobic metabolism and causing a compensatory increase in anaerobic metabolism, thereby generating lactate and diminishing locomotor capacity. Concentrations of lactate measured after display production were higher than baseline, consistent with the proposed mechanism. By restricting aerobic metabolism, the threat posture can act as a quality handicap, simultaneously advertising and expending the endurance capacity of displaying lizards. PMID:12803896

Determination of sucralose in Splenda and a sugar-free beverage using high-performance anion-exchange chromatography with pulsed amperometric detection.

PubMed

Hanko, Valoran P; Rohrer, Jeffrey S

2004-07-14

Sucralose is a chlorinated carbohydrate nonnutritive sweetener of food and beverage products. The determination of sucralose in food and beverages is important to ensure consistency in product quality. Sucralose was determined in two commercial products without sample preparation using high-performance anion-exchange (HPAE) chromatography coupled with pulsed amperometric detection (PAD). Sucralose was determined with a 10 min isocratic separation. To determine sucralose and other carbohydrates (e.g., dextrose) simultaneously, a gradient separation was developed. The linear range of electrochemical response extended over 3 orders of magnitude, from 0.01 (LOD) to 40 microM (16 microg/mL; 25 microL injection). High precision, high spike recovery, and method ruggedness were observed for both samples.

Engineering of mechanical manufacturing from the cradle to cradle

NASA Astrophysics Data System (ADS)

Peralta, M. E.; Aguayo, F.; Lama, J. R.

2012-04-01

The sustainability of manufacturing processes lies in industrial planning and productive activity. Industrial plants are characterized by the management of resource (inputs and outputs), processing and conversion processes, which usually are organized in a linear system. Good planning will optimize the manufacturing and promoting the quality of the industrial system. Cradle to Cradle is a new paradigm for engineering and sustainable manufacturing that integrates projects (industrial parks, manufacturing plants, systems and products) in a framework consistent with the environment, adapted to the society and technology and economically viable. To carry it out, we implement this paradigm in the MGE2 (Genomic Model of Eco-innovation and Eco-design), as a methodology for designing and developing products and manufacturing systems with an approach from the cradle to cradle.

Cryogenics and its application with reference to spice grinding: a review.

PubMed

Balasubramanian, S; Gupta, Manoj Kumar; Singh, K K

2012-01-01

Cryogenics is the study of very low temperature and its application on different materials including biological products. Cryogenics has numerous applications in space science, electronics, automobiles, the manufacturing industry, sports and musical instruments, biological science and agriculture, etc. Cryogenic freezing finds pivotal application in food, that is, spices and condiments. Although there is a wide range of cryogens to produce the desired low temperature, generally liquid nitrogen (LN₂) is used in food grinding. The application of low temperature shows a promising pathway to produce higher quality end product with higher flavor and volatile oil retention. Cryogenic grinders generally consist of precoolers and grinder with the cryogen distribution system. In such grinding systems, cryogens subject the raw material up to or lower than glass transition temperature before it is ground, thus eliminating much of the material and quality hassles of traditional grinding. At present, the capital investment including cryogen and handling costs escalate the final cost of the product. Thus, for large-scale production, a proper design to optimize and make it feasible is the need of the hour and understanding the behavior of different food materials at these low temperature conditions. This article reviews the scenario and application of cryogenics in different sectors, especially to spice grinding.

Algorithm integration using ADL (Algorithm Development Library) for improving CrIMSS EDR science product quality

NASA Astrophysics Data System (ADS)

Das, B.; Wilson, M.; Divakarla, M. G.; Chen, W.; Barnet, C.; Wolf, W.

2013-05-01

Algorithm Development Library (ADL) is a framework that mimics the operational system IDPS (Interface Data Processing Segment) that is currently being used to process data from instruments aboard Suomi National Polar-orbiting Partnership (S-NPP) satellite. The satellite was launched successfully in October 2011. The Cross-track Infrared and Microwave Sounder Suite (CrIMSS) consists of the Advanced Technology Microwave Sounder (ATMS) and Cross-track Infrared Sounder (CrIS) instruments that are on-board of S-NPP. These instruments will also be on-board of JPSS (Joint Polar Satellite System) that will be launched in early 2017. The primary products of the CrIMSS Environmental Data Record (EDR) include global atmospheric vertical temperature, moisture, and pressure profiles (AVTP, AVMP and AVPP) and Ozone IP (Intermediate Product from CrIS radiances). Several algorithm updates have recently been proposed by CrIMSS scientists that include fixes to the handling of forward modeling errors, a more conservative identification of clear scenes, indexing corrections for daytime products, and relaxed constraints between surface temperature and air temperature for daytime land scenes. We have integrated these improvements into the ADL framework. This work compares the results from ADL emulation of future IDPS system incorporating all the suggested algorithm updates with the current official processing results by qualitative and quantitative evaluations. The results prove these algorithm updates improve science product quality.

Microalgal process-monitoring based on high-selectivity spectroscopy tools: status and future perspectives.

PubMed

Podevin, Michael; Fotidis, Ioannis A; Angelidaki, Irini

2018-08-01

Microalgae are well known for their ability to accumulate lipids intracellularly, which can be used for biofuels and mitigate CO 2 emissions. However, due to economic challenges, microalgae bioprocesses have maneuvered towards the simultaneous production of food, feed, fuel, and various high-value chemicals in a biorefinery concept. On-line and in-line monitoring of macromolecules such as lipids, proteins, carbohydrates, and high-value pigments will be more critical to maintain product quality and consistency for downstream processing in a biorefinery to maintain and valorize these markets. The main contribution of this review is to present current and prospective advances of on-line and in-line process analytical technology (PAT), with high-selectivity - the capability of monitoring several analytes simultaneously - in the interest of improving product quality, productivity, and process automation of a microalgal biorefinery. The high-selectivity PAT under consideration are mid-infrared (MIR), near-infrared (NIR), and Raman vibrational spectroscopies. The current review contains a critical assessment of these technologies in the context of recent advances in software and hardware in order to move microalgae production towards process automation through multivariate process control (MVPC) and software sensors trained on "big data". The paper will also include a comprehensive overview of off-line implementations of vibrational spectroscopy in microalgal research as it pertains to spectral interpretation and process automation to aid and motivate development.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Profiling metals in Cordyceps sinensis by using inductively coupled plasma mass spectrometry.

PubMed

Wei, Xin; Hu, Hankun; Zheng, Baogeng; Arslan, Zikri; Huang, Hung-Chung; Mao, Weidong; Liu, Yi-Ming

2017-01-28

Cordyceps sinensis ( C. sinensis ) is a natural product that has diverse nutritional and medicinal values. Since the availability of natural C. sinensis becomes limited its authentication and quality control is of high significance. Herein we report on profiling of metals in C. sinensis by using inductively coupled plasma mass spectrometry (ICP-MS). The analysis reveals that C. sinensis contains a wide array of essential elements, including P, Mg, Zn, Cu, Fe, etc. Toxic metals detected are Cd, Pb, and As. In all five samples analyzed Pb contents are below 2.0 ppm. Arsenic level in C. sinensis caterpillar is significantly higher than that in its mycelium and varies from 3.0 to 32 ppm likely due to soil contamination. It's for the first time demonstrated in this work that clustering analysis on the proposed metal profiles consisting of 24 elements is very useful to identify "abnormal" C. sinensis samples, thus adding another dimension to the effective means for authentication and quality assessment of this highly demanded previous natural product.

Effectiveness and efficiency of potassium fertilizer application to increase the production and quality of rice in entisols

NASA Astrophysics Data System (ADS)

Hartati, S.; Suryono; Purnomo, D.

2018-03-01

The study aimed to determine the appropriate dose of K-type fertilizer on the production and quality of IR-64 rice varieties in Entisols. The study was conducted on Entisols, Nglarang, Basin, Kebonarum, Klaten, Central Java, Indonesia. Randomized Complete Block Design (RCBD) was used with 2 factors and three replicates. Factor I: types of K fertilizer: KCl, ZK, and KNO3. Factor II: K fertilizer dose consists of four levels: 0, 50, 100 and 150 kg K2O ha-1. The results showed that the type of K fertilizer KCl, ZK, and KNO3 gave similar effect on growth and yield of rice variety IR 64 on Entisols. Dose of K fertilizer increased the growth and yield of rice but an increased dose provides improved meaningful results. K fertilizer with a dose of 50 kg ha-1 K2O is the most efficient, with the agronomic efficiency for dry grain highest yield of 13.6 kg/kg K2O achieved by ZK fertilizer.

Precision vineyard management from space - from Bacchus to Eneide

NASA Astrophysics Data System (ADS)

Cheli, Simonetta; Fusco, Luigi; Sandrelli, Stefano

2005-08-01

In a highly competitive global market such as the wine business, consistent quality is a must, especially if Europe wants to maintain its position as world leader. It currently accounts for 55% of the world's vine-growing areas, 60% of wine production and 70% of exports. In this very special sector of agriculture, technology and science play fundamental roles in all phases of activity, from the start of the vine-growing season, through the ripening of the grapes, to the bottling of the wine. The quality of the wine produced depends on many parameters, including the soil characteristics in the area, the weather and growth conditions during the season, the ability to monitor and control vine diseases, the degree of maturity of the grapes at harvest time, their grade, colour, organic acis, etc. during fermentation and, finally, the wine production techniques employed. In general, however, European vineyard managers still have little access to technical means or reliable systems to guide them in their decision-making.

Polychaete/amphipod ratio as an indicator of environmental impact related to offshore oil and gas production along the Norwegian continental shelf.

PubMed

Andrade, Hector; Renaud, Paul E

2011-12-01

Benthic faunal data is regularly collected worldwide to assess the ecological quality of marine environments. Recently, there has been renewed interest in developing biological indices able to identify environmental status and potential anthropogenic impacts. In this paper we evaluate the performance of a general polychaete/amphipod ratio along the Norwegian continental shelf as an environmental indicator for offshore oil and gas impacts. Two main trends are apparent: first, a contamination gradient is discernible from where production takes place compared to stations 10,000 m away. Second, the quality of the marine environment has improved over time. These results are consistent with monitoring reports employing a combination of uni- and multi-variate statistics. Thus, we consider this ratio as a relatively simple, useful and potentially cost-effective complement to other more demanding assessment techniques. Because of its strong theoretical basis, it may also be useful for detecting ecological change as a result of other activities. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Development of products for the elderly population: vitamin enriched pudding].

PubMed

Vera, M S; de Penna, E W; Bunger, A; Soto, D; Cariaga, L; Fuenzalida, R; Cornejo, E; Lopez, L

1995-03-01

An instant dessert powder, pudding type was developed to be consumed at lunch or dinner time. The dessert was designed to be prepared in skim milk and meets the nutritional needs of elderly people. The dessert contains modified starch, carragenine, vegetal fat, sacharose. Each serving has been enriched with 30% of the daily vitamin requirement advised for adults over 51 years old. The optimized process was carried out according to the Karlsruhe test. Each serving consists of 22g powder prepared in proportion of 18% in skim milk. The optimized dessert powder was controlled by means of physical, chemical and microbiological analyses. The sensory quality was determined in the ready to eat product and the acceptability level was measured in a group of people selected according to the characteristics of the target population. The dessert powder contains 1.1% protein, 5.2% fats, 89.76% carbohidrates, and provides 409 Kcal/100g. Both the sensory and microbiological quality were good and the level of acceptance reached 98%.

Elements of EAF automation processes

NASA Astrophysics Data System (ADS)

Ioana, A.; Constantin, N.; Dragna, E. C.

2017-01-01

Our article presents elements of Electric Arc Furnace (EAF) automation. So, we present and analyze detailed two automation schemes: the scheme of electrical EAF automation system; the scheme of thermic EAF automation system. The application results of these scheme of automation consists in: the sensitive reduction of specific consummation of electrical energy of Electric Arc Furnace, increasing the productivity of Electric Arc Furnace, increase the quality of the developed steel, increasing the durability of the building elements of Electric Arc Furnace.

Fatty acid profiles and antioxidants of organic and conventional milk from low- and high-input systems during outdoor period.

PubMed

Kusche, Daniel; Kuhnt, Katrin; Ruebesam, Karin; Rohrer, Carsten; Nierop, Andreas F M; Jahreis, Gerhard; Baars, Ton

2015-02-01

Intensification of organic dairy production leads to the question of whether the implementation of intensive feeding incorporating maize silage and concentrates is altering milk quality. Therefore the fatty acid (FA) and antioxidant (AO) profiles of milk on 24 farms divided into four system groups in three replications (n = 71) during the outdoor period were analyzed. In this system comparison, a differentiation of the system groups and the effects of the main system factors 'intensification level' (high-input versus low-input) and 'origin' (organic versus conventional) were evaluated in a multivariate statistical approach. Consistent differentiation of milk from the system groups due to feeding-related impacts was possible in general and on the basis of 15 markers. The prediction of the main system factors was based on four or five markers. The prediction of 'intensification level' was based mainly on CLA c9,t11 and C18:1 t11, whereas that of 'origin' was based on n-3 PUFA. It was possible to demonstrate consistent differences in the FA and AO profiles of organic and standard conventional milk samples. Highest concentrations of nutritionally beneficial compounds were found in the low-input organic system. Adapted grass-based feeding strategies including pasture offer the potential to produce a distinguishable organic milk product quality. © 2014 Society of Chemical Industry.

The development of national quality performance standards for disposable absorbent products for adult incontinence.

PubMed

Muller, Nancy; McInnis, Elaine

2013-09-01

Disposable absorbent products are widely used in inpatient care settings and in the community to manage adult urinary and fecal incontinence, but few product standards exist to help guide their production or optimal use. Increasing costs and reduced revenues have caused a number of states to evaluate absorbent product use among persons who receive care at home with the assistance of the Medicaid Waiver Program, further increasing concerns about the lack of product performance standards. To address these issues, the National Association For Continence (NAFC) formed a council of experts and key stakeholders with the objective of establishing national, independent quality performance standards for disposable absorbent products provided by states to Waiver Program recipients. The Council consisted of representatives from five purposefully selected states, technical directors from six nonwoven product manufacturers, an officer of the nonwoven manufactures trade association, a delegate from an academic nursing program and professional societies, a family caregiver, and a patient representative. Following a consensus method and guidelines for use, nine specific recommendations were developed, posted for public comment, and further refined. Final recommendations for product performance assessment include: rewet rate (a measure of a product's ability to withstand multiple incontinent episodes between changes), rate of acquisition (a measure of the speed at which urine is drawn away from the skin by a product, product retention capacity (a measure of a product's capacity to hold fluid without rewetting the skin), sizing options, absorbency levels, product safety, closure technology, breathable zones (a measure of the air permeability across a textile-like fabric at a controlled differential pressure), and elasticity. The Council also set values for and recommended four quantifiable parameters, and the testing methodology associated with each, to help consumers and states evaluate absorbent products (medium adult size): Maximum Rewet Rate: <1.0-2.0 g for briefs and <0.5-1.0 g for underwear; Maximum Rate of Acquisition: <50-60 seconds for briefs and <35-45 seconds for underwear; Minimum Retention Capacity: >250 g for standard briefs or underwear and >400 g for premium briefs or underwear; and Breathability of Zones: Minimum of >100 cubic feet per minute. As these recommendations are implemented, research is needed to evaluate the impact on both cost and quality of care for further refinement and modifications, particularly as technology and knowledge is advanced.

Effects of dimethyl dicarbonate (DMDC) on the fermentation of litchi juice by Lactobacillus casei as an alternative of heat treatment.

PubMed

Yu, Yuanshan; Xiao, Gengsheng; Xu, Yujuan; Wu, Jijun; Wen, Jing

2014-05-01

This study investigated the effects of dimethyl dicarbonate (DMDC) on the fermentation of litchi juice by Lactobacillus casei as an alternative of heat treatment that may have undesirable effect on the juice. Quality attributes and products stability of both the fermented heat- and DMDC-treated litchi juice by L. casei were compared. It was found that residual indigenous microorganisms in both the heat- and DMDC-treated litchi juice cannot grow into dominant bacteria during further fermentation of litchi juice by L. casei. Compared with fermented heat-treated litchi juice, fermented DMDC-treated litchi juice showed a better color, flavor, and overall acceptance, and also retained more total phenolics and antioxidant capacity. The viability counts of L. casei in both the heat- and DMDC-treated litchi juice were more 8.0 lg CFU/mL after 4 wk of storage at 4 °C. Also, some quality attributes in both the fermented heat- and DMDC-treated litchi juices, including pH, total phenolics, ascorbic acid, antioxidant capacity, and so on, showed the tendency to slow decrease during storage at 4 °C, but the scores of overall acceptance showed no reduction after the storage of 4 wk at 4 °C. On the whole, the application of DMDC treatment could be an ideal alternative of heat treatment to ensure the microbial safety, consistent sensory, and nutritional quality of fermented litchi juice prior to fermentation. The pasteurization treatment is often recommended prior to fermentation of fruit juice by probiotics, as it would lead to a rapid inactivation and inhibition of spoilage and pathogenic bacteria, and ensure the fermented products with consistent sensory and nutritional quality. Dimethyl dicarbonate (DMDC) is a powerful antimicrobial agent, which was approved for use as a microbial control agent in juice beverages by FDA. This study provides a scientific basis for the application of DMDC prior to fermentation of litchi juice. © 2014 Institute of Food Technologists®

Atlantic Ocean CARINA data: overview and salinity adjustments

NASA Astrophysics Data System (ADS)

Tanhua, T.; Steinfeldt, R.; Key, R. M.; Brown, P.; Gruber, N.; Wanninkhof, R.; Perez, F.; Körtzinger, A.; Velo, A.; Schuster, U.; van Heuven, S.; Bullister, J. L.; Stendardo, I.; Hoppema, M.; Olsen, A.; Kozyr, A.; Pierrot, D.; Schirnick, C.; Wallace, D. W. R.

2009-08-01

Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon IN the Atlantic). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the data products, i.e. three merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. Arctic, Atlantic and Southern Ocean. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30° S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report details of the secondary QC for salinity for this data set. Procedures of quality control - including crossover analysis between stations and inversion analysis of all crossover data - are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal accuracy of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA database is consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s (Key et al., 2004), and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

Impact of rearing conditions on the microbiological quality of raw retail poultry meat.

PubMed

Hardy, Bridgshe; Crilly, Nate; Pendleton, Sean; Andino, Ana; Wallis, Audra; Zhang, Nan; Hanning, Irene

2013-08-01

There is a gap in knowledge of microbiological quality in raw chicken products produced by nonconventional methods and no studies have reported the microbiological quality of turkeys produced under different rearing environments. Thus, the aim of this study was to compare the microbiological quality of conventionally and organically reared whole chicken and turkey carcasses purchased from 3 retail outlets in Knoxville, Tenn., U.S.A. A total of 100 raw broiler chickens organically (n = 50) and 50 raw turkey carcasses consisting of 3 brands reared either conventionally (n = 25) or organically (n = 25) were evaluated. The FDA BAM protocol for rinsing poultry carcasses was used to enumerate of aerobic bacteria, Campylobacter, and Staphylococcus spp., and for qualitative analysis of Salmonella. Organic chickens from one brand had the highest average counts of aerobic bacteria, Staphylococcus spp. and Campylobacter (4.8, 4.8, and 4.7 Log10 CFU/mL rinsate, respectively) while the other organic brand had the lowest average counts (3.4, 3.3, and 3.1, respectively) of all 4 brands evaluated. The organic turkeys had the highest average counts of these same bacteria (4, 3.9, and 3.8, respectively) compared to the 2 brands of conventional turkeys evaluated. Salmonella (5% prevalence) was isolated only from organic chickens and turkeys. From these data, it appears that the microbiological quality of the raw product was not dependent on rearing conditions and, thus, it cannot be assumed that organic raw poultry is safer than conventionally raised poultry in terms of microbiological quality. © 2013 Institute of Food Technologists®

Did online publishers "get it right"? Using a naturalistic search strategy to review cognitive health promotion content on internet webpages.

PubMed

Hunter, P V; Delbaere, M; O'Connell, M E; Cammer, A; Seaton, J X; Friedrich, T; Fick, F

2017-06-15

One of the most common uses of the Internet is to search for health-related information. Although scientific evidence pertaining to cognitive health promotion has expanded rapidly in recent years, it is unclear how much of this information has been made available to Internet users. Thus, the purpose of our study was to assess the reliability and quality of information about cognitive health promotion encountered by typical Internet users. To generate a list of relevant search terms employed by Internet users, we entered seed search terms in Google Trends and recorded any terms consistently used in the prior 2 years. To further approximate the behaviour of typical Internet users, we entered each term in Google and sampled the first two relevant results. This search, completed in October 2014, resulted in a sample of 86 webpages, 48 of which had content related to cognitive health promotion. An interdisciplinary team rated the information reliability and quality of these webpages using a standardized measure. We found that information reliability and quality were moderate, on average. Just one retrieved page mentioned best practice, national recommendations, or consensus guidelines by name. Commercial content (i.e., product promotion, advertising content, or non-commercial) was associated with differences in reliability and quality, with product promoter webpages having the lowest mean reliability and quality ratings. As efforts to communicate the association between lifestyle and cognitive health continue to expand, we offer these results as a baseline assessment of the reliability and quality of cognitive health promotion on the Internet.

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

Ensuring and Improving Information Quality for Earth Science Data and Products Role of the ESIP Information Quality Cluster

NASA Technical Reports Server (NTRS)

Ramapriyan, H. K. (Rama); Peng, Ge; Moroni, David; Shie, Chung-Lin

2016-01-01

Quality of products is always of concern to users regardless of the type of products. The focus of this paper is on the quality of Earth science data products. There are four different aspects of quality scientific, product, stewardship and service. All these aspects taken together constitute Information Quality. With increasing requirement on ensuring and improving information quality, there has been considerable work related to information quality during the last several years. Given this rich background of prior work, the Information Quality Cluster (IQC), established within the Federation of Earth Science Information Partners (ESIP) has been active with membership from multiple organizations. Its objectives and activities, aimed at ensuring and improving information quality for Earth science data and products, are discussed briefly.

Ensuring and Improving Information Quality for Earth Science Data and Products: Role of the ESIP Information Quality Cluster

NASA Technical Reports Server (NTRS)

Ramapriyan, Hampapuram; Peng, Ge; Moroni, David; Shie, Chung-Lin

2016-01-01

Quality of products is always of concern to users regardless of the type of products. The focus of this paper is on the quality of Earth science data products. There are four different aspects of quality - scientific, product, stewardship and service. All these aspects taken together constitute Information Quality. With increasing requirement on ensuring and improving information quality, there has been considerable work related to information quality during the last several years. Given this rich background of prior work, the Information Quality Cluster (IQC), established within the Federation of Earth Science Information Partners (ESIP) has been active with membership from multiple organizations. Its objectives and activities, aimed at ensuring and improving information quality for Earth science data and products, are discussed briefly.

Enabling Interactive Measurements from Large Coverage Microscopy

PubMed Central

Bajcsy, Peter; Vandecreme, Antoine; Amelot, Julien; Chalfoun, Joe; Majurski, Michael; Brady, Mary

2017-01-01

Microscopy could be an important tool for characterizing stem cell products if quantitative measurements could be collected over multiple spatial and temporal scales. With the cells changing states over time and being several orders of magnitude smaller than cell products, modern microscopes are already capable of imaging large spatial areas, repeat imaging over time, and acquiring images over several spectra. However, characterizing stem cell products from such large image collections is challenging because of data size, required computations, and lack of interactive quantitative measurements needed to determine release criteria. We present a measurement web system consisting of available algorithms, extensions to a client-server framework using Deep Zoom, and the configuration know-how to provide the information needed for inspecting the quality of a cell product. The cell and other data sets are accessible via the prototype web-based system at http://isg.nist.gov/deepzoomweb. PMID:28663600

7 CFR 58.142 - Product quality and stability.

Code of Federal Regulations, 2010 CFR

2010-01-01

... production of the highest quality of finished product and improve product stability. Milk should not be more... 7 Agriculture 3 2010-01-01 2010-01-01 false Product quality and stability. 58.142 Section 58.142... Procedures § 58.142 Product quality and stability. The receiving, holding and processing of milk and cream...

Improved Methods to Produce Tissue-Engineered Skin Substitutes Suitable for the Permanent Closure of Full-Thickness Skin Injuries

PubMed Central

Larouche, Danielle; Cantin-Warren, Laurence; Desgagné, Maxime; Guignard, Rina; Martel, Israël; Ayoub, Akram; Lavoie, Amélie; Gauvin, Robert; Auger, François A.; Moulin, Véronique J.; Germain, Lucie

2016-01-01

Abstract There is a clinical need for skin substitutes to replace full-thickness skin loss. Our group has developed a bilayered skin substitute produced from the patient's own fibroblasts and keratinocytes referred to as Self-Assembled Skin Substitute (SASS). After cell isolation and expansion, the current time required to produce SASS is 45 days. We aimed to optimize the manufacturing process to standardize the production of SASS and to reduce production time. The new approach consisted in seeding keratinocytes on a fibroblast-derived tissue sheet before its detachment from the culture plate. Four days following keratinocyte seeding, the resulting tissue was stacked on two fibroblast-derived tissue sheets and cultured at the air–liquid interface for 10 days. The resulting total production time was 31 days. An alternative method adapted to more contractile fibroblasts was also developed. It consisted in adding a peripheral frame before seeding fibroblasts in the culture plate. SASSs produced by both new methods shared similar histology, contractile behavior in vitro and in vivo evolution after grafting onto mice when compared with SASSs produced by the 45-day standard method. In conclusion, the new approach for the production of high-quality human skin substitutes should allow an earlier autologous grafting for the treatment of severely burned patients. PMID:27872793

Recycle of Inorganic Nutrients for Hydroponic Crop Production Following Incineration of Inedible Biomass

NASA Technical Reports Server (NTRS)

Bubenheim, David L.; Wignarajah, Kanapathipillai; Kliss, Mark H. (Technical Monitor)

1996-01-01

Recovery of resources from waste streams is essential for future implementation and reliance on a regenerative life support system. The major waste streams of concern are from human activities and plant wastes. Carbon, water and inorganics are the primary desired raw materials of interest. The goal of resource recovery is maintenance of product quality to insure support of reliable and predictable levels of life support function performance by the crop plant component. Further, these systems must be maintained over extended periods of time, requiring maintenance of nutrient solutions to avoid toxicity and deficiencies. Today, reagent grade nutrients are used to make nutrient solutions for hydroponic culture and these solutions are frequently changed during the life cycle or sometimes managed for only one crop life cycle. The focus of this study was to determine the suitability of the ash product following incineration of inedible biomass as a source of inorganic nutrients for hydroponic crop production. Inedible wheat biomass was incinerated and ash quality characterized. The incinerator ash was dissolved in adequate nitric acid to establish a consistent nitrogen concentration in all nutrient solution treatments. Four experimental nutrient treatments were included: control, ash only, ash supplemented to match control, and ash only quality formulated with reagent grade chemicals. When nutrient solutions are formulated using only ash following-incineration of inedible biomass, a balance in solution is established representing elemental retention following incineration and nutrient proportions present in the original biomass. The resulting solution is not identical to the control. This imbalance resulted in suppression of crop growth. When the ash is supplemented with nutrients to establish the same balance as in the control, growth is identical to the control. The ash appears to carry no phytotoxic materials. Growth in solution formulated with reagent grade chemicals but matching the quality of the ash only treatment resulted in growth similar to that of the ash only treatment. The ash product resulting from incineration of inedible biomass appears to be a suitable form for recycle of inorganic nutrients to crop production.

Process-based quality for thermal spray via feedback control

NASA Astrophysics Data System (ADS)

Dykhuizen, R. C.; Neiser, R. A.

2006-09-01

Quality control of a thermal spray system manufacturing process is difficult due to the many input variables that need to be controlled. Great care must be taken to ensure that the process remains constant to obtain a consistent quality of the parts. Control is greatly complicated by the fact that measurement of particle velocities and temperatures is a noisy stochastic process. This article illustrates the application of quality control concepts to a wire flame spray process. A central feature of the real-time control system is an automatic feedback control scheme that provides fine adjustments to ensure that uncontrolled variations are accommodated. It is shown how the control vectors can be constructed from simple process maps to independently control particle velocity and temperature. This control scheme is shown to perform well in a real production environment. We also demonstrate that slight variations in the feed wire curvature can greatly influence the process. Finally, the geometry of the spray system and sensor must remain constant for the best reproducibility.

The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets.

PubMed

Sukkari, Sana R; Al Humaidan, Abdullah S; Sasich, Larry D

2012-07-01

Inadequate access to useful scientifically accurate patient information is a major cause of the inappropriate use of drugs resulting in serious personal injury and related costs to the health care system. The definition of useful scientifically accurate patient information for prescription drugs was accepted by the US Secretary of the Department of Health and Human Services in 1996 as that derived from or consistent with the US FDA approved professional product label for a drug. Previous quality content studies found that English language patient drug information leaflets distributed by US pharmacies failed to meet minimum criteria defining useful and scientifically accurate information. Evaluation forms containing the explicit elements that define useful scientifically accurate information for three drugs with known serious adverse drug reactions were created based on the current US FDA approved professional product labels. The Arabic language patient drug information leaflets for celecoxib, paroxetine, and lamotrigine were obtained locally and evaluated using a methodology similar to that used in previous quality content patient drug information studies in the US. The Arabic leaflets failed to meet the definition of useful scientifically accurate information. The celecoxib leaflet contained 30% of the required information and the paroxetine and lamotrigine leaflets contained 24% and 20%, respectively. There are several limitations to this study. The Arabic leaflets from only one commercial North American vendor were evaluated and the evaluation included a limited number of drugs. A larger study is necessary to be able to generalize these results. The study results are consistent with those of previous quality content studies of commercially available English patient drug information leaflets. The results have important implications for patients as access to a reliable source of drug information may prevent harm or limit the suffering from serious adverse drug reactions.

ThedaCare's business performance system: sustaining continuous daily improvement through hospital management in a lean environment.

PubMed

Barnas, Kim

2011-09-01

For 2003-2008, ThedaCare, a community health system in Wisconsin, achieved significant improvements in quality and the elimination of waste through the development of an improvement system, which included Value Stream analysis, rapid improvement events, and projects applied to specific processes. However, to meet its continuous daily improvement goals, particularly the goal of increasing productivity by 10% annually, ThedaCare needed to change the way its managers and leaders (in its hospital division) conduct and manage their daily work. Accordingly, it developed its Business Performance System (BPS) to achieve and sustain continuous daily improvement. BUILDING THE BPS: ThedaCare devised a multipart pilot project, consisting of "learning to see" and then, "problem solving." On completion of the 15-week alpha phase (6 units) in July 2009, the BPS was spread to the beta pilot (12 units; September 2009-January 2010) and then to cohort 3 (10 units; September 2010-January 2011). Each alpha unit improved performance on (1) the key driver metric of increasing productivity from 2008 to year-end 2009 (by 1%-11%) and (2) its respective safety/ quality drivers over the respective 2008 baselines. For 2010, improvements across the alpha, beta, and cohort 3 units were found for 11 of the 14 safety/quality drivers-85% of the 11 customer satisfaction drivers, 83% of 6 people engagement drivers; and 48% of 23 financial stewardship drivers. The tools developed for the BPS have enabled teams to see, prioritize, and pursue continuous daily improvement opportunities. Unit leaders now have a structured management reporting system to reduce variation in their management styles. Leaders all now follow leadership standard work, and their daily work is now consistently aligned with the hospital and system strategy.

Metatranscriptomics reveals temperature-driven functional changes in microbiome impacting cheese maturation rate

DOE Office of Scientific and Technical Information (OSTI.GOV)

De Filippis, Francesca; Genovese, Alessandro; Ferranti, Pasquale

Traditional cheeses harbour complex microbial consortia that play an important role in shaping typical sensorial properties. However, the microbial metabolism is considered difficult to control. Microbial community succession and the related gene expression were analysed during ripening of a traditional Italian cheese, identifying parameters that could be modified to accelerate ripening. Afterwards, we modulated ripening conditions and observed consistent changes in microbial community structure and function. We provide concrete evidence of the essential contribution of non-starter lactic acid bacteria in ripening-related activities. An increase in the ripening temperature promoted the expression of genes related to proteolysis, lipolysis and amino acid/lipidmore » catabolism and significantly increases the cheese maturation rate. Moreover, temperature-promoted microbial metabolisms were consistent with the metabolomic profiles of proteins and volatile organic compounds in the cheese. Finally, the results clearly indicate how processing-driven microbiome responses can be modulated in order to optimize production efficiency and product quality.« less

A 30+ Year AVHRR LAI and FAPAR Climate Data Record: Algorithm Description, Validation, and Case Study

NASA Technical Reports Server (NTRS)

Claverie, Martin; Matthews, Jessica L.; Vermote, Eric F.; Justice, Christopher O.

2016-01-01

In- land surface models, which are used to evaluate the role of vegetation in the context ofglobal climate change and variability, LAI and FAPAR play a key role, specifically with respect to thecarbon and water cycles. The AVHRR-based LAIFAPAR dataset offers daily temporal resolution,an improvement over previous products. This climate data record is based on a carefully calibratedand corrected land surface reflectance dataset to provide a high-quality, consistent time-series suitablefor climate studies. It spans from mid-1981 to the present. Further, this operational dataset is availablein near real-time allowing use for monitoring purposes. The algorithm relies on artificial neuralnetworks calibrated using the MODIS LAI/FAPAR dataset. Evaluation based on cross-comparisonwith MODIS products and in situ data show the dataset is consistent and reliable with overalluncertainties of 1.03 and 0.15 for LAI and FAPAR, respectively. However, a clear saturation effect isobserved in the broadleaf forest biomes with high LAI (greater than 4.5) and FAPAR (greater than 0.8) values.

Metatranscriptomics reveals temperature-driven functional changes in microbiome impacting cheese maturation rate

DOE PAGES

De Filippis, Francesca; Genovese, Alessandro; Ferranti, Pasquale; ...

2016-02-25

Traditional cheeses harbour complex microbial consortia that play an important role in shaping typical sensorial properties. However, the microbial metabolism is considered difficult to control. Microbial community succession and the related gene expression were analysed during ripening of a traditional Italian cheese, identifying parameters that could be modified to accelerate ripening. Afterwards, we modulated ripening conditions and observed consistent changes in microbial community structure and function. We provide concrete evidence of the essential contribution of non-starter lactic acid bacteria in ripening-related activities. An increase in the ripening temperature promoted the expression of genes related to proteolysis, lipolysis and amino acid/lipidmore » catabolism and significantly increases the cheese maturation rate. Moreover, temperature-promoted microbial metabolisms were consistent with the metabolomic profiles of proteins and volatile organic compounds in the cheese. Finally, the results clearly indicate how processing-driven microbiome responses can be modulated in order to optimize production efficiency and product quality.« less

MODIS Snow-Cover Products

NASA Technical Reports Server (NTRS)

Hall, Dorothy K.; Riggs, George A.; Salomonson, Vinvent V.; DiGirolamo, Nicolo; Bayr, Klaus J.; Houser, Paul (Technical Monitor)

2001-01-01

On December 18, 1999, the Terra satellite was launched with a complement of five instruments including the Moderate Resolution Imaging Spectroradiometer (MODIS). Many geophysical products are derived from MODIS data including global snow-cover products. These products have been available through the National Snow and Ice Data Center (NSIDC) Distributed Active Archive Center (DAAC) since September 13, 2000. MODIS snow-cover products represent potential improvement to the currently available operation products mainly because the MODIS products are global and 500-m resolution, and have the capability to separate most snow and clouds. Also the snow-mapping algorithms are automated which means that a consistent data set is generated for long-term climates studies that require snow-cover information. Extensive quality assurance (QA) information is stored with the product. The snow product suite starts with a 500-m resolution swath snow-cover map which is gridded to the Integerized Sinusoidal Grid to produce daily and eight-day composite tile products. The sequence then proceeds to a climate-modeling grid product at 5-km spatial resolution, with both daily and eight-day composite products. A case study from March 6, 2000, involving MODIS data and field and aircraft measurements, is presented. Near-term enhancements include daily snow albedo and fractional snow cover.

Force Sensitive Handles and Capacitive Touch Sensor for Driving a Flexible Haptic-Based Immersive System

PubMed Central

Covarrubias, Mario; Bordegoni, Monica; Cugini, Umberto

2013-01-01

In this article, we present an approach that uses both two force sensitive handles (FSH) and a flexible capacitive touch sensor (FCTS) to drive a haptic-based immersive system. The immersive system has been developed as part of a multimodal interface for product design. The haptic interface consists of a strip that can be used by product designers to evaluate the quality of a 3D virtual shape by using touch, vision and hearing and, also, to interactively change the shape of the virtual object. Specifically, the user interacts with the FSH to move the virtual object and to appropriately position the haptic interface for retrieving the six degrees of freedom required for both manipulation and modification modalities. The FCTS allows the system to track the movement and position of the user's fingers on the strip, which is used for rendering visual and sound feedback. Two evaluation experiments are described, which involve both the evaluation and the modification of a 3D shape. Results show that the use of the haptic strip for the evaluation of aesthetic shapes is effective and supports product designers in the appreciation of the aesthetic qualities of the shape. PMID:24113680

Product diversification of banana cv. Mas Kirana off grade by using a double rotating screw extruder

NASA Astrophysics Data System (ADS)

Setyadjit, S.; Sukasih, E.; Risfaheri, R.

2018-01-01

Extrusion technology is today’s favorite technology since it has a varied, practical and consistent product form. The purpose of this research was to get precise composite flour composition so that the quality of the resulted product has optimum quality for breakfast meals. The experimental design used was Design Expert vs. 7 with response surface box-behnken. The flour composition and level to be inputted to the program were banana flour (10-50g), mung beans (10-30g), egg flour (10-20g). Formula made was based on 200 g with addition of maize flour if the amount is less than 200 g. The extrusion tool used is a Thermo Scientific double rotating screw; with Haake Reomax OS. The best results in terms of carbohydrate content is the Formula 8 with a composition of 60 g of banana flour, 20 g eggs, 20 g of green beans and 100 g maize flour. The proximate chemical content of this formula is carbohydrate 84.04%, protein 8.55%, fat 5.49%, ash content 1.24%. K-calories per 100 g is 419.5 which is higher than the standard of breakfast meals calories.

Force sensitive handles and capacitive touch sensor for driving a flexible haptic-based immersive system.

PubMed

Covarrubias, Mario; Bordegoni, Monica; Cugini, Umberto

2013-10-09

In this article, we present an approach that uses both two force sensitive handles (FSH) and a flexible capacitive touch sensor (FCTS) to drive a haptic-based immersive system. The immersive system has been developed as part of a multimodal interface for product design. The haptic interface consists of a strip that can be used by product designers to evaluate the quality of a 3D virtual shape by using touch, vision and hearing and, also, to interactively change the shape of the virtual object. Specifically, the user interacts with the FSH to move the virtual object and to appropriately position the haptic interface for retrieving the six degrees of freedom required for both manipulation and modification modalities. The FCTS allows the system to track the movement and position of the user's fingers on the strip, which is used for rendering visual and sound feedback. Two evaluation experiments are described, which involve both the evaluation and the modification of a 3D shape. Results show that the use of the haptic strip for the evaluation of aesthetic shapes is effective and supports product designers in the appreciation of the aesthetic qualities of the shape.

Establishing the pharmaceutical quality of Chinese herbal medicine: a provisional BCS classification.

PubMed

Fong, Sophia Y K; Liu, Mary; Wei, Hai; Löbenberg, Raimar; Kanfer, Isadore; Lee, Vincent H L; Amidon, Gordon L; Zuo, Zhong

2013-05-06

The Biopharmaceutical Classification System (BCS), which is a scientific approach to categorize active drug ingredient based on its solubility and intestinal permeability into one of the four classes, has been used to set the pharmaceutical quality standards for drug products in western society. However, it has received little attention in the area of Chinese herbal medicine (CHM). This is likely, in part, due to the presence of multiple active components as well as lack of standardization of CHM. In this report, we apply BCS classification to CHMs provisionally as a basis for establishing improved in vitro quality standards. Based on a top-200 drugs selling list in China, a total of 31 CHM products comprising 50 official active marker compounds (AMCs) were provisionally classified according to BCS. Information on AMC content and doses of these CHM products were retrieved from the Chinese Pharmacopoeia. BCS parameters including solubility and permeability of the AMCs were predicted in silico (ACD/Laboratories). A BCS classification of CHMs according to biopharmaceutical properties of their AMCs is demonstrated to be feasible in the current study and can be used to provide a minimum set of quality standards. Our provisional results showed that 44% of the included AMCs were classified as Class III (high solubility, low permeability), followed by Class II (26%), Class I (18%), and Class IV (12%). A similar trend was observed when CHMs were classified in accordance with the BCS class of AMCs. Most (45%) of the included CHMs were classified as Class III, followed by Class II (16%), Class I (10%), and Class IV (6%); whereas 23% of the CHMs were of mixed class due to the presence of multiple individual AMCs with different BCS classifications. Moreover, about 60% of the AMCs were classified as high-solubility compounds (Class I and Class III), suggesting an important role for an in vitro dissolution test in setting quality control standards ensuring consistent biopharmaceutical quality for the commercially available CHM products. That is, provisionally, more than half of the AMCs of the top-selling CHMs included in this study would be candidates for a bioequivalence (BE) biowaiver, based on WHO recommendations and EMEA guidelines. Thus a dissolution requirement on these AMCs would represent a significant advance in the pharmaceutical quality of CHM today.

Interacting Microbe and Litter Quality Controls on Litter Decomposition: A Modeling Analysis

PubMed Central

Moorhead, Daryl; Lashermes, Gwenaëlle; Recous, Sylvie; Bertrand, Isabelle

2014-01-01

The decomposition of plant litter in soil is a dynamic process during which substrate chemistry and microbial controls interact. We more clearly quantify these controls with a revised version of the Guild-based Decomposition Model (GDM) in which we used a reverse Michaelis-Menten approach to simulate short-term (112 days) decomposition of roots from four genotypes of Zea mays that differed primarily in lignin chemistry. A co-metabolic relationship between the degradation of lignin and holocellulose (cellulose+hemicellulose) fractions of litter showed that the reduction in decay rate with increasing lignin concentration (LCI) was related to the level of arabinan substitutions in arabinoxylan chains (i.e., arabinan to xylan or A∶X ratio) and the extent to which hemicellulose chains are cross-linked with lignin in plant cell walls. This pattern was consistent between genotypes and during progressive decomposition within each genotype. Moreover, decay rates were controlled by these cross-linkages from the start of decomposition. We also discovered it necessary to divide the Van Soest soluble (labile) fraction of litter C into two pools: one that rapidly decomposed and a second that was more persistent. Simulated microbial production was consistent with recent studies suggesting that more rapidly decomposing materials can generate greater amounts of potentially recalcitrant microbial products despite the rapid loss of litter mass. Sensitivity analyses failed to identify any model parameter that consistently explained a large proportion of model variation, suggesting that feedback controls between litter quality and microbial activity in the reverse Michaelis-Menten approach resulted in stable model behavior. Model extrapolations to an independent set of data, derived from the decomposition of 12 different genotypes of maize roots, averaged within <3% of observed respiration rates and total CO2 efflux over 112 days. PMID:25264895

Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 improve quality-of-life and IBS symptoms: a double-blind, randomised, placebo-controlled study.

PubMed

Preston, K; Krumian, R; Hattner, J; de Montigny, D; Stewart, M; Gaddam, S

2018-06-11

A combination of Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 was compared to placebo for relief of symptoms of irritable bowel syndrome (IBS). A total of 113 subjects at 3 clinical sites were randomised in a 2:1 ratio and followed for 12 weeks. Subjects ingested either 2 capsules of active study product, containing 50×10 9 cfu of live organisms, or 2 placebo capsules daily. Endpoints included improvement in abdominal pain, days of pain, distention, stool consistency and frequency, quality of life (QOL), and adequate relief (AR) of IBS symptoms. IBS subtypes constipation (IBS-C), diarrhoea (IBS-D), and mixed (IBS-M) were evaluated separately; the effect of gender was also examined. For all efficacy endpoints improvement of 30% or more vs placebo was considered clinically significant. With the exception of pain intensity and AR, the endpoints demonstrated a therapeutic advantage of active over placebo for IBS symptoms in at least some subject subgroups. The IBS-D and female subgroups showed the largest and most consistent effects. Stool frequency and consistency were evaluated in the IBS-C and IBS-D subgroups, and improvement of active vs placebo was noted in both. QOL improvement was seen overall and in specific domains. Adverse events (AEs) were limited to 7 subjects; all were of mild or moderate intensity except one, severe cramping. Four AEs in the same subject in the placebo group were judged to be related to study product; these resolved by the end of study. There were no serious AEs.

Patient-centered care as value-added service by compounding pharmacists.

PubMed

McPherson, Timothy B; Fontane, Patrick E; Day, Jonathan R

2013-01-01

The term "value-added" is widely used to describe business and professional services that complement a product or service or that differentiate it from competing products and services. The objective of this study was to determine compounding pharmacists' self-perceptions of the value-added services they provide. A web-based survey method was used. Respondents' perceptions of their most important value-added service frequently fell into one of two categories: (1) enhanced pharmacist contribution to developing and implementing patient therapeutic plans and (2) providing customized medications of high pharmaceutical quality. The results were consistent with a hybrid community clinical practice model for compounding pharmacists wherein personalization of the professional relationship is the value-added characteristic.

The Consumer Motivation Scale: A detailed review of item generation, exploration, confirmation, and validation procedures.

PubMed

Barbopoulos, I; Johansson, L-O

2017-08-01

This data article offers a detailed description of analyses pertaining to the development of the Consumer Motivation Scale (CMS), from item generation and the extraction of factors, to confirmation of the factor structure and validation of the emergent dimensions. The established goal structure - consisting of the sub-goals Value for Money, Quality, Safety, Stimulation, Comfort, Ethics, and Social Acceptance - is shown to be related to a variety of consumption behaviors in different contexts and for different products, and should thereby prove useful in standard marketing research, as well as in the development of tailored marketing strategies, and the segmentation of consumer groups, settings, brands, and products.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Atanov, N.; et al.

The Mu2e experiment at Fermilab will search for the coherentmore » $$\\mu \\to e$$ conversion on aluminum atoms. The detector system consists of a straw tube tracker and a crystal calorimeter. A pre-production of 150 Silicon Photomultiplier arrays for the Mu2e calorimeter has been procured. A detailed quality assur- ance has been carried out on each SiPM for the determination of its own operation voltage, gain, dark current and PDE. The measurement of the mean-time-to-failure for a small random sample of the pro-production group has been also completed as well as the determination of the dark current increase as a function of the ioninizing and non-ioninizing dose.« less

In-process fault detection for textile fabric production: onloom imaging

NASA Astrophysics Data System (ADS)

Neumann, Florian; Holtermann, Timm; Schneider, Dorian; Kulczycki, Ashley; Gries, Thomas; Aach, Til

2011-05-01

Constant and traceable high fabric quality is of high importance both for technical and for high-quality conventional fabrics. Usually, quality inspection is carried out by trained personal, whose detection rate and maximum period of concentration are limited. Low resolution automated fabric inspection machines using texture analysis were developed. Since 2003, systems for the in-process inspection on weaving machines ("onloom") are commercially available. With these defects can be detected, but not measured quantitative precisely. Most systems are also prone to inevitable machine vibrations. Feedback loops for fault prevention are not established. Technology has evolved since 2003: Camera and computer prices dropped, resolutions were enhanced, recording speeds increased. These are the preconditions for real-time processing of high-resolution images. So far, these new technological achievements are not used in textile fabric production. For efficient use, a measurement system must be integrated into the weaving process; new algorithms for defect detection and measurement must be developed. The goal of the joint project is the development of a modern machine vision system for nondestructive onloom fabric inspection. The system consists of a vibration-resistant machine integration, a high-resolution machine vision system, and new, reliable, and robust algorithms with quality database for defect documentation. The system is meant to detect, measure, and classify at least 80 % of economically relevant defects. Concepts for feedback loops into the weaving process will be pointed out.

Spacelab data processing facility (SLDPF) quality assurance (QA)/data accounting (DA) expert systems - Transition from prototypes to operational systems

NASA Technical Reports Server (NTRS)

Basile, Lisa

1988-01-01

The SLDPF is responsible for the capture, quality monitoring processing, accounting, and shipment of Spacelab and/or Attached Shuttle Payloads (ASP) telemetry data to various user facilities. Expert systems will aid in the performance of the quality assurance and data accounting functions of the two SLDPF functional elements: the Spacelab Input Processing System (SIPS) and the Spacelab Output Processing System (SOPS). Prototypes were developed for each as independent efforts. The SIPS Knowledge System Prototype (KSP) used the commercial shell OPS5+ on an IBM PC/AT; the SOPS Expert System Prototype used the expert system shell CLIPS implemented on a Macintosh personal computer. Both prototypes emulate the duties of the respective QA/DA analysts based upon analyst input and predetermined mission criteria parameters, and recommended instructions and decisions governing the reprocessing, release, or holding for further analysis of data. These prototypes demonstrated feasibility and high potential for operational systems. Increase in productivity, decrease of tedium, consistency, concise historical records, and a training tool for new analyses were the principal advantages. An operational configuration, taking advantage of the SLDPF network capabilities, is under development with the expert systems being installed on SUN workstations. This new configuration in conjunction with the potential of the expert systems will enhance the efficiency, in both time and quality, of the SLDPF's release of Spacelab/AST data products.

Spacelab data processing facility (SLDPF) Quality Assurance (QA)/Data Accounting (DA) expert systems: Transition from prototypes to operational systems

NASA Technical Reports Server (NTRS)

Basile, Lisa

1988-01-01

The SLDPF is responsible for the capture, quality monitoring processing, accounting, and shipment of Spacelab and/or Attached Shuttle Payloads (ASP) telemetry data to various user facilities. Expert systems will aid in the performance of the quality assurance and data accounting functions of the two SLDPF functional elements: the Spacelab Input Processing System (SIPS) and the Spacelab Output Processing System (SOPS). Prototypes were developed for each as independent efforts. The SIPS Knowledge System Prototype (KSP) used the commercial shell OPS5+ on an IBM PC/AT; the SOPS Expert System Prototype used the expert system shell CLIPS implemented on a Macintosh personal computer. Both prototypes emulate the duties of the respective QA/DA analysts based upon analyst input and predetermined mission criteria parameters, and recommended instructions and decisions governing the reprocessing, release, or holding for further analysis of data. These prototypes demonstrated feasibility and high potential for operational systems. Increase in productivity, decrease of tedium, consistency, concise historial records, and a training tool for new analyses were the principal advantages. An operational configuration, taking advantage of the SLDPF network capabilities, is under development with the expert systems being installed on SUN workstations. This new configuration in conjunction with the potential of the expert systems will enhance the efficiency, in both time and quality, of the SLDPF's release of Spacelab/AST data products.

The effect of improving primary care depression management on employee absenteeism and productivity. A randomized trial.

PubMed

Rost, Kathryn; Smith, Jeffrey L; Dickinson, Miriam

2004-12-01

To test whether an intervention to improve primary care depression management significantly improves productivity at work and absenteeism over 2 years. Twelve community primary care practices recruiting depressed primary care patients identified in a previsit screening. Practices were stratified by depression treatment patterns before randomization to enhanced or usual care. After delivering brief training, enhanced care clinicians provided improved depression management over 24 months. The research team evaluated productivity and absenteeism at baseline, 6, 12, 18, and 24 months in 326 patients who reported full-or part-time work at one or more completed waves. Employed patients in the enhanced care condition reported 6.1% greater productivity and 22.8% less absenteeism over 2 years. Consistent with its impact on depression severity and emotional role functioning, intervention effects were more observable in consistently employed subjects where the intervention improved productivity by 8.2% over 2 years at an estimated annual value of US 1982 dollars per depressed full-time equivalent and reduced absenteeism by 28.4% or 12.3 days over 2 years at an estimated annual value of US 619 dollars per depressed full-time equivalent. This trial, which is the first to our knowledge to demonstrate that improving the quality of care for any chronic disease has positive consequences for productivity and absenteeism, encourages formal cost-benefit research to assess the potential return-on-investment employers of stable workforces can realize from using their purchasing power to encourage better depression treatment for their employees.

Liquid chromatography/tandem mass spectrometry study of forced degradation of azilsartan medoxomil potassium.

PubMed

Swain, Debasish; Patel, Prinesh N; Palaniappan, Ilayaraja; Sahu, Gayatri; Samanthula, Gananadhamu

2015-08-15

Azilsartan medoxomil potassium (AZM) is a new antihypertensive drug introduced in the year 2011. The presence of degradation products not only affects the quality, but also the safety aspects of the drug. Thus, it is essential to develop an efficient analytical method which could be useful to selectively separate and identify the degradation products of azilsartan medoxomil potassium. AZM was subjected to forced degradation under hydrolytic (acid, base and neutral), oxidative, photolytic and thermal stress conditions. Separation of the drug and degradation products was achieved by a liquid chromatography (LC) method using an Acquity UPLC(®) C18 CSH column with mobile phase consisting of 0.02% trifluoroacetic acid and acetonitrile using a gradient method. Identification and characterization of the degradation products was carried out using LC/electrospray ionization quadrupole time-of-flight mass spectrometry (ESI-QTOFMS). A total of five degradation products (DP 1 to DP 5) were formed under various stress conditions and their structures were proposed with the help of tandem mass spectrometry (MS/MS) experiments and accurate mass data. A common degradation product (DP 4) was observed under all the degradation conditions. DP 1, DP 2 and DP 5 were observed under acid hydrolytic conditions whereas DP 3 was observed under alkaline conditions. AZM was found to degrade under hydrolytic, oxidative and photolytic stress conditions. The structures of all the degradation products were proposed. The degradation pathway for the formation of degradation products was also hypothesized. A selective method was developed to quantify the drug in the presence of degradation products which is useful to monitor the quality of AZM. Copyright © 2015 John Wiley & Sons, Ltd.

How Clean is your Local Air? Here's an app for that

NASA Astrophysics Data System (ADS)

Maskey, M.; Yang, E.; Christopher, S. A.; Keiser, K.; Nair, U. S.; Graves, S. J.

2011-12-01

Air quality is a vital element of our environment. Accurate and localized air quality information is critical for characterizing environmental impacts at the local and regional levels. Advances in location-aware handheld devices and air quality modeling have enabled a group of UAHuntsville scientists to develop a mobile app, LocalAQI, that informs users of current conditions and forecasts of up to twenty-four hours, of air quality indices. The air quality index is based on Community Multiscale Air Quality Modeling System (CMAQ). UAHuntsville scientists have used satellite remote sensing products as inputs to CMAQ, resulting in forecast guidance for particulate matter air quality. The CMAQ output is processed to compute a standardized air quality index. Currently, the air quality index is available for the eastern half of the United States. LocalAQI consists of two main views: air quality index view and map view. The air quality index view displays current air quality for the zip code of a location of interest. Air quality index value is translated into a color-coded advisory system. In addition, users are able to cycle through available hourly forecasts for a location. This location-aware app defaults to the current air quality of user's location. The map view displays color-coded air quality information for the eastern US with an ability to animate through the available forecasts. The app is developed using a cross-platform native application development tool, appcelerator; hence LocalAQI is available for iOS and Android-based phones and pads.

Age-related changes in the anticipatory coarticulation in the speech of young children

NASA Astrophysics Data System (ADS)

Parson, Mathew; Lloyd, Amanda; Stoddard, Kelly; Nissen, Shawn L.

2003-10-01

This paper investigates the possible patterns of anticipatory coarticulation in the speech of young children. Speech samples were elicited from three groups of children between 3 and 6 years of age and one comparison group of adults. The utterances were recorded online in a quiet room environment using high quality microphones and direct analog-to-digital conversion to computer disk. Formant frequency measures (F1, F2, and F3) were extracted from a centralized and unstressed vowel (schwa) spoken prior to two different sets of productions. The first set of productions consisted of the target vowel followed by a series of real words containing an initial CV(C) syllable (voiceless obstruent-monophthongal vowel) in a range of phonetic contexts, while the second set consisted of a series of nonword productions with a relatively constrained phonetic context. An analysis of variance was utilized to determine if the formant frequencies varied systematically as a function of age, gender, and phonetic context. Results will also be discussed in association with spectral moment measures extracted from the obstruent segment immediately following the target vowel. [Work supported by research funding from Brigham Young University.

Status of CSR RL06 GRACE reprocessing and preliminary results

NASA Astrophysics Data System (ADS)

Save, H.

2017-12-01

The GRACE project plans to re-processes the GRACE mission data in order to be consistent with the first gravity products released by the GRACE-FO project. The RL06 reprocessing will harmonize the GRACE time-series with the first release of GRACE-FO. This paper catalogues the changes in the upcoming RL06 release and discusses the quality improvements as compared to the current RL05 release. The processing and parameterization changes as compared to the current release are also discussed. This paper discusses the evolution of the quality of the GRACE solutions and characterize the errors over the past few years. The possible challenges associated with connecting the GRACE time series with that from GRACE-FO are also discussed.

A study on the quality control of slow burning polyester

NASA Astrophysics Data System (ADS)

Chen, Bin; Wang, Yinglei; Yan, Zhengfeng; Yu, Tao

2018-04-01

In this paper, the influence of the alcohol/acid mole ratio, reaction temperature, warm-up mode, end-capping, vacuity to the quality of slow burning polyester was studied. The hydroxyl value will increase when the alcohol/acid mole ratio increase, but the acid value and molecular weight will decrease. The molecular weight and molecular weight distribution of the polyester consistent with the designed one can be obtained by stepped heating up. Monobasic alcohol end-capping can be used to control the molecular weight effectively and reduce acid value. Stripping process narrow the molecular weight distribution and reduce the hydroxyl value. Decompression is in favor of the decrease of acid value and increase of the reaction speed to get qualified production.

Defining the performance gap: Conducting a self-assessment

NASA Technical Reports Server (NTRS)

Braymer, Susan A.; Stoner, David L.; Powell, William C.

1992-01-01

This paper presents two different approaches to performing self-assessments of continuous improvement activities. Case Study 1 describes the activities performed by JSC to assess the implementation of continuous improvement efforts at the NASA Center. The JSC approach included surveys administered to randomly selected NASA personnel and personal interviews with NASA and contractor management personnel. Case Study 2 describes the continuous improvement survey performed by the JSC Safety, Reliability, and Quality Assurance (SR&QA) organization. This survey consisted of a short questionnaire (50 questions) administered to all NASA and contractor SR&QA personnel. The questionnaire is based on the eight categories of the President's Award for Quality and Productivity Improvement. It is designed to objectively determine placement on the TQ benchmark and identify a roadmap for improvement.

Quality management of human resources. Providers should begin by focusing on education, performance management, and reward systems.

PubMed

Blair, C S; Fordyce, M; Barney, S M

1993-10-01

For a quality management transformation to occur, a healthcare organization must focus on education and development, performance management, and recognition and reward systems during the first years of implementation. Education and development are perhaps the most important human resource management functions when implementing quality management principles and processes because behavioral changes will be required at all organizational levels. Specific programs that support an organization's quality management effort will vary but should include the conceptual, cultural, and technical aspects of quality management. The essence of quality management is to always satisfy the customer and to continuously improve the services and products the organization offers. The approach to performance management should therefore rely on customer feedback and satisfaction. An organization committed to quality management should base its performance management approach on customer orientation, process improvement, employee involvement, decision making with data, and continuous improvement. Managers and trustees are being challenged to provide innovative recognition and reward systems that reinforce the values and behaviors consistent with quality management. Such systems must also be aligned with the behaviors and outcomes that support the philosophy, mission, and values of the Catholic healthcare ministry. The following components should be considered for a recognition and reward system: base pay, incentives, benefits, and nonmonetary rewards.

[Classification of disposable medical plastics and search for alternatives without polyvinyl chloride in the Hospital Virgen de las Nieves (Granada, Spain)].

PubMed

Sañudo Hacar, P; Blanco, M G; Martínez, E; Duarte, J A; González, A; Hernández, M; Martínez, M; Cueto, E; Navajas, J A; Navarrete, M J

2012-01-01

To identify and classify disposable hospital products containing polyvinyl chloride (PVC), including the search and evaluation of cost-effective sustainable alternative products free of PVC. A descriptive observational analysis was performed, after classifying the latest research in major databases, and disposable products that could contain PVC. These were divided into 5 groups: cannulas, catheters, tubes, bags, and equipment, purchased in the period 2008-2009, differentiating between the technical and economic assessment of the materials. In the analysis of the composition of 492 articles selected, 234 (47.5%) contained PVC, and 19.4% were considered PVC-free alternatives, with only 11.3% of these being economically viable. This study highlights the advantages of the classification of PVC products, by showing that safe and efficient alternatives exist for some product lines that are consistent with patient safety and quality in the work by doctors. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

Optimised isolation of polysaccharides from Lentinula edodes strain NCBI JX915793 using response surface methodology and their antibacterial activities.

PubMed

Sharma, Shivani; Khanna, P K; Kapoor, S

2016-01-01

Mycelial growth in a defined medium by submerged fermentation is a rapid and alternative method for obtaining fungal biomass of consistent quality. Biomass, exopolysaccharides (EPS) and intracellular polysaccharides (IPS) production were optimised by response surface methodology in Lentinula edodes strain LeS (NCBI JX915793). The optimised conditions were pH 5.0, temperature 26°C, incubation period of 25 days and agitation rate of 52 r/min for L. edodes strain LeS. Under the calculated optimal culture conditions, biomass production (5.88 mg mL(-1)), EPS production (0.40 mg mL(-1)) and IPS production (12.45 mg g(-1)) were in agreement with the predicted values for biomass (5.93 mg mL(-1)), EPS (0.55 mg mL(-1)) and IPS production (12.64 mg g(-1)). Crude lentinan exhibited highest antibacterial effects followed by alcoholic, crude and aqueous extracts. The results obtained may be useful for highly effective yield of biomass and bioactive metabolites.

Pretreatment of Whole-Crop Harvested, Ensiled Maize for Ethanol Production

NASA Astrophysics Data System (ADS)

Thomsen, M. H.; Holm-Nielsen, J. B.; Oleskowicz-Popiel, P.; Thomsen, A. B.

To have all-year-round available feedstock, whole-crop maize is harvested premature, when it still contains enough moisture for the anaerobic ensiling process. Silage preparation is a well-known procedure for preserving plant material. At first, this method was applied to obtain high-quality animal feed. However, it was found that such ensiled crops are very suitable for bioenergy production. Maize silage, which consists of hardly degradable lignocellulosic material, hemicellulosic material, and starch, was evaluated for its potential as a feedstock in the production of bioethanol. It was pretreated at low severity (185 °C, 15 min) giving very high glucan (˜100%) and hemicellulose recoveries (<80%)—as well as very high ethanol yield in simultaneous saccharification and fermentation experiments (98% of the theoretical production based on available glucan in the medium). The theoretical ethanol production of maize silage pretreated at 185 °C for 15 min without oxygen or catalyst was 392 kg ethanol per ton of dry maize silage.

Photosynthesis-irradiance parameters of marine phytoplankton: synthesis of a global data set

NASA Astrophysics Data System (ADS)

Bouman, Heather A.; Platt, Trevor; Doblin, Martina; Figueiras, Francisco G.; Gudmundsson, Kristinn; Gudfinnsson, Hafsteinn G.; Huang, Bangqin; Hickman, Anna; Hiscock, Michael; Jackson, Thomas; Lutz, Vivian A.; Mélin, Frédéric; Rey, Francisco; Pepin, Pierre; Segura, Valeria; Tilstone, Gavin H.; van Dongen-Vogels, Virginie; Sathyendranath, Shubha

2018-02-01

The photosynthetic performance of marine phytoplankton varies in response to a variety of factors, environmental and taxonomic. One of the aims of the MArine primary Production: model Parameters from Space (MAPPS) project of the European Space Agency is to assemble a global database of photosynthesis-irradiance (P-E) parameters from a range of oceanographic regimes as an aid to examining the basin-scale variability in the photophysiological response of marine phytoplankton and to use this information to improve the assignment of P-E parameters in the estimation of global marine primary production using satellite data. The MAPPS P-E database, which consists of over 5000 P-E experiments, provides information on the spatio-temporal variability in the two P-E parameters (the assimilation number, PmB, and the initial slope, αB, where the superscripts B indicate normalisation to concentration of chlorophyll) that are fundamental inputs for models (satellite-based and otherwise) of marine primary production that use chlorophyll as the state variable. Quality-control measures consisted of removing samples with abnormally high parameter values and flags were added to denote whether the spectral quality of the incubator lamp was used to calculate a broad-band value of αB. The MAPPS database provides a photophysiological data set that is unprecedented in number of observations and in spatial coverage. The database will be useful to a variety of research communities, including marine ecologists, biogeochemical modellers, remote-sensing scientists and algal physiologists. The compiled data are available at https://doi.org/10.1594/PANGAEA.874087 (Bouman et al., 2017).

Investigating the Effects of Glottal Stop Productions on Voice in Children With Cleft Palate Using Multidimensional Voice Assessment Methods.

PubMed

Aydınlı, Fatma Esen; Özcebe, Esra; Kulak Kayıkçı, Maviş E; Yılmaz, Taner; Özgür, Fatma F

2016-11-01

The aim was to investigate the effects of glottal stop productions (GS) on voice in children with cleft palate using multidimensional voice assessment methods. This is a prospective case-control study. Children with repaired cleft palate (n = 34) who did not have any vocal fold lesions were separated into two groups based on the results of the articulation test. The glottal stop group (GSG) consisted of 17 children who had GS. The control group (CG) consisted of an equal number of age- and gender-matched children who did not have GS. The voice evaluation protocol included acoustic analysis, Pediatric Voice Handicap Index (pVHI), and perceptual analysis (Grade, Roughness, Breathiness, Asthenia, Strain method). The velopharyngeal statuses of the groups were compared using the nasopharyngoscopy and the nasometer. The total pVHI score and the subscales of the pVHI were found to be significantly higher in the GSG. The F0, jitter, and shimmer were found to be numerically higher in the GSG with the difference being statistically significant in jitter (P < 0.05). Audioperceptual analysis revealed a difference in overall voice quality and roughness between the groups. Greater incidence of significant velopharyngeal insufficiency and higher nasalance scores were found in the GSG (P < 0.05). These results may indicate that the vocal quality characteristics of children with GS differ from children who do not have this type of production. It is suggested that children with cleft palate who have GS should receive a comprehensive speech and language pathology intervention including voice therapy techniques. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Consistency of vegetation index seasonality across the Amazon rainforest

NASA Astrophysics Data System (ADS)

Maeda, Eduardo Eiji; Moura, Yhasmin Mendes; Wagner, Fabien; Hilker, Thomas; Lyapustin, Alexei I.; Wang, Yujie; Chave, Jérôme; Mõttus, Matti; Aragão, Luiz E. O. C.; Shimabukuro, Yosio

2016-10-01

Vegetation indices (VIs) calculated from remotely sensed reflectance are widely used tools for characterizing the extent and status of vegetated areas. Recently, however, their capability to monitor the Amazon forest phenology has been intensely scrutinized. In this study, we analyze the consistency of VIs seasonal patterns obtained from two MODIS products: the Collection 5 BRDF product (MCD43) and the Multi-Angle Implementation of Atmospheric Correction algorithm (MAIAC). The spatio-temporal patterns of the VIs were also compared with field measured leaf litterfall, gross ecosystem productivity and active microwave data. Our results show that significant seasonal patterns are observed in all VIs after the removal of view-illumination effects and cloud contamination. However, we demonstrate inconsistencies in the characteristics of seasonal patterns between different VIs and MODIS products. We demonstrate that differences in the original reflectance band values form a major source of discrepancy between MODIS VI products. The MAIAC atmospheric correction algorithm significantly reduces noise signals in the red and blue bands. Another important source of discrepancy is caused by differences in the availability of clear-sky data, as the MAIAC product allows increased availability of valid pixels in the equatorial Amazon. Finally, differences in VIs seasonal patterns were also caused by MODIS collection 5 calibration degradation. The correlation of remote sensing and field data also varied spatially, leading to different temporal offsets between VIs, active microwave and field measured data. We conclude that recent improvements in the MAIAC product have led to changes in the characteristics of spatio-temporal patterns of VIs seasonality across the Amazon forest, when compared to the MCD43 product. Nevertheless, despite improved quality and reduced uncertainties in the MAIAC product, a robust biophysical interpretation of VIs seasonality is still missing.

Consistency of Vegetation Index Seasonality Across the Amazon Rainforest

NASA Technical Reports Server (NTRS)

Maeda, Eduardo Eiji; Moura, Yhasmin Mendes; Wagner, Fabien; Hilker, Thomas; Lyapustin, Alexei I.; Wang, Yujie; Chave, Jerome; Mottus, Matti; Aragao, Luiz E.O.C.; Shimabukuro, Yosio

2016-01-01

Vegetation indices (VIs) calculated from remotely sensed reflectance are widely used tools for characterizing the extent and status of vegetated areas. Recently, however, their capability to monitor the Amazon forest phenology has been intensely scrutinized. In this study, we analyze the consistency of VIs seasonal patterns obtained from two MODIS products: the Collection 5 BRDF product (MCD43) and the Multi-Angle Implementation of Atmospheric Correction algorithm (MAIAC). The spatio-temporal patterns of the VIs were also compared with field measured leaf litterfall, gross ecosystem productivity and active microwave data. Our results show that significant seasonal patterns are observed in all VIs after the removal of view-illumination effects and cloud contamination. However, we demonstrate inconsistencies in the characteristics of seasonal patterns between different VIs and MODIS products. We demonstrate that differences in the original reflectance band values form a major source of discrepancy between MODIS VI products. The MAIAC atmospheric correction algorithm significantly reduces noise signals in the red and blue bands. Another important source of discrepancy is caused by differences in the availability of clear-sky data, as the MAIAC product allows increased availability of valid pixels in the equatorial Amazon. Finally, differences in VIs seasonal patterns were also caused by MODIS collection 5 calibration degradation. The correlation of remote sensing and field data also varied spatially, leading to different temporal offsets between VIs, active microwave and field measured data. We conclude that recent improvements in the MAIAC product have led to changes in the characteristics of spatio-temporal patterns of VIs seasonality across the Amazon forest, when compared to the MCD43 product. Nevertheless, despite improved quality and reduced uncertainties in the MAIAC product, a robust biophysical interpretation of VIs seasonality is still missing.

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

High impact technologies for natural products screening.

PubMed

Koehn, Frank E

2008-01-01

Natural products have historically been a rich source of lead molecules in drug discovery. However, natural products have been de-emphasized as high throughput screening resources in the recent past, in part because of difficulties in obtaining high quality natural products screening libraries, or in applying modern screening assays to these libraries. In addition, natural products programs based on screening of extract libraries, bioassay-guided isolation, structure elucidation and subsequent production scale-up are challenged to meet the rapid cycle times that are characteristic of the modern HTS approach. Fortunately, new technologies in mass spectrometry, NMR and other spectroscopic techniques can greatly facilitate the first components of the process - namely the efficient creation of high-quality natural products libraries, bimolecular target or cell-based screening, and early hit characterization. The success of any high throughput screening campaign is dependent on the quality of the chemical library. The construction and maintenance of a high quality natural products library, whether based on microbial, plant, marine or other sources is a costly endeavor. The library itself may be composed of samples that are themselves mixtures - such as crude extracts, semi-pure mixtures or single purified natural products. Each of these library designs carries with it distinctive advantages and disadvantages. Crude extract libraries have lower resource requirements for sample preparation, but high requirements for identification of the bioactive constituents. Pre-fractionated libraries can be an effective strategy to alleviate interferences encountered with crude libraries, and may shorten the time needed to identify the active principle. Purified natural product libraries require substantial resources for preparation, but offer the advantage that the hit detection process is reduced to that of synthetic single component libraries. Whether the natural products library consists of crude or partially fractionated mixtures, the library contents should be profiled to identify the known components present - a process known as dereplication. The use of mass spectrometry and HPLC-mass spectrometry together with spectral databases is a powerful tool in the chemometric profiling of bio-sources for natural product production. High throughput, high sensitivity flow NMR is an emerging tool in this area as well. Whether by cell based or biomolecular target based assays, screening of natural product extract libraries continues to furnish novel lead molecules for further drug development, despite challenges in the analysis and prioritization of natural products hits. Spectroscopic techniques are now being used to directly screen natural product and synthetic libraries. Mass spectrometry in the form of methods such as ESI-ICRFTMS, and FACS-MS as well as NMR methods such as SAR by NMR and STD-NMR have been utilized to effectively screen molecular libraries. Overall, emerging advances in mass spectrometry, NMR and other technologies are making it possible to overcome the challenges encountered in screening natural products libraries in today's drug discovery environment. As we apply these technologies and develop them even further, we can look forward to increased impact of natural products in the HTS based drug discovery.

Measuring Software Product Quality: The ISO 25000 Series and CMMI

DTIC Science & Technology

2004-06-14

performance objectives” covers objectives and requirements for product quality, service quality , and process performance. Process performance objectives...such that product quality, service quality , and process performance attributes are measurable and controlled throughout the project (internal and

Disinfection aboard cruise liners and naval units: formation of disinfection by-products using chlorine dioxide in different qualities of drinking water.

PubMed

Ufermann, Petra; Petersen, Hauke; Exner, Martin

2011-12-01

The world-wide deployment of cruise liners and naval units has caused an increased need for the disinfection of drinking water. The main cause for this is the unknown quality of drinking water in foreign harbours--besides the formation of bio-films due to the climatically disadvantageous conditions in the operational area. Water conduits on board are currently disinfected with calcium hypochlorite in case of microbiological contamination. Chemical and physical analyses after disinfection with calcium hypochlorite have shown that organic by-products consisting of trihalomethanes develop in considerable amounts during disinfection. Furthermore, the method is susceptible to handling errors and thus often leads to insufficient disinfection results. Hitherto, the use of other disinfection methods allowed by government regulations, especially chlorine dioxide, is not widely spread. Unlike disinfection with calcium hypochlorite, chlorine dioxide does not lead to the formation of trihalomethanes. Typical disinfection by-products (DBP) are the anions chlorite and chlorate, which are formed in oxidative processes. The formation conditions of these anions have not yet been elucidated. For this reason, the probability of the generation of inorganic by-products after disinfection with chlorine dioxide has been determined, and their occurrence in drinking water on board has been examined with respect to a possible correlation between water quality and the formation of chlorate and chlorite. Therefore, a chromatographic method was developed and validated in order to determine the periodical development of chlorate and chlorite from chorine dioxide in purified water at different pH-values as well as in actual drinking water samples from water conduits on board. The formation of the by-products chlorite and chlorate after disinfection with chlorine dioxide is influenced neither by pH-value nor by chemical properties of the disinfected water. Considering the examined conditions, chlorine dioxide is suitable for usage on board due to its simple handling and the low potential of producing by-products. Copyright © 2011 Elsevier GmbH. All rights reserved.

Scenarios reveal pathways to sustain future ecosystem services in an agricultural landscape.

PubMed

Qiu, Jiangxiao; Carpenter, Stephen R; Booth, Eric G; Motew, Melissa; Zipper, Samuel C; Kucharik, Christopher J; Chen, Xi; Loheide, Steven P; Seifert, Jenny; Turner, Monica G

2018-01-01

Sustaining food production, water quality, soil retention, flood, and climate regulation in agricultural landscapes is a pressing global challenge given accelerating environmental changes. Scenarios are stories about plausible futures, and scenarios can be integrated with biophysical simulation models to explore quantitatively how the future might unfold. However, few studies have incorporated a wide range of drivers (e.g., climate, land-use, management, population, human diet) in spatially explicit, process-based models to investigate spatial-temporal dynamics and relationships of a portfolio of ecosystem services. Here, we simulated nine ecosystem services (three provisioning and six regulating services) at 220 × 220 m from 2010 to 2070 under four contrasting scenarios in the 1,345-km 2 Yahara Watershed (Wisconsin, USA) using Agro-IBIS, a dynamic model of terrestrial ecosystem processes, biogeochemistry, water, and energy balance. We asked (1) How does ecosystem service supply vary among alternative future scenarios? (2) Where on the landscape is the provision of ecosystem services most susceptible to future social-ecological changes? (3) Among alternative future scenarios, are relationships (i.e., trade-offs, synergies) among food production, water, and biogeochemical services consistent over time? Our results showed that food production varied substantially with future land-use choices and management, and its trade-offs with water quality and soil retention persisted under most scenarios. However, pathways to mitigate or even reverse such trade-offs through technological advances and sustainable agricultural practices were apparent. Consistent relationships among regulating services were identified across scenarios (e.g., trade-offs of freshwater supply vs. flood and climate regulation, and synergies among water quality, soil retention, and climate regulation), suggesting opportunities and challenges to sustaining these services. In particular, proactive land-use changes and management may buffer water quality against undesirable future climate changes, but changing climate may overwhelm management efforts to sustain freshwater supply and flood regulation. Spatially, changes in ecosystem services were heterogeneous across the landscape, underscoring the power of local actions and fine-scale management. Our research highlights the value of embracing spatial and temporal perspectives in managing ecosystem services and their complex interactions, and provides a system-level understanding for achieving sustainability of the food-water-climate nexus in agricultural landscapes. © 2017 by the Ecological Society of America.

Developing ratings for food products: lessons learned from media rating systems.

PubMed

Kunkel, Dale; McKinley, Christopher

2007-01-01

Children regularly consume low-nutrient, high-calorie food that is not consistent with a healthful diet, contributing to an increasing epidemic of overweight and obesity. Among the multiple causes of this problem is the food industry's emphasis on marketing calorie-dense food products to children. The Institute of Medicine (IOM) has recommended that industry adopt a uniform system of simplified food ratings to convey the nutritional qualities of food in a manner that is understandable and appealing to children and youth. This report analyzes the need for such a system in a food marketing environment that increasingly identifies healthful products for the consumer in inconsistent fashion. It considers evidence regarding current usage of food labeling and draws parallels with media rating systems in discussing the prospects for a uniform food rating system that would accomplish the IOM's objective.

Polymorph selection: the role of nucleation, crystal growth and molecular modeling.

PubMed

Erdemir, Deniz; Lee, Alfred Y; Myerson, Allan S

2007-11-01

Solution crystallization is an important separation and purification process used in the chemical, pharmaceutical and food industries. The quality of a crystalline product is generally judged by four main criteria: purity, crystal habit, particle size and solid form. Consistent production of the desired polymorph is crucial as the unanticipated emergence of a different crystal form may have severe consequences. Thus, the selection of a solid-state form for a crystalline product is vital and is ultimately based on knowledge of the properties of the other polymorphs. This review discusses the role of nucleation, crystal growth and molecular modeling on polymorphism in molecular crystals. Examples are presented demonstrating how the first two factors can govern the appearance of a particular crystalline form, and how the latter factor can be used as a tool for understanding polymorphism.

Fabrication of light water reactor tritium targets

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pilger, J.P.

1991-11-01

The mission of the Fabrication Development Task of the Tritium Target Development Project is: to produce a documented technology basis, including specifications and procedures for target rod fabrication; to demonstrate that light water tritium targets can be manufactured at a rate consistent with tritium production requirements; and to develop quality control methods to evaluate target rod components and assemblies, and establish correlations between evaluated characteristics and target rod performance. Many of the target rod components: cladding tubes, end caps, plenum springs, etc., have similar counterparts in LWR fuel rods. High production rate manufacture and inspection of these components has beenmore » adequately demonstrated by nuclear fuel rod manufacturers. This summary describes the more non-conventional manufacturing processes and inspection techniques developed to fabricate target rod components whose manufacturability at required production rates had not been previously demonstrated.« less

Modeling on-column reduction of trisulfide bonds in monoclonal antibodies during protein A chromatography.

PubMed

Ghose, Sanchayita; Rajshekaran, Rupshika; Labanca, Marisa; Conley, Lynn

2017-01-06

Trisulfides can be a common post-translational modification in many recombinant monoclonal antibodies. These are a source of product heterogeneity that add to the complexity of product characterization and hence, need to be reduced for consistent product quality. Trisulfide bonds can be converted to the regular disulfide bonds by incorporating a novel cysteine wash step during Protein A affinity chromatography. An empirical model is developed for this on-column reduction reaction to compare the reaction rates as a function of typical operating parameters such as temperature, cysteine concentration, reaction time and starting level of trisulfides. The model presented here is anticipated to assist in the development of optimal wash conditions for the Protein A step to effectively reduce trisulfides to desired levels. Copyright © 2016 Elsevier B.V. All rights reserved.

Attitudes and values of Peruvian coca growers.

PubMed

Rojas, Maritza R

2002-01-01

This study uses semi-structured interviews to examine the attitudes and values of Peruvian coca growers toward coca leaf and cocaine basic paste (CBP) consumption and its distribution. The subjects of the study were 186 coca growers from Peruvian jungle valleys who are involved in illegal commercialization of coca leaf and cocaine paste production. Data collected in 1994 reveal that growers consider coca leaf to be a most profitable product and a unique opportunity to improve their quality of life. Although growers acknowledge that a problem exists among local users, they do not assume any responsibility for CBP consumption and dissemination in rural areas. This leads to the conclusion that awareness of a CBP consumption problem is not enough for growers to stop drug production; they need consistent training in social values, as well as support in legal and economic alternatives.