Assessment Methodology for Process Validation Lifecycle Stage 3A.

PubMed

Sayeed-Desta, Naheed; Pazhayattil, Ajay Babu; Collins, Jordan; Chen, Shu; Ingram, Marzena; Spes, Jana

2017-07-01

The paper introduces evaluation methodologies and associated statistical approaches for process validation lifecycle Stage 3A. The assessment tools proposed can be applied to newly developed and launched small molecule as well as bio-pharma products, where substantial process and product knowledge has been gathered. The following elements may be included in Stage 3A: number of 3A batch determination; evaluation of critical material attributes, critical process parameters, critical quality attributes; in vivo in vitro correlation; estimation of inherent process variability (IPV) and PaCS index; process capability and quality dashboard (PCQd); and enhanced control strategy. US FDA guidance on Process Validation: General Principles and Practices, January 2011 encourages applying previous credible experience with suitably similar products and processes. A complete Stage 3A evaluation is a valuable resource for product development and future risk mitigation of similar products and processes. Elements of 3A assessment were developed to address industry and regulatory guidance requirements. The conclusions made provide sufficient information to make a scientific and risk-based decision on product robustness.

Developing a new production host from a blueprint: Bacillus pumilus as an industrial enzyme producer.

PubMed

Küppers, Tobias; Steffen, Victoria; Hellmuth, Hendrik; O'Connell, Timothy; Bongaerts, Johannes; Maurer, Karl-Heinz; Wiechert, Wolfgang

2014-03-24

Since volatile and rising cost factors such as energy, raw materials and market competitiveness have a significant impact on the economic efficiency of biotechnological bulk productions, industrial processes need to be steadily improved and optimized. Thereby the current production hosts can undergo various limitations. To overcome those limitations and in addition increase the diversity of available production hosts for future applications, we suggest a Production Strain Blueprinting (PSB) strategy to develop new production systems in a reduced time lapse in contrast to a development from scratch.To demonstrate this approach, Bacillus pumilus has been developed as an alternative expression platform for the production of alkaline enzymes in reference to the established industrial production host Bacillus licheniformis. To develop the selected B. pumilus as an alternative production host the suggested PSB strategy was applied proceeding in the following steps (dedicated product titers are scaled to the protease titer of Henkel's industrial production strain B. licheniformis at lab scale): Introduction of a protease production plasmid, adaptation of a protease production process (44%), process optimization (92%) and expression optimization (114%). To further evaluate the production capability of the developed B. pumilus platform, the target protease was substituted by an α-amylase. The expression performance was tested under the previously optimized protease process conditions and under subsequently adapted process conditions resulting in a maximum product titer of 65% in reference to B. licheniformis protease titer. In this contribution the applied PSB strategy performed very well for the development of B. pumilus as an alternative production strain. Thereby the engineered B. pumilus expression platform even exceeded the protease titer of the industrial production host B. licheniformis by 14%. This result exhibits a remarkable potential of B. pumilus to be the basis for a next generation production host, since the strain has still a large potential for further genetic engineering. The final amylase titer of 65% in reference to B. licheniformis protease titer suggests that the developed B. pumilus expression platform is also suitable for an efficient production of non-proteolytic enzymes reaching a final titer of several grams per liter without complex process modifications.

Process Metallurgy an Enabler of Resource Efficiency: Linking Product Design to Metallurgy in Product Centric Recycling

NASA Astrophysics Data System (ADS)

Reuter, Markus; van Schaik, Antoinette

In this paper the link between process metallurgy, classical minerals processing, product centric recycling and urban/landfill mining is discussed. The depth that has to be achieved in urban mining and recycling must glean from the wealth of theoretical knowledge and insight that have been developed in the past in minerals and metallurgical processing. This background learns that recycling demands a product centric approach, which considers simultaneously the multi-material interactions in man-made complex `minerals'. Fast innovation in recycling and urban mining can be achieved by further evolving from this well developed basis, evolving the techniques and tools that have been developed over the years. This basis has already been used for many years to design, operate and control industrial plants for metal production. This has been the basis for Design for Recycling rules for End-of-Life products. Using, among others, the UNEP Metal Recycling report as a basis (authors are respectively Lead and Main authors of report), it is demonstrated that a common theoretical basis as developed in metallurgy and minerals processing can help much to level the playing field between primary processing, secondary processing, recycling, and urban/landfill mining and product design hence enhancing resource efficiency. Thus various scales of detail link product design with metallurgical process design and its fundamentals.

Flat-plate solar array project. Volume 5: Process development

NASA Technical Reports Server (NTRS)

Gallagher, B.; Alexander, P.; Burger, D.

1986-01-01

The goal of the Process Development Area, as part of the Flat-Plate Solar Array (FSA) Project, was to develop and demonstrate solar cell fabrication and module assembly process technologies required to meet the cost, lifetime, production capacity, and performance goals of the FSA Project. R&D efforts expended by Government, Industry, and Universities in developing processes capable of meeting the projects goals during volume production conditions are summarized. The cost goals allocated for processing were demonstrated by small volume quantities that were extrapolated by cost analysis to large volume production. To provide proper focus and coverage of the process development effort, four separate technology sections are discussed: surface preparation, junction formation, metallization, and module assembly.

New Product Development (NPD) Process - An Example of Industrial Sector

NASA Astrophysics Data System (ADS)

Kazimierska, Marianna; Grębosz-Krawczyk, Magdalena

2017-12-01

This aim of this article is to present the process of new product introduction on example of industrial sector in context of new product development (NPD) concept. In the article, the concept of new product development is discussed and the different stages of the process of new electric motor development are analysed taking into account its objectives, implemented procedures, functions and responsibilities division. In the article, information from secondary sources and the results of empirical research - conducted in an international manufacturing company - are used. The research results show the significance of project leader and regular cooperation with final client in the NPD process.

New Vistas in Chemical Product and Process Design.

PubMed

Zhang, Lei; Babi, Deenesh K; Gani, Rafiqul

2016-06-07

Design of chemicals-based products is broadly classified into those that are process centered and those that are product centered. In this article, the designs of both classes of products are reviewed from a process systems point of view; developments related to the design of the chemical product, its corresponding process, and its integration are highlighted. Although significant advances have been made in the development of systematic model-based techniques for process design (also for optimization, operation, and control), much work is needed to reach the same level for product design. Timeline diagrams illustrating key contributions in product design, process design, and integrated product-process design are presented. The search for novel, innovative, and sustainable solutions must be matched by consideration of issues related to the multidisciplinary nature of problems, the lack of data needed for model development, solution strategies that incorporate multiscale options, and reliability versus predictive power. The need for an integrated model-experiment-based design approach is discussed together with benefits of employing a systematic computer-aided framework with built-in design templates.

Intracellular response to process optimization and impact on productivity and product aggregates for a high-titer CHO cell process.

PubMed

Handlogten, Michael W; Lee-O'Brien, Allison; Roy, Gargi; Levitskaya, Sophia V; Venkat, Raghavan; Singh, Shailendra; Ahuja, Sanjeev

2018-01-01

A key goal in process development for antibodies is to increase productivity while maintaining or improving product quality. During process development of an antibody, titers were increased from 4 to 10 g/L while simultaneously decreasing aggregates. Process development involved optimization of media and feed formulations, feed strategy, and process parameters including pH and temperature. To better understand how CHO cells respond to process changes, the changes were implemented in a stepwise manner. The first change was an optimization of the feed formulation, the second was an optimization of the medium, and the third was an optimization of process parameters. Multiple process outputs were evaluated including cell growth, osmolality, lactate production, ammonium concentration, antibody production, and aggregate levels. Additionally, detailed assessment of oxygen uptake, nutrient and amino acid consumption, extracellular and intracellular redox environment, oxidative stress, activation of the unfolded protein response (UPR) pathway, protein disulfide isomerase (PDI) expression, and heavy and light chain mRNA expression provided an in-depth understanding of the cellular response to process changes. The results demonstrate that mRNA expression and UPR activation were unaffected by process changes, and that increased PDI expression and optimized nutrient supplementation are required for higher productivity processes. Furthermore, our findings demonstrate the role of extra- and intracellular redox environment on productivity and antibody aggregation. Processes using the optimized medium, with increased concentrations of redox modifying agents, had the highest overall specific productivity, reduced aggregate levels, and helped cells better withstand the high levels of oxidative stress associated with increased productivity. Specific productivities of different processes positively correlated to average intracellular values of total glutathione. Additionally, processes with the optimized media maintained an oxidizing intracellular environment, important for correct disulfide bond pairing, which likely contributed to reduced aggregate formation. These findings shed important understanding into how cells respond to process changes and can be useful to guide future development efforts to enhance productivity and improve product quality. © 2017 Wiley Periodicals, Inc.

New advances in the integrated management of food processing by-products in Europe: sustainable exploitation of fruit and cereal processing by-products with the production of new food products (NAMASTE EU).

PubMed

Fava, Fabio; Zanaroli, Giulio; Vannini, Lucia; Guerzoni, Elisabetta; Bordoni, Alessandra; Viaggi, Davide; Robertson, Jim; Waldron, Keith; Bald, Carlos; Esturo, Aintzane; Talens, Clara; Tueros, Itziar; Cebrián, Marta; Sebők, András; Kuti, Tunde; Broeze, Jan; Macias, Marta; Brendle, Hans-Georg

2013-09-25

By-products generated every year by the European fruit and cereal processing industry currently exceed several million tons. They are disposed of mainly through landfills and thus are largely unexploited sources of several valuable biobased compounds potentially profitable in the formulation of novel food products. The opportunity to design novel strategies to turn them into added value products and food ingredients via novel and sustainable processes is the main target of recently EC-funded FP7 project NAMASTE-EU. NAMASTE-EU aims at developing new laboratory-scale protocols and processes for the exploitation of citrus processing by-products and wheat bran surpluses via the production of ingredients useful for the formulation of new beverage and food products. Among the main results achieved in the first two years of the project, there are the development and assessment of procedures for the selection, stabilization and the physical/biological treatment of citrus and wheat processing by-products, the obtainment and recovery of some bioactive molecules and ingredients and the development of procedures for assessing the quality of the obtained ingredients and for their exploitation in the preparation of new food products. Copyright © 2013 Elsevier B.V. All rights reserved.

Product Development and its Comparative Analysis by SLA, SLS and FDM Rapid Prototyping Processes

NASA Astrophysics Data System (ADS)

Choudhari, C. M.; Patil, V. D.

2016-09-01

To grab market and meeting deadlines has increased the scope of new methods in product design and development. Industries continuously strive to optimize the development cycles with high quality and cost efficient products to maintain market competitiveness. Thus the need of Rapid Prototyping Techniques (RPT) has started to play pivotal role in rapid product development cycle for complex product. Dimensional accuracy and surface finish are the corner stone of Rapid Prototyping (RP) especially if they are used for mould development. The paper deals with the development of part made with the help of Selective Laser Sintering (SLS), Stereo-lithography (SLA) and Fused Deposition Modelling (FDM) processes to benchmark and investigate on various parameters like material shrinkage rate, dimensional accuracy, time, cost and surface finish. This helps to conclude which processes can be proved to be effective and efficient in mould development. In this research work the emphasis was also given to the design stage of a product development to obtain an optimum design solution for an existing product.

[Contribution of microbiologists of Kirov City to development of penicillin and streptomycin production processes (70 years since development of technology for submerged production of first domestic antibiotics)].

PubMed

Bakulin, M K; Tumanov, A S; Bakulin, V M; Kalininskiĭ, V B

2014-01-01

The publication is concerned with development of the technological processes for submered production of the first domestic antibiotics 70 years age. The literature data on the contribution of the microbiologists of the Kirov City and mainly the workers of the Red Army Research Institute of Epidemiology and Hygiene (nowadays Central Research Institute No. 48 of the Ministry of Defense of the Russian Federation, Kirov), to development of the manufacture processes for production of penicillin and streptomycin are reviewed.

Quality risk management in pharmaceutical development.

PubMed

Charoo, Naseem Ahmad; Ali, Areeg Anwer

2013-07-01

The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by design paradigm, the product performance properties relevant to the patient are predefined in target product profile (TPP). Together with prior knowledge and experience, TPP helps in identification of critical quality attributes (CQA's). Initial risk assessment which identifies risks to these CQA's provides impetus for product development. Product and process are designed to gain knowledge about these risks, devise strategies to eliminate or mitigate these risks and meet objectives set in TPP. By laying more emphasis on high risk events the protection level of patient is increased. The process being scientifically driven improves the transparency and reliability of the manufacturer. The focus on risk to the patient together with flexible development approach saves invaluable resources, increases confidence on quality and reduces compliance risk. The knowledge acquired in analysing risks to CQA's permits construction of meaningful design space. Within the boundaries of the design space, variation in critical material characteristics and process parameters must be managed in order to yield a product having the desired characteristics. Specifications based on product and process understanding are established such that product will meet the specifications if tested. In this way, the product is amenable to real time release, since specifications only confirm quality but they do not serve as a means of effective process control.

Measuring the impact of computer resource quality on the software development process and product

NASA Technical Reports Server (NTRS)

Mcgarry, Frank; Valett, Jon; Hall, Dana

1985-01-01

The availability and quality of computer resources during the software development process was speculated to have measurable, significant impact on the efficiency of the development process and the quality of the resulting product. Environment components such as the types of tools, machine responsiveness, and quantity of direct access storage may play a major role in the effort to produce the product and in its subsequent quality as measured by factors such as reliability and ease of maintenance. During the past six years, the NASA Goddard Space Flight Center has conducted experiments with software projects in an attempt to better understand the impact of software development methodologies, environments, and general technologies on the software process and product. Data was extracted and examined from nearly 50 software development projects. All were related to support of satellite flight dynamics ground-based computations. The relationship between computer resources and the software development process and product as exemplified by the subject NASA data was examined. Based upon the results, a number of computer resource-related implications are provided.

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.

Experimental study of the space-time development of the particle production process in hadron-nucleon collisions, using massive target nucleus as a detector

NASA Technical Reports Server (NTRS)

Strugalski, Z.

1985-01-01

Experimental study of the space-time development of the particle production process in hadronic collisions at its initial stage was performed. Massive target nuclei have been used as fine detectors of properties of the particle production process development within time intervals smaller than 10 to the 22nd power s and spatial distances smaller than 10 to the 12th power cm. In hadron-nucleon collisions, in particular in nucleon-nucleon collisions, the particle production process goes through intermediate objects in 2 yields 2 type endoergic reactions. The objects decay into commonly observed resonances and paricles.

Challenges in Introducing New Products: A Case Study on the New Product Development Process

ERIC Educational Resources Information Center

Rankin, Robert; Mintu-Wimsatt, Alma

2017-01-01

The case is based on an actual product introduction, and is designed to provide instruction on the new product development process. With the cost to launch new products estimated at least US $15 million and new product failure rates ranging from 40% to 80%, it is imperative that students learn how to determine the financial and market feasibility…

Optimization of insect cell based protein production processes - online monitoring, expression systems, scale up.

PubMed

Druzinec, Damir; Salzig, Denise; Brix, Alexander; Kraume, Matthias; Vilcinskas, Andreas; Kollewe, Christian; Czermak, Peter

2013-01-01

Due to the increasing use of insect cell based expression systems in research and industrial recombinant protein production, the development of efficient and reproducible production processes remains a challenging task. In this context, the application of online monitoring techniques is intended to ensure high and reproducible product qualities already during the early phases of process development. In the following chapter, the most common transient and stable insect cell based expression systems are briefly introduced. Novel applications of insect cell based expression systems for the production of insect derived antimicrobial peptides/proteins (AMPs) are discussed using the example of G. mellonella derived gloverin. Suitable in situ sensor techniques for insect cell culture monitoring in disposable and common bioreactor systems are outlined with respect to optical and capacitive sensor concepts. Since scale up of production processes is one of the most critical steps in process development, a conclusive overview is given about scale up aspects for industrial insect cell culture processes.

Development of a commercial scale process for production of 1,4-butanediol from sugar.

PubMed

Burgard, Anthony; Burk, Mark J; Osterhout, Robin; Van Dien, Stephen; Yim, Harry

2016-12-01

A sustainable bioprocess for the production of 1,4-butanediol (BDO) from carbohydrate feedstocks was developed. BDO is a chemical intermediate that goes into a variety of products including automotive parts, electronics, and apparel, and is currently manufactured commercially through energy-intensive petrochemical processes using fossil raw materials. This review highlights the development of an Escherichia coli strain and an overall process that successfully performed at commercial scale for direct production of bio-BDO from dextrose. Achieving such high level performance required an integrated technology platform enabling detailed engineering of enzyme, pathway, metabolic network, and organism, as well as development of effective fermentation and downstream recovery processes. Copyright © 2016 Elsevier Ltd. All rights reserved.

New Catalyst Reduces Wasted Carbon in Biofuel Process, Lowers Cost

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

Researchers at NREL recently developed a catalyst formulation that incorporates more hydrogen into the DME-to-high-octane gasoline process, resulting in a higher yield to gasoline-range products. Further, the researchers developed a secondary process that efficiently couples a portion of the gasoline-range product to yield jet/diesel fuels. The modified catalyst doubles the conversion rate of DME, which can be produced from biomass, to the high-octane gasoline product and significantly decreases the formation of wasted byproducts. For the distillate-range product, 80% of the mixture is in line with ASTM standards for use as a jet fuel blendstock. The increased productivity of high-octane gasolinemore » and the development of a value-added distillate blendstock process further improve the economic viability toward commercially implementing this renewable fuels process.« less

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

Control and Diagnosis in Integrated Product Development - Observations during the Development of an AGV

NASA Astrophysics Data System (ADS)

Stetter, R.; Simundsson, A.

2015-11-01

This paper is concerned with the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of integrated product development have attracted significant attention during the last decades. Today, it is generally observed that product development processes of complex systems can only be successful if the activities in the different domains are well connected and synchronised and if an ongoing communication is present - an ongoing communication spanning the technical domains and also including functions such as production planning, marketing/distribution, quality assurance, service and project planning. Obviously, numerous approaches to tackle this challenge are present in scientific literature and in industrial practice, as well. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The main source of insight of the presented research is the product development process of an Automated Guided Vehicle (AGV) which is intended to be used on rough terrain. The paper starts with a background describing Integrated Product Development. The second section deals with the product development of the sample product. The third part summarizes some insights and formulates first hypotheses concerning control and diagnosis in Integrated Product Development.

Advanced development: Fuels

NASA Astrophysics Data System (ADS)

Ramohalli, K.

1981-05-01

The solar thermal fuels and chemicals program at Jet Propulsion Laboratory are described. High technology is developed and applied to displace fossil fuel (oil) use in the production/processing of valuable fuels and chemicals. The technical and economic feasibility is demonstrated to extent that enables the industry to participate and commercialize the product. A representative process, namely Furfural production with a bottoming of acetone, butanol and ethanol, is described. Experimental data from all solar production of furfural is discussed. Estimates are given to show the attractiveness of this process, considering its flexibility to be adaptable to dishes, troughs or central receivers. Peat, lignite and low rank coal processing, heavy oil stripping and innovative technologies for process diagnostics and control are mentioned as examples of current projects under intensive development.

Advanced development: Fuels

NASA Technical Reports Server (NTRS)

Ramohalli, K.

1981-01-01

The solar thermal fuels and chemicals program at Jet Propulsion Laboratory are described. High technology is developed and applied to displace fossil fuel (oil) use in the production/processing of valuable fuels and chemicals. The technical and economic feasibility is demonstrated to extent that enables the industry to participate and commercialize the product. A representative process, namely Furfural production with a bottoming of acetone, butanol and ethanol, is described. Experimental data from all solar production of furfural is discussed. Estimates are given to show the attractiveness of this process, considering its flexibility to be adaptable to dishes, troughs or central receivers. Peat, lignite and low rank coal processing, heavy oil stripping and innovative technologies for process diagnostics and control are mentioned as examples of current projects under intensive development.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

Development of environmentally conscious cleaning process for leadless chip carrier assemblies. Final report

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

Adams, B.E.

1995-04-01

A cross-functional team of process, product, quality, material, and design lab engineers was assembled to develop an environmentally friendly cleaning process for leadless chip carrier assemblies (LCCAs). Using flush and filter testing, Auger surface analysis, GC-Mass spectrophotometry, production yield results, and electrical testing results over an extended testing period, the team developed an aqueous cleaning process for LCCAs. The aqueous process replaced the Freon vapor degreasing/ultrasonic rinse process.

Quality by design case study: an integrated multivariate approach to drug product and process development.

PubMed

Huang, Jun; Kaul, Goldi; Cai, Chunsheng; Chatlapalli, Ramarao; Hernandez-Abad, Pedro; Ghosh, Krishnendu; Nagi, Arwinder

2009-12-01

To facilitate an in-depth process understanding, and offer opportunities for developing control strategies to ensure product quality, a combination of experimental design, optimization and multivariate techniques was integrated into the process development of a drug product. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Two types of analyses were performed to extract maximal information, DOE effect & response surface analysis and multivariate analysis (PCA and PLS). The DOE effect analysis was used to evaluate the interactions and effects of three design factors (water amount, wet massing time and lubrication time), on response variables (blend flow, compressibility and tablet dissolution). The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. Multivariate analysis of all variables from the DOE batches was conducted to study relationships between the variables and to evaluate the impact of material attributes/process parameters on manufacturability and final product CQAs. The integrated multivariate approach exemplifies application of QbD principles and tools to drug product and process development.

Improving product introduction through effective design reviews.

PubMed

Pelnik, Tammy M

2003-01-01

The design review process is a part of the manufacturer's due diligence in developing a safe and effective product. Design review provides early and on-going independent feedback to developers. By adopting a proactive review process, design improvements can be pursued at an optimum time in the product development effort, i.e., when it will cost less to implement changes and when these changes may have the greatest impact. Effective implementation of the design review requirement will lead to better medical products and improved product introduction results.

Citrus Waste Biomass Program

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

Karel Grohman; Scott Stevenson

Renewable Spirits is developing an innovative pilot plant bio-refinery to establish the commercial viability of ehtanol production utilizing a processing waste from citrus juice production. A novel process based on enzymatic hydrolysis of citrus processing waste and fermentation of resulting sugars to ethanol by yeasts was successfully developed in collaboration with a CRADA partner, USDA/ARS Citrus and Subtropical Products Laboratory. The process was also successfully scaled up from laboratory scale to 10,000 gal fermentor level.

Process and utility water requirements for cellulosic ethanol production processes via fermentation pathway

EPA Science Inventory

The increasing need of additional water resources for energy production is a growing concern for future economic development. In technology development for ethanol production from cellulosic feedstocks, a detailed assessment of the quantity and quality of water required, and the ...

Advanced Manufacturing and Value-added Products from US Agriculture

NASA Technical Reports Server (NTRS)

Villet, Ruxton H.; Child, Dennis R.; Acock, Basil

1992-01-01

An objective of the US Department of Agriculture (USDA) Agriculture Research Service (ARS) is to develop technology leading to a broad portfolio of value-added marketable products. Modern scientific disciplines such as chemical engineering are brought into play to develop processes for converting bulk commodities into high-margin products. To accomplish this, the extremely sophisticated processing devices which form the basis of modern biotechnology, namely, genes and enzymes, can be tailored to perform the required functions. The USDA/ARS is a leader in the development of intelligent processing equipment (IPE) for agriculture in the broadest sense. Applications of IPE are found in the production, processing, grading, and marketing aspects of agriculture. Various biotechnology applications of IPE are discussed.

Biosynthesis of indigo using recombinant E. coli: Development of a biological system for the cost-effective production of a large volume chemical

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

Berry, A.; Battist, S.; Chotani, G.

1995-11-01

Cost-effective production of any large-volume chemical by fermentation requires extensive manipulation of both the production organism and the fermentation and recovery processes. We have developed a recombinant E. coli system for the production of tryptophan and several other products derived from the aromatic amino acid pathway. By linking our technology for low-cost production of tryptophan from glucose with the enzyme naphthalene dioxygenase (NDO), we have achieved an overall process for the production of indigo dye from glucose. To successfully join these two technologies, both the tryptophan pathway and NDO were extensively modified via genetic engineering. In addition, systems were developedmore » to remove deleterious by-products generated during the chemical oxidations leading to indigo formation. Low-cost fermentation processes were developed that utilized minimal-salts media containing glucose as the sole carbon source. Finally, economical recovery processes were used that preserved the environmental friendliness of the biosynthetic route to indigo.« less

Advanced model-based control strategies for the intensification of upstream and downstream processing in mAb production.

PubMed

Papathanasiou, Maria M; Quiroga-Campano, Ana L; Steinebach, Fabian; Elviro, Montaña; Mantalaris, Athanasios; Pistikopoulos, Efstratios N

2017-07-01

Current industrial trends encourage the development of sustainable, environmentally friendly processes with minimal energy and material consumption. In particular, the increasing market demand in biopharmaceutical industry and the tight regulations in product quality necessitate efficient operating procedures that guarantee products of high purity. In this direction, process intensification via continuous operation paves the way for the development of novel, eco-friendly processes, characterized by higher productivity and lower production costs. This work focuses on the development of advanced control strategies for (i) a cell culture system in a bioreactor and (ii) a semicontinuous purification process. More specifically, we consider a fed-batch culture of GS-NS0 cells and the semicontinuous Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) for the purification process. The controllers are designed following the PAROC framework/software platform and their capabilities are assessed in silico, against the process models. It is demonstrated that the proposed controllers efficiently manage to increase the system productivity, returning strategies that can lead to continuous, stable process operation. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:966-988, 2017. © 2017 American Institute of Chemical Engineers.

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

PubMed

Burcham, Christopher L; Florence, Alastair J; Johnson, Martin D

2018-06-07

The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

Use of consumer insight in the new product development process in the meat sector.

PubMed

Grunert, Klaus G; Verbeke, Wim; Kügler, Jens O; Saeed, Faiza; Scholderer, Joachim

2011-11-01

Successful new product development requires input from the market throughout the product development process, from identification of opportunities via screening of ideas, development of concepts, development of physical prototypes and to launch. Drawing on work done in the EU FP6 projects PROSAFEBEEF and Q-PORKCHAINS and a Danish project, all dealing with new product development in the meat sector, it is shown how the use of consumer insight techniques can a) support the identification of market opportunities, b) make sure that technologies applied are acceptable to consumers, c) aid the selection and optimisation of new product concepts and related communication, and d) be used to test product prototypes before final launch. Copyright © 2011 Elsevier Ltd. All rights reserved.

Microbial bioinformatics for food safety and production

PubMed Central

Alkema, Wynand; Boekhorst, Jos; Wels, Michiel

2016-01-01

In the production of fermented foods, microbes play an important role. Optimization of fermentation processes or starter culture production traditionally was a trial-and-error approach inspired by expert knowledge of the fermentation process. Current developments in high-throughput ‘omics’ technologies allow developing more rational approaches to improve fermentation processes both from the food functionality as well as from the food safety perspective. Here, the authors thematically review typical bioinformatics techniques and approaches to improve various aspects of the microbial production of fermented food products and food safety. PMID:26082168

Concept Engineering: An Investigation Of TIME versus Market Orientation in Product Concept Development

DTIC Science & Technology

1993-06-01

Designers and Champions of Innovation. Journal of Product Innovation Management . Vol. 8,91-103 Barabba, V. P., & Zaltman, G. (1991). Hearing the Voice of...Kleinschmidt, E. K. (1986). An Investigation into the New Product Process: Steps, Deficiencies, and Impact. Journal of Product Innovation Management . Vol...Product and Process Development. Journal of Product Innovation Management . Vol. 4,81-88 Goodman, M. (1974). Study Notes in System Dynamics. Cambridge, MA

Recent advances and state-of-the-art strategies in strain and process engineering for biobutanol production by Clostridium acetobutylicum.

PubMed

Xue, Chuang; Zhao, Jingbo; Chen, Lijie; Yang, Shang-Tian; Bai, Fengwu

Butanol as an advanced biofuel has gained great attention due to its environmental benefits and superior properties compared to ethanol. However, the cost of biobutanol production via conventional acetone-butanol-ethanol (ABE) fermentation by Clostridium acetobutylicum is not economically competitive, which has hampered its industrial application. The strain performance and downstream process greatly impact the economics of biobutanol production. Although various engineered strains with carefully orchestrated metabolic and sporulation-specific pathways have been developed, none of them is ideal for industrial biobutanol production. For further strain improvement, it is necessary to develop advanced genome editing tools and a deep understanding of cellular functioning of genes in metabolic and regulatory pathways. Processes with integrated product recovery can increase fermentation productivity by continuously removing inhibitory products while generating butanol (ABE) in a concentrated solution. In this review, we provide an overview of recent advances in C. acetobutylicum strain engineering and process development focusing on in situ product recovery. With deep understanding of systematic cellular bioinformatics, the exploration of state-of-the-art genome editing tools such as CRISPR-Cas for targeted gene knock-out and knock-in would play a vital role in Clostridium cell engineering for biobutanol production. Developing advanced hybrid separation processes for in situ butanol recovery, which will be discussed with a detailed comparison of advantages and disadvantages of various recovery techniques, is also imperative to the economical development of biobutanol. Copyright © 2017 Elsevier Inc. All rights reserved.

ISO 9000 and/or Systems Engineering Capability Maturity Model?

NASA Technical Reports Server (NTRS)

Gholston, Sampson E.

2002-01-01

For businesses and organizations to remain competitive today they must have processes and systems in place that will allow them to first identify customer needs and then develop products/processes that will meet or exceed the customers needs and expectations. Customer needs, once identified, are normally stated as requirements. Designers can then develop products/processes that will meet these requirements. Several functions, such as quality management and systems engineering management are used to assist product development teams in the development process. Both functions exist in all organizations and both have a similar objective, which is to ensure that developed processes will meet customer requirements. Are efforts in these organizations being duplicated? Are both functions needed by organizations? What are the similarities and differences between the functions listed above? ISO 9000 is an international standard of goods and services. It sets broad requirements for the assurance of quality and for management's involvement. It requires organizations to document the processes and to follow these documented processes. ISO 9000 gives customers assurance that the suppliers have control of the process for product development. Systems engineering can broadly be defined as a discipline that seeks to ensure that all requirements for a system are satisfied throughout the life of the system by preserving their interrelationship. The key activities of systems engineering include requirements analysis, functional analysis/allocation, design synthesis and verification, and system analysis and control. The systems engineering process, when followed properly, will lead to higher quality products, lower cost products, and shorter development cycles. The System Engineering Capability Maturity Model (SE-CMM) will allow companies to measure their system engineering capability and continuously improve those capabilities. ISO 9000 and SE-CMM seem to have a similar objective, which is to document the organization's processes and certify to potential customers the capability of a supplier to control the processes that determine the quality of the product or services being produced. The remaining sections of this report examine the differences and similarities between ISO 9000 and SE-CMM and make recommendations for implementation.

Aerospace Engineering Systems

NASA Technical Reports Server (NTRS)

VanDalsem, William R.; Livingston, Mary E.; Melton, John E.; Torres, Francisco J.; Stremel, Paul M.

1999-01-01

Continuous improvement of aerospace product development processes is a driving requirement across much of the aerospace community. As up to 90% of the cost of an aerospace product is committed during the first 10% of the development cycle, there is a strong emphasis on capturing, creating, and communicating better information (both requirements and performance) early in the product development process. The community has responded by pursuing the development of computer-based systems designed to enhance the decision-making capabilities of product development individuals and teams. Recently, the historical foci on sharing the geometrical representation and on configuration management are being augmented: Physics-based analysis tools for filling the design space database; Distributed computational resources to reduce response time and cost; Web-based technologies to relieve machine-dependence; and Artificial intelligence technologies to accelerate processes and reduce process variability. Activities such as the Advanced Design Technologies Testbed (ADTT) project at NASA Ames Research Center study the strengths and weaknesses of the technologies supporting each of these trends, as well as the overall impact of the combination of these trends on a product development event. Lessons learned and recommendations for future activities will be reported.

Production and Distribution of NASA MODIS Remote Sensing Products

NASA Technical Reports Server (NTRS)

Wolfe, Robert

2007-01-01

The two Moderate Resolution Imaging Spectroradiometer (MODIS) instruments on-board NASA's Earth Observing System (EOS) Terra and Aqua satellites make key measurements for understanding the Earth's terrestrial ecosystems. Global time-series of terrestrial geophysical parameters have been produced from MODIS/Terra for over 7 years and for MODIS/Aqua for more than 4 1/2 years. These well calibrated instruments, a team of scientists and a large data production, archive and distribution systems have allowed for the development of a new suite of high quality product variables at spatial resolutions as fine as 250m in support of global change research and natural resource applications. This talk describes the MODIS Science team's products, with a focus on the terrestrial (land) products, the data processing approach and the process for monitoring and improving the product quality. The original MODIS science team was formed in 1989. The team's primary role is the development and implementation of the geophysical algorithms. In addition, the team provided feedback on the design and pre-launch testing of the instrument and helped guide the development of the data processing system. The key challenges the science team dealt with before launch were the development of algorithms for a new instrument and provide guidance of the large and complex multi-discipline processing system. Land, Ocean and Atmosphere discipline teams drove the processing system requirements, particularly in the area of the processing loads and volumes needed to daily produce geophysical maps of the Earth at resolutions as fine as 250 m. The processing system had to handle a large number of data products, large data volumes and processing loads, and complex processing requirements. Prior to MODIS, daily global maps from heritage instruments, such as Advanced Very High Resolution Radiometer (AVHRR), were not produced at resolutions finer than 5 km. The processing solution evolved into a combination of processing the lower level (Level 1) products and the higher level discipline specific Land and Atmosphere products in the MODIS Science Investigator Lead Processing System (SIPS), the MODIS Adaptive Processing System (MODAPS), and archive and distribution of the Land products to the user community by two of NASA s EOS Distributed Active Archive Centers (DAACs). Recently, a part of MODAPS, the Level 1 and Atmosphere Archive and Distribution System (LAADS), took over the role of archiving and distributing the Level 1 and Atmosphere products to the user community.

Economics of polysilicon process: A view from Japan

NASA Technical Reports Server (NTRS)

Shimizu, Y.

1986-01-01

The production process of solar grade silicon (SOG-Si) through trichlorosilane (TCS) was researched in a program sponsored by New Energy Development Organization (NEDO). The NEDO process consists of the following two steps: TCS production from by-product silicon tetrachloride (STC) and SOG-Si formation from TCS using a fluidized bed reactor. Based on the data obtained during the research program, the manufacturing cost of the NEDO process and other polysilicon manufacturing processes were compared. The manufacturing cost was calculated on the basis of 1000 tons/year production. The cost estimate showed that the cost of producing silicon by all of the new processes is less than the cost by the conventional Siemens process. Using a new process, the cost of producing semiconductor grade silicon was found to be virtually the same with any to the TCS, diclorosilane, and monosilane processes when by-products were recycled. The SOG-Si manufacturing processes using the fluidized bed reactor, which needs further development, shows a greater probablility of cost reduction than the filament processes.

Creativity in ergonomic design: a supplemental value-adding source for product and service development.

PubMed

Zeng, Liang; Proctor, Robert W; Salvendy, Gavriel

2010-08-01

This article investigates the role of creativity in ergonomic design and the generic process of developing creative products and services. Creativity is gaining increased emphasis in both academia and industry. More than 50 years of research in creativity indicates that creativity is key to product and service innovation. Nevertheless, there is scarcely any comprehensive review dedicated to appraising the complex construct of creativity, the underlying cognitive process, and the role of creativity in product and service development. We review relevant literature regarding creativity, creative cognition, and the engineering design process to appraise the role of creativity in ergonomic design and to construct a conceptual model of creative product and service development. A framework of ergodesign creativity is advanced that highlights the central role of creativity in synergistically addressing the four dimensions of ergonomic design: functionality, safety, usability, and affectivity. A conceptual model of creative design process is then constructed that is goal oriented and is initiated by active problem finding and problem formulating. This process is carried out in a recursive and dynamic way, facilitated by creative thinking strategies. It is proposed that ergodesign creativity can add supplemental value to products and services, which subsequently affects consumer behavior and helps organizations gain competitive advantage. The proposed conceptual framework of ergodesign creativity and creative design process can serve as the ground for future theory development. Propositions advanced in this study should facilitate designers generating products and services that are creative and commercially competitive.

Biotechnology in Food Production and Processing

NASA Astrophysics Data System (ADS)

Knorr, Dietrich; Sinskey, Anthony J.

1985-09-01

The food processing industry is the oldest and largest industry using biotechnological processes. Further development of food products and processes based on biotechnology depends upon the improvement of existing processes, such as fermentation, immobilized biocatalyst technology, and production of additives and processing aids, as well as the development of new opportunities for food biotechnology. Improvements are needed in the characterization, safety, and quality control of food materials, in processing methods, in waste conversion and utilization processes, and in currently used food microorganism and tissue culture systems. Also needed are fundamental studies of the structure-function relationship of food materials and of the cell physiology and biochemistry of raw materials.

A roadmap for cost-of-goods planning to guide economic production of cell therapy products.

PubMed

Lipsitz, Yonatan Y; Milligan, William D; Fitzpatrick, Ian; Stalmeijer, Evelien; Farid, Suzanne S; Tan, Kah Yong; Smith, David; Perry, Robert; Carmen, Jessica; Chen, Allen; Mooney, Charles; Fink, John

2017-12-01

Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long-term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Virtual Collaborative Simulation Environment for Integrated Product and Process Development

NASA Technical Reports Server (NTRS)

Gulli, Michael A.

1997-01-01

Deneb Robotics is a leader in the development of commercially available, leading edge three- dimensional simulation software tools for virtual prototyping,, simulation-based design, manufacturing process simulation, and factory floor simulation and training applications. Deneb has developed and commercially released a preliminary Virtual Collaborative Engineering (VCE) capability for Integrated Product and Process Development (IPPD). This capability allows distributed, real-time visualization and evaluation of design concepts, manufacturing processes, and total factory and enterprises in one seamless simulation environment.

Cooperative optimization of reconfigurable machine tool configurations and production process plan

NASA Astrophysics Data System (ADS)

Xie, Nan; Li, Aiping; Xue, Wei

2012-09-01

The production process plan design and configurations of reconfigurable machine tool (RMT) interact with each other. Reasonable process plans with suitable configurations of RMT help to improve product quality and reduce production cost. Therefore, a cooperative strategy is needed to concurrently solve the above issue. In this paper, the cooperative optimization model for RMT configurations and production process plan is presented. Its objectives take into account both impacts of process and configuration. Moreover, a novel genetic algorithm is also developed to provide optimal or near-optimal solutions: firstly, its chromosome is redesigned which is composed of three parts, operations, process plan and configurations of RMTs, respectively; secondly, its new selection, crossover and mutation operators are also developed to deal with the process constraints from operation processes (OP) graph, otherwise these operators could generate illegal solutions violating the limits; eventually the optimal configurations for RMT under optimal process plan design can be obtained. At last, a manufacturing line case is applied which is composed of three RMTs. It is shown from the case that the optimal process plan and configurations of RMT are concurrently obtained, and the production cost decreases 6.28% and nonmonetary performance increases 22%. The proposed method can figure out both RMT configurations and production process, improve production capacity, functions and equipment utilization for RMT.

Acid and alkaline solubilization (pH shift) process: a better approach for the utilization of fish processing waste and by-products.

PubMed

Surasani, Vijay Kumar Reddy

2018-05-22

Several technologies and methods have been developed over the years to address the environmental pollution and nutritional losses associated with the dumping of fish processing waste and low-cost fish and by-products. Despite the continuous efforts put in this field, none of the developed technologies was successful in addressing the issues due to various technical problems. To solve the problems associated with the fish processing waste and low-value fish and by-products, a process called pH shift/acid and alkaline solubilization process was developed. In this process, proteins are first solubilized using acid and alkali followed by precipitating them at their isoelectric pH to recover functional and stable protein isolates from underutilized fish species and by-products. Many studies were conducted using pH shift process to recover proteins from fish and fish by-products and found to be most successful in recovering proteins with increased yields than conventional surimi (three cycle washing) process and with good functional properties. In this paper, problems associated with conventional processing, advantages and principle of pH shift processing, effect of pH shift process on the quality and storage stability of recovered isolates, applications protein isolates, etc. are discussed in detail for better understanding.

The influence of different screw concepts while processing fibre reinforced thermoplastics with the concept of inline-compounding on an injection moulding machine

NASA Astrophysics Data System (ADS)

Moritzer, E.; Müller, E.; Kleeschulte, R.

2014-05-01

Today, the global market poses major challenges for industrial product development. Complexity, the wide range of variants, flexibility and individuality are just some of the features that products have to fulfil. Product series additionally have shorter and shorter lifetimes. Because of their high capacity for adaptation, polymers are increasingly able to substitute traditional materials such as wood, glass and metals in various fields of application [1]. But polymers can only substitute other materials if they are optimally suited to the applications in question. Hence, product-specific material development is becoming increasingly important [2]. The problem is that the traditional development process for new polymer formulations is much too complex, too slow and therefore too expensive. Product-specific material development is thus out of the question for most processors. Integrating the compounding step in the injection moulding process would lead to a more efficient and faster development process for a new polymer formulation, providing an opportunity to create new product-specific materials. This process is called inline-compounding on an injection moulding machine. In order to develop this innovative formulation concept, with the focus on fibre reinforced thermoplastics, different screw-concepts are compared with regard to the resultant performance characteristics in the part, such as mechanical properties and fibre length distribution.

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.

A communication channel model of the software process

NASA Technical Reports Server (NTRS)

Tausworthe, R. C.

1988-01-01

Reported here is beginning research into a noisy communication channel analogy of software development process productivity, in order to establish quantifiable behavior and theoretical bounds. The analogy leads to a fundamental mathematical relationship between human productivity and the amount of information supplied by the developers, the capacity of the human channel for processing and transmitting information, the software product yield (object size), the work effort, requirements efficiency, tool and process efficiency, and programming environment advantage. Also derived is an upper bound to productivity that shows that software reuse is the only means than can lead to unbounded productivity growth; practical considerations of size and cost of reusable components may reduce this to a finite bound.

A communication channel model of the software process

NASA Technical Reports Server (NTRS)

Tausworthe, Robert C.

1988-01-01

Beginning research into a noisy communication channel analogy of software development process productivity, in order to establish quantifiable behavior and theoretical bounds is discussed. The analogy leads to a fundamental mathematical relationship between human productivity and the amount of information supplied by the developers, the capacity of the human channel for processing and transmitting information, the software product yield (object size) the work effort, requirements efficiency, tool and process efficiency, and programming environment advantage. An upper bound to productivity is derived that shows that software reuse is the only means that can lead to unbounded productivity growth; practical considerations of size and cost of reusable components may reduce this to a finite bound.

Chinese ethnic meat products: Continuity and development.

PubMed

Zeng, Weicai; Wen, Wenting; Deng, Yue; Tian, Yuanyuan; Sun, Honghu; Sun, Qun

2016-10-01

With their distinctive sensory characterizations and unique processing technologies, Chinese ethnic meat products possess great potential for development and continuity in modern China's meat industry. Due to the greater demand for meat products and higher quality and safety concerns in economically fast growing China, the development and continuity of ethnic meat products face its own unique challenges. In this review, the classification of typical ethnic products and their characteristics, and the research progress on their quality and processing technologies are discussed. The application of innovative and green technologies to improve the safety and quality of ethnic meat products for greater industrialization and sustainable development is highlighted. Furthermore, the strategy for promoting the production of Chinese ethnic meat products during the next five years is presented. Copyright © 2016 Elsevier Ltd. All rights reserved.

Engineering development of selective agglomeration: Task 5, Bench- scale process testing

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

Not Available

1991-09-01

Under the overall objectives of DOE Contract ``Engineering Development of Selective Agglomeration,`` there were a number of specific objectives in the Task 5 program. The prime objectives of Task 5 are highlighted below: (1) Maximize process performance in pyritic sulfur rejection and BTU recovery, (2) Produce a low ash product, (3) Compare the performance of the heavy agglomerant process based on diesel and the light agglomerant process using heptane, (4) Define optimum processing conditions for engineering design, (5) Provide first-level evaluation of product handleability, and (6) Explore and investigate process options/ideas which may enhance process performance and/or product handleability.

Engineering development of selective agglomeration: Task 5, Bench- scale process testing

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

Not Available

1991-09-01

Under the overall objectives of DOE Contract Engineering Development of Selective Agglomeration,'' there were a number of specific objectives in the Task 5 program. The prime objectives of Task 5 are highlighted below: (1) Maximize process performance in pyritic sulfur rejection and BTU recovery, (2) Produce a low ash product, (3) Compare the performance of the heavy agglomerant process based on diesel and the light agglomerant process using heptane, (4) Define optimum processing conditions for engineering design, (5) Provide first-level evaluation of product handleability, and (6) Explore and investigate process options/ideas which may enhance process performance and/or product handleability.

Using TRACI for Sustainability Metrics

EPA Science Inventory

TRACI, the Tool for the Reduction and Assessment of Chemical and other environmental Impacts, has been developed for sustainability metrics, life cycle impact assessment, and product and process design impact assessment for developing increasingly sustainable products, processes,...

TAMU: A New Space Mission Operations Paradigm

NASA Technical Reports Server (NTRS)

Meshkat, Leila; Ruszkowski, James; Haensly, Jean; Pennington, Granvil A.; Hogle, Charles

2011-01-01

The Transferable, Adaptable, Modular and Upgradeable (TAMU) Flight Production Process (FPP) is a model-centric System of System (SoS) framework which cuts across multiple organizations and their associated facilities, that are, in the most general case, in geographically diverse locations, to develop the architecture and associated workflow processes for a broad range of mission operations. Further, TAMU FPP envisions the simulation, automatic execution and re-planning of orchestrated workflow processes as they become operational. This paper provides the vision for the TAMU FPP paradigm. This includes a complete, coherent technique, process and tool set that result in an infrastructure that can be used for full lifecycle design and decision making during any flight production process. A flight production process is the process of developing all products that are necessary for flight.

Reduction of product-related species during the fermentation and purification of a recombinant IL-1 receptor antagonist at the laboratory and pilot scale.

PubMed

Schirmer, Emily B; Golden, Kathryn; Xu, Jin; Milling, Jesse; Murillo, Alec; Lowden, Patricia; Mulagapati, Srihariraju; Hou, Jinzhao; Kovalchin, Joseph T; Masci, Allyson; Collins, Kathryn; Zarbis-Papastoitsis, Gregory

2013-08-01

Through a parallel approach of tracking product quality through fermentation and purification development, a robust process was designed to reduce the levels of product-related species. Three biochemically similar product-related species were identified as byproducts of host-cell enzymatic activity. To modulate intracellular proteolytic activity, key fermentation parameters (temperature, pH, trace metals, EDTA levels, and carbon source) were evaluated through bioreactor optimization, while balancing negative effects on growth, productivity, and oxygen demand. The purification process was based on three non-affinity steps and resolved product-related species by exploiting small charge differences. Using statistical design of experiments for elution conditions, a high-resolution cation exchange capture column was optimized for resolution and recovery. Further reduction of product-related species was achieved by evaluating a matrix of conditions for a ceramic hydroxyapatite column. The optimized fermentation process was transferred from the 2-L laboratory scale to the 100-L pilot scale and the purification process was scaled accordingly to process the fermentation harvest. The laboratory- and pilot-scale processes resulted in similar process recoveries of 60 and 65%, respectively, and in a product that was of equal quality and purity to that of small-scale development preparations. The parallel approach for up- and downstream development was paramount in achieving a robust and scalable clinical process. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2010 CFR

2010-04-01

... chemicals. 359.Processing miscellaneous products. 430.Sterilizing and preserving solutions. (2) As a raw... chemicals (including alkaloids). 345.Processing blood and blood products. 351.Processing dyes and... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2011 CFR

2011-04-01

... chemicals. 359.Processing miscellaneous products. 430.Sterilizing and preserving solutions. (2) As a raw... chemicals (including alkaloids). 345.Processing blood and blood products. 351.Processing dyes and... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.41 - Formula No. 13-A.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use... medicinal chemicals (including alkaloids). 345.Processing blood and blood products. 349.Miscellaneous drug... photographic chemicals. 358.Processing other chemicals. 359.Processing miscellaneous products. 430.Sterilizing...

Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

NASA Astrophysics Data System (ADS)

Kirkire, Milind Shrikant; Rane, Santosh B.; Jadhav, Jagdish Rajaram

2015-12-01

Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

The roles of a process development group in biopharmaceutical process startup.

PubMed

Goochee, Charles F

2002-01-01

The transfer of processes for biotherapeutic products into finalmanufacturing facilities was frequently problematic during the 1980's and early 1990's, resulting in costly delays to licensure(Pisano 1997). While plant startups for this class of products can become chaotic affairs, this is not an inherent or intrinsic feature. Major classes of process startup problems have been identified andmechanisms have been developed to reduce their likelihood of occurrence. These classes of process startup problems and resolution mechanisms are the major topic of this article. With proper planning and sufficient staffing, the probably of a smooth process startup for a biopharmaceutical product can be very high - i.e., successful process performance will often beachieved within the first two full-scale process lots in the plant. The primary focus of this article is the role of the Process Development Group in helping to assure this high probability of success.

A method for tailoring the information content of a software process model

NASA Technical Reports Server (NTRS)

Perkins, Sharon; Arend, Mark B.

1990-01-01

The framework is defined for a general method for selecting a necessary and sufficient subset of a general software life cycle's information products, to support new software development process. Procedures for characterizing problem domains in general and mapping to a tailored set of life cycle processes and products is presented. An overview of the method is shown using the following steps: (1) During the problem concept definition phase, perform standardized interviews and dialogs between developer and user, and between user and customer; (2) Generate a quality needs profile of the software to be developed, based on information gathered in step 1; (3) Translate the quality needs profile into a profile of quality criteria that must be met by the software to satisfy the quality needs; (4) Map the quality criteria to set of accepted processes and products for achieving each criterion; (5) Select the information products which match or support the accepted processes and product of step 4; and (6) Select the design methodology which produces the information products selected in step 5.

A method for tailoring the information content of a software process model

NASA Technical Reports Server (NTRS)

Perkins, Sharon; Arend, Mark B.

1990-01-01

The framework is defined for a general method for selecting a necessary and sufficient subset of a general software life cycle's information products, to support new software development process. Procedures for characterizing problem domains in general and mapping to a tailored set of life cycle processes and products is presented. An overview of the method is shown using the following steps: (1) During the problem concept definition phase, perform standardized interviews and dialogs between developer and user, and between user and customer; (2) Generate a quality needs profile of the software to be developed, based on information gathered in step 1; (3) Translate the quality needs profile into a profile of quality criteria that must be met by the software to satisfy the quality needs; (4) Map the quality criteria to a set of accepted processes and products for achieving each criterion; (5) select the information products which match or support the accepted processes and product of step 4; and (6) Select the design methodology which produces the information products selected in step 5.

Measuring the software process and product: Lessons learned in the SEL

NASA Technical Reports Server (NTRS)

Basili, V. R.

1985-01-01

The software development process and product can and should be measured. The software measurement process at the Software Engineering Laboratory (SEL) has taught a major lesson: develop a goal-driven paradigm (also characterized as a goal/question/metric paradigm) for data collection. Project analysis under this paradigm leads to a design for evaluating and improving the methodology of software development and maintenance.

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.

A mathematical study of a random process proposed as an atmospheric turbulence model

NASA Technical Reports Server (NTRS)

Sidwell, K.

1977-01-01

A random process is formed by the product of a local Gaussian process and a random amplitude process, and the sum of that product with an independent mean value process. The mathematical properties of the resulting process are developed, including the first and second order properties and the characteristic function of general order. An approximate method for the analysis of the response of linear dynamic systems to the process is developed. The transition properties of the process are also examined.

Process and product development in the manufacturing of molecular therapeutics.

PubMed

Atkinson, E M; Christensen, J R

1999-08-01

In the development of molecular therapies, a great deal of attention has focused on tissue targets, gene delivery vectors, and expression cassettes. In order to become an approved therapy, however, a molecular therapeutic has to pass down the same product registration pathway as any other biological product. Moving from research into industrial production requires careful attention to regulatory, manufacturing and quality concerns. Early work on developing and characterizing robust and scaleable manufacturing processes will ultimately be rewarded by ease of implementation as the product is successful in clinical trials. Regulatory agencies require solid process and product characterization studies to demonstrate control and understanding of the molecular therapeutic. As the gene therapy industry matures, standards will continue to rise, creating an industry that is capable of producing safe, high-quality and effective therapies for many of the world's most difficult disease targets.

Understanding Acceptance of Software Metrics--A Developer Perspective

ERIC Educational Resources Information Center

Umarji, Medha

2009-01-01

Software metrics are measures of software products and processes. Metrics are widely used by software organizations to help manage projects, improve product quality and increase efficiency of the software development process. However, metrics programs tend to have a high failure rate in organizations, and developer pushback is one of the sources…

Industrialization of mAb production technology The bioprocessing industry at a crossroads

PubMed Central

2009-01-01

Manufacturing processes for therapeutic monoclonal antibodies (mAbs) have evolved tremendously since the first licensed mAb product in 1986. The rapid growth in product demand for mAbs triggered parallel efforts to increase production capacity through construction of large bulk manufacturing plants as well as improvements in cell culture processes to raise product titers. This combination has led to an excess of manufacturing capacity, and together with improvements in conventional purification technologies, promises nearly unlimited production capacity in the foreseeable future. The increase in titers has also led to a marked reduction in production costs, which could then become a relatively small fraction of sales price for future products which are sold at prices at or near current levels. The reduction of capacity and cost pressures for current state-of-the-art bulk production processes may shift the focus of process development efforts and have important implications for both plant design and product development strategies for both biopharmaceutical and contract manufacturing companies. PMID:20065641

The limited benefit of "product-by-process" claim.

PubMed

Chang, Bao-Chi; Wang, Shyh-Jen

2016-10-02

A product-by-process claim was initially developed when the invention could not otherwise be adequately defined. In the US, a patent applicant can use a product-by-process claim for a new product, no matter whether the product can also be defined by using structure features. However, the applicant mainly bears the burden to establish the novelty between the claimed product and the prior art product. Moreover, in terms of infringement, the very recent CAFC cases indicate that the product must be made by a process recited in the claim to infringe a product-by-process claim. Thus, an assignee almost can not take advantage from product-by-process claims during the patent enforcement by comparing with process claims. From the points of the burden during patent prosecution and confined scope in determining infringement, the benefit of using a product-by-process claim would be very limited.

ISRU System Model Tool: From Excavation to Oxygen Production

NASA Technical Reports Server (NTRS)

Santiago-Maldonado, Edgardo; Linne, Diane L.

2007-01-01

In the late 80's, conceptual designs for an in situ oxygen production plant were documented in a study by Eagle Engineering [1]. In the "Summary of Findings" of this study, it is clearly pointed out that: "reported process mass and power estimates lack a consistent basis to allow comparison." The study goes on to say: "A study to produce a set of process mass, power, and volume requirements on a consistent basis is recommended." Today, approximately twenty years later, as humans plan to return to the moon and venture beyond, the need for flexible up-to-date models of the oxygen extraction production process has become even more clear. Multiple processes for the production of oxygen from lunar regolith are being investigated by NASA, academia, and industry. Three processes that have shown technical merit are molten regolith electrolysis, hydrogen reduction, and carbothermal reduction. These processes have been selected by NASA as the basis for the development of the ISRU System Model Tool (ISMT). In working to develop up-to-date system models for these processes NASA hopes to accomplish the following: (1) help in the evaluation process to select the most cost-effective and efficient process for further prototype development, (2) identify key parameters, (3) optimize the excavation and oxygen production processes, and (4) provide estimates on energy and power requirements, mass and volume of the system, oxygen production rate, mass of regolith required, mass of consumables, and other important parameters. Also, as confidence and high fidelity is achieved with each component's model, new techniques and processes can be introduced and analyzed at a fraction of the cost of traditional hardware development and test approaches. A first generation ISRU System Model Tool has been used to provide inputs to the Lunar Architecture Team studies.

Strategy of Trade-Reliable Featured Product Supporting Regional Innovation Systems

NASA Astrophysics Data System (ADS)

Riskiawan, H. Y.; Purnomo, B. H.; Abdurahman, A.; Hariono, B.; Puspitasari, T. D.

2018-01-01

Pacitan, Ponorogo, and Magetan had planned the development of featured products as contained in the Medium Term Development Plan (MTDP) until 2020. The focus of development is almost similar to featured products derived from agribusiness, food processing, handycrafts, and tourism. The geographical proximity results characteristics of natural resources and social culture have similarities, including the type of featured products, constraints, problems, and opportunities for development. Given the characteristics and the support system of some featured products contained in these three regions have a lot in common and their functional interactions involving actors from across the region, it is necessary to develop cross-jurisdictional policy. The resulting strategy should be able to support the development of Regional Innovation System (RIS). The purpose of this research is 1) Determining featured product cross-regional between Pacitan regency; Ponorogo and Magetan districts in support of RIS development; and 2) Designing a featured product development strategy using supply chain management in order to drive the local economy. Based on the results of research conducted, featured products across the region that have potentiality to be developed are: processed products of “janggelan” leather products, and woven bamboo.

Aerospace Engineering Systems and the Advanced Design Technologies Testbed Experience

NASA Technical Reports Server (NTRS)

VanDalsem, William R.; Livingston, Mary E.; Melton, John E.; Torres, Francisco J.; Stremel, Paul M.

1999-01-01

Continuous improvement of aerospace product development processes is a driving requirement across much of the aerospace community. As up to 90% of the cost of an aerospace product is committed during the first 10% of the development cycle, there is a strong emphasis on capturing, creating, and communicating better information (both requirements and performance) early in the product development process. The community has responded by pursuing the development of computer-based systems designed to enhance the decision-making capabilities of product development individuals and teams. Recently, the historical foci on sharing the geometrical representation and on configuration management are being augmented: 1) Physics-based analysis tools for filling the design space database; 2) Distributed computational resources to reduce response time and cost; 3) Web-based technologies to relieve machine-dependence; and 4) Artificial intelligence technologies to accelerate processes and reduce process variability. The Advanced Design Technologies Testbed (ADTT) activity at NASA Ames Research Center was initiated to study the strengths and weaknesses of the technologies supporting each of these trends, as well as the overall impact of the combination of these trends on a product development event. Lessons learned and recommendations for future activities are reported.

Messiah College Biodiesel Fuel Generation Project Final Technical Report

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

Zummo, Michael M; Munson, J; Derr, A

Many obvious and significant concerns arise when considering the concept of small-scale biodiesel production. Does the fuel produced meet the stringent requirements set by the commercial biodiesel industry? Is the process safe? How are small-scale producers collecting and transporting waste vegetable oil? How is waste from the biodiesel production process handled by small-scale producers? These concerns and many others were the focus of the research preformed in the Messiah College Biodiesel Fuel Generation project over the last three years. This project was a unique research program in which undergraduate engineering students at Messiah College set out to research the feasibilitymore » of small-biodiesel production for application on a campus of approximately 3000 students. This Department of Energy (DOE) funded research program developed out of almost a decade of small-scale biodiesel research and development work performed by students at Messiah College. Over the course of the last three years the research team focused on four key areas related to small-scale biodiesel production: Quality Testing and Assurance, Process and Processor Research, Process and Processor Development, and Community Education. The objectives for the Messiah College Biodiesel Fuel Generation Project included the following: 1. Preparing a laboratory facility for the development and optimization of processors and processes, ASTM quality assurance, and performance testing of biodiesel fuels. 2. Developing scalable processor and process designs suitable for ASTM certifiable small-scale biodiesel production, with the goals of cost reduction and increased quality. 3. Conduct research into biodiesel process improvement and cost optimization using various biodiesel feedstocks and production ingredients.« less

Implementation of quality by design toward processing of food products.

PubMed

Rathore, Anurag S; Kapoor, Gautam

2017-05-28

Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time. Investments made for development of tools and approaches that facilitate high-throughput analytical and process development, process analytical technology, design of experiments, risk analysis, knowledge management, and enhancement of process/product understanding would pave way for operational and economic benefits later in the commercialization process and across other product pipelines. This article aims to achieve two major objectives. First, to review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and second, present a case study that illustrates benefits of such QbD implementation.

User-driven product data manager system design

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

NONE

1995-03-01

With the infusion of information technologies into product development and production processes, effective management of product data is becoming essential to modern production enterprises. When an enterprise-wide Product Data Manager (PDM) is implemented, PDM designers must satisfy the requirements of individual users with different job functions and requirements, as well as the requirements of the enterprise as a whole. Concern must also be shown for the interrelationships between information, methods for retrieving archival information and integration of the PDM into the product development process. This paper describes a user-driven approach applied to PDM design for an agile manufacturing pilot projectmore » at Sandia National Laboratories that has been successful in achieving a much faster design-to-production process for a precision electro mechanical surety device.« less

Biofuels: An Alternative to U.S. Air Force Petroleum Fuel Dependency

DTIC Science & Technology

2007-12-01

Ethanol Production 1999-2012 11 Figure 6. Reducing the Cost of Cellulosic Ethanol Production 12 Figure 7. Biodiesel Production Process ...14 Figure 8. Biodiesel Production Capacity, 1999 to 2005 15 Figure 9. Jet Fuel From Algae Process 17...the goal of this biofuels program is to develop an affordable biodiesel alternative production process that will achieve a 60 percent greater energy

Phase 111A Crew Interface Specifications Development for Inflight Maintenance and Stowage Functions

NASA Technical Reports Server (NTRS)

Carl, John G.

1973-01-01

This report presents the findings and data products developed during the Phase IIIA Crew Interface Specification Study for Inflight Maintenance and Stowage Functions, performed by General Electric for the NASA, Johnson Space Center with a set of documentation that can be used as definitive guidelines to improve the present process of defining, controlling and managing flight crew interface requirements that are related to inflight maintenance (including assembly and servicing) and stowage functions. During the Phase IIIA contract period, the following data products were developed: 1) Projected NASA Crew Procedures/Flight Data File Development Process. 2) Inflight Maintenance Management Process Description. 3) Preliminary Draft, General Specification, Inflight Maintenance Management Requirements. 4) Inflight Maintenance Operational Process Description. 5) Preliminary Draft, General Specification, Inflight Maintenance Task and Support Requirements Analysis. 6) Suggested IFM Data Processing Reports for Logistics Management The above Inflight Maintenance data products have been developed during the Phase IIIA study after review of Space Shuttle Program Documentation, including the Level II Integrated Logistics Requirements and other DOD and NASA data relative to Payloads Accommodations and Satellite On-Orbit Servicing. These Inflight Maintenance data products were developed to be in consonance with Space Shuttle Program technical and management requirements.

FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products.

PubMed

Arcidiacono, Judith A; Bauer, Steven R; Kaplan, David S; Allocca, Clare M; Sarkar, Sumona; Lin-Gibson, Sheng

2018-06-01

The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development. Published by Elsevier Inc.

New irradiation facilities for development of production methods of medical radionuclides at cyclotrons at Forschungszentrum Jülich

NASA Astrophysics Data System (ADS)

Spellerberg, S.; Scholten, B.; Spahn, I.; Felden, O.; Gebel, R.; Qaim, S. M.; Bai, M.; Neumaier, B.

2017-05-01

An essential basis for research and development work on radiopharmaceuticals is the efficient production of radionuclides of high quality. In this process research-oriented studies aiming for elucidation of biochemical processes require novel products. The radionuclide development at INM-5 entails basic research, e.g. the determination of nuclear reaction data, as well as technical aspects of practical production, such as high-current targetry, chemical separation, formulation and quality control. In this work developments, adaptation and optimization of irradiation facilities at the BC 1710, JULIC as Injector of COSY and COSY itself are summarized, which shall allow the extension of radionuclide production possibilities, aiming at innovations in medical applications.

Concise Review: Process Development Considerations for Cell Therapy

PubMed Central

Brieva, Thomas; Raviv, Lior; Rowley, Jon; Niss, Knut; Brandwein, Harvey; Oh, Steve; Karnieli, Ohad

2015-01-01

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials toward approval. A successful cell therapy will be a consistent, safe, and effective cell product, regardless of the cell type or application. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful. Significance The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective. PMID:26315572

Auditory Perception, Suprasegmental Speech Processing, and Vocabulary Development in Chinese Preschoolers.

PubMed

Wang, Hsiao-Lan S; Chen, I-Chen; Chiang, Chun-Han; Lai, Ying-Hui; Tsao, Yu

2016-10-01

The current study examined the associations between basic auditory perception, speech prosodic processing, and vocabulary development in Chinese kindergartners, specifically, whether early basic auditory perception may be related to linguistic prosodic processing in Chinese Mandarin vocabulary acquisition. A series of language, auditory, and linguistic prosodic tests were given to 100 preschool children who had not yet learned how to read Chinese characters. The results suggested that lexical tone sensitivity and intonation production were significantly correlated with children's general vocabulary abilities. In particular, tone awareness was associated with comprehensive language development, whereas intonation production was associated with both comprehensive and expressive language development. Regression analyses revealed that tone sensitivity accounted for 36% of the unique variance in vocabulary development, whereas intonation production accounted for 6% of the variance in vocabulary development. Moreover, auditory frequency discrimination was significantly correlated with lexical tone sensitivity, syllable duration discrimination, and intonation production in Mandarin Chinese. Also it provided significant contributions to tone sensitivity and intonation production. Auditory frequency discrimination may indirectly affect early vocabulary development through Chinese speech prosody. © The Author(s) 2016.

Low cost solar array project: Experimental process system development unit for producing semiconductor-grade silicon using silane-to-silicon process

NASA Technical Reports Server (NTRS)

1980-01-01

The design, fabrication, and installation of an experimental process system development unit (EPSDU) were analyzed. Supporting research and development were performed to provide an information data base usable for the EPSDU and for technological design and economical analysis for potential scale-up of the process. Iterative economic analyses were conducted for the estimated product cost for the production of semiconductor grade silicon in a facility capable of producing 1000-MT/Yr.

Optimization of a micro-scale, high throughput process development tool and the demonstration of comparable process performance and product quality with biopharmaceutical manufacturing processes.

PubMed

Evans, Steven T; Stewart, Kevin D; Afdahl, Chris; Patel, Rohan; Newell, Kelcy J

2017-07-14

In this paper, we discuss the optimization and implementation of a high throughput process development (HTPD) tool that utilizes commercially available micro-liter sized column technology for the purification of multiple clinically significant monoclonal antibodies. Chromatographic profiles generated using this optimized tool are shown to overlay with comparable profiles from the conventional bench-scale and clinical manufacturing scale. Further, all product quality attributes measured are comparable across scales for the mAb purifications. In addition to supporting chromatography process development efforts (e.g., optimization screening), comparable product quality results at all scales makes this tool is an appropriate scale model to enable purification and product quality comparisons of HTPD bioreactors conditions. The ability to perform up to 8 chromatography purifications in parallel with reduced material requirements per run creates opportunities for gathering more process knowledge in less time. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Superstructure-based Design and Optimization of Batch Biodiesel Production Using Heterogeneous Catalysts

NASA Astrophysics Data System (ADS)

Nuh, M. Z.; Nasir, N. F.

2017-08-01

Biodiesel as a fuel comprised of mono alkyl esters of long chain fatty acids derived from renewable lipid feedstock, such as vegetable oil and animal fat. Biodiesel production is complex process which need systematic design and optimization. However, no case study using the process system engineering (PSE) elements which are superstructure optimization of batch process, it involves complex problems and uses mixed-integer nonlinear programming (MINLP). The PSE offers a solution to complex engineering system by enabling the use of viable tools and techniques to better manage and comprehend the complexity of the system. This study is aimed to apply the PSE tools for the simulation of biodiesel process and optimization and to develop mathematical models for component of the plant for case A, B, C by using published kinetic data. Secondly, to determine economic analysis for biodiesel production, focusing on heterogeneous catalyst. Finally, the objective of this study is to develop the superstructure for biodiesel production by using heterogeneous catalyst. The mathematical models are developed by the superstructure and solving the resulting mixed integer non-linear model and estimation economic analysis by using MATLAB software. The results of the optimization process with the objective function of minimizing the annual production cost by batch process from case C is 23.2587 million USD. Overall, the implementation a study of process system engineering (PSE) has optimized the process of modelling, design and cost estimation. By optimizing the process, it results in solving the complex production and processing of biodiesel by batch.

Description of Latvian Metal Production and Processing Enterprises' Air Emissions

NASA Astrophysics Data System (ADS)

Pubule, Jelena; Zahare, Dace; Blumberga, Dagnija

2010-01-01

The metal production and processing sector in Latvia has acquired a stable position in the national economy. Smelting of ferrous and nonferrous metals, production of metalware, galvanisation, etc. are developed in Latvia. The metal production and processing sector has an impact on air quality due to polluting substances which are released in the air from metal treatment processes. Therefore it is necessary to determine the total volume of emissions produced by the metal production and processing sector in Latvia. This article deals with the air polluting emissions of the Latvian metal production and processing industry, and sets the optimum sector emission volumes using the emissions benchmark methodology.

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.

Biocatalyzed processes for production of commodity chemicals: Assessment of future research advances for N-butanol production

NASA Technical Reports Server (NTRS)

Ingham, J. D.

1984-01-01

This report is a summary of assessments by Chem Systems Inc. and a further evaluation of the impacts of research advances on energy efficiency and the potential for future industrial production of acetone-butanol-ethanol (ABE) solvents and other products by biocatalyzed processes. Brief discussions of each of the assessments made by CSI, followed by estimates of minimum projected energy consumption and costs for production of solvents by ABE biocatalyzed processes are included. These assessments and further advances discussed in this report show that substantial decreases in energy consumption and costs are possible on the basis of specific research advances; therefore, it appears that a biocatalyzed process for ABE can be developed that will be competitive with conventional petrochemical processes for production of n-butanol and acetone. (In this work, the ABE process was selected and utilized only as an example for methodology development; other possible bioprocesses for production of commodity chemicals are not intended to be excluded.) It has been estimated that process energy consumption can be decreased by 50%, with a corresponding cost reduction of 15-30% (in comparison with a conventional petrochemical process) by increasing microorganism tolerance to n-butanol and efficient recovery of product solvents from the vapor phase.

Removal of inhibitors from pre-hydrolysis liquor of kraft-based dissolving pulp production process using adsorption and flocculation processes.

PubMed

Liu, Xin; Fatehi, Pedram; Ni, Yonghao

2012-07-01

A process for removing inhibitors from pre-hydrolysis liquor (PHL) of a kraft-based dissolving pulp production process by adsorption and flocculation, and the characteristics of this process were studied. In this process, industrially produced PHL was treated with unmodified and oxidized activated carbon as an absorbent and polydiallyldimethylammonium chloride (PDADMAC) as a flocculant. The overall removal of lignin and furfural in the developed process was 83.3% and 100%, respectively, while that of hemicelluloses was 32.7%. These results confirmed that the developed process can remove inhibitors from PHL prior to producing value-added products, e.g. ethanol and xylitol via fermentation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Developing an experimental case in aluminium foils 1100 to determine the maximum angle of formability in a piece by Dieless-SPIF process

NASA Astrophysics Data System (ADS)

Gabriel, Paramo; Adrian, Benitez

2014-07-01

Incremental sheet forming by the method of single point incremental forming Dieless-SPIF, is a widely studied process, experimented and developed in countries with high manufacturing technologies, with friendly costs when the productive configuration in a productivity system is based in small production batches. United states, United kingdom and France lead this type of studies and cases, developing various proof with experimental geometries, different from the national environment such as Colombia, Bolivia, Chile, Ecuador and Peru where this process where discretely studied. Previously mentioned, it pretends develop an experimental case of a particular geometry, identifying the maximum formability angle of material permissible for the forming of a piece in one pass, the analysis of forming limit curve (FLC), with the objective to emphasizes in this innovative method based in CAD-CAM technologies, compare with other analogous process of deformation sheet metal like embossing, take correct decisions about the viability and applicability of this process (Dieless) in a particular industrial piece, which responses to the necessities of productive configurations mentioned and be highly taken like a manufacturing alternative to the other conventional process of forming sheet metal like embossing, for systems with slow batches production.

Kinetic studies on batch cultivation of Trichoderma reesei and application to enhance cellulase production by fed-batch fermentation.

PubMed

Ma, Lijuan; Li, Chen; Yang, Zhenhua; Jia, Wendi; Zhang, Dongyuan; Chen, Shulin

2013-07-20

Reducing the production cost of cellulase as the key enzyme for cellulose hydrolysis to fermentable sugars remains a major challenge for biofuel production. Because of the complexity of cellulase production, kinetic modeling and mass balance calculation can be used as effective tools for process design and optimization. In this study, kinetic models for cell growth, substrate consumption and cellulase production in batch fermentation were developed, and then applied in fed-batch fermentation to enhance cellulase production. Inhibition effect of substrate was considered and a modified Luedeking-Piret model was developed for cellulase production and substrate consumption according to the growth characteristics of Trichoderma reesei. The model predictions fit well with the experimental data. Simulation results showed that higher initial substrate concentration led to decrease of cellulase production rate. Mass balance and kinetic simulation results were applied to determine the feeding strategy. Cellulase production and its corresponding productivity increased by 82.13% after employing the proper feeding strategy in fed-batch fermentation. This method combining mathematics and chemometrics by kinetic modeling and mass balance can not only improve cellulase fermentation process, but also help to better understand the cellulase fermentation process. The model development can also provide insight to other similar fermentation processes. Copyright © 2013 Elsevier B.V. All rights reserved.

[Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD].

PubMed

Feng, Yi; Hong, Yan-Long; Xian, Jie-Chen; Du, Ruo-Fei; Zhao, Li-Jie; Shen, Lan

2014-09-01

Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.

Development of the Upgraded DC Brush Gear Motor for Spacebus Platforms

NASA Technical Reports Server (NTRS)

Berning, Robert H.; Viout, Olivier

2010-01-01

The obsolescence of materials and processes used in the manufacture of traditional DC brush gear motors has necessitated the development of an upgraded DC brush gear motor (UBGM). The current traditional DC brush gear motor (BGM) design was evaluated using Six-Sigma process to identify potential design and production process improvements. The development effort resulted in a qualified UBGM design which improved manufacturability and reduced production costs. Using Six-Sigma processes and incorporating lessons learned during the development process also improved motor performance for UBGM making it a more viable option for future use as a deployment mechanism in space flight applications.

STAR Algorithm Integration Team - Facilitating operational algorithm development

NASA Astrophysics Data System (ADS)

Mikles, V. J.

2015-12-01

The NOAA/NESDIS Center for Satellite Research and Applications (STAR) provides technical support of the Joint Polar Satellite System (JPSS) algorithm development and integration tasks. Utilizing data from the S-NPP satellite, JPSS generates over thirty Environmental Data Records (EDRs) and Intermediate Products (IPs) spanning atmospheric, ocean, cryosphere, and land weather disciplines. The Algorithm Integration Team (AIT) brings technical expertise and support to product algorithms, specifically in testing and validating science algorithms in a pre-operational environment. The AIT verifies that new and updated algorithms function in the development environment, enforces established software development standards, and ensures that delivered packages are functional and complete. AIT facilitates the development of new JPSS-1 algorithms by implementing a review approach based on the Enterprise Product Lifecycle (EPL) process. Building on relationships established during the S-NPP algorithm development process and coordinating directly with science algorithm developers, the AIT has implemented structured reviews with self-contained document suites. The process has supported algorithm improvements for products such as ozone, active fire, vegetation index, and temperature and moisture profiles.

Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples.

PubMed

Ooi, Shing Ming; Sarkar, Srimanta; van Varenbergh, Griet; Schoeters, Kris; Heng, Paul Wan Sia

2013-04-01

Continuous processing and production in pharmaceutical manufacturing has received increased attention in recent years mainly due to the industries' pressing needs for more efficient, cost-effective processes and production, as well as regulatory facilitation. To achieve optimum product quality, the traditional trial-and-error method for the optimization of different process and formulation parameters is expensive and time consuming. Real-time evaluation and the control of product quality using an online process analyzer in continuous processing can provide high-quality production with very high-throughput at low unit cost. This review focuses on continuous processing and the application of different real-time monitoring tools used in the pharmaceutical industry for continuous processing from powder to tablets.

BIOWINOL TECHNOLOGIES: A HYBRID GREEN PROCESS FOR BIOFUEL PRODUCTION – PHASE 2

EPA Science Inventory

The development of hollow fiber membrane (HFM) reactor will result in improved gas utilization that will positively impact overall process efficiencies. Successful completion of this project could result in the development of many decentralized biofuel production systems near ...

Modeling of an integrated fermentation/membrane extraction process for the production of 2-phenylethanol and 2-phenylethylacetate.

PubMed

Adler, Philipp; Hugen, Thorsten; Wiewiora, Marzena; Kunz, Benno

2011-03-07

An unstructured model for an integrated fermentation/membrane extraction process for the production of the aroma compounds 2-phenylethanol and 2-phenylethylacetate by Kluyveromyces marxianus CBS 600 was developed. The extent to which this model, based only on data from the conventional fermentation and separation processes, provided an estimation of the integrated process was evaluated. The effect of product inhibition on specific growth rate and on biomass yield by both aroma compounds was approximated by multivariate regression. Simulations of the respective submodels for fermentation and the separation process matched well with experimental results. With respect to the in situ product removal (ISPR) process, the effect of reduced product inhibition due to product removal on specific growth rate and biomass yield was predicted adequately by the model simulations. Overall product yields were increased considerably in this process (4.0 g/L 2-PE+2-PEA vs. 1.4 g/L in conventional fermentation) and were even higher than predicted by the model. To describe the effect of product concentration on product formation itself, the model was extended using results from the conventional and the ISPR process, thus agreement between model and experimental data improved notably. Therefore, this model can be a useful tool for the development and optimization of an efficient integrated bioprocess. Copyright © 2010 Elsevier Inc. All rights reserved.

Manufacturing Squares: An Integrative Statistical Process Control Exercise

ERIC Educational Resources Information Center

Coy, Steven P.

2016-01-01

In the exercise, students in a junior-level operations management class are asked to manufacture a simple product. Given product specifications, they must design a production process, create roles and design jobs for each team member, and develop a statistical process control plan that efficiently and effectively controls quality during…

Ionic liquid-based green processes for energy production.

PubMed

Zhang, Suojiang; Sun, Jian; Zhang, Xiaochun; Xin, Jiayu; Miao, Qingqing; Wang, Jianji

2014-11-21

To mitigate the growing pressure on resource depletion and environment degradation, the development of green processes for the production of renewable energy is highly required. As a class of novel and promising media, ionic liquids (ILs) have shown infusive potential applications in energy production. Aiming to offer a critical overview regarding the new challenges and opportunities of ILs for developing green processes of renewable energy, this article emphasises the role of ILs as catalysts, solvents, or electrolytes in three broadly interesting energy production processes from renewable resources, such as CO2 conversion to fuels and fuel additives, biomass pretreatment and conversion to biofuels, as well as solar energy and energy storage. It is expected that this article will stimulate a generation of new ideas and new technologies in IL-based renewable energy 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.

Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic.

PubMed

Rathore, Anurag S

2016-05-01

Quality by Design (QbD) is currently receiving increased attention from the pharmaceutical community. As a result, most major biotech manufacturers are in varying stages of implementing QbD. Here, I present a case study that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product: granulocyte colony-stimulating factor (GCSF). I also highlight and discuss the advantages that QbD-based process development offers over traditional approaches. The case study is intended to help those who wish to implement QbD towards the development and commercialization of biotech products. Copyright © 2016 Elsevier Ltd. All rights reserved.

Low cost solar array project production process and equipment task. A Module Experimental Process System Development Unit (MEPSDU)

NASA Technical Reports Server (NTRS)

1981-01-01

Technical readiness for the production of photovoltaic modules using single crystal silicon dendritic web sheet material is demonstrated by: (1) selection, design and implementation of solar cell and photovoltaic module process sequence in a Module Experimental Process System Development Unit; (2) demonstration runs; (3) passing of acceptance and qualification tests; and (4) achievement of a cost effective module.

Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV.

PubMed

Bakker, Wilfried A M; Thomassen, Yvonne E; van't Oever, Aart G; Westdijk, Janny; van Oijen, Monique G C T; Sundermann, Lars C; van't Veld, Peter; Sleeman, Eelco; van Nimwegen, Fred W; Hamidi, Ahd; Kersten, Gideon F A; van den Heuvel, Nico; Hendriks, Jan T; van der Pol, Leo A

2011-09-22

Industrial-scale inactivated polio vaccine (IPV) production dates back to the 1960s when at the Rijks Instituut voor de Volksgezondheid (RIV) in Bilthoven a process was developed based on micro-carrier technology and primary monkey kidney cells. This technology was freely shared with several pharmaceutical companies and institutes worldwide. In this contribution, the history of one of the first cell-culture based large-scale biological production processes is summarized. Also, recent developments and the anticipated upcoming shift from regular IPV to Sabin-IPV are presented. Responding to a call by the World Health Organization (WHO) for new polio vaccines, the development of Sabin-IPV was continued, after demonstrating proof of principle in the 1990s, at the Netherlands Vaccine Institute (NVI). Development of Sabin-IPV plays an important role in the WHO polio eradication strategy as biocontainment will be critical in the post-OPV cessation period. The use of attenuated Sabin strains instead of wild-type Salk polio strains will provide additional safety during vaccine production. Initially, the Sabin-IPV production process will be based on the scale-down model of the current, and well-established, Salk-IPV process. In parallel to clinical trial material production, process development, optimization and formulation research is being carried out to further optimize the process and reduce cost per dose. Also, results will be shown from large-scale (to prepare for future technology transfer) generation of Master- and Working virus seedlots, and clinical trial material (for phase I studies) production. Finally, the planned technology transfer to vaccine manufacturers in low and middle-income countries is discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Quantitative detection of pork in commercial meat products by TaqMan® real-time PCR assay targeting the mitochondrial D-loop region.

PubMed

Kim, Miju; Yoo, Insuk; Lee, Shin-Young; Hong, Yeun; Kim, Hae-Yeong

2016-11-01

The TaqMan® real-time PCR assay using the mitochondrial D-loop region was developed for the quantitative detection of pork in processed meat products. The newly designed primers and probe specifically amplified pork without any cross-reactivity with non-target animal species. The limit of detection of the real-time PCR assay was 0.1pg of heat-treated pork meat and 0.1% (w/w) pork meat in beef and chicken meat mixtures. The quantitative real-time PCR assay was applied to analyze the pork meat content in 22 commercial processed meat products including jerkies, press hams, sausages, hamburger patties and steaks, grilled short rib patties, and nuggets. The developed real-time PCR method was able to detect pork meat in various types of processed meat products that declared the use of pork meat on their label. All processed meat products that declared no use of pork meat showed a negative result in the assay. The method developed in this study showed sensitivity and specificity in the quantification of pork meat in commercial processed meat products. Copyright © 2016 Elsevier Ltd. All rights reserved.

DEVELOPMENT OF CONTINUOUS SOLVENT EXTRACTION PROCESSES FOR COAL DERIVED CARBON PRODUCTS

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

Elliot B. Kennel; Chong Chen; Dady Dadyburjor

2005-04-13

The purpose of this DOE-funded effort is to develop continuous processes for solvent extraction of coal for the production of carbon products. These carbon products include materials used in metals smelting, especially in the aluminum and steel industries, as well as porous carbon structural material referred to as ''carbon foam'' and carbon fibers. Table 1 provides an overview of the major markets for carbon products. Current sources of materials for these processes generally rely on petroleum distillation products or coal tar distillates obtained as a byproduct of metcoke production facilities. In the former case, the American materials industry, just asmore » the energy industry, is dependent upon foreign sources of petroleum. In the latter case, metcoke production is decreasing every year due to the combined difficulties associated with poor economics and a significant environmental burden. Thus, a significant need exists for an environmentally clean process which can used domestically obtained raw materials and which can still be very competitive economically.« less

Analytical study of space processing of immiscible materials for superconductors and electrical contacts

NASA Technical Reports Server (NTRS)

Gelles, S. H.; Collings, E. W.; Abbott, W. H.; Maringer, R. E.

1977-01-01

The results of a study conducted to determine the role space processing or materials research in space plays in the superconductor and electrical contact industries are presented. Visits were made to manufacturers, users, and research organizations connected with these products to provide information about the potential benefits of the space environment and to exchange views on the utilization of space facilities for manufacture, process development, or research. In addition, space experiments were suggested which could result in improved terrestrial processes or products. Notable examples of these are, in the case of superconductors, the development of Nb-bronze alloys (Tsuei alloys) and, in the electrical contact field, the production of Ag-Ni or Ag-metal oxide alloys with controlled microstructure for research and development activities as well as for product development. A preliminary experimental effort to produce and evaluate rapidly cooled Pb-Zn and Cu-Nb-Sn alloys in order to understand the relationship between microstructure and superconducting properties and to simulate the fine structure potentially achievable by space processing was also described.

The potential environmental impact of waste from cellulosic ethanol production.

PubMed

Menetrez, Marc Y

2010-02-01

The increasing production of ethanol has been established as an important contributor to future energy independence. Although ethanol demand is increasing, a growing economic trend in decreased profitability and resource conflicts have called into question the future of grain-based ethanol production. Growing emphasis is being placed on utilizing cellulosic feedstocks to produce ethanol, and the need for renewable resources has made the development of cellulosic ethanol a national priority. Cellulosic ethanol production plants are being built in many areas of the United States to evaluate various feedstocks and processes. The waste streams from many varying processes that are being developed contain a variety of components. Differences in ethanol generation processes and feedstocks are producing waste streams unique to biofuel production, which could be potentially harmful to the environment if adequate care is not taken to manage those risks. Waste stream management and utilization of the cellulosic ethanol process are equally important components of the development of this industry.

Lysine Fermentation: History and Genome Breeding.

PubMed

Ikeda, Masato

Lysine fermentation by Corynebacterium glutamicum was developed in 1958 by Kyowa Hakko Kogyo Co. Ltd. (current Kyowa Hakko Bio Co. Ltd.) and is the second oldest amino acid fermentation process after glutamate fermentation. The fundamental mechanism of lysine production, discovered in the early stages of the process's history, gave birth to the concept known as "metabolic regulatory fermentation," which is now widely applied to metabolite production. After the development of rational metabolic engineering, research on lysine production first highlighted the need for engineering of the central metabolism from the viewpoints of precursor supply and NADPH regeneration. Furthermore, the existence of active export systems for amino acids was first demonstrated for lysine in C. glutamicum, and this discovery has resulted in the current recognition of such exporters as an important consideration in metabolite production. Lysine fermentation is also notable as the first process to which genomics was successfully applied to improve amino acid production. The first global "genome breeding" strategy was developed using a lysine producer as a model; this has since led to new lysine producers that are more efficient than classical industrial producers. These advances in strain development technology, combined with recent systems-level approaches, have almost achieved the optimization of entire cellular systems as cell factories for lysine production. In parallel, the continuous improvement of the process has resulted not only in fermentation processes with reduced load on downstream processing but also in commercialization of various product forms according to their intended uses. Nowadays lysine fermentation underpins a giant lysine demand of more than 2 million metric tons per year.

Deployment of ERP Systems at Automotive Industries, Security Inspection (Case Study: IRAN KHODRO Automotive Company)

NASA Astrophysics Data System (ADS)

Ali, Hatamirad; Hasan, Mehrjerdi

Automotive industry and car production process is one of the most complex and large-scale production processes. Today, information technology (IT) and ERP systems incorporates a large portion of production processes. Without any integrated systems such as ERP, the production and supply chain processes will be tangled. The ERP systems, that are last generation of MRP systems, make produce and sale processes of these industries easier and this is the major factor of development of these industries anyhow. Today many of large-scale companies are developing and deploying the ERP systems. The ERP systems facilitate many of organization processes and make organization to increase efficiency. The security is a very important part of the ERP strategy at the organization, Security at the ERP systems, because of integrity and extensive, is more important of local and legacy systems. Disregarding of this point can play a giant role at success or failure of this kind of systems. The IRANKHODRO is the biggest automotive factory in the Middle East with an annual production over 600.000 cars. This paper presents ERP security deployment experience at the "IRANKHODRO Company". Recently, by launching ERP systems, it moved a big step toward more developments.

SHARP's systems engineering challenge: rectifying integrated product team requirements with performance issues in an evolutionary spiral development acquisition

NASA Astrophysics Data System (ADS)

Kuehl, C. Stephen

2003-08-01

Completing its final development and early deployment on the Navy's multi-role aircraft, the F/A-18 E/F Super Hornet, the SHAred Reconnaissance Pod (SHARP) provides the war fighter with the latest digital tactical reconnaissance (TAC Recce) Electro-Optical/Infrared (EO/IR) sensor system. The SHARP program is an evolutionary acquisition that used a spiral development process across a prototype development phase tightly coupled into overlapping Engineering and Manufacturing Development (EMD) and Low Rate Initial Production (LRIP) phases. Under a tight budget environment with a highly compressed schedule, SHARP challenged traditional acquisition strategies and systems engineering (SE) processes. Adopting tailored state-of-the-art systems engineering process models allowd the SHARP program to overcome the technical knowledge transition challenges imposed by a compressed program schedule. The program's original goal was the deployment of digital TAC Recce mission capabilities to the fleet customer by summer of 2003. Hardware and software integration technical challenges resulted from requirements definition and analysis activities performed across a government-industry led Integrated Product Team (IPT) involving Navy engineering and test sites, Boeing, and RTSC-EPS (with its subcontracted hardware and government furnished equipment vendors). Requirements development from a bottoms-up approach was adopted using an electronic requirements capture environment to clarify and establish the SHARP EMD product baseline specifications as relevant technical data became available. Applying Earned-Value Management (EVM) against an Integrated Master Schedule (IMS) resulted in efficiently managing SE task assignments and product deliveries in a dynamically evolving customer requirements environment. Application of Six Sigma improvement methodologies resulted in the uncovering of root causes of errors in wiring interconnectivity drawings, pod manufacturing processes, and avionics requirements specifications. Utilizing the draft NAVAIR SE guideline handbook and the ANSI/EIA-632 standard: Processes for Engineering a System, a systems engineering tailored process approach was adopted for the accelerated SHARP EMD prgram. Tailoring SE processes in this accelerated product delivery environment provided unique opportunities to be technically creative in the establishment of a product performance baseline. This paper provides an historical overview of the systems engineering activities spanning the prototype phase through the EMD SHARP program phase, the performance requirement capture activities and refinement process challenges, and what SE process improvements can be applied to future SHARP-like programs adopting a compressed, evolutionary spiral development acquisition paradigm.

A Framework for the Development of Automatic DFA Method to Minimize the Number of Components and Assembly Reorientations

NASA Astrophysics Data System (ADS)

Alfadhlani; Samadhi, T. M. A. Ari; Ma’ruf, Anas; Setiasyah Toha, Isa

2018-03-01

Assembly is a part of manufacturing processes that must be considered at the product design stage. Design for Assembly (DFA) is a method to evaluate product design in order to make it simpler, easier and quicker to assemble, so that assembly cost is reduced. This article discusses a framework for developing a computer-based DFA method. The method is expected to aid product designer to extract data, evaluate assembly process, and provide recommendation for the product design improvement. These three things are desirable to be performed without interactive process or user intervention, so product design evaluation process could be done automatically. Input for the proposed framework is a 3D solid engineering drawing. Product design evaluation is performed by: minimizing the number of components; generating assembly sequence alternatives; selecting the best assembly sequence based on the minimum number of assembly reorientations; and providing suggestion for design improvement.

Advances in ingredient and processing systems for meat and meat products.

PubMed

Weiss, Jochen; Gibis, Monika; Schuh, Valerie; Salminen, Hanna

2010-09-01

Changes in consumer demand of meat products as well as increased global competition are causing an unprecedented spur in processing and ingredient system developments within the meat manufacturing sector. Consumers demand healthier meat products that are low in salt, fat, cholesterol, nitrites and calories in general and contain in addition health-promoting bioactive components such as for example carotenoids, unsaturated fatty acids, sterols, and fibers. On the other hand, consumers expect these novel meat products with altered formulations to taste, look and smell the same way as their traditionally formulated and processed counterparts. At the same time, competition is forcing the meat processing industry to use the increasingly expensive raw material "meat" more efficiently and produce products at lower costs. With these changes in mind, this article presents a review of novel ingredient systems and processing approaches that are emerging to create high quality, affordable meat products not only in batch mode but also in large-scale continuous processes. Fat replacers, fat profile modification and cholesterol reduction techniques, new texture modifiers and alternative antioxidant and antimicrobial systems are being discussed. Modern processing equipment to establish continuously operating product manufacturing lines and that allow new meat product structures to be created and novel ingredients to be effectively utilized including vacuum fillers, grinders and fine dispersers, and slicers is reviewed in the context of structure creation in meat products. Finally, trends in future developments of ingredient and processing systems for meat products are highlighted.

Integrating artificial and human intelligence into tablet production process.

PubMed

Gams, Matjaž; Horvat, Matej; Ožek, Matej; Luštrek, Mitja; Gradišek, Anton

2014-12-01

We developed a new machine learning-based method in order to facilitate the manufacturing processes of pharmaceutical products, such as tablets, in accordance with the Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives. Our approach combines the data, available from prior production runs, with machine learning algorithms that are assisted by a human operator with expert knowledge of the production process. The process parameters encompass those that relate to the attributes of the precursor raw materials and those that relate to the manufacturing process itself. During manufacturing, our method allows production operator to inspect the impacts of various settings of process parameters within their proven acceptable range with the purpose of choosing the most promising values in advance of the actual batch manufacture. The interaction between the human operator and the artificial intelligence system provides improved performance and quality. We successfully implemented the method on data provided by a pharmaceutical company for a particular product, a tablet, under development. We tested the accuracy of the method in comparison with some other machine learning approaches. The method is especially suitable for analyzing manufacturing processes characterized by a limited amount of data.

The Elements of an Effective Software Development Plan - Software Development Process Guidebook

DTIC Science & Technology

2011-11-11

standards and practices required for all XMPL software development. This SDP implements the <corporate> Standard Software Process (SSP). as tailored...Developing and integrating reusable software products • Approach to managing COTS/Reuse software implementation • COTS/Reuse software selection...final selection and submit to change board for approval MAINTENANCE Monitor current products for obsolescence or end of support Track new

Active biopolymers in green non-conventional media: a sustainable tool for developing clean chemical processes.

PubMed

Lozano, Pedro; Bernal, Juana M; Nieto, Susana; Gomez, Celia; Garcia-Verdugo, Eduardo; Luis, Santiago V

2015-12-21

The greenness of chemical processes turns around two main axes: the selectivity of catalytic transformations, and the separation of pure products. The transfer of the exquisite catalytic efficiency shown by enzymes in nature to chemical processes is an important challenge. By using appropriate reaction systems, the combination of biopolymers with supercritical carbon dioxide (scCO2) and ionic liquids (ILs) resulted in synergetic and outstanding platforms for developing (multi)catalytic green chemical processes, even under flow conditions. The stabilization of biocatalysts, together with the design of straightforward approaches for separation of pure products including the full recovery and reuse of enzymes/ILs systems, are essential elements for developing clean chemical processes. By understanding structure-function relationships of biopolymers in ILs, as well as for ILs themselves (e.g. sponge-like ionic liquids, SLILs; supported ionic liquids-like phases, SILLPs, etc.), several integral green chemical processes of (bio)catalytic transformation and pure product separation are pointed out (e.g. the biocatalytic production of biodiesel in SLILs, etc.). Other developments based on DNA/ILs systems, as pathfinder studies for further technological applications in the near future, are also considered.

Enzymes in Fish and Seafood Processing

PubMed Central

Fernandes, Pedro

2016-01-01

Enzymes have been used for the production and processing of fish and seafood for several centuries in an empirical manner. In recent decades, a growing trend toward a rational and controlled application of enzymes for such goals has emerged. Underlying such pattern are, among others, the increasingly wider array of enzyme activities and enzyme sources, improved enzyme formulations, and enhanced requirements for cost-effective and environmentally friendly processes. The better use of enzyme action in fish- and seafood-related application has had a significant impact on fish-related industry. Thus, new products have surfaced, product quality has improved, more sustainable processes have been developed, and innovative and reliable analytical techniques have been implemented. Recent development in these fields are presented and discussed, and prospective developments are suggested. PMID:27458583

BER-Myriant Succinic Acid Biorefinery

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

Shmorhun, Mark

Myriant Corporation (Myriant) has successfully produced the bioproduct succinic acid by the fermentation of glucose at a commercial scale operation in Lake Providence, Louisiana. The MySAB facility (Myriant Succinic Acid Biorefinery) came on stream in May 2013 and has been producing product since then. The MySAB facility is a demonstration-scale plant, capable of utilizing sorghum grits and commercially available dextrose, to ferment glucose into succinic acid. A downstream processing train has demonstrated the ability to produce an industrial, a standard and a polymer grade product. It consists of cell separation, membrane filtration, continuous chromatography, polishing to remove ionic and colormore » bodies impurities, and final evaporation and crystallization. A by-product of the process is ammonium sulfate which is sold as a liquid fertilizer product. Since 2007 when development work began in the Woburn, Massachusetts R&D laboratories, the succinic acid bio-process has evolved through: Process development (microbiology, fermentation, and downstream) – R&D development laboratories; Piloting efforts at Fermic S.A. de C.V., Mexico City, Mexico – upstream and downstream processes; Design, construction, commissioning, and commercial production operations at the MySAB facility Additionally, Myriant became a wholly-owned subsidiary of the PTT Global Chemical Plc., Thailand, in late 2015, their investment into and support of Myriant goes back to 2011. The support of PTT Global Chemical Plc. helped to improve the upstream and downstream processes, and produce significant metric ton quantities of high quality bio-based succinic acid. The product has gone into a number of commercial markets worldwide for customer applications, development and production. The experience base gained via operations at the MySAB facility since May 2013, along with continued R&D development efforts involving Microbiology, Fermentation, and Downstream processes, at both the Woburn, Massachusetts and PTT Global Chemical Plc. Thailand laboratories, positions the company well for future production at the plant and commercialization of new bio-based products. This will be especially important and valuable as the green chemistry business climate continues to take root and flourish.« less

Development of pulsed processes for the manufacture of solar cells

NASA Technical Reports Server (NTRS)

Minnucci, J. A.

1978-01-01

The results of a 1-year program to develop the processes required for low-energy ion implantation for the automated production of silicon solar cells are described. The program included: (1) demonstrating state-of-the-art ion implantation equipment and designing an automated ion implanter, (2) making efforts to improve the performance of ion-implanted solar cells to 16.5 percent AM1, (3) developing a model of the pulse annealing process used in solar cell production, and (4) preparing an economic analysis of the process costs of ion implantation.

The Evolvement of Automobile Steering System Based on TRIZ

NASA Astrophysics Data System (ADS)

Zhao, Xinjun; Zhang, Shuang

Products and techniques pass through a process of birth, growth, maturity, death and quit the stage like biological evolution process. The developments of products and techniques conform to some evolvement rules. If people know and hold these rules, they can design new kind of products and forecast the develop trends of the products. Thereby, enterprises can grasp the future technique directions of products, and make product and technique innovation. Below, based on TRIZ theory, the mechanism evolvement, the function evolvement and the appearance evolvement of automobile steering system had been analyzed and put forward some new ideas about future automobile steering system.

Modeling and experimental studies on intermittent starch feeding and citrate addition in simultaneous saccharification and fermentation of starch to flavor compounds.

PubMed

Chavan, Abhijit R; Raghunathan, Anuradha; Venkatesh, K V

2009-04-01

Simultaneous saccharification and fermentation (SSF) is a combined process of saccharification of a renewable bioresource and fermentation process to produce products, such as lactic acid and ethanol. Recently, SSF has been extensively used to convert various sources of cellulose and starch into fermentative products. Here, we present a study on production of buttery flavors, namely diacetyl and acetoin, by growing Lactobacillus rhamnosus on a starch medium containing the enzyme glucoamylase. We further develop a structured kinetics for the SSF process, which includes enzyme and growth kinetics. The model was used to simulate the effect of pH and temperature on the SSF process so as to obtain optimum operating conditions. The model was experimentally verified by conducting SSF using an initial starch concentration of 100 g/L. The study demonstrated that the developed kinetic was able to suggest strategies for improved productivities. The developed model was able to accurately predict the enhanced productivity of flavors in a three stage process with intermittent addition of starch. Experimental and simulations demonstrated that citrate addition can also lead to enhanced productivity of flavors. The developed optimal model for SSF was able to capture the dynamics of SSF in batch mode as well as in a three stage process. The structured kinetics was also able to quantify the effect of multiple substrates present in the medium. The study demonstrated that structured kinetic models can be used in the future for design and optimization of SSF as a batch or a fed-batch process.

On the Development of a Computing Infrastructure that Facilitates IPPD from a Decision-Based Design Perspective

NASA Technical Reports Server (NTRS)

Hale, Mark A.; Craig, James I.; Mistree, Farrokh; Schrage, Daniel P.

1995-01-01

Integrated Product and Process Development (IPPD) embodies the simultaneous application of both system and quality engineering methods throughout an iterative design process. The use of IPPD results in the time-conscious, cost-saving development of engineering systems. Georgia Tech has proposed the development of an Integrated Design Engineering Simulator that will merge Integrated Product and Process Development with interdisciplinary analysis techniques and state-of-the-art computational technologies. To implement IPPD, a Decision-Based Design perspective is encapsulated in an approach that focuses on the role of the human designer in product development. The approach has two parts and is outlined in this paper. First, an architecture, called DREAMS, is being developed that facilitates design from a decision-based perspective. Second, a supporting computing infrastructure, called IMAGE, is being designed. The current status of development is given and future directions are outlined.

Planning Model of Physics Learning In Senior High School To Develop Problem Solving Creativity Based On National Standard Of Education

NASA Astrophysics Data System (ADS)

Putra, A.; Masril, M.; Yurnetti, Y.

2018-04-01

One of the causes of low achievement of student’s competence in physics learning in high school is the process which they have not been able to develop student’s creativity in problem solving. This is shown that the teacher’s learning plan is not accordance with the National Eduction Standard. This study aims to produce a reconstruction model of physics learning that fullfil the competency standards, content standards, and assessment standards in accordance with applicable curriculum standards. The development process follows: Needs analysis, product design, product development, implementation, and product evaluation. The research process involves 2 peers judgment, 4 experts judgment and two study groups of high school students in Padang. The data obtained, in the form of qualitative and quantitative data that collected through documentation, observation, questionnaires, and tests. The result of this research up to the product development stage that obtained the physics learning plan model that meets the validity of the content and the validity of the construction in terms of the fulfillment of Basic Competence, Content Standards, Process Standards and Assessment Standards.

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.

Biotic and abiotic processes in eastside ecosystems: the effects of management on soil properties, processes, and productivity.

Treesearch

Alan E. Harvey; J. Michael Geist; Gerald L McDonald; Martin F. Jurgensen; Patrick H. Cochran; Darlene Zabowski; Robert T. Meurisse

1994-01-01

Productivity of forest and range land soils is based on a combination of diverse physical, chemical and biological properties. In ecosystems characteristic of eastside regions of Oregon and Washington, the productive zone is usually in the upper 1 or 2 m. Not only are the biological processes that drive both soil productivity and root development concentrated in...

Enzymatic corn wet milling: engineering process and cost model

PubMed Central

Ramírez, Edna C; Johnston, David B; McAloon, Andrew J; Singh, Vijay

2009-01-01

Background Enzymatic corn wet milling (E-milling) is a process derived from conventional wet milling for the recovery and purification of starch and co-products using proteases to eliminate the need for sulfites and decrease the steeping time. In 2006, the total starch production in USA by conventional wet milling equaled 23 billion kilograms, including modified starches and starches used for sweeteners and ethanol production [1]. Process engineering and cost models for an E-milling process have been developed for a processing plant with a capacity of 2.54 million kg of corn per day (100,000 bu/day). These models are based on the previously published models for a traditional wet milling plant with the same capacity. The E-milling process includes grain cleaning, pretreatment, enzymatic treatment, germ separation and recovery, fiber separation and recovery, gluten separation and recovery and starch separation. Information for the development of the conventional models was obtained from a variety of technical sources including commercial wet milling companies, industry experts and equipment suppliers. Additional information for the present models was obtained from our own experience with the development of the E-milling process and trials in the laboratory and at the pilot plant scale. The models were developed using process and cost simulation software (SuperPro Designer®) and include processing information such as composition and flow rates of the various process streams, descriptions of the various unit operations and detailed breakdowns of the operating and capital cost of the facility. Results Based on the information from the model, we can estimate the cost of production per kilogram of starch using the input prices for corn, enzyme and other wet milling co-products. The work presented here describes the E-milling process and compares the process, the operation and costs with the conventional process. Conclusion The E-milling process was found to be cost competitive with the conventional process during periods of high corn feedstock costs since the enzymatic process enhances the yields of the products in a corn wet milling process. This model is available upon request from the authors for educational, research and non-commercial uses. PMID:19154623

Modeling and Analysis of the Reverse Water Gas Shift Process for In-Situ Propellant Production

NASA Technical Reports Server (NTRS)

Whitlow, Jonathan E.

2000-01-01

This report focuses on the development of mathematical models and simulation tools developed for the Reverse Water Gas Shift (RWGS) process. This process is a candidate technology for oxygen production on Mars under the In-Situ Propellant Production (ISPP) project. An analysis of the RWGS process was performed using a material balance for the system. The material balance is very complex due to the downstream separations and subsequent recycle inherent with the process. A numerical simulation was developed for the RWGS process to provide a tool for analysis and optimization of experimental hardware, which will be constructed later this year at Kennedy Space Center (KSC). Attempts to solve the material balance for the system, which can be defined by 27 nonlinear equations, initially failed. A convergence scheme was developed which led to successful solution of the material balance, however the simplified equations used for the gas separation membrane were found insufficient. Additional more rigorous models were successfully developed and solved for the membrane separation. Sample results from these models are included in this report, with recommendations for experimental work needed for model validation.

Flat-plate solar array project: Experimental process system development unit for producing semiconductor-grade silicon using the silane-to-silicon process

NASA Technical Reports Server (NTRS)

1983-01-01

The process technology for the manufacture of semiconductor-grade silicon in a large commercial plant by 1986, at a price less than $14 per kilogram of silicon based on 1975 dollars is discussed. The engineering design, installation, checkout, and operation of an Experimental Process System Development unit was discussed. Quality control of scaling-up the process and an economic analysis of product and production costs are discussed.

Cost Models for MMC Manufacturing Processes

NASA Technical Reports Server (NTRS)

Elzey, Dana M.; Wadley, Haydn N. G.

1996-01-01

Processes for the manufacture of advanced metal matrix composites are rapidly approaching maturity in the research laboratory and there is growing interest in their transition to industrial production. However, research conducted to date has almost exclusively focused on overcoming the technical barriers to producing high-quality material and little attention has been given to the economical feasibility of these laboratory approaches and process cost issues. A quantitative cost modeling (QCM) approach was developed to address these issues. QCM are cost analysis tools based on predictive process models relating process conditions to the attributes of the final product. An important attribute, of the QCM approach is the ability to predict the sensitivity of material production costs to product quality and to quantitatively explore trade-offs between cost and quality. Applications of the cost models allow more efficient direction of future MMC process technology development and a more accurate assessment of MMC market potential. Cost models were developed for two state-of-the art metal matrix composite (MMC) manufacturing processes: tape casting and plasma spray deposition. Quality and Cost models are presented for both processes and the resulting predicted quality-cost curves are presented and discussed.

Life cycle analysis within pharmaceutical process optimization and intensification: case study of active pharmaceutical ingredient production.

PubMed

Ott, Denise; Kralisch, Dana; Denčić, Ivana; Hessel, Volker; Laribi, Yosra; Perrichon, Philippe D; Berguerand, Charline; Kiwi-Minsker, Lioubov; Loeb, Patrick

2014-12-01

As the demand for new drugs is rising, the pharmaceutical industry faces the quest of shortening development time, and thus, reducing the time to market. Environmental aspects typically still play a minor role within the early phase of process development. Nevertheless, it is highly promising to rethink, redesign, and optimize process strategies as early as possible in active pharmaceutical ingredient (API) process development, rather than later at the stage of already established processes. The study presented herein deals with a holistic life-cycle-based process optimization and intensification of a pharmaceutical production process targeting a low-volume, high-value API. Striving for process intensification by transfer from batch to continuous processing, as well as an alternative catalytic system, different process options are evaluated with regard to their environmental impact to identify bottlenecks and improvement potentials for further process development activities. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A Digital Methodology for the Design Process of Aerospace Assemblies with Sustainable Composite Processes & Manufacture

NASA Astrophysics Data System (ADS)

McEwan, W.; Butterfield, J.

2011-05-01

The well established benefits of composite materials are driving a significant shift in design and manufacture strategies for original equipment manufacturers (OEMs). Thermoplastic composites have advantages over the traditional thermosetting materials with regards to sustainability and environmental impact, features which are becoming increasingly pertinent in the aerospace arena. However, when sustainability and environmental impact are considered as design drivers, integrated methods for part design and product development must be developed so that any benefits of sustainable composite material systems can be assessed during the design process. These methods must include mechanisms to account for process induced part variation and techniques related to re-forming, recycling and decommissioning, which are in their infancy. It is proposed in this paper that predictive techniques related to material specification, part processing and product cost of thermoplastic composite components, be integrated within a Through Life Management (TLM) product development methodology as part of a larger strategy of product system modeling to improve disciplinary concurrency, realistic part performance, and to place sustainability at the heart of the design process. This paper reports the enhancement of digital manufacturing tools as a means of drawing simulated part manufacturing scenarios, real time costing mechanisms, and broader lifecycle performance data capture into the design cycle. The work demonstrates predictive processes for sustainable composite product manufacture and how a Product-Process-Resource (PPR) structure can be customised and enhanced to include design intent driven by `Real' part geometry and consequent assembly. your paper.

New product development: A batik multifunctional chair

NASA Astrophysics Data System (ADS)

Indrawati, Sri; Sukmaningsih, Nias

2017-11-01

The biggest challenge facing by Batik industry in ASEAN Economic Community (AEC) era is the greater number of fashion competitors both domestically and internationally. Based on that condition, the development of new product variants by considering product performance and price is needed. This research was conducted to develop batik products with a new target market. Products that being developed is batik multifunctional chair using integrated value engineering and analytic hierarchy process methods. This research has been done in several stages, ie. Information stage, creative stage, value analysis and product prototyping. The results of this research shows that the batik multifunctional chair product criteria are aesthetic (29%), multifunctional (34%) and ergonomic (37%). There are three new product design alternatives that successfully being developed. Based on value analysis, the product design alternatives that have the highest value is alternative design 2, the value is 2,37. The production cost for this design is Rp. 500.000,-. Alternative design 2 specification are using Mahoni wood, Batik parang rusak pattern with natural coloring process, can be used as table and fit with customer's body anthropometry. Then a batik multifunctional chair prototype is developed based on the best alternative design.

Mobil process converts methanol to high-quality synthetic gasoline

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

Wood, A.

1978-12-11

If production of gasoline from coal becomes commercially attractive in the United States, a process under development at the Mobil Research and Development Corp. may compete with better known coal liquefaction processes. Mobil process converts methanol to high-octane, unleaded gasoline; methanol can be produced commercially from coal. If gasoline is the desired product, the Mobil process offers strong technical and cost advantages over H-coal, Exxon donor solvent, solvent-refined coal, and Fischer--Tropsch processes. The cost analysis, contained in a report to the Dept. of Energy, concludes that the Mobil process produces more-expensive liquid products than any other liquefaction process except Fischer--Tropsch.more » But Mobil's process produces ready-to-use gasoline, while the others produce oils which require further expensive refining to yield gasoline. Disadvantages and advantages are discussed.« less

Plant-Scale Concentration Column Designs for SHINE Target Solution Utilizing AG 1 Anion Exchange Resin

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

Stepinski, Dominique C.; Vandegrift, G. F.

2015-09-30

Argonne is assisting SHINE Medical Technologies (SHINE) in their efforts to develop SHINE, an accelerator-driven process that will utilize a uranyl-sulfate solution for the production of fission product Mo-99. An integral part of the process is the development of a column for the separation and recovery of Mo-99, followed by a concentration column to reduce the product volume from 15-25 L to <1 L. Argonne has collected data from batch studies and breakthrough column experiments to utilize the VERSE (Versatile Reaction Separation) simulation program (Purdue University) to design plant-scale product recovery and concentration processes.

Updates on Managing Type 2 Diabetes Mellitus with Natural Products: Towards Antidiabetic Drug Development.

PubMed

Alam, Fahmida; Islam, Md Asiful; Kamal, M A; Gan, Siew Hua

2016-08-13

Over the years, natural products have shown success as antidiabetics in vitro, in vivo and in clinical trials. Because natural product-derived drugs are more affordable and effective with fewer side-effects compared to conventional therapies, pharmaceutical research is increasingly leaning towards the discovery of new antidiabetic drugs from natural products targeting pathways or components associated with type 2 diabetes mellitus (T2DM) pathophysiology. However, the drug discovery process is very lengthy and costly with significant challenges. Therefore, various techniques are currently being developed for the preclinical research phase of drug discovery with the aim of drug development with less time and efforts from natural products. In this review, we have provided an update on natural products including fruits, vegetables, spices, nuts, beverages and mushrooms with potential antidiabetic activities from in vivo, in vitro and clinical studies. Synergistic interactions between natural products and antidiabetic drugs; and potential antidiabetic active compounds from natural products are also documented to pave the way for combination treatment and new drug discovery, respectively. Additionally, a brief idea of the drug discovery process along with the challenges that arise during drug development from natural products and the methods to conquer those challenges are discussed to create a more convenient future drug discovery process.

Production Process of Biocompatible Magnesium Alloy Tubes Using Extrusion and Dieless Drawing Processes

NASA Astrophysics Data System (ADS)

Kustra, Piotr; Milenin, Andrij; Płonka, Bartłomiej; Furushima, Tsuyoshi

2016-06-01

Development of technological production process of biocompatible magnesium tubes for medical applications is the subject of the present paper. The technology consists of two stages—extrusion and dieless drawing process, respectively. Mg alloys for medical applications such as MgCa0.8 are characterized by low technological plasticity during deformation that is why optimization of production parameters is necessary to obtain good quality product. Thus, authors developed yield stress and ductility model for the investigated Mg alloy and then used the numerical simulations to evaluate proper manufacturing conditions. Grid Extrusion3d software developed by authors was used to determine optimum process parameters for extrusion—billet temperature 400 °C and extrusion velocity 1 mm/s. Based on those parameters the tube with external diameter 5 mm without defects was manufactured. Then, commercial Abaqus software was used for modeling dieless drawing. It was shown that the reduction in the area of 60% can be realized for MgCa0.8 magnesium alloy. Tubes with the final diameter of 3 mm were selected as a case study, to present capabilities of proposed processes.

Successful development of recombinant DNA-derived pharmaceuticals.

PubMed

Werner, R G; Pommer, C H

1990-11-01

Successful development of recombinant DNA-derived pharmaceuticals, a new class of therapeutic agents, is determined by a variety of factors affecting the selection and positioning of the compound under development. For an efficient development it is of utmost importance that the mechanism of action of the compound selected be understood on a molecular level. The compound's potential therapeutical profile and a strong patent position are key positioning considerations, as well as vital elements in shortening the development phase and protecting innovation. Installation of an interdisciplinary project management team, along with a clear definition of team members' responsibilities, is required to avoid delays and improve communication during development. Selection of the organism to be used in production must take into consideration both the structure of the protein and the quality and safety of the final product. New technologies require a considerable investment in new manufacturing facilities and equipment. Often, the decision for such an investment must be made early and with a high degree of uncertainty. Desired product yield, expected dosage, and estimated market potential are the most important considerations in this decision. Following public disclosure of the plan to develop recombinant DNA-derived products, approval of the production plant and expansion or adaptation to the new process and technology may be delayed. For this reason, they should be considered as a critical step in the overall development phase. Recruitment of qualified staff is a time-consuming and critical element of the production process. Its impact on the product timeline should not be underestimated, especially if such technologies are new to the company. The entire production process must be validated in respect to identity, purity, and safety of the product to guarantee constant product quality, as well as for safety aspects in the environment. Adequate in-process and final product controls have to be established and specifications determined for release or rejection of batches for preclinical and clinical studies as well as for marketing. Preclinical testing is limited because recombinant DNA-derived proteins cannot be differentiated from naturally occurring human proteins, and because some proteins are species-specific.

Mars Observer data production, transfer, and archival: The data production assembly line

NASA Technical Reports Server (NTRS)

Childs, David B.

1993-01-01

This paper describes the data production, transfer, and archival process designed for the Mars Observer Flight Project. It addresses the developmental and operational aspects of the archive collection production process. The developmental aspects cover the design and packaging of data products for archival and distribution to the planetary community. Also discussed is the design and development of a data transfer and volume production process capable of handling the large throughput and complexity of the Mars Observer data products. The operational aspects cover the main functions of the process: creating data and engineering products, collecting the data products and ancillary products in a central repository, producing archive volumes, validating volumes, archiving, and distributing the data to the planetary community.

Documenting the decision structure in software development

NASA Technical Reports Server (NTRS)

Wild, J. Christian; Maly, Kurt; Shen, Stewart N.

1990-01-01

Current software development paradigms focus on the products of the development process. Much of the decision making process which produces these products is outside the scope of these paradigms. The Decision-Based Software Development (DBSD) paradigm views the design process as a series of interrelated decisions which involve the identification and articulation of problems, alternates, solutions and justifications. Decisions made by programmers and analysts are recorded in a project data base. Unresolved problems are also recorded and resources for their resolution are allocated by management according to the overall development strategy. This decision structure is linked to the products affected by the relevant decision and provides a process oriented view of the resulted system. Software maintenance uses this decision view of the system to understand the rationale behind the decisions affecting the part of the system to be modified. D-HyperCase, a prototype Decision-Based Hypermedia System is described and results of applying the DBSD approach during its development are presented.

Digitalisierung - Management Zwischen 0 und 1

NASA Astrophysics Data System (ADS)

Friedrich, Stefan; Rachholz, Josef

2017-09-01

Digitization as a process of expressing actions and values by codes 0 and 1 has already has become part of our lives. Digitization enables enterprises to improve production, sales and to increase volume of production. However, no standard digitization strategy has been yet developed. Even in the digitized business process management system, the most important position remains to a human being. The improvement of software products, their availability and the education system in the area of introduction and use of information technology is thus a striking feature in development of managing (but also other) current processes.

Design control considerations for biologic-device combination products.

PubMed

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting development of innovative, safe and effective combination products. It remains the manufacturer's responsibility to comply with the relevant requirements and regulations, and develop good business practices that clearly describe how these practices comply with FDA's final rule (21 CFR Part 4) and aligns with the company's already established quality system. Copyright © 2017 Elsevier B.V. All rights reserved.

Product quality considerations for mammalian cell culture process development and manufacturing.

PubMed

Gramer, Michael J

2014-01-01

The manufacturing of a biologic drug from mammalian cells results in not a single substance, but an array of product isoforms, also known as variants. These isoforms arise due to intracellular or extracellular events as a result of biological or chemical modification. The most common examples related to biomanufacturing include amino acid modifications (glycosylation, isomerization, oxidation, adduct formation, pyroglutamate formation, phosphorylation, sulfation, amidation), amino acid sequence variants (genetic mutations, amino acid misincorporation, N- and C-terminal heterogeneity, clipping), and higher-order structure modifications (misfolding, aggregation, disulfide pairing). Process-related impurities (HCP, DNA, media components, viral particles) are also important quality attributes related to product safety. The observed ranges associated with each quality attribute define the product quality profile. A biologic drug must have a correct and consistent quality profile throughout clinical development and scale-up to commercial production to ensure product safety and efficacy. In general, the upstream process (cell culture) defines the quality of product-related substances, whereas the downstream process (purification) defines the residual level of process- and product-related impurities. The purpose of this chapter is to review the impact of the cell culture process on product quality. Emphasis is placed on studies with industrial significance and where the direct mechanism of product quality impact was determined. Where possible, recommendations for maintaining consistent or improved quality are provided.

Science and Technology in Development Environments - Industry and Department of Defense Case Studies

DTIC Science & Technology

2003-11-01

an acronym for Product and Cycle Time Excellence, is designed to manage product development , business development , and business alliance processes...experiments. 3. Test Practicality—Pilot development with limited production. 4. Prove Profitability—Pilot production. 5. Manage Life Cycle —Manufacturing and...compressor, particularly in a turbofan configuration, was developed primarily under a CIP for these two engines. The TF30 and F100 experiences provide

Process Architecture for Managing Digital Object Identifiers

NASA Astrophysics Data System (ADS)

Wanchoo, L.; James, N.; Stolte, E.

2014-12-01

In 2010, NASA's Earth Science Data and Information System (ESDIS) Project implemented a process for registering Digital Object Identifiers (DOIs) for data products distributed by Earth Observing System Data and Information System (EOSDIS). For the first 3 years, ESDIS evolved the process involving the data provider community in the development of processes for creating and assigning DOIs, and guidelines for the landing page. To accomplish this, ESDIS established two DOI User Working Groups: one for reviewing the DOI process whose recommendations were submitted to ESDIS in February 2014; and the other recently tasked to review and further develop DOI landing page guidelines for ESDIS approval by end of 2014. ESDIS has recently upgraded the DOI system from a manually-driven system to one that largely automates the DOI process. The new automated feature include: a) reviewing the DOI metadata, b) assigning of opaque DOI name if data provider chooses, and c) reserving, registering, and updating the DOIs. The flexibility of reserving the DOI allows data providers to embed and test the DOI in the data product metadata before formally registering with EZID. The DOI update process allows the changing of any DOI metadata except the DOI name unless the name has not been registered. Currently, ESDIS has processed a total of 557 DOIs of which 379 DOIs are registered with EZID and 178 are reserved with ESDIS. The DOI incorporates several metadata elements that effectively identify the data product and the source of availability. Of these elements, the Uniform Resource Locator (URL) attribute has the very important function of identifying the landing page which describes the data product. ESDIS in consultation with data providers in the Earth Science community is currently developing landing page guidelines that specify the key data product descriptive elements to be included on each data product's landing page. This poster will describe in detail the unique automated process and underlying system implemented by ESDIS for registering DOIs, as well as some of the lessons learned from the development of the process. In addition, this paper will summarize the recommendations made by the DOI Process and DOI Landing Page User Working Groups, and the procedures developed for implementing those recommendations.

Computational Features of Flow Modeling in Nanostructured Sensors

NASA Astrophysics Data System (ADS)

Ionescu, Adela; Savu, Dan; Savu, Sorin; Coman, Daniela

2009-04-01

Nowadays the productivity of the welding processes represents an important factor in economy concepts. The technologies which are developed by the researchers are oriented to the increasing of the welding processes' productivity and to the improvement of the products' quality.

A continuous process for the development of Kodak Aerochrome Infrared Film 2443 as a negative

NASA Astrophysics Data System (ADS)

Klimes, D.; Ross, D. I.

1993-02-01

A process for the continuous dry-to-dry development of Kodak Aerochrome Infrared Film 2443 as a negative (CIR-neg) is described. The process is well suited for production processing of long film lengths. Chemicals from three commercial film processes are used with modifications. Sensitometric procedures are recommended for the monitoring of processing quality control. Sensitometric data and operational aerial exposures indicate that films developed in this process have approximately the same effective aerial film speed as films processed in the reversal process recommended by the manufacturer (Kodak EA-5). The CIR-neg process is useful when aerial photography is acquired for resources management applications which require print reproductions. Originals can be readily reproduced using conventional production equipment (electronic dodging) in black and white or color (color compensation).

Development and in-line validation of a Process Analytical Technology to facilitate the scale up of coating processes.

PubMed

Wirges, M; Funke, A; Serno, P; Knop, K; Kleinebudde, P

2013-05-05

Incorporation of an active pharmaceutical ingredient (API) into the coating layer of film-coated tablets is a method mainly used to formulate fixed-dose combinations. Uniform and precise spray-coating of an API represents a substantial challenge, which could be overcome by applying Raman spectroscopy as process analytical tool. In pharmaceutical industry, Raman spectroscopy is still mainly used as a bench top laboratory analytical method and usually not implemented in the production process. Concerning the application in the production process, a lot of scientific approaches stop at the level of feasibility studies and do not manage the step to production scale and process applications. The present work puts the scale up of an active coating process into focus, which is a step of highest importance during the pharmaceutical development. Active coating experiments were performed at lab and production scale. Using partial least squares (PLS), a multivariate model was constructed by correlating in-line measured Raman spectral data with the coated amount of API. By transferring this model, being implemented for a lab scale process, to a production scale process, the robustness of this analytical method and thus its applicability as a Process Analytical Technology (PAT) tool for the correct endpoint determination in pharmaceutical manufacturing could be shown. Finally, this method was validated according to the European Medicine Agency (EMA) guideline with respect to the special requirements of the applied in-line model development strategy. Copyright © 2013 Elsevier B.V. All rights reserved.

Control of the dehydration process in production of intermediate-moisture meat products: a review.

PubMed

Chang, S F; Huang, T C; Pearson, A M

1996-01-01

IM meat products are produced by lowering the aw to 0.90 to 0.60. Such products are stable at ambient temperature and humidity and are produced in nearly every country in the world, especially in developing areas where refrigeration is limited or unavailable. Traditionally IM meats use low cost sources of energy for drying, such as sun drying, addition of salt, or fermentation. Products produced by different processes are of interest since they do not require refrigeration during distribution and storage. Many different IM meat products can be produced by utilizing modern processing equipment and methods. Production can be achieved in a relatively short period of time and their advantages during marketing and distribution can be utilized. Nevertheless, a better understanding of the principles involved in heat transfer and efficiency of production are still needed to increase efficiency of processing. A basic understanding of the influence of water vapor pressure and sorption phenomena on water activity can materially improve the efficiency of drying of IM meats. Predrying treatments, such as fermentation and humidity control, can also be taken advantage of during the dehydration process. Such information can lead to process optimization and reduction of energy costs during production of IM meats. The development of sound science-based methods to assure the production of high-quality and nutritious IM meats is needed. Finally, such products also must be free of pathogenic microorganisms to assure their success in production and marketing.

The Production Data Approach for Full Lifecycle Management

NASA Astrophysics Data System (ADS)

Schopf, J.

2012-04-01

The amount of data generated by scientists is growing exponentially, and studies have shown [Koe04] that un-archived data sets have a resource half-life that is only a fraction of those resources that are electronically archived. Most groups still lack standard approaches and procedures for data management. Arguably, however, scientists know something about building software. A recent article in Nature [Mer10] stated that 45% of research scientists spend more time now developing software than they did 5 years ago, and 38% spent at least 1/5th of their time developing software. Fox argues [Fox10] that a simple release of data is not the correct approach to data curation. In addition, just as software is used in a wide variety of ways never initially envisioned by its developers, we're seeing this even to a greater extent with data sets. In order to address the need for better data preservation and access, we propose that data sets should be managed in a similar fashion to building production quality software. These production data sets are not simply published once, but go through a cyclical process, including phases such as design, development, verification, deployment, support, analysis, and then development again, thereby supporting the full lifecycle of a data set. The process involved in academically-produced software changes over time with respect to issues such as how much it is used outside the development group, but factors in aspects such as knowing who is using the code, enabling multiple developers to contribute to code development with common procedures, formal testing and release processes, developing documentation, and licensing. When we work with data, either as a collection source, as someone tagging data, or someone re-using it, many of the lessons learned in building production software are applicable. Table 1 shows a comparison of production software elements to production data elements. Table 1: Comparison of production software and production data. Production Software Production Data End-user considerations End-user considerations Multiple Coders: Repository with check-in procedures Coding standards Multiple producers/collectors Local archive with check-in procedure Metadata Standards Formal testing Formal testing Bug tracking and fixes Bug tracking and fixes, QA/QC Documentation Documentation Formal Release Process Formal release process to external archive License Citation/usage statement The full presentation of this abstract will include a detailed discussion of these issues so that researchers can produce usable and accessible data sets as a first step toward reproducible science. By creating production-quality data sets, we extend the potential of our data, both in terms of usability and usefulness to ourselves and other researchers. The more we treat data with formal processes and release cycles, the more relevant and useful it can be to the scientific community.

Eco-Efficient Process Improvement at the Early Development Stage: Identifying Environmental and Economic Process Hotspots for Synergetic Improvement Potential.

PubMed

Piccinno, Fabiano; Hischier, Roland; Seeger, Stefan; Som, Claudia

2018-05-15

We present here a new eco-efficiency process-improvement method to highlight combined environmental and costs hotspots of the production process of new material at a very early development stage. Production-specific and scaled-up results for life cycle assessment (LCA) and production costs are combined in a new analysis to identify synergetic improvement potentials and trade-offs, setting goals for the eco-design of new processes. The identified hotspots and bottlenecks will help users to focus on the relevant steps for improvements from an eco-efficiency perspective and potentially reduce their associated environmental impacts and production costs. Our method is illustrated with a case study of nanocellulose. The results indicate that the production route should start with carrot pomace, use heat and solvent recovery, and deactivate the enzymes with bleach instead of heat. To further improve the process, the results show that focus should be laid on the carrier polymer, sodium alginate, and the production of the GripX coating. Overall, the method shows that the underlying LCA scale-up framework is valuable for purposes beyond conventional LCA studies and is applicable at a very early stage to provide researchers with a better understanding of their production process.

27 CFR 21.42 - Formula No. 17.

Code of Federal Regulations, 2014 CFR

2014-04-01

...: 344.Processing medicinal chemicals (including alkaloids). 358.Processing other chemicals. 359.Processing miscellaneous products. (2) As a raw material: 575.Drugs and medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). ...

27 CFR 21.42 - Formula No. 17.

Code of Federal Regulations, 2012 CFR

2012-04-01

...: 344.Processing medicinal chemicals (including alkaloids). 358.Processing other chemicals. 359.Processing miscellaneous products. (2) As a raw material: 575.Drugs and medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). ...

27 CFR 21.42 - Formula No. 17.

Code of Federal Regulations, 2013 CFR

2013-04-01

...: 344.Processing medicinal chemicals (including alkaloids). 358.Processing other chemicals. 359.Processing miscellaneous products. (2) As a raw material: 575.Drugs and medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). ...

Modelling energy and environmental impacts of traditional and improved shea butter production in West Africa for food security.

PubMed

Naughton, Colleen C; Zhang, Qiong; Mihelcic, James R

2017-01-15

This study improves the global application of methods and analyses, especially Life Cycle Assessment (LCA), that properly incorporates environmental impacts of firewood and a social sustainability indicator (human energy) as tools for sustainable human development. Specifically shea butter production processes, common throughout sub-Saharan Africa and crucial to food security, environmental sustainability, and women's empowerment, are analyzed. Many economic activities in the world rely on firewood for energy and labor that aren't included in traditional LCAs. Human energy (entirely from women) contributed 25-100% of shea butter production processes (2000-6100kJ/kg of shea butter) and mechanized production processes had reduced human energy without considerably greater total energy. Firewood accounted for 94-100% of total embodied energy (103 and 172MJ/kg of shea butter for improved and traditional shea butter production processes respectively) and global warming potential and 18-100% of human toxicity of the production processes. Implementation of improved cookstoves modeled in this study could reduce: (1) global warming potential by 78% (from 18 to 4.1kg CO 2 eq/kg and 11 to 2.4kg CO 2 eq/kg of shea butter for the traditional and improved processes respectively), (2) the embodied energy of using firewood by 52% (from 170 to 82MJ/kg and 103 to 49MJ/kg for the traditional and improved processes respectively), and (3) human toxicity by 83% for the non-mechanized traditional and improved processes (from 0.041 to 0.0071 1,4 DB eq/kg and 0.025 to 0.0042 1,4 DB eq/kg respectively). In addition, this is the first study to compare Economic Input-Output Life Cycle Assessment (EIO-LCA) and process-based LCA in a developing country and evaluate five traditional and improved shea butter production processes over different impact categories. Overall, this study developed a framework to evaluate and improve processes for achievement of the United Nation's Sustainable Development Goals for 2030 particularly to obtain food security. Copyright © 2016 Elsevier B.V. All rights reserved.

Metric integration architecture for product development

NASA Astrophysics Data System (ADS)

Sieger, David B.

1997-06-01

Present-day product development endeavors utilize the concurrent engineering philosophy as a logical means for incorporating a variety of viewpoints into the design of products. Since this approach provides no explicit procedural provisions, it is necessary to establish at least a mental coupling with a known design process model. The central feature of all such models is the management and transformation of information. While these models assist in structuring the design process, characterizing the basic flow of operations that are involved, they provide no guidance facilities. The significance of this feature, and the role it plays in the time required to develop products, is increasing in importance due to the inherent process dynamics, system/component complexities, and competitive forces. The methodology presented in this paper involves the use of a hierarchical system structure, discrete event system specification (DEVS), and multidimensional state variable based metrics. This approach is unique in its capability to quantify designer's actions throughout product development, provide recommendations about subsequent activity selection, and coordinate distributed activities of designers and/or design teams across all design stages. Conceptual design tool implementation results are used to demonstrate the utility of this technique in improving the incremental decision making process.

Fungal Laccases: Production, Function, and Applications in Food Processing

PubMed Central

Brijwani, Khushal; Rigdon, Anne; Vadlani, Praveen V.

2010-01-01

Laccases are increasingly being used in food industry for production of cost-effective and healthy foods. To sustain this trend widespread availability of laccase and efficient production systems have to be developed. The present paper delineate the recent developments that have taken place in understanding the role of laccase action, efforts in overexpression of laccase in heterologous systems, and various cultivation techniques that have been developed to efficiently produce laccase at the industrial scale. The role of laccase in different food industries, particularly the recent developments in laccase application for food processing, is discussed. PMID:21048859

The Establishment of a New Friction Stir Welding Process Development Facility at NASA/MSFC

NASA Technical Reports Server (NTRS)

Carter, Robert W.

2009-01-01

Full-scale weld process development is being performed at MSFC to develop the tools, fixtures, and facilities necessary for Ares I production. Full scale development in-house at MSFC fosters technical acuity within the NASA engineering community, and allows engineers to identify and correct tooling and equipment shortcomings before they become problems on the production floor. Finally, while the new weld process development facility is currently being outfitted in support of Ares I development, it has been established to support all future Constellation Program needs. In particular, both the RWT and VWT were sized with the larger Ares V hardware in mind.

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

Tan, Eric C. D.; Talmadge, Michael; Dutta, Abhijit

This report was developed as part of the U.S. Department of Energy’s Bioenergy Technologies Office’s (BETO’s) efforts to enable the development of technologies for the production of infrastructure-compatible, cost-competitive liquid hydrocarbon fuels from lignocellulosic biomass feedstocks. The research funded by BETO is designed to advance the state of technology of biomass feedstock supply and logistics, conversion, and overall system sustainability. It is expected that these research improvements will be made within the 2022 timeframe. As part of their involvement in this research and development effort, the National Renewable Energy Laboratory and the Pacific Northwest National Laboratory investigate the economics ofmore » conversion pathways through the development of conceptual biorefinery process models and techno-economic analysis models. This report describes in detail one potential conversion process for the production of high-octane gasoline blendstock via indirect liquefaction of biomass. The processing steps of this pathway include the conversion of biomass to synthesis gas or syngas via indirect gasification, gas cleanup, catalytic conversion of syngas to methanol intermediate, methanol dehydration to dimethyl ether (DME), and catalytic conversion of DME to high-octane, gasoline-range hydrocarbon blendstock product. The conversion process configuration leverages technologies previously advanced by research funded by BETO and demonstrated in 2012 with the production of mixed alcohols from biomass. Biomass-derived syngas cleanup via reforming of tars and other hydrocarbons is one of the key technology advancements realized as part of this prior research and 2012 demonstrations. The process described in this report evaluates a new technology area for the downstream utilization of clean biomass-derived syngas for the production of high-octane hydrocarbon products through methanol and DME intermediates. In this process, methanol undergoes dehydration to DME, which is subsequently converted via homologation reactions to high-octane, gasoline-range hydrocarbon products.« less

Guidance for Product Category Rule Development: Process, Outcome and Next Steps

EPA Science Inventory

Background The development of Product Category Rules (PCRs) is inconsistent among the program operators using ISO 14025 as the basis. Furthermore, the existence of several other product claim standards and specifications that require PCRs for making product claims, has the potent...

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2012 CFR

2012-04-01

... products, vitamins, hormones, and yeasts. 343.Processing antibiotics and vaccines. 344.Processing medicinal... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2013 CFR

2013-04-01

... products, vitamins, hormones, and yeasts. 343.Processing antibiotics and vaccines. 344.Processing medicinal... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2014 CFR

2014-04-01

... products, vitamins, hormones, and yeasts. 343.Processing antibiotics and vaccines. 344.Processing medicinal... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.33 - Formula No. 2-B.

Code of Federal Regulations, 2012 CFR

2012-04-01

... crude drugs. 342.Processing glandular products, vitamins, hormones, and yeasts. 343.Processing.... (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). (c) Conditions...

27 CFR 21.33 - Formula No. 2-B.

Code of Federal Regulations, 2011 CFR

2011-04-01

... crude drugs. 342.Processing glandular products, vitamins, hormones, and yeasts. 343.Processing.... (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). (c) Conditions...

27 CFR 21.33 - Formula No. 2-B.

Code of Federal Regulations, 2013 CFR

2013-04-01

... crude drugs. 342.Processing glandular products, vitamins, hormones, and yeasts. 343.Processing.... (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). (c) Conditions...

27 CFR 21.33 - Formula No. 2-B.

Code of Federal Regulations, 2014 CFR

2014-04-01

... crude drugs. 342.Processing glandular products, vitamins, hormones, and yeasts. 343.Processing.... (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). (c) Conditions...

Simulation of generation of new ideas for new product development and IT services

NASA Astrophysics Data System (ADS)

Nasiopoulos, Dimitrios K.; Sakas, Damianos P.; Vlachos, D. S.; Mavrogianni, Amanda

2015-02-01

This paper describes a dynamic model of the New Product Development (NPD) process. The model has been occurring from best practice noticed in our research conducted at a range of situations. The model contributes to determine and put an IT company's NPD activities into the frame of the overall NPD process[1]. It has been found to be a useful tool for organizing data on IT company's NPD activities without enforcement an excessively restrictive research methodology refers to the model of NPD. The framework, which strengthens the model, will help to promote a research of the methods undertaken within an IT company's NPD process, thus promoting understanding and improvement of the simulation process[2]. IT companies tested many techniques with several different practices designed to improve the validity and efficacy of their NPD process[3]. Supported by the model, this research examines how widely accepted stated tactics are and what impact these best tactics have on NPD performance. The main assumption of this study is that simulation of generation of new ideas[4] will lead to greater NPD effectiveness and more successful products in IT companies. With the model implementation, practices concern the implementation strategies of NPD (product selection, objectives, leadership, marketing strategy and customer satisfaction) are all more widely accepted than best practices related with controlling the application of NPD (process control, measurements, results). In linking simulation with impact, our results states product success depends on developing strong products and ensuring organizational emphasis, through proper project selection. Project activities strengthens both product and project success. IT products and services success also depends on monitoring the NPD procedure through project management and ensuring team consistency with group rewards. Sharing experiences between projects can positively influence the NPD process.

Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.

PubMed

Edwards, Eric S; Edwards, Evan T; Simons, F Estelle R; North, Robert

2015-05-01

The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration. A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: 'human factors engineering,' 'human factors,' 'medical products,' 'epinephrine/adrenaline auto-injector,' 'healthcare' and 'patient safety.' This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program. For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.

Product Development and Commercialization of Diagnostic or Life Science Products for Scientists and Researchers.

PubMed

Alonso, Meghan M

2017-01-01

Commercializing a diagnostic or life science product often encompasses different goals than that of research and grant funding. There are several necessary steps, and a strategy needs to be well defined in order to be successful. Product development requires input from and between various groups within a company and, for academia, outside entities. The product development stakeholder groups/entities are research, marketing, development, regulatory, manufacturing, clinical, safety/efficacy, and quality. After initial research and development, much of the work in product development can be outsourced or jointly created using public-private partnerships. This chapter serves as an overview of the product development process and provides a guide to best define a product strategy.

Characteristics of products generated by selective sintering and stereolithography rapid prototyping processes

NASA Technical Reports Server (NTRS)

Cariapa, Vikram

1993-01-01

The trend in the modern global economy towards free market policies has motivated companies to use rapid prototyping technologies to not only reduce product development cycle time but also to maintain their competitive edge. A rapid prototyping technology is one which combines computer aided design with computer controlled tracking of focussed high energy source (eg. lasers, heat) on modern ceramic powders, metallic powders, plastics or photosensitive liquid resins in order to produce prototypes or models. At present, except for the process of shape melting, most rapid prototyping processes generate products that are only dimensionally similar to those of the desired end product. There is an urgent need, therefore, to enhance the understanding of the characteristics of these processes in order to realize their potential for production. Currently, the commercial market is dominated by four rapid prototyping processes, namely selective laser sintering, stereolithography, fused deposition modelling and laminated object manufacturing. This phase of the research has focussed on the selective laser sintering and stereolithography rapid prototyping processes. A theoretical model for these processes is under development. Different rapid prototyping sites supplied test specimens (based on ASTM 638-84, Type I) that have been measured and tested to provide a data base on surface finish, dimensional variation and ultimate tensile strength. Further plans call for developing and verifying the theoretical models by carefully designed experiments. This will be a joint effort between NASA and other prototyping centers to generate a larger database, thus encouraging more widespread usage by product designers.

Relationship between individual differences in speech processing and cognitive functions.

PubMed

Ou, Jinghua; Law, Sam-Po; Fung, Roxana

2015-12-01

A growing body of research has suggested that cognitive abilities may play a role in individual differences in speech processing. The present study took advantage of a widespread linguistic phenomenon of sound change to systematically assess the relationships between speech processing and various components of attention and working memory in the auditory and visual modalities among typically developed Cantonese-speaking individuals. The individual variations in speech processing are captured in an ongoing sound change-tone merging in Hong Kong Cantonese, in which typically developed native speakers are reported to lose the distinctions between some tonal contrasts in perception and/or production. Three groups of participants were recruited, with a first group of good perception and production, a second group of good perception but poor production, and a third group of good production but poor perception. Our findings revealed that modality-independent abilities of attentional switching/control and working memory might contribute to individual differences in patterns of speech perception and production as well as discrimination latencies among typically developed speakers. The findings not only have the potential to generalize to speech processing in other languages, but also broaden our understanding of the omnipresent phenomenon of language change in all languages.

Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products.

PubMed

Nicolette, C A; Healey, D; Tcherepanova, I; Whelton, P; Monesmith, T; Coombs, L; Finke, L H; Whiteside, T; Miesowicz, F

2007-09-27

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.

Introduction to Session 5

NASA Astrophysics Data System (ADS)

Zullo, Luca; Snyder, Seth W.

Production of bio-based products that are cost competitive in the market place requires well-developed operations that include innovative processes and separation solutions. Separations costs can make the difference between an interesting laboratory project and a successful commercial process. Bioprocessing and separations research and development addresses some of the most significant cost barriers in production of bioffuels and bio-based chemicals. Models of integrated biorefineries indicate that success will require production of higher volume fuels in conjunction with high margin chemical products. Addressing the bioprocessing and separations cost barriers will be critical to the overall success of the integrated biorefinery.

Process development for automated solar cell and module production. Task 4: Automated array assembly

NASA Technical Reports Server (NTRS)

1980-01-01

A process sequence which can be used in conjunction with automated equipment for the mass production of solar cell modules for terrestrial use was developed. The process sequence was then critically analyzed from a technical and economic standpoint to determine the technological readiness of certain process steps for implementation. The steps receiving analysis were: back contact metallization, automated cell array layup/interconnect, and module edge sealing. For automated layup/interconnect, both hard automation and programmable automation (using an industrial robot) were studied. The programmable automation system was then selected for actual hardware development.

SPITFIRE-1

NASA Technical Reports Server (NTRS)

Ryntz, Edward F.

1995-01-01

The purpose of this effort is to develop low-cost rapid forming superplastic aluminum that will be evaluated in pilot production trials for automotive SPF components. The alloy development study conducted under SPITFIRE-1 showed that the addition of CU or Mn to the base 5083 aluminum alloy refined the grain size, leading to enhanced superplastic properties. In SPITFIRE-2, these alloy variants will be further refined and studied to meet the target properties established earlier in the program. Mechanical properties, component forming and post-forming properties will be evaluated. Also, the alloy production process, including thermomechanical processing (TMP) optimization to reduce production cost, will be investigated during SPITFIRE-2. After identifying preferred compositions and production processing, the most promising alloy will be manufactured into production coils for verification during SPITFIRE-3. Components will be produced from these coils in SPITFIRE-4, and the process and component performance will be assessed.

Process simulation of ethanol production from biomass gasification and syngas fermentation.

PubMed

Pardo-Planas, Oscar; Atiyeh, Hasan K; Phillips, John R; Aichele, Clint P; Mohammad, Sayeed

2017-12-01

The hybrid gasification-syngas fermentation platform can produce more bioethanol utilizing all biomass components compared to the biochemical conversion technology. Syngas fermentation operates at mild temperatures and pressures and avoids using expensive pretreatment processes and enzymes. This study presents a new process simulation model developed with Aspen Plus® of a biorefinery based on a hybrid conversion technology for the production of anhydrous ethanol using 1200tons per day (wb) of switchgrass. The simulation model consists of three modules: gasification, fermentation, and product recovery. The results revealed a potential production of about 36.5million gallons of anhydrous ethanol per year. Sensitivity analyses were also performed to investigate the effects of gasification and fermentation parameters that are keys for the development of an efficient process in terms of energy conservation and ethanol production. Copyright © 2017 Elsevier Ltd. All rights reserved.

A PBOM configuration and management method based on templates

NASA Astrophysics Data System (ADS)

Guo, Kai; Qiao, Lihong; Qie, Yifan

2018-03-01

The design of Process Bill of Materials (PBOM) holds a hinge position in the process of product development. The requirements of PBOM configuration design and management for complex products are analysed in this paper, which include the reuse technique of configuration procedure and urgent management need of huge quantity of product family PBOM data. Based on the analysis, the function framework of PBOM configuration and management has been established. Configuration templates and modules are defined in the framework to support the customization and the reuse of configuration process. The configuration process of a detection sensor PBOM is shown as an illustration case in the end. The rapid and agile PBOM configuration and management can be achieved utilizing template-based method, which has a vital significance to improve the development efficiency for complex products.

Protein and starch digestibilities and mineral availability of products developed from potato, soy and corn flour.

PubMed

Gahlawat, P; Sehgal, S

1998-01-01

A technique for development of potato flour was standardized. Five products viz. cake, biscuit, weaning food, panjiri and ladoo were prepared incorporating potato flour, defatted soy flour and corn flour. Baking and roasting were the major processing techniques employed for the development of these products. Protein, ash and fat contents of potato flour were almost similar to those of raw potatoes. Significant differences in protein, ash and fat contents of all the products were observed. Protein and starch digestibility of potato flour was significantly higher than that of raw potatoes. Protein digestibility increased by 12 to 17 percent on baking or roasting of products. Processed products had significantly higher starch digestibility and mineral availability compared to raw products. Thus, it can be concluded that roasting and baking are effective means of improving starch and protein digestibility and mineral availability of products.

Early Benchmarks of Product Generation Capabilities of the GOES-R Ground System for Operational Weather Prediction

NASA Astrophysics Data System (ADS)

Kalluri, S. N.; Haman, B.; Vititoe, D.

2014-12-01

The ground system under development for Geostationary Operational Environmental Satellite-R (GOES-R) series of weather satellite has completed a key milestone in implementing the science algorithms that process raw sensor data to higher level products in preparation for launch. Real time observations from GOES-R are expected to make significant contributions to Earth and space weather prediction, and there are stringent requirements to product weather products at very low latency to meet NOAA's operational needs. Simulated test data from all the six GOES-R sensors are being processed by the system to test and verify performance of the fielded system. Early results show that the system development is on track to meet functional and performance requirements to process science data. Comparison of science products generated by the ground system from simulated data with those generated by the algorithm developers show close agreement among data sets which demonstrates that the algorithms are implemented correctly. Successful delivery of products to AWIPS and the Product Distribution and Access (PDA) system from the core system demonstrate that the external interfaces are working.

Creating breakthroughs at 3M.

PubMed

von Hippel, E; Thomke, S; Sonnack, M

1999-01-01

Most senior managers want their product development teams to create break-throughs--new products that will allow their companies to grow rapidly and maintain high margins. But more often they get incremental improvements to existing products. That's partly because companies must compete in the short term. Searching for breakthroughs is expensive and time consuming; line extensions can help the bottom line immediately. In addition, developers simply don't know how to achieve breakthroughs, and there is usually no system in place to guide them. By the mid-1990s, the lack of such a system was a problem even for an innovative company like 3M. Then a project team in 3M's Medical-Surgical Markets Division became acquainted with a method for developing breakthrough products: the lead user process. The process is based on the fact that many commercially important products are initially thought of and even prototyped by "lead users"--companies, organizations, or individuals that are well ahead of market trends. Their needs are so far beyond those of the average user that lead users create innovations on their own that may later contribute to commercially attractive breakthroughs. The lead user process transforms the job of inventing breakthroughs into a systematic task of identifying lead users and learning from them. The authors explain the process and how the 3M project team successfully navigated through it. In the end, the team proposed three major new product lines and a change in the division's strategy that has led to the development of breakthrough products. And now several more divisions are using the process to break away from incrementalism.

Lagging behind Writing Pedagogical Developments: The Impact of Implementing Process-Based Approach on Learners' Writing in a Vietnamese Secondary Education Context

ERIC Educational Resources Information Center

Ngo, Chau M.; Trinh, Lap Q.

2011-01-01

The field of English language education has seen developments in writing pedagogy, moving from product-based to process-based and then to genre-based approaches. In Vietnam, teaching secondary school students how to write in English is still lagging behind these growing developments. Product-based approach is commonly seen in English writing…

Agile manufacturing: The factory of the future

NASA Technical Reports Server (NTRS)

Loibl, Joseph M.; Bossieux, Terry A.

1994-01-01

The factory of the future will require an operating methodology which effectively utilizes all of the elements of product design, manufacturing and delivery. The process must respond rapidly to changes in product demand, product mix, design changes or changes in the raw materials. To achieve agility in a manufacturing operation, the design and development of the manufacturing processes must focus on customer satisfaction. Achieving greatest results requires that the manufacturing process be considered from product concept through sales. This provides the best opportunity to build a quality product for the customer at a reasonable rate. The primary elements of a manufacturing system include people, equipment, materials, methods and the environment. The most significant and most agile element in any process is the human resource. Only with a highly trained, knowledgeable work force can the proper methods be applied to efficiently process materials with machinery which is predictable, reliable and flexible. This paper discusses the affect of each element on the development of agile manufacturing systems.

Potential of Continuous Manufacturing for Liposomal Drug Products.

PubMed

Worsham, Robert D; Thomas, Vaughan; Farid, Suzanne S

2018-05-21

Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g. improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application. This article is protected by copyright. All rights reserved.

The extraction of bitumen from western oil sands. Annual report, July 1991--July 1992

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

Oblad, A.G.; Bunger, J.W.; Dahlstrom, D.A.

1992-08-01

The University of Utah tar sand research and development program is concerned with research and development on Utah is extensive oil sands deposits. The program has been intended to develop a scientific and technological base required for eventual commercial recovery of the heavy oils from oil sands and processing these oils to produce synthetic crude oil and other products such as asphalt. The overall program is based on mining the oil sand, processing the mined sand to recover the heavy oils and upgrading them to products. Multiple deposits are being investigated since it is believed that a large scale (approximatelymore » 20,000 bbl/day) plant would require the use of resources from more than one deposit. The tasks or projects in the program are organized according to the following classification: Recovery technologies which includes thermal recovery methods, water extraction methods, and solvent extraction methods; upgrading and processing technologies which covers hydrotreating, hydrocracking, and hydropyrolysis; solvent extraction; production of specialty products; and environmental aspects of the production and processing technologies. These tasks are covered in this report.« less

Development and demonstration of a lignite-pelletizing process. Phase II report

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

Not Available

1980-01-01

The current work began with scale-up of laboratory equipment to commercial size equipment. For this purpose, BCI used an existing pilot plant that had been assembled to pelletize and indurate taconite ore. BCI determined therewith that lignite pellets can be produced continuously on a pilot scale using the basic process developed in the laboratory. The resulting pellets were found to be similar to the laboratory pellets at equivalent binder compositions. Tests of product made during a 5-ton test run are reported. A 50-ton demonstration test run was made with the pilot plant. Pellet production was sustained for a two-week period.more » The lignite pelletizing process has, therefore, been developed to the point of demonstration in a 50-ton test. BCI has completed and cost estimated a conceptually designed 4000 TPD facility. BCI believes it has demonstrated a technically feasible process to agglomerate lignite by using an asphalt emulsion binder. Product quality is promising. Capital and operating costs appear acceptable to justify continuing support and development. The next step should focus on three areas: production development, process refinement, and cost reduction. For further development, BCI recommends consideration of a 5 to 10 ton/h pilot plant or a 20 to 40 ton/h module of a full sized plant, the lower first cost of the former being offset by the ability to incorporate the latter into a future production unit. Other specific recommendations are made for future study that could lead to process and cost improvements: Binder Formulation, disc Sizing, Drier Bed Depth, and Mixing Approach. Pellet use other than power plant fuel is considered.« less

Viirs Land Science Investigator-Led Processing System

NASA Astrophysics Data System (ADS)

Devadiga, S.; Mauoka, E.; Roman, M. O.; Wolfe, R. E.; Kalb, V.; Davidson, C. C.; Ye, G.

2015-12-01

The objective of the NASA's Suomi National Polar Orbiting Partnership (S-NPP) Land Science Investigator-led Processing System (Land SIPS), housed at the NASA Goddard Space Flight Center (GSFC), is to produce high quality land products from the Visible Infrared Imaging Radiometer Suite (VIIRS) to extend the Earth System Data Records (ESDRs) developed from NASA's heritage Earth Observing System (EOS) Moderate Resolution Imaging Spectroradiometer (MODIS) onboard the EOS Terra and Aqua satellites. In this paper we will present the functional description and capabilities of the S-NPP Land SIPS, including system development phases and production schedules, timeline for processing, and delivery of land science products based on coordination with the S-NPP Land science team members. The Land SIPS processing stream is expected to be operational by December 2016, generating land products either using the NASA science team delivered algorithms, or the "best-of" science algorithms currently in operation at NASA's Land Product Evaluation and Algorithm Testing Element (PEATE). In addition to generating the standard land science products through processing of the NASA's VIIRS Level 0 data record, the Land SIPS processing system is also used to produce a suite of near-real time products for NASA's application community. Land SIPS will also deliver the standard products, ancillary data sets, software and supporting documentation (ATBDs) to the assigned Distributed Active Archive Centers (DAACs) for archival and distribution. Quality assessment and validation will be an integral part of the Land SIPS processing system; the former being performed at Land Data Operational Product Evaluation (LDOPE) facility, while the latter under the auspices of the CEOS Working Group on Calibration & Validation (WGCV) Land Product Validation (LPV) Subgroup; adopting the best-practices and tools used to assess the quality of heritage EOS-MODIS products generated at the MODIS Adaptive Processing System (MODAPS).

Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing.

PubMed

Russom, Diana; Ahmed, Amira; Gonzalez, Nancy; Alvarnas, Joseph; DiGiusto, David

2012-01-01

Regulatory requirements for the manufacturing of cell products for clinical investigation require a significant level of record-keeping, starting early in process development and continuing through to the execution and requisite follow-up of patients on clinical trials. Central to record-keeping is the management of documentation related to patients, raw materials, processes, assays and facilities. To support these requirements, we evaluated several laboratory information management systems (LIMS), including their cost, flexibility, regulatory compliance, ongoing programming requirements and ability to integrate with laboratory equipment. After selecting a system, we performed a pilot study to develop a user-configurable LIMS for our laboratory in support of our pre-clinical and clinical cell-production activities. We report here on the design and utilization of this system to manage accrual with a healthy blood-donor protocol, as well as manufacturing operations for the production of a master cell bank and several patient-specific stem cell products. The system was used successfully to manage blood donor eligibility, recruiting, appointments, billing and serology, and to provide annual accrual reports. Quality management reporting features of the system were used to capture, report and investigate process and equipment deviations that occurred during the production of a master cell bank and patient products. Overall the system has served to support the compliance requirements of process development and phase I/II clinical trial activities for our laboratory and can be easily modified to meet the needs of similar laboratories.

Development, upscaling and validation of the purification process for human-cl rhFVIII (Nuwiq®), a new generation recombinant factor VIII produced in a human cell-line.

PubMed

Winge, Stefan; Yderland, Louise; Kannicht, Christoph; Hermans, Pim; Adema, Simon; Schmidt, Torben; Gilljam, Gustav; Linhult, Martin; Tiemeyer, Maya; Belyanskaya, Larisa; Walter, Olaf

2015-11-01

Human-cl rhFVIII (Nuwiq®), a new generation recombinant factor VIII (rFVIII), is the first rFVIII produced in a human cell-line approved by the European Medicines Agency. To describe the development, upscaling and process validation for industrial-scale human-cl rhFVIII purification. The purification process involves one centrifugation, two filtration, five chromatography columns and two dedicated pathogen clearance steps (solvent/detergent treatment and 20 nm nanofiltration). The key purification step uses an affinity resin (VIIISelect) with high specificity for FVIII, removing essentially all host-cell proteins with >80% product recovery. The production-scale multi-step purification process efficiently removes process- and product-related impurities and results in a high-purity rhFVIII product, with an overall yield of ∼50%. Specific activity of the final product was >9000 IU/mg, and the ratio between active FVIII and total FVIII protein present was >0.9. The entire production process is free of animal-derived products. Leaching of potential harmful compounds from chromatography resins and all pathogens tested were below the limit of quantification in the final product. Human-cl rhFVIII can be produced at 500 L bioreactor scale, maintaining high purity and recoveries. The innovative purification process ensures a high-purity and high-quality human-cl rhFVIII product with a high pathogen safety margin. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Integrating data mining technique and AHP in market analysis to propose new product development in real estate

NASA Astrophysics Data System (ADS)

Yunita; Galinium, M.; Lukas

2017-01-01

New product development in real estate industry is a challenging process since it is related to long term concept and high cost. A newly proposed product development should meet customer need and their preferences which appropriate with customer buying power and company value. This research use data mining for profiling customer transaction and Analytic Hierarchy Process (AHP) method for product selection in new product development. This research utilizes Weka as data mining open source software to profiling data customers. The analysis correlated product preferences and profiling demography such as city, age, gender and occupation. Demography profiles gives description buying power and product preferences. The products proposed are based on customer profiles and rank of the product by AHP method. The product with the highest score will be proposed as new product development. Case studies of this research are real estate projects in Serang, Makassar, and Balikpapan. Makassar and Balikpapan are the project that already gained success and Serang is new project which new products development will be proposed to launch. Based on profiling and product preference of customer in Balikpapan, Makassar, and prospectus of Serang markets, new products development that will be proposed are house type of 120/200 m2 with price around Rp1.300.000.000 and house type of 71/120 m2 with price around Rp800.000.000. The markets of Serang and Balikpapan have similarities in profiles as urban city so the new products development will adopt the succeed story of Balikpapan project.

75 FR 61502 - Cooperative Agreement With the Pan American Health Organization for the Development of an...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... Medical Products and Related Regulatory Processes and Systems in the Americas Region AGENCY: Food and Drug... Health Organization (PAHO) for the development of an information hub in the areas of medical products and related regulatory processes and systems (e.g., including drugs, biologics, vaccines, medical devices, and...

T. S. Eliot on a CD-ROM: A Narrative of the Production of a CD.

ERIC Educational Resources Information Center

Boaz, John K.; Boaz, Mildred M.

1996-01-01

Narrates the development of a CD-ROM product for use in an interart study of music, art, and literature, specifically T. S. Eliot's "The Waste Land." Traces the process of idea formulation, project conceptualization, and project development. Also discusses details of the technological process and marketing. (DSK)

Cybersecurity and the Medical Device Product Development Lifecycle.

PubMed

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

Development of processes for the production of solar grade silicon from halides and alkali metals

NASA Technical Reports Server (NTRS)

Dickson, C. R.; Gould, R. K.

1980-01-01

High temperature reactions of silicon halides with alkali metals for the production of solar grade silicon in volume at low cost were studied. Experiments were performed to evaluate product separation and collection processes, measure heat release parameters for scaling purposes, determine the effects of reactants and/or products on materials of reactor construction, and make preliminary engineering and economic analyses of a scaled-up process.

PROCESS AND EQUIPMENT CHANGES FOR CLEANER PRODUCTION IN FEDERAL FACILITIES

EPA Science Inventory

The paper discusses process and equipment changes for cleaner production in federal facilities. During the 1990s, DoD and EPA conducted joint research and development, aimed at reducing the discharge of hazardous and toxic pollutants from military production and maintenance faci...

Natural fiber production, harvesting, and preliminary processing: options and opportunities

USDA-ARS?s Scientific Manuscript database

The utilization of natural fibers and plant oils in bio-products introduces numerous logistical challenges not typically encountered with non-agricultural resources. Once it has been determined that a plant material is suitable for commercial development, the production, harvesting, and processing s...

Low-Energy, Low-Cost Production of Ethylene by Low- Temperature Oxidative Coupling of Methane

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

Radaelli, Guido; Chachra, Gaurav; Jonnavittula, Divya

In this project, we develop a catalytic process technology for distributed small-scale production of ethylene by oxidative coupling of methane at low temperatures using an advanced catalyst. The Low Temperature Oxidative Coupling of Methane (LT-OCM) catalyst system is enabled by a novel chemical catalyst and process pioneered by Siluria, at private expense, over the last six years. Herein, we develop the LT-OCM catalyst system for distributed small-scale production of ethylene by identifying and addressing necessary process schemes, unit operations and process parameters that limit the economic viability and mass penetration of this technology to manufacture ethylene at small-scales. The outputmore » of this program is process concepts for small-scale LT-OCM catalyst based ethylene production, lab-scale verification of the novel unit operations adopted in the proposed concept, and an analysis to validate the feasibility of the proposed concepts.« less

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

Lutwack, R.

The goal of the Silicon Material Task, a part of the FSA Project, was to develop and demonstrate the technology for the low-cost production of silicon of suitable purity to be used as the basic material for the manufacture of terrestrial photovoltaic solar cells. To be compatible with the price goals of the FSA Project, the price of the produced silicon was to be less than $10/kg (in 1975 dollars). Summarized in this document are 11 different processes for the production of silicon that were investigated and developed to varying extent by industrial, university, and government researchers. The silane-production sectionmore » of the Union Carbide Corp. (UCC) silane process was developed completely in this program. Coupled with Siemens-type chemical vapor deposition reactors, the process was carried through the pilot plant stage. The overall UCC process involves the conversion of metallurgical-grade silicon to silane followed by decomposition of the silane to purified silicon. Production of very high-purity silane and silicon was demonstrated. Although it has as yet not achieved commercial application, the development of fluidized-bed technology for the low-cost, high-throughput conversion of silane-to-silicon has been demonstrated in the research laboratory and now is in engineering development.« less

Propulsion and Power Rapid Response Research and Development (R&D) Support. Task Order 0004: Advanced Propulsion Fuels R&D, Subtask: Optimization of Lipid Production and Processing of Microalgae for the Development of Biofuels

DTIC Science & Technology

2013-02-01

Purified cultures are tested for optimized production under heterotrophic conditions with several organic carbon sources like beet and sorghum juice using ...Moreover, AFRL support sponsored the Master’s in Chemical Engineering project titled “Cost Analysis Of Local Bio- Products Processing Plant Using ...unlimited. 2.5 Screening for High Lipid Production Mutants Procedure: A selection of 84 single colony cultures was analyzed in this phase using the

Developing and commercializing sustainable new wood products : a process for identifying viable products.

Treesearch

Gordon A. Enk; Stuart L. Hart

2003-01-01

A process was designed to evaluate the sustainability and potential marketability of USDA Forest Service patented technologies. The process was designed and tested jointly by the University of North Carolina, the University of Michigan, Partners for Strategic Change, and the USDA Forest Service. Two technologies were evaluated: a fiber-based product and a wood fiber/...

Lactic acid bacteria associated with a heat-processed pork product and sources of variation affecting chemical indices of spoilage and sensory characteristics.

PubMed

Laursen, B G; Byrne, D V; Kirkegaard, J B; Leisner, J J

2009-02-01

To evaluate the potential for developing a quality index for a Danish modified atmosphere packaged (MAP) heat-processed and naturally contaminated pork meat product stored at 5 degrees C. The composition of the predominating microflora and changes in contents of tyramine, arginine, organic acids and sensory characteristics were analysed. The microflora was predominated by Lactobacillus sakei, Leuconostoc carnosum and Carnobacterium divergens. The presence of each species varied between products and batches resulting in limited usefulness of the concentrations of these bacteria or their metabolites as indices of quality. Furthermore, the three species differed in their metabolic activities as shown by use of a model meat extract. However, when MAP storage of the processed pork product was followed by aerobic storage then acetic acid showed some potential as a chemical indicator of sensory quality. Variation in processing parameters and spoilage microbiota limited the usefulness of concentrations of micro-organisms and their metabolites as indices of spoilage for the studied processed MAP pork product. The present study contributes to an understanding of the difficulties experienced in developing quality indices to be used in the control of microbial spoilage of processed MAP meat products.

Discussion on the Development of Green Chemistry and Chemical Engineering

NASA Astrophysics Data System (ADS)

Zhang, Yunshen

2017-11-01

Chemical industry plays a vital role in the development process of national economy. However, in view of the special nature of the chemical industry, a large number of poisonous and harmful substances pose a great threat to the ecological environment and human health in the entire process of raw material acquisition, production, transportation, product manufacturing, and the final practical application. Therefore, it is a general trend to promote the development of chemistry and chemical engineering towards a greener environment. This article will focus on some basic problems occurred in the development process of green chemistry and chemical engineering.

Recent developments in processing systems for cell and tissue cultures toward therapeutic application.

PubMed

Kino-oka, Masahiro; Taya, Masahito

2009-10-01

Innovative techniques of cell and tissue processing, based on tissue engineering, have been developed for therapeutic applications. Cell expansion and tissue reconstruction through ex vivo cultures are core processes used to produce engineered tissues with sufficient structural integrity and functionality. In manufacturing, strict management against contamination and human error is compelled due to direct use of un-sterilable products and the laboriousness of culture operations, respectively. Therefore, the development of processing systems for cell and tissue cultures is one of the critical issues for ensuring a stable process and quality of therapeutic products. However, the siting criterion of culture systems to date has not been made clear. This review article classifies some of the known processing systems into 'sealed-chamber' and 'sealed-vessel' culture systems based on the difference in their aseptic spaces, and describes the potential advantages of these systems and current states of culture systems, especially those established by Japanese companies. Moreover, on the basis of the guidelines for isolator systems used in aseptic processing for healthcare products, which are issued by the International Organization for Standardization, the siting criterion of the processing systems for cells and tissue cultures is discussed in perspective of manufacturing therapeutic products in consideration of the regulations according to the Good Manufacturing Practice.

The Auburn Engineering Technical Assistance Program investigation of polyvinyl alcohol film developments pertaining to radioactive particle decontamination and industrial waste minimization

NASA Astrophysics Data System (ADS)

Mole, Tracey Lawrence

In this work, an effective and systematic model is devised to synthesize the optimal formulation for an explicit engineering application in the nuclear industry, i.e. radioactive decontamination and waste reduction. Identification of an optimal formulation that is suitable for the desired system requires integration of all the interlacing behaviors of the product constituents. This work is unique not only in product design, but also in these design techniques. The common practice of new product development is to design the optimized product for a particular industrial niche and then subsequent research for the production process is conducted, developed and optimized separately from the product formulation. In this proposed optimization design technique, the development process, disposal technique and product formulation is optimized simultaneously to improve production profit, product behavior and disposal emissions. This "cradle to grave" optimization approach allowed a complex product formulation development process to be drastically simplified. The utilization of these modeling techniques took an industrial idea to full scale testing and production in under 18 months by reducing the number of subsequent laboratory trials required to optimize the formula, production and waste treatment aspects of the product simultaneously. This particular development material involves the use of a polymer matrix that is applied to surfaces as part of a decontamination system. The polymer coating serves to initially "fix" the contaminants in place for detection and ultimate elimination. Upon mechanical entrapment and removal, the polymer coating containing the radioactive isotopes can be dissolved in a solvent processor, where separation of the radioactive metallic particles can take place. Ultimately, only the collection of divided solids should be disposed of as nuclear waste. This creates an attractive alternative to direct land filling or incineration. This philosophy also provides waste generators a way to significantly reduce waste and associated costs, and help meet regulatory, safety and environmental requirements. In order for the polymeric film exhibit the desired performance, a combination of discrete constraints must be fulfilled. These interacting characteristics include the choice of polymer used for construction, drying time, storage constraints, decontamination ability, removal behavior, application process, coating strength and dissolvability processes. Identification of an optimized formulation that is suitable for this entire decontamination system requires integration of all the interlacing characteristics of the coating composition that affect the film behavior. A novel systematic method for developing quantitative values for theses qualitative characteristics is being developed in order to simultaneously optimize the design formulation subject to the discrete product specifications. This synthesis procedure encompasses intrinsic characteristics vital to successful product development, which allows for implementation of the derived model optimizations to operate independent of the polymer film application. This contribution illustrates the optimized synthesis example by which a large range of polymeric compounds and mixtures can be completed. (Abstract shortened by UMI.)

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

PubMed

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.

PubMed

Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N; Szot, Gregory L; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W; Barbaro, Barbara; Bridges, Nancy D; Cano, Jose; Clarke, William R; Eggerman, Thomas L; Hunsicker, Lawrence G; Kaufman, Dixon B; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S; Lei, Ji; Wang, Ling-Jia; Wilhelm, Joshua J; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J; Posselt, Andrew M; Stock, Peter G; Shapiro, A M James; Chen, Xiaojuan

2016-11-01

Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. © 2016 by the American Diabetes Association.

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

PubMed Central

Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

2016-01-01

Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

New electron beam facility for R&D and production at acsion industries

NASA Astrophysics Data System (ADS)

Lopata, V. J.; Barnard, J. W.; Saunders, C. B.; Stepanik, T. M.

2003-08-01

Since its incorporation in 1998, Acsion Industries Inc. has been working with clients to develop industrial uses of electron processing for improving products and manufacturing processes. Acsion has promoted this technology for sterilizing medical devices and pharmaceuticals, for treating wood pulp in the viscose/rayon process, for reducing pathogens in food and animal feed, and for curing advanced composites for the aerospace industry. As a result of significant developments in its composite curing programs, Acsion has recently made major modifications to its facility to increase its production and R&D capabilities. These modifications are described in this paper.

A Model for the Evaluation of Educational Products.

ERIC Educational Resources Information Center

Bertram, Charles L.

A model for the evaluation of educational products based on experience with development of three such products is described. The purpose of the evaluation model is to indicate the flow of evaluation activity as products undergo development. Evaluation is given Stufflebeam's definition as the process of delineating, obtaining, and providing useful…

Software Quality Assurance Metrics

NASA Technical Reports Server (NTRS)

McRae, Kalindra A.

2004-01-01

Software Quality Assurance (SQA) is a planned and systematic set of activities that ensures conformance of software life cycle processes and products conform to requirements, standards and procedures. In software development, software quality means meeting requirements and a degree of excellence and refinement of a project or product. Software Quality is a set of attributes of a software product by which its quality is described and evaluated. The set of attributes includes functionality, reliability, usability, efficiency, maintainability, and portability. Software Metrics help us understand the technical process that is used to develop a product. The process is measured to improve it and the product is measured to increase quality throughout the life cycle of software. Software Metrics are measurements of the quality of software. Software is measured to indicate the quality of the product, to assess the productivity of the people who produce the product, to assess the benefits derived from new software engineering methods and tools, to form a baseline for estimation, and to help justify requests for new tools or additional training. Any part of the software development can be measured. If Software Metrics are implemented in software development, it can save time, money, and allow the organization to identify the caused of defects which have the greatest effect on software development. The summer of 2004, I worked with Cynthia Calhoun and Frank Robinson in the Software Assurance/Risk Management department. My task was to research and collect, compile, and analyze SQA Metrics that have been used in other projects that are not currently being used by the SA team and report them to the Software Assurance team to see if any metrics can be implemented in their software assurance life cycle process.

Bacillus thuringiensis: fermentation process and risk assessment. A short review.

PubMed

Capalbo, D M

1995-01-01

Several factors make the local production of Bacillus thuringiensis (Bt) highly appropriate for pest control in developing nations. Bt can be cheaply produced on a wide variety of low cost, organic substrates. Local production results in considerable savings in hard currency which otherwise would be spent on importation of chemical and biological insecticides. The use of Bt in Brazil has been limited in comparison with chemical insecticides. Although Bt is imported, some Brazilian researchers have been working on its development and production. Fermentation processes (submerged and semi-solid) were applied, using by-products from agro-industries. As the semi-solid fermentation process demonstrated to be interesting for Bt endotoxins production, it could be adopted for small scale local production. Although promising results had been achieved, national products have not been registered due to the absence of a specific legislation for biological products. Effective actions are being developed in order to solve this gap. Regardless of the biocontrol agents being considered atoxic and harmless to the environment, information related to direct and indirect effects of microbials are still insufficient in many cases. The risk analysis of the use of microbial control agents is of upmost importance nowadays, and is also discussed.

Environmental biocatalysis: from remediation with enzymes to novel green processes.

PubMed

Alcalde, Miguel; Ferrer, Manuel; Plou, Francisco J; Ballesteros, Antonio

2006-06-01

Modern biocatalysis is developing new and precise tools to improve a wide range of production processes, which reduce energy and raw material consumption and generate less waste and toxic side-products. Biocatalysis is also achieving new advances in environmental fields, from enzymatic bioremediation to the synthesis of renewable and clean energies and biochemical cleaning of 'dirty' fossil fuels. Despite the obvious benefits of biocatalysis, the major hurdles hindering the exploitation of the repertoire of enzymatic processes are, in many cases, the high production costs and the low yields obtained. This article will discuss these issues, pinpointing specific new advances in recombinant DNA techniques amenable to future biocatalyst development, in addition to drawing the attention of the biotechnology community to the active pursuit and development of environmental biocatalysis, from remediation with enzymes to novel green processes.

IPL Processing of the Viking Orbiter Images of Mars

NASA Technical Reports Server (NTRS)

Ruiz, R. M.; Elliott, D. A.; Yagi, G. M.; Pomphrey, R. B.; Power, M. A.; Farrell, W., Jr.; Lorre, J. J.; Benton, W. D.; Dewar, R. E.; Cullen, L. E.

1977-01-01

The Viking orbiter cameras returned over 9000 images of Mars during the 6-month nominal mission. Digital image processing was required to produce products suitable for quantitative and qualitative scientific interpretation. Processing included the production of surface elevation data using computer stereophotogrammetric techniques, crater classification based on geomorphological characteristics, and the generation of color products using multiple black-and-white images recorded through spectral filters. The Image Processing Laboratory of the Jet Propulsion Laboratory was responsible for the design, development, and application of the software required to produce these 'second-order' products.

Crew interface specifications development functions, phase 3A

NASA Technical Reports Server (NTRS)

Carl, J. G.

1973-01-01

The findings and data products developed during the crew interface specification study for inflight maintenance and stowage functions are presented. Guidelines are provided for improving the present progress of defining, controlling, and managing the flight crew requirements. The following data products were developed: (1) description of inflight maintenance management process, (2) specifications for inflight maintenance management requirements, and (3) suggested inflight maintenance data processing reports for logistics management.

Development and demonstration of manufacturing processes for fabricating graphite/Larc-160 polyimide structural elements, part 4, paragraph B

NASA Technical Reports Server (NTRS)

1981-01-01

Progress in the development of processes for production of Celion/LARC-160 graphite-polyimide materials, quality control, and the fabrication of Space Shuttle composite structure components is reported. Liquid chromatographic analyses of three repeatibility batches were performed and are compared to previous Hexcel standard production and to variables study LARC-160 intermediate resins. Development of processes for chopped fiber molding are described and flexural strength, elastic modulus, and other physical and mechanical properties of the molding are presented.

Software metrics: The quantitative impact of four factors on work rates experienced during software development. [reliability engineering

NASA Technical Reports Server (NTRS)

Gaffney, J. E., Jr.; Judge, R. W.

1981-01-01

A model of a software development process is described. The software development process is seen to consist of a sequence of activities, such as 'program design' and 'module development' (or coding). A manpower estimate is made by multiplying code size by the rates (man months per thousand lines of code) for each of the activities relevant to the particular case of interest and summing up the results. The effect of four objectively determinable factors (organization, software product type, computer type, and code type) on productivity values for each of nine principal software development activities was assessed. Four factors were identified which account for 39% of the observed productivity variation.

Manufacturing Process Development for Dust and Rain Erosion Resistant Coated Metallic Clads for Helicopter Rotors

DTIC Science & Technology

1980-06-01

program is to develop, on a timely basis, manufacturing processes, techniques and equipment for use in production of Army materiel. Comments are...solicited on the potential utilization of the information contained herein as applied to present and/or future production programs. Such comments should be...manufacturers in this report shall not be construed as advertising nor as an official indorsement or approval of such products or companies by the United

Beneficial uses of space

NASA Technical Reports Server (NTRS)

Bloom, H. L.

1977-01-01

The study elicited over 100 ideas for Space Processing. Of the elicited ideas, more than 20% involved processing of biologicals, or related medical and life sciences applications. Among these were High Purity Separation of Isoenzymes, and Development of Biorhythms applications data. Program planning for four products is outlined. Experimentation and testing resulted in definition of nearly 70 series of tests in ground-based laboratories, sounding rockets, etc., and space shuttle. Development schedules established timing and interrelationships of decisions involved in carrying these products to the point of production. The potential profitability of the four products is determined. Resources needed to achieve full scale production included use of shuttle for transportation, for which cost apportionment model was developed. R and D resources for the four products totalled $46,000,000 with Isoenzymes requiring the smallest expenditure, $4,000,000. A computerized profitability model (INVEST) was used to determine the measures of profitability of each product. Results build confidence that there will be a payoff.

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®

Waste valorization by biotechnological conversion into added value products.

PubMed

Liguori, Rossana; Amore, Antonella; Faraco, Vincenza

2013-07-01

Fossil fuel reserves depletion, global warming, unrelenting population growth, and costly and problematic waste recycling call for renewable resources of energy and consumer products. As an alternative to the 100 % oil economy, production processes based on biomass can be developed. Huge amounts of lignocellulosic wastes are yearly produced all around the world. They include agricultural residues, food farming wastes, "green-grocer's wastes," tree pruning residues, and organic and paper fraction of urban solid wastes. The common ways currently adopted for disposal of these wastes present environmental and economic disadvantages. As an alternative, processes for adding value to wastes producing high added products should be developed, that is the upgrading concept: adding value to wastes by production of a product with desired reproducible properties, having economic and ecological advantages. A wide range of high added value products, such as enzymes, biofuels, organic acids, biopolymers, bioelectricity, and molecules for food and pharmaceutical industries, can be obtained by upgrading solid wastes. The most recent advancements of their production by biotechnological processes are overviewed in this manuscript.

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

Price, L.K.; Phylipsen, G.J.M.; Worrell, E.

Iron and steel production consumes enormous quantities of energy, especially in developing countries where outdated, inefficient technologies are still used to produce iron and steel. Carbon dioxide emissions from steel production, which range between 5 and 15% of total country emissions in key developing countries (Brazil, China, India, Mexico, and South Africa), will continue to grow as these countries develop and as demand for steel products such as materials, automobiles, and appliances increases. In this report, we describe the key steel processes, discuss typical energy-intensity values for these processes, review historical trends in iron and steel production by process inmore » five key developing countries, describe the steel industry in each of the five key developing countries, present international comparisons of energy use and carbon dioxide emissions among these countries, and provide our assessment of the technical potential to reduce these emissions based on best-practice benchmarking. Using a best practice benchmark, we find that significant savings, in the range of 33% to 49% of total primary energy used to produce steel, are technically possible in these countries. Similarly, we find that the technical potential for reducing intensities of carbon dioxide emissions ranges between 26% and 49% of total carbon dioxide emissions from steel production in these countries.« less

Process optimization at small and medium-sized enterprises: production of small and medium-sized batches

NASA Astrophysics Data System (ADS)

Stettmer, J.

2017-06-01

The organization of a company needs to refer to the production process and especially to the number of employees. Many enterprises which are growing, are primarily focused on the development of the technology and not on the development of the organization. This ends up in an increase of the turnover but in a reduced margin. For the development of the organization in growing companies there are two things necessary. The development of the staff to work systematically and coordinated in teams as well as the flow of the information and material between the teams. ERP - systems are required to install the material and information flow especially in the work floor. Unfortunately many enterprises don't use the ERP-systems to plan and control the material and information flow very detailed. In companies where the control of the material and information flow was installed, it could be demonstrated that the margin increased analog to it. The requirements to the development of the organization based on the increasing number of the employees are basically the same for most of the production processes like the production of metal sheet housings or the production of mirrors and lenses.

Controlling high-throughput manufacturing at the nano-scale

NASA Astrophysics Data System (ADS)

Cooper, Khershed P.

2013-09-01

Interest in nano-scale manufacturing research and development is growing. The reason is to accelerate the translation of discoveries and inventions of nanoscience and nanotechnology into products that would benefit industry, economy and society. Ongoing research in nanomanufacturing is focused primarily on developing novel nanofabrication techniques for a variety of applications—materials, energy, electronics, photonics, biomedical, etc. Our goal is to foster the development of high-throughput methods of fabricating nano-enabled products. Large-area parallel processing and highspeed continuous processing are high-throughput means for mass production. An example of large-area processing is step-and-repeat nanoimprinting, by which nanostructures are reproduced again and again over a large area, such as a 12 in wafer. Roll-to-roll processing is an example of continuous processing, by which it is possible to print and imprint multi-level nanostructures and nanodevices on a moving flexible substrate. The big pay-off is high-volume production and low unit cost. However, the anticipated cost benefits can only be realized if the increased production rate is accompanied by high yields of high quality products. To ensure product quality, we need to design and construct manufacturing systems such that the processes can be closely monitored and controlled. One approach is to bring cyber-physical systems (CPS) concepts to nanomanufacturing. CPS involves the control of a physical system such as manufacturing through modeling, computation, communication and control. Such a closely coupled system will involve in-situ metrology and closed-loop control of the physical processes guided by physics-based models and driven by appropriate instrumentation, sensing and actuation. This paper will discuss these ideas in the context of controlling high-throughput manufacturing at the nano-scale.

Post Processing Methods used to Improve Surface Finish of Products which are Manufactured by Additive Manufacturing Technologies: A Review

NASA Astrophysics Data System (ADS)

Kumbhar, N. N.; Mulay, A. V.

2016-08-01

The Additive Manufacturing (AM) processes open the possibility to go directly from Computer-Aided Design (CAD) to a physical prototype. These prototypes are used as test models before it is finalized as well as sometimes as a final product. Additive Manufacturing has many advantages over the traditional process used to develop a product such as allowing early customer involvement in product development, complex shape generation and also save time as well as money. Additive manufacturing also possess some special challenges that are usually worth overcoming such as Poor Surface quality, Physical Properties and use of specific raw material for manufacturing. To improve the surface quality several attempts had been made by controlling various process parameters of Additive manufacturing and also applying different post processing techniques on components manufactured by Additive manufacturing. The main objective of this work is to document an extensive literature review in the general area of post processing techniques which are used in Additive manufacturing.

[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.

[Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

PubMed

Yang, Ming; Yang, Yuan-Zhen; Wang, Ya-Qi; Wu, Zhen-Feng; Wang, Xue-Cheng; Luo, Jing

2017-03-01

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation. Copyright© by the Chinese Pharmaceutical Association.

Innovation through developing consumers communities. Part II: Digitalizing the innovation processes

NASA Astrophysics Data System (ADS)

Avasilcai, S.; Galateanu (Avram, E.

2015-11-01

The current research recognises the concept of innovation as the main driver for organisational growth and profitability. The companies seek to develop new ways to engage consumers and customers into co - creation value through the product design, development and distribution processes. However the main concern is manifested for new and creative ways of customization products based on consumers’ requirements and needs. Thus the need for innovative virtual instruments arose as the demand from social communities for personalised products or services increased. Basically companies should develop own innovative platforms, where consumers can participate, with ideas, concepts or other relevant contributions, and interact with designers or engineers for product development. This paper aims to present the most important features of platform development within BMW Group as a concept and as innovative instrument. From this point of view it is important to enhance past experiences of the company in the field of co - creation projects. There will be highlighted the dual consumers’ character as co - creator and co - evaluator based on their involvement in the proposed and developed projects and platform structure. The significant impact on platform functioning it has the diversity of company's concerns for Research & Development and innovation activities. From this point of view there will be assessed the platform structure, the main proposed themes and the evaluation process. The main outcome is to highlight the significance of platform development as innovative tool for consumers’ communities’ enhancement. Based on the analysis of “BMW Co-Creation Lab”, there will be revealed the main consumers concerns in terms of safety, comfort and appearance of the products. Thus it is important to understand the evaluation process of gathered ideas and intellectual property policy. The importance of platform development and implementation will be highlighted by company's results in terms of Research & Development investments and future projects which will be proposed, assessed and implemented by BMW Group in order to show the responsibility for their products and consumers.

Contribution au developpement d'une methode de controle des procedes dans une usine de bouletage

NASA Astrophysics Data System (ADS)

Gosselin, Claude

This thesis, a collaborative effort between Ecole de technologie superieure and ArcelorMittal Company, presents the development of a methodology for monitoring and quality control of multivariable industrial production processes. This innovation research mandate was developed at ArcelorMittal Exploitation Miniere (AMEM) pellet plant in Port-Cartier (Quebec, Canada). With this undertaking, ArcelorMittal is striving to maintain its world class level of excellence and continues to pursue initiatives that can augment its competitive advantage worldwide. The plant's gravimetric classification process was retained as a prototype and development laboratory due to its effect on the company's competitiveness and its impact on subsequent steps leading to final production of iron oxide pellets. Concretely, the development of this expertise in process control and in situ monitoring will establish a firm basic knowledge in the fields of complex system physical modeling, data reconciliation, statistical observers, multivariate command and quality control using real-time monitoring of the desirability function. The hydraulic classifier is mathematically modeled. Using planned disturbances on the production line, an identification procedure was established to provide empirical estimations of the model's structural parameters. A new sampling campaign and a previously unpublished data collection and consolidation policy were implemented plant-wide. Access to these invaluable data sources has enabled the establishment of new thresholds that govern the production process and its control. Finally, as a substitute for the traditional quality control process, we have implemented a new strategy based on the use of the desirability function. Our innovation is not in using this Finally, as a substitute for the traditional quality control process, we have implemented a new strategy based on the use of the desirability function. Our innovation is not in using this function as an indicator of overall (economic) satisfaction in the production process, but rather in proposing it as an "observer" of the system's state. The first implementation steps have already demonstrated the method's feasibility as well as other numerous industrial impacts on production processes within the company. Namely, the emergence of the economical aspect as a strategic variable that assures better governance of production processes where quality variables present strategic issues.

Integrated development of up- and downstream processes supported by the Cherry-Tag™ for real-time tracking of stability and solubility of proteins.

PubMed

Baumann, Pascal; Bluthardt, Nicolai; Renner, Sarah; Burghardt, Hannah; Osberghaus, Anna; Hubbuch, Jürgen

2015-04-20

Product analytics is the bottleneck of most processes in bioprocess engineering, as it is rather time-consuming. Real-time and in-line product tracing without sample pre-treatment is only possible for few products. The Cherry-Tag™ (Delphi Genetics, Belgium) which can be fused to any target protein allows for straightforward product analytics by VIS absorption measurements. When the fused protein becomes unstable or insoluble, the chromophore function of the group is lost, which makes this technology an ideal screening tool for solubility and stability in up- and downstream process development. The Cherry-Tag™ technology will be presented for the tagged enzyme glutathione-S-transferase (GST) from Escherichia coli in a combined up- and downstream process development study. High-throughput cultivations were carried out in a 48-well format in a BioLector system (m2p-Labs, Germany). The best cultivation setup of highest product titer was scaled up to a 2.5L shake flask culture, followed by a selective affinity chromatography product capturing step. In upstream applications the tag was capable of identifying conditions where insoluble and non-native inclusion bodies were formed. In downstream applications the red-colored product was found to be bound effectively to a GST affinity column. Thus, it was identified to be a native and active protein, as the binding mechanism relies on catalytic activity of the enzyme. The Cherry-Tag™ was found to be a reliable and quantitative tool for real-time tracking of stable and soluble proteins in up- and downstream processing applications. Denaturation and aggregation of the product can be detected in-line at any stage of the process. Critical stages can be identified and subsequently changed or replaced. Copyright © 2015 Elsevier B.V. All rights reserved.

A comprehensive study on regulatory requirements for development and filing of generic drugs globally

PubMed Central

Handoo, Shweta; Arora, Vandana; Khera, Deepak; Nandi, Prafulla Kumar; Sahu, Susanta Kumar

2012-01-01

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. PMID:23373001

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

Dafler, J.R.; Sinnott, J.; Novil, M.

The first phase of a study to identify candidate processes and products suitable for future exploitation using high-temperature solar energy is presented. This phase has been principally analytical, consisting of techno-economic studies, thermodynamic assessments of chemical reactions and processes, and the determination of market potentials for major chemical commodities that use significant amounts of fossil resources today. The objective was to identify energy-intensive processes that would be suitable for the production of chemicals and fuels using solar energy process heat. Of particular importance was the comparison of relative costs and energy requirements for the selected solar product versus costs formore » the product derived from conventional processing. The assessment methodology used a systems analytical approach to identify processes and products having the greatest potential for solar energy-thermal processing. This approach was used to establish the basis for work to be carried out in subsequent phases of development. It has been the intent of the program to divide the analysis and process identification into the following three distinct areas: (1) process selection, (2) process evaluation, and (3) ranking of processes. Four conventional processes were selected for assessment namely, methanol synthesis, styrene monomer production, vinyl chloride monomer production, and terephthalic acid production.« less

Land transportation model for supply chain manufacturing industries

NASA Astrophysics Data System (ADS)

Kurniawan, Fajar

2017-12-01

Supply chain is a system that integrates production, inventory, distribution and information processes for increasing productivity and minimize costs. Transportation is an important part of the supply chain system, especially for supporting the material distribution process, work in process products and final products. In fact, Jakarta as the distribution center of manufacturing industries for the industrial area. Transportation system has a large influences on the implementation of supply chain process efficiency. The main problem faced in Jakarta is traffic jam that will affect on the time of distribution. Based on the system dynamic model, there are several scenarios that can provide solutions to minimize timing of distribution that will effect on the cost such as the construction of ports approaching industrial areas other than Tanjung Priok, widening road facilities, development of railways system, and the development of distribution center.

Study for Identification of Beneficial Uses of Space (BUS). Volume 2: Technical report. Book 4: Development and business analysis of space processed surface acoustic wave devices

NASA Technical Reports Server (NTRS)

1975-01-01

Preliminary development plans, analysis of required R and D and production resources, the costs of such resources, and, finally, the potential profitability of a commercial space processing opportunity for the production of very high frequency surface acoustic wave devices are presented.

Applied Integrated Design in Composite UAV Development

NASA Astrophysics Data System (ADS)

Vasić, Zoran; Maksimović, Stevan; Georgijević, Dragutin

2018-04-01

This paper presents a modern approach to integrated development of Unmanned Aerial Vehicle made of laminated composite materials from conceptual design, through detail design, strength and stiffness analyses, definition and management of design and production data, detailed tests results and other activities related to development of laminated composite structures with main of its particularities in comparison to metal structures. Special attention in this work is focused to management processes of product data during life cycle of an UAV and experimental tests of its composite wing. Experience shows that the automation management processes of product data during life cycle, as well as processes of manufacturing, are inevitable if a company wants to get cheaper and quality composite aircraft structures. One of the most effective ways of successful management of product data today is Product Life cycle Management (PLM). In terms of the PLM, a spectrum of special measures and provisions has to be implemented when defining fiber-reinforced composite material structures in comparison to designing with metals which is elaborated in the paper.

Solid State Lighting Program (Falcon)

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

Meeks, Steven

2012-06-30

Over the past two years, KLA-Tencor and partners successfully developed and deployed software and hardware tools that increase product yield for High Brightness LED (HBLED) manufacturing and reduce product development and factory ramp times. This report summarizes our development effort and details of how the results of the Solid State Light Program (Falcon) have started to help HBLED manufacturers optimize process control by enabling them to flag and correct identified killer defect conditions at any point of origin in the process manufacturing flow. This constitutes a quantum leap in yield management over current practice. Current practice consists of die dispositioningmore » which is just rejection of bad die at end of process based upon probe tests, loosely assisted by optical in-line monitoring for gross process deficiencies. For the first time, and as a result of our Solid State Lighting Program, our LED manufacturing partners have obtained the software and hardware tools that optimize individual process steps to control killer defects at the point in the processes where they originate. Products developed during our two year program enable optimized inspection strategies for many product lines to minimize cost and maximize yield. The Solid State Lighting Program was structured in three phases: i) the development of advanced imaging modes that achieve clear separation between LED defect types, improves signal to noise and scan rates, and minimizes nuisance defects for both front end and back end inspection tools, ii) the creation of defect source analysis (DSA) software that connect the defect maps from back-end and front-end HBLED manufacturing tools to permit the automatic overlay and traceability of defects between tools and process steps, suppress nuisance defects, and identify the origin of killer defects with process step and conditions, and iii) working with partners (Philips Lumileds) on product wafers, obtain a detailed statistical correlation of automated defect and DSA map overlay to failed die identified using end product probe test results. Results from our two year effort have led to “automated end-to-end defect detection” with full defect traceability and the ability to unambiguously correlate device killer defects to optically detected features and their point of origin within the process. Success of the program can be measured by yield improvements at our partner’s facilities and new product orders.« less

Bioeconomy Initiative at MBI International

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

Kleff, Susanne, Ph.D.

Di-carboxylic acids have the potential to replace petrochemicals used in the polymer industry (Werpy and Petersen, 2004). MBI developed a process for the production of succinic acid using a proprietary organism. During this work MBI assessed the feasibility to produce other carboxylic acids either using A. succinogenes or other organisms. The development of recombinant A. succinogenes strain derivatives for a mono-carboxylic acid through over-expression of enzymatic activities was successful. Fermentations achieved titers of 58 g/L for this organic acid. Recombinant strains that produced the same acid, but a different stereoisomer, reached titers of 10 g/L. Attempts to increase the titersmore » for this isomer as well as other organic acids were unsuccessful. MBI is looking for commercial partners to pursue the development of recombinant A. succinogenes strains for the production of other organic acids. Attempts to develop recombinant strains of A. succinogenes for fumaric acid production through introduction of various antisense RNA constructs were unsuccessful. Alternative suitable organisms were evaluated and Rhizopus oryzae, a natural fumaric acid producer with potential for process improvements, was selected. A novel fermentation and one-step recovery process was developed that allowed capture of IP, produced titers of >80 g/L with a productivity of 1.8 g/L-h and 57% (g/g glucose) yield. The process was scaled to 2000 L pilot scale. The economic analysis projected a production cost of 72 c/lb. Recycling and re-use of the base was demonstrated and incorporated into the process. The ability of the organism to produce fumaric acid from other carbon sources and biomass hydrolysate was demonstrated. The production of other organic acids was evaluated and techno-economic de-risking roadmap documents were prepared.« less

Development and quality characteristics of shelf-stable soy-agushie: a residual by-product of soymilk production.

PubMed

Nti, Christina A; Plahar, Wisdom A; Annan, Nana T

2016-03-01

A process was developed for the production of a high-protein food ingredient, soy-agushie, from the residual by-product of soymilk production. The product, with a moisture content of about 6%, was evaluated for its quality characteristics and performance in traditional dishes. The protein content was about 26% with similar amino acids content as that of the whole soybean. Lysine remained high in the dehydrated product (6.57 g/16 g N). While over 60% of the original B vitamins content in the beans was extracted with the milk, high proportions of the minerals were found to be retained in the residual by-product. The process adequately reduced the trypsin inhibitor levels in the beans from 25 to 1.5 mg/g. High sensory scores were obtained for recipes developed with soy-agushie in traditional dishes. The scope of utilization of the soy-agushie could be widened to include several traditional foods and bakery products for maximum nutritional benefits.

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.

Development of parametric material, energy, and emission inventories for wafer fabrication in the semiconductor industry.

PubMed

Murphy, Cynthia F; Kenig, George A; Allen, David T; Laurent, Jean-Philippe; Dyer, David E

2003-12-01

Currently available data suggest that most of the energy and material consumption related to the production of an integrated circuit is due to the wafer fabrication process. The complexity of wafer manufacturing, requiring hundreds of steps that vary from product to product and from facility to facility and which change every few years, has discouraged the development of material, energy, and emission inventory modules for the purpose of insertion into life cycle assessments. To address this difficulty, a flexible, process-based system for estimating material requirements, energy requirements, and emissions in wafer fabrication has been developed. The method accounts for mass and energy use atthe unit operation level. Parametric unit operation modules have been developed that can be used to predict changes in inventory as the result of changes in product design, equipment selection, or process flow. A case study of the application of the modules is given for energy consumption, but a similar methodology can be used for materials, individually or aggregated.

Applied modern biotechnology for cultivation of Ganoderma and development of their products.

PubMed

Zhou, Xuan-Wei; Su, Kai-Qi; Zhang, Yong-Ming

2012-02-01

A white-rot basidiomycete Ganoderma spp. has long been used as a medicinal mushroom in Asia, and it has an array of pharmacological properties for immunomodulatory activity. There have been many reports about the bioactive components and their pharmacological properties. In order to analyze the current status of Ganoderma products, the detailed process of cultivation of Ganoderma spp. and development of their products are restated in this review article. These include the breeding, cultivating, extracting bioactive component, and processing Ganoderma products, etc. This article will expand people's common knowledge on Ganoderma, and provide a beneficial reference for research and industrial production.

Artificial neural networks to model formulation-property correlations in the process of inline-compounding on an injection moulding machine

NASA Astrophysics Data System (ADS)

Moritzer, Elmar; Müller, Ellen; Martin, Yannick; Kleeschulte, Rainer

2015-05-01

Today the global market poses great challenges for industrial product development. Complexity, diversity of variants, flexibility and individuality are just some of the features that products have to offer today. In addition, the product series have shorter lifetimes. Because of their high capacity for adaption, polymers are increasingly able to displace traditional materials such as wood, glass and metals from various fields of application. Polymers can only be used to substitute other materials, however, if they are optimally suited to the applications in question. Hence, product-specific material development is becoming increasingly important. Integrating the compounding step in the injection moulding process permits a more efficient and faster development process for a new polymer formulation, making it possible to create new product-specific materials. This process is called inline-compounding on an injection moulding machine. The entire process sequence is supported by software from Bayer Technology called Product Design Workbench (PDWB), which provides assistance in all the individual steps from data management, via analysis and model compilation, right through to the optimization of the formulation and the design of experiments. The software is based on artificial neural networks and can model the formulation-property correlations and thus enable different formulations to be optimized. In the study presented, the workflow and the modelling with the software are presented.

Data Processing and First Products from the Hyperspectral Imager for the Coastal Ocean (HICO) on the International Space Station

DTIC Science & Technology

2010-04-01

NRL Stennis Space Center (NRL-SSC) for further processing using the NRL SSC Automated Processing System (APS). APS was developed for processing...have not previously developed automated processing for 73 hyperspectral ocean color data. The hyperspectral processing branch includes several

Exploring Group Communication and Productivity Improvement: Using an Experiential Process.

ERIC Educational Resources Information Center

Mandeville, Mary Y.; Mandeville, David E.

Engineering students at Oklahoma State University used an experiential process (the ACME Basket Exercise) to develop an understanding of how quality and productivity can be improved. The exercise simulates a traditional production organization in the classroom and mirrors the efforts, the successes, and the frustrations of individuals and work…

POLLUTION BALANCE: A NEW METHODOLOGY FOR MINIMIZING WASTE PRODUCTION IN MANUFACTURING PROCESSES.

EPA Science Inventory

A new methodolgy based on a generic pollution balance equation, has been developed for minimizing waste production in manufacturing processes. A "pollution index," defined as the mass of waste produced per unit mass of a product, has been introduced to provide a quantitative meas...

STATISTICAL ANALYSIS OF SNAP 10A THERMOELECTRIC CONVERTER ELEMENT PROCESS DEVELOPMENT VARIABLES

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

Fitch, S.H.; Morris, J.W.

1962-12-15

Statistical analysis, primarily analysis of variance, was applied to evaluate several factors involved in the development of suitable fabrication and processing techniques for the production of lead telluride thermoelectric elements for the SNAP 10A energy conversion system. The analysis methods are described as to their application for determining the effects of various processing steps, estabIishing the value of individual operations, and evaluating the significance of test results. The elimination of unnecessary or detrimental processing steps was accomplished and the number of required tests was substantially reduced by application of these statistical methods to the SNAP 10A production development effort. (auth)

A risk-based approach to management of leachables utilizing statistical analysis of extractables.

PubMed

Stults, Cheryl L M; Mikl, Jaromir; Whelehan, Oliver; Morrical, Bradley; Duffield, William; Nagao, Lee M

2015-04-01

To incorporate quality by design concepts into the management of leachables, an emphasis is often put on understanding the extractable profile for the materials of construction for manufacturing disposables, container-closure, or delivery systems. Component manufacturing processes may also impact the extractable profile. An approach was developed to (1) identify critical components that may be sources of leachables, (2) enable an understanding of manufacturing process factors that affect extractable profiles, (3) determine if quantitative models can be developed that predict the effect of those key factors, and (4) evaluate the practical impact of the key factors on the product. A risk evaluation for an inhalation product identified injection molding as a key process. Designed experiments were performed to evaluate the impact of molding process parameters on the extractable profile from an ABS inhaler component. Statistical analysis of the resulting GC chromatographic profiles identified processing factors that were correlated with peak levels in the extractable profiles. The combination of statistically significant molding process parameters was different for different types of extractable compounds. ANOVA models were used to obtain optimal process settings and predict extractable levels for a selected number of compounds. The proposed paradigm may be applied to evaluate the impact of material composition and processing parameters on extractable profiles and utilized to manage product leachables early in the development process and throughout the product lifecycle.

Assessment of Advanced Coal Gasification Processes

NASA Technical Reports Server (NTRS)

McCarthy, John; Ferrall, Joseph; Charng, Thomas; Houseman, John

1981-01-01

This report represents a technical assessment of the following advanced coal gasification processes: AVCO High Throughput Gasification (HTG) Process; Bell Single-Stage High Mass Flux (HMF) Process; Cities Service/Rockwell (CS/R) Hydrogasification Process; Exxon Catalytic Coal Gasification (CCG) Process. Each process is evaluated for its potential to produce SNG from a bituminous coal. In addition to identifying the new technology these processes represent, key similarities/differences, strengths/weaknesses, and potential improvements to each process are identified. The AVCO HTG and the Bell HMF gasifiers share similarities with respect to: short residence time (SRT), high throughput rate, slagging and syngas as the initial raw product gas. The CS/R Hydrogasifier is also SRT but is non-slagging and produces a raw gas high in methane content. The Exxon CCG gasifier is a long residence time, catalytic, fluidbed reactor producing all of the raw product methane in the gasifier. The report makes the following assessments: 1) while each process has significant potential as coal gasifiers, the CS/R and Exxon processes are better suited for SNG production; 2) the Exxon process is the closest to a commercial level for near-term SNG production; and 3) the SRT processes require significant development including scale-up and turndown demonstration, char processing and/or utilization demonstration, and reactor control and safety features development.

Integrated Process Modeling-A Process Validation Life Cycle Companion.

PubMed

Zahel, Thomas; Hauer, Stefan; Mueller, Eric M; Murphy, Patrick; Abad, Sandra; Vasilieva, Elena; Maurer, Daniel; Brocard, Cécile; Reinisch, Daniela; Sagmeister, Patrick; Herwig, Christoph

2017-10-17

During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation. Once the IPM is established, its capability in risk and criticality assessment is furthermore demonstrated. IPMs can be used to enable holistic production control strategies that take interactions of process parameters of multiple unit operations into account. Moreover, IPMs can be trained with development data, refined with qualification runs, and maintained with routine manufacturing data which underlines the lifecycle concept. These applications will be shown by means of a process characterization study recently conducted at a world-leading contract manufacturing organization (CMO). The new IPM methodology therefore allows anticipation of out of specification (OOS) events, identify critical process parameters, and take risk-based decisions on counteractions that increase process robustness and decrease the likelihood of OOS events.

Amorphous silicon photovoltaic manufacturing technology, phase 2A

NASA Astrophysics Data System (ADS)

Duran, G.; Mackamul, K.; Metcalf, D.

1995-01-01

Utility Power Group (UPG), and its lower-tier subcontractor, Advanced Photovoltaic Systems, Inc. (APS) have conducted efforts in developing their manufacturing lines. UPG has focused on the automation of encapsulation and termination processes developed in Phase 1. APS has focused on completion of the encapsulation and module design tasks, while continuing the process and quality control and automation projects. The goal is to produce 55 watt (stabilized) EP50 modules in a new facility. In the APS Trenton EUREKA manufacturing facility, APS has: (1) Developed high throughput lamination procedures; (2) Optimized existing module designs; (3) Developed new module designs for architectural applications; (4) Developed enhanced deposition parameter control; (5) Designed equipment required to manufacture new EUREKA modules developed during Phase II; (6) Improved uniformity of thin-film materials deposition; and (7) Improved the stabilized power output of the APS EP50 EUREKA module to 55 watts. In the APS Fairfield EUREKA manufacturing facility, APS has: (1) Introduced the new products developed under Phase 1 into the APS Fairfield EUREKA module production line; (2) Increased the extent of automation in the production line; (3) Introduced Statistical Process Control to the module production line; and (4) Transferred-progress made in the APS Trenton facility into the APS Fairfield facility.

Sustainable development in agriculture, food and nutrition--a patent analysis.

PubMed

Vani, Kohila P; Doble, Mukesh

2011-05-01

The paper discusses the patents that have been filed in the areas of sustainable development in agriculture, food and nutrition and use of natural resources in achieving this goal. A large number of patents deal with the production of fertilizers from animal manure, plant sources and other organic wastes, which are more sustainable that the chemical fertilizers that are being currently used. Sustainability in agriculture is achieved in developing processes for the manufacture of biopesticides/insecticides and bioactive agricultural products. Development of novel sustainable agricultural processes has also been the focus of researchers and technologists. Plant derived nutritious food products are sustainable and can cater for the growing population burden. This has been the focus of several patents. Processes for enhancing the nutrition in food also serve the purpose of catering for the under nourished population.

A Quality Assurance Initiative for Commercial-Scale Production in High-Throughput Cryopreservation of Blue Catfish Sperm

PubMed Central

Hu, E; Liao, T. W.; Tiersch, T. R.

2013-01-01

Cryopreservation of fish sperm has been studied for decades at a laboratory (research) scale. However, high-throughput cryopreservation of fish sperm has recently been developed to enable industrial-scale production. This study treated blue catfish (Ictalurus furcatus) sperm high-throughput cryopreservation as a manufacturing production line and initiated quality assurance plan development. The main objectives were to identify: 1) the main production quality characteristics; 2) the process features for quality assurance; 3) the internal quality characteristics and their specification designs; 4) the quality control and process capability evaluation methods, and 5) the directions for further improvements and applications. The essential product quality characteristics were identified as fertility-related characteristics. Specification design which established the tolerance levels according to demand and process constraints was performed based on these quality characteristics. Meanwhile, to ensure integrity throughout the process, internal quality characteristics (characteristics at each quality control point within process) that could affect fertility-related quality characteristics were defined with specifications. Due to the process feature of 100% inspection (quality inspection of every fish), a specific calculation method, use of cumulative sum (CUSUM) control charts, was applied to monitor each quality characteristic. An index of overall process evaluation, process capacity, was analyzed based on in-control process and the designed specifications, which further integrates the quality assurance plan. With the established quality assurance plan, the process could operate stably and quality of products would be reliable. PMID:23872356

Recombinant organisms for production of industrial products

PubMed Central

Adrio, Jose-Luis

2010-01-01

A revolution in industrial microbiology was sparked by the discoveries of ther double-stranded structure of DNA and the development of recombinant DNA technology. Traditional industrial microbiology was merged with molecular biology to yield improved recombinant processes for the industrial production of primary and secondary metabolites, protein biopharmaceuticals and industrial enzymes. Novel genetic techniques such as metabolic engineering, combinatorial biosynthesis and molecular breeding techniques and their modifications are contributing greatly to the development of improved industrial processes. In addition, functional genomics, proteomics and metabolomics are being exploited for the discovery of novel valuable small molecules for medicine as well as enzymes for catalysis. The sequencing of industrial microbal genomes is being carried out which bodes well for future process improvement and discovery of new industrial products. PMID:21326937

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

PubMed

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

2015-01-01

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing.

PubMed

Stauffer, F; Vanhoorne, V; Pilcer, G; Chavez, P-F; Rome, S; Schubert, M A; Aerts, L; De Beer, T

2018-06-01

Active Pharmaceutical Ingredients (API) raw material variability is not always thoroughly considered during pharmaceutical process development, mainly due to low quantities of drug substance available. However, synthesis, crystallization routes and production sites evolve during product development and product life cycle leading to changes in physical material attributes which can potentially affect their processability. Recent literature highlights the need for a global approach to understand the link between material synthesis, material variability, process and product quality. The study described in this article aims at explaining the raw material variability of an API using extensive material characterization on a restricted number of representative batches using multivariate data analysis. It is part of a larger investigation trying to link the API drug substance manufacturing process, the resulting physical API raw material attributes and the drug product continuous manufacturing process. Eight API batches produced using different synthetic routes, crystallization, drying, delumping processes and processing equipment were characterized, extensively. Seventeen properties from seven characterization techniques were retained for further analysis using Principal Component Analysis (PCA). Three principal components (PCs) were sufficient to explain 92.9% of the API raw material variability. The first PC was related to crystal length, agglomerate size and fraction, flowability and electrostatic charging. The second PC was driven by the span of the particle size distribution and the agglomerates strength. The third PC was related to surface energy. Additionally, the PCA allowed to summarize the API batch-to-batch variability in only three PCs which can be used in future drug product development studies to quantitatively evaluate the impact of the API raw material variability upon the drug product process. The approach described in this article could be applied to any other compound which is prone to batch-to-batch variability. Copyright © 2018 Elsevier B.V. All rights reserved.

Multi-objective optimization of chromatographic rare earth element separation.

PubMed

Knutson, Hans-Kristian; Holmqvist, Anders; Nilsson, Bernt

2015-10-16

The importance of rare earth elements in modern technological industry grows, and as a result the interest for developing separation processes increases. This work is a part of developing chromatography as a rare earth element processing method. Process optimization is an important step in process development, and there are several competing objectives that need to be considered in a chromatographic separation process. Most studies are limited to evaluating the two competing objectives productivity and yield, and studies of scenarios with tri-objective optimizations are scarce. Tri-objective optimizations are much needed when evaluating the chromatographic separation of rare earth elements due to the importance of product pool concentration along with productivity and yield as process objectives. In this work, a multi-objective optimization strategy considering productivity, yield and pool concentration is proposed. This was carried out in the frame of a model based optimization study on a batch chromatography separation of the rare earth elements samarium, europium and gadolinium. The findings from the multi-objective optimization were used to provide with a general strategy for achieving desirable operation points, resulting in a productivity ranging between 0.61 and 0.75 kgEu/mcolumn(3), h(-1) and a pool concentration between 0.52 and 0.79 kgEu/m(3), while maintaining a purity above 99% and never falling below an 80% yield for the main target component europium. Copyright © 2015 Elsevier B.V. All rights reserved.

A three-prong strategy to develop functional food using protein isolates recovered from chicken processing by-products with isoelectric solubilization/precipitation.

PubMed

Tahergorabi, Reza; Sivanandan, Litha; Beamer, Sarah K; Matak, Kristen E; Jaczynski, Jacek

2012-09-01

Skin-on bone-in chicken drumsticks were processed with isoelectric solubilization/precipitation to recover muscle proteins. The drumsticks were used as a model for dark chicken meat processing by-products. The main objective of this study was conversion of dark chicken meat processing by-products to restructured functional food product. An attempt was made to develop functional food product that would resemble respective product made from boneless skinless chicken breast meat. A three-prong strategy to address diet-driven cardiovascular disease (CVD)with a functional food was used in this study. The strategy included addition of three ingredients with well-documented cardiovascular benefits: (i) ω-3 polyunsaturated fatty acid-rich oil (flaxseed-algae, 9:1); (ii) soluble fiber; and (iii) salt substitute. Titanium dioxide, potato starch, polyphosphate, and transglutaminase were also added. The batters were formulated and cooked resulting in heat-set gels. Color (L*a*b*), texture (torsion test, Kramer shear test, and texture profile analysis), thermal denaturation (differential scanning calorimetry), and gelation (dynamic rheology) of chicken drumstick gels and chicken breast gels were determined and compared. Chicken drumstick gels generally had comparable color and texture properties to the gels made from chicken breast meat. The endothermic transition (thermal denaturation) of myosin was more pronounced and gelation properties were better for the drumstick gels. This study demonstrated a feasibility to develop functional food made of muscle proteins recovered with isoelectric solubilization/precipitation from low-value dark chicken meat processing by-products. The functional food developed in this study was enriched with CVD-beneficial nutrients and had comparable instrumental quality attributes to respective products made of chicken breast meat. Although the results of this study point towards the potential for a novel, marketable functional food product, sensory tests and storage stability study are recommended. Copyright © 2012 Society of Chemical Industry.

Polyfire project- an example of an industrial research project promoting safe industrial production of fire-resistant nanocomposites

NASA Astrophysics Data System (ADS)

Vaquero, C.; López de Ipiña, J.; Galarza, N.; Hargreaves, B.; Weager, B.; Breen, C.

2011-07-01

New developments based on nanotechnology have to guarantee safe products and processes to be accepted by society. The Polyfire project will develop and scale-up techniques for processing halogen-free, fire-retardant nanocomposite materials and coatings based on unsaturated polyester resins and organoclays. The project includes a work package that will assess the Health and Environmental impacts derived from the manipulation of nanoparticles. This work package includes the following tasks: (1) Identification of Health and Environment Impacts derived from the processes, (2) Experimentation to study specific Nanoparticle Emissions, (3) Development of a Risk Management Methodology for the process, and (4) A Comparison of the Health and Environmental Impact of New and Existing Materials. To date, potential exposure scenarios to nanomaterials have been identified through the development of a Preliminary Hazard Analysis (PHA) of the new production processes. In the next step, these scenarios will be studied and simulated to evaluate potential emissions of nanomaterials. Polyfire is a collaborative European project, funded by the European Commission 7th Framework Programme (Grant Agreement No 229220). It features 11 partners from 5 countries (5 SMEs, 3 research institutes, 2 large companies, 1 association) and runs for three years (1st September 2009 - 31st August 2012). This project is an example of an industrial research development which aims to introduce to the market new products promoting the safe use of nanomaterials.

Process development and modeling of fluidized-bed reactor with coimmobilized biocatalyst for fuel ethanol production

NASA Astrophysics Data System (ADS)

Sun, May Yongmei

This research focuses on two steps of commercial fuel ethanol production processes: the hydrolysis starch process and the fermentation process. The goal of this research is to evaluate the performance of co-immobilized biocatalysts in a fluidized bed reactor with emphasis on economic and engineering aspects and to develop a predictive mathematical model for this system. The productivity of an FBR is higher than productivity of a traditional batch reactor or CSTR. Fluidized beds offer great advantages over packed beds for immobilized cells when small particles are used or when the reactant feed contains suspended solids. Plugging problems, excessive pressure drops (and thus attrition), or crushing risks may be avoided. No mechanical stirring is required as mixing occurs due to the natural turbulence in the fluidized process. Both enzyme and microorganism are immobilized in one catalyst bead which is called co-immobilization. Inside this biocatalyst matrix, starch is hydrolyzed by the enzyme glucoamylase to form glucose and then converted to ethanol and carbon dioxide by microorganisms. Two biocatalysts were evaluated: (1) co-immobilized yeast strain Saccharomyces cerevisiae and glucoamylase. (2) co-immobilized Zymomonas mobilis and glucoamylase. A co-immobilized biocatalyst accomplishes the simultaneous saccharification and fermentation (SSF process). When compared to a two-step process involving separate saccharification and fermentation stages, the SSF process has productivity values twice that given by the pre-saccharified process when the time required for pre-saccharification (15--25 h) was taken into account. The SSF process should also save capital cost. The information about productivity, fermentation yield, concentration profiles along the bed, ethanol inhibition, et al., was obtained from the experimental data. For the yeast system, experimental results showed that: no apparent decrease of productivity occurred after two and half months, the productivity was 25--44g/L-hr (based on reactor volume), the average yield was 0.45 g ethanol/g starch, the biocatalyst retained physical integrity and contamination did not affect fermentation. For the Z. mobilis system the maximum volumetric productivity was 38 g ethanol/L-h, the average yield was 0.51 g ethanol/g starch and the FBR was successfully operated for almost one month. In order to develop, scale-up and economically evaluate this system more efficiently, a predictive mathematical model that is based on fundamental principles was developed and verified. This model includes kinetics of reactions, transport phenomena of the reactant and product by diffusion within the biocatalyst bead, and the hydrodynamics of the three phase fluidized bed. The co-immobilized biocatalyst involves a consecutive reaction mechanism The mathematical descriptions of the effectiveness factors of reactant and the intermediate product were developed. Hydrodynamic literature correlations were used to develop the dispersion coefficient and gas, liquid, and solid holdup. The solutions of coupled non-linear second order equations for biocatalyst bead and reactor together with the boundary conditions were solved numerically. This model gives considerable information about the system, such as concentration profiles inside both the beads and column, flow rate and feed concentration influences on productivity and phase hold up, and the influence of enzyme and cell mass loading in the catalyst. This model is generic in nature such that it can be easily applied to a diverse set of applications and operating conditions.

Manufacturing methods of a composite cell case for a Ni-Cd battery

NASA Technical Reports Server (NTRS)

Bauer, J. L.

1979-01-01

Basic manufacturing method refinements for using graphite epoxy material for a nickel cadmium battery cell case were performed to demonstrate production feasibility. The various facets of production scale-up, i.e., process and tooling development, together with material and process control, were integrated into a comprehensive manufacturing process that assures production reproducibility and product uniformity. Test results substantiate that a battery cell case produced from graphite epoxy pre-impregnated material, utilizing the internal pressure bag fabrication method, is feasible.

A novel cell factory for efficient production of ethanol from dairy waste.

PubMed

Liu, Jianming; Dantoft, Shruti Harnal; Würtz, Anders; Jensen, Peter Ruhdal; Solem, Christian

2016-01-01

Sustainable and economically feasible ways to produce ethanol or other liquid fuels are becoming increasingly relevant due to the limited supply of fossil fuels and the environmental consequences associated with their consumption. Microbial production of fuel compounds has gained a lot of attention and focus has mostly been on developing bio-processes involving non-food plant biomass feedstocks. The high cost of the enzymes needed to degrade such feedstocks into its constituent sugars as well as problems due to various inhibitors generated in pretreatment are two challenges that have to be addressed if cost-effective processes are to be established. Various industries, especially within the food sector, often have waste streams rich in carbohydrates and/or other nutrients, and these could serve as alternative feedstocks for such bio-processes. The dairy industry is a good example, where large amounts of cheese whey or various processed forms thereof are generated. Because of their nutrient-rich nature, these substrates are particularly well suited as feedstocks for microbial production. We have generated a Lactococcus lactis strain which produces ethanol as its sole fermentation product from the lactose contained in residual whey permeate (RWP), by introducing lactose catabolism into a L. lactis strain CS4435 (MG1363 Δ(3) ldh, Δpta, ΔadhE, pCS4268), where the carbon flow has been directed toward ethanol instead of lactate. To achieve growth and ethanol production on RWP, we added corn steep liquor hydrolysate (CSLH) as the nitrogen source. The outcome was efficient ethanol production with a titer of 41 g/L and a yield of 70 % of the theoretical maximum using a fed-batch strategy. The combination of a low-cost medium from industrial waste streams and an efficient cell factory should make the developed process industrially interesting. A process for the production of ethanol using L. lactis and a cheap renewable feedstock was developed. The results demonstrate that it is possible to achieve sustainable bioconversion of waste products from the dairy industry (RWP) and corn milling industry (CSLH) to ethanol and the process developed shows great potential for commercial realization.

Development of a Rolling Process Design Tool for Use in Improving Hot Roll Slab Recovery

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

Couch, R; Becker, R; Rhee, M

2004-09-24

Lawrence Livermore National Laboratory participated in a U. S. Department of Energy/Office of Industrial Technology sponsored research project 'Development of a Rolling Process Design Tool for Use in Improving Hot Roll Slab Recovery', as a Cooperative Agreement TC-02028 with the Alcoa Technical Center (ATC). The objective of the joint project with Alcoa is to develop a numerical modeling capability to optimize the hot rolling process used to produce aluminum plate. Product lost in the rolling process and subsequent recycling, wastes resources consumed in the energy-intensive steps of remelting and reprocessing the ingot. The modeling capability developed by project partners willmore » be used to produce plate more efficiently and with reduced product loss.« less

Flat-plate solar array project. Volume 2: Silicon material

NASA Technical Reports Server (NTRS)

Lutwack, R.

1986-01-01

The goal of the Silicon Material Task, a part of the Flat Plate Solar Array (FSA) Project, was to develop and demonstate the technology for the low cost production of silicon of suitable purity to be used as the basic material for the manufacture of terrestrial photovoltaic solar cells. Summarized are 11 different processes for the production of silicon that were investigated and developed to varying extent by industrial, university, and Government researchers. The silane production section of the Union Carbide Corp. (UCC) silane process was developed completely in this program. Coupled with Siemens-type chemical vapor deposition reactors, the process was carried through the pilot stage. The overall UCC process involves the conversion of metallurgical-grade silicon to silane followed by decomposition of the silane to purified silicon. The other process developments are described to varying extents. Studies are reported on the effects of impurities in silicon on both silicon-material properties and on solar cell performance. These studies on the effects of impurities yielded extensive information and models for relating specific elemental concentrations to levels of deleterious effects.

Flat-plate solar array project. Volume 2: Silicon material

NASA Astrophysics Data System (ADS)

Lutwack, R.

1986-10-01

The goal of the Silicon Material Task, a part of the Flat Plate Solar Array (FSA) Project, was to develop and demonstate the technology for the low cost production of silicon of suitable purity to be used as the basic material for the manufacture of terrestrial photovoltaic solar cells. Summarized are 11 different processes for the production of silicon that were investigated and developed to varying extent by industrial, university, and Government researchers. The silane production section of the Union Carbide Corp. (UCC) silane process was developed completely in this program. Coupled with Siemens-type chemical vapor deposition reactors, the process was carried through the pilot stage. The overall UCC process involves the conversion of metallurgical-grade silicon to silane followed by decomposition of the silane to purified silicon. The other process developments are described to varying extents. Studies are reported on the effects of impurities in silicon on both silicon-material properties and on solar cell performance. These studies on the effects of impurities yielded extensive information and models for relating specific elemental concentrations to levels of deleterious effects.

NASA Space Engineering Research Center for Utilization of Local Planetary Resources

NASA Technical Reports Server (NTRS)

Ramohalli, Kumar; Lewis, John S.

1991-01-01

In the processing of propellants, volatiles, and metals subject area, the following topics are discussed: reduction of lunar regolith; reduction of carbon dioxide; and reduction of carbonaceous materials. Other areas addressed include: (1) production of structural and refractory materials; (2) resource discovery and characterization; (3) system automation and optimization; and (4) database development. The majority of these topics are discussed with respect to the development of lunar and mars bases. Some main topics of interest include: asteroid resources, lunar resources, mars resources, materials processing, construction materials, propellant production, oxygen production, and space-based oxygen production plants.

Scale-up of ethanol production from winter barley by the EDGE (enhanced dry grind enzymatic) process in fermentors up to 300 liters

USDA-ARS?s Scientific Manuscript database

A fermentation process, which was designated the EDGE (enhanced dry grind enzymatic) process, has recently been developed for barley ethanol production. In the EDGE process, in addition to the enzymes normally required for starch hydrolysis, commercial Beta-glucanases were used to hydrolyze (1,3)(1,...

Prospects of microbial cell factories developed through systems metabolic engineering.

PubMed

Gustavsson, Martin; Lee, Sang Yup

2016-09-01

While academic-level studies on metabolic engineering of microorganisms for production of chemicals and fuels are ever growing, a significantly lower number of such production processes have reached commercial-scale. In this work, we review the challenges associated with moving from laboratory-scale demonstration of microbial chemical or fuel production to actual commercialization, focusing on key requirements on the production organism that need to be considered during the metabolic engineering process. Metabolic engineering strategies should take into account techno-economic factors such as the choice of feedstock, the product yield, productivity and titre, and the cost effectiveness of midstream and downstream processes. Also, it is important to develop an industrial strain through metabolic engineering for pathway construction and flux optimization together with increasing tolerance to products and inhibitors present in the feedstock, and ensuring genetic stability and strain robustness under actual fermentation conditions. © 2016 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

Operationalizing Space Weather Products - Process and Issues

NASA Astrophysics Data System (ADS)

Scro, K. D.; Quigley, S.

2006-12-01

Developing and transitioning operational products for any customer base is a complicated process. This is the case for operational space weather products and services for the USAF. This presentation will provide information on the current state of affairs regarding the process required to take an idea from the research field to the real-time application of 24-hour space weather operations support. General principles and specific issues are discussed and will include: customer requirements, organizations in-play, funding, product types, acquisition of engineering and validation data, security classification, version control, and various important changes that occur during the process. The author's viewpoint is as an individual developing space environmental system-impact products for the US Air Force: 1) as a member of its primary research organization (Air Force Research Laboratory), 2) working with its primary space environment technology transition organization (Technology Application Division of the Space and Missile Systems Center, SMC/WXT), and 3) delivering to the primary sponsor/customer of such system-impact products (Air Force Space Command). The experience and focus is obviously on specific military operationalization process and issues, but most of the paradigm may apply to other (commercial) enterprises as well.

Production of lentiviral vectors

PubMed Central

Merten, Otto-Wilhelm; Hebben, Matthias; Bovolenta, Chiara

2016-01-01

Lentiviral vectors (LV) have seen considerably increase in use as gene therapy vectors for the treatment of acquired and inherited diseases. This review presents the state of the art of the production of these vectors with particular emphasis on their large-scale production for clinical purposes. In contrast to oncoretroviral vectors, which are produced using stable producer cell lines, clinical-grade LV are in most of the cases produced by transient transfection of 293 or 293T cells grown in cell factories. However, more recent developments, also, tend to use hollow fiber reactor, suspension culture processes, and the implementation of stable producer cell lines. As is customary for the biotech industry, rather sophisticated downstream processing protocols have been established to remove any undesirable process-derived contaminant, such as plasmid or host cell DNA or host cell proteins. This review compares published large-scale production and purification processes of LV and presents their process performances. Furthermore, developments in the domain of stable cell lines and their way to the use of production vehicles of clinical material will be presented. PMID:27110581

Application of high-throughput mini-bioreactor system for systematic scale-down modeling, process characterization, and control strategy development.

PubMed

Janakiraman, Vijay; Kwiatkowski, Chris; Kshirsagar, Rashmi; Ryll, Thomas; Huang, Yao-Ming

2015-01-01

High-throughput systems and processes have typically been targeted for process development and optimization in the bioprocessing industry. For process characterization, bench scale bioreactors have been the system of choice. Due to the need for performing different process conditions for multiple process parameters, the process characterization studies typically span several months and are considered time and resource intensive. In this study, we have shown the application of a high-throughput mini-bioreactor system viz. the Advanced Microscale Bioreactor (ambr15(TM) ), to perform process characterization in less than a month and develop an input control strategy. As a pre-requisite to process characterization, a scale-down model was first developed in the ambr system (15 mL) using statistical multivariate analysis techniques that showed comparability with both manufacturing scale (15,000 L) and bench scale (5 L). Volumetric sparge rates were matched between ambr and manufacturing scale, and the ambr process matched the pCO2 profiles as well as several other process and product quality parameters. The scale-down model was used to perform the process characterization DoE study and product quality results were generated. Upon comparison with DoE data from the bench scale bioreactors, similar effects of process parameters on process yield and product quality were identified between the two systems. We used the ambr data for setting action limits for the critical controlled parameters (CCPs), which were comparable to those from bench scale bioreactor data. In other words, the current work shows that the ambr15(TM) system is capable of replacing the bench scale bioreactor system for routine process development and process characterization. © 2015 American Institute of Chemical Engineers.

Usability in product design--the importance and need for systematic assessment models in product development--Usa-Design Model (U-D) ©.

PubMed

Merino, Giselle Schmidt Alves Díaz; Teixeira, Clarissa Stefani; Schoenardie, Rodrigo Petry; Merino, Eugenio Andrés Diáz; Gontijo, Leila Amaral

2012-01-01

In product design, human factors are considered as an element of differentiation given that today's consumer demands are increasing. Safety, wellbeing, satisfaction, health, effectiveness, efficiency, and other aspects must be effectively incorporated into the product development process. This work proposes a usability assessment model that can be incorporated as an assessment tool. The methodological approach is settled in two stages. First a literature review focus specifically on usability and developing user-centred products. After this, a model of usability named Usa-Design (U-D©) is presented. Consisted of four phases: understanding the use context, pre-preliminary usability assessment (efficiency/effectiveness/satisfaction); assessment of usability principles and results, U-D© features are modular and flexible, allowing principles used in Phase 3 to be changed according to the needs and scenario of each situation. With qualitative/quantitative measurement scales of easy understanding and application, the model results are viable and applicable throughout all the product development process.

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.

Evaluation of Selected Chemical Processes for Production of Low-cost Silicon, Phase 3. [using a fluidized bed reactor

NASA Technical Reports Server (NTRS)

Blocher, J. M., Jr.; Browning, M. F.

1979-01-01

The construction and operation of an experimental process system development unit (EPSDU) for the production of granular semiconductor grade silicon by the zinc vapor reduction of silicon tetrachloride in a fluidized bed of seed particles is presented. The construction of the process development unit (PDU) is reported. The PDU consists of four critical units of the EPSDU: the fluidized bed reactor, the reactor by product condenser, the zinc vaporizer, and the electrolytic cell. An experimental wetted wall condenser and its operation are described. Procedures are established for safe handling of SiCl4 leaks and spills from the EPSDU and PDU.

The TMIS life-cycle process document, revision A

NASA Technical Reports Server (NTRS)

1991-01-01

The Technical and Management Information System (TMIS) Life-Cycle Process Document describes the processes that shall be followed in the definition, design, development, test, deployment, and operation of all TMIS products and data base applications. This document is a roll out of TMIS Standards Document (SSP 30546). The purpose of this document is to define the life cycle methodology that the developers of all products and data base applications and any subsequent modifications shall follow. Included in this methodology are descriptions of the tasks, deliverables, reviews, and approvals that are required before a product or data base application is accepted in the TMIS environment.

Process-Product Research: A Cornerstone in Educational Effectiveness Research

ERIC Educational Resources Information Center

Creemers, Bert; Kyriakides, Leonidas

2015-01-01

This article links the contribution of process-product studies in developing the theoretical framework of educational effectiveness by pointing out the importance of teacher behavior in the classroom. The role that Jere Brophy played in this evolving research is described within the various phases of teacher effectiveness research. Process-product…

Potential uses for cuphea oil processing byproducts and processed oils

USDA-ARS?s Scientific Manuscript database

Cuphea spp. has seeds that contain high levels of medium chain fatty acids and have the potential to be commercially cultivated. In the course of processing and refining Cuphea oil a number of bi-products are generated. Developing commercial uses for these bi-products would improve the economics of...

Peering into the secrets of food and agricultural co-products

NASA Astrophysics Data System (ADS)

Wood, Delilah; Williams, Tina; Glenn, Gregory; Pan, Zhongli; Orts, William; McHugh, Tara

2010-06-01

Scanning electron microscopy is a useful tool for understanding food contamination and directing product development of food and industrial products. The current trend in food research is to produce foods that are fast to prepare and/or ready to eat. At the same time, these processed foods must be safe, high quality and maintain all or most of the nutritional value of the original whole foods. Minimally processed foods, is the phrase used to characterize these "new" foods. New techniques are needed which take advantage of minimal processing or processing which enhances the fresh properties and characteristics of whole foods while spending less time on food preparation. The added benefit coupled to less cooking time in an individual kitchen translates to an overall energy savings and reduces the carbon emissions to the environment. Food processing changes the microstructure, and therefore, the quality, texture and flavor, of the resulting food product. Additionally, there is the need to reduce waste, transportation costs and product loss during transportation and storage. Unlike food processing, structural changes are desirable in co-products as function follows form for food packaging films and boxes as well as for building materials and other industrial products. Thus, the standard materials testing procedures are coupled with SEM to provide direction in the development of products from agricultural residues or what would otherwise be considered waste materials. The use of agricultural residues reduces waste and adds value to a currently underutilized or unutilized product. The product might be biodegradable or compostable, thus reducing landfill requirements. Manufacturing industrial and packaging products from biological materials also reduces the amount of petroleum products currently standard in the industry.

The Application of Concurrent Engineering Tools and Design Structure Matrix in Designing Tire

NASA Astrophysics Data System (ADS)

Ginting, Rosnani; Fachrozi Fitra Ramadhan, T.

2016-02-01

The development of automobile industry in Indonesia is growing rapidly. This phenomenon causes companies related to the automobile industry such as tire industry must develop products based on customers’ needs and considering the timeliness of delivering the product to the customer. It could be reached by applying strategic planning in developing an integrated concept of product development. This research was held in PT. XYZ that applied the sequential approach in designing and developing products. The need to improve in one stage of product development could occur re-designing that needs longer time in developing a new product. This research is intended to get an integrated product design concept of tire pertaining to the customer's needs using Concurrent Engineering Tools by implementing the two-phased of product development. The implementation of Concurrent Engineering approach results in applying the stage of project planning, conceptual design, and product modules. The product modules consist of four modules that using Product Architecture - Design Structure Matrix to ease the designing process of new product development.

Instrumentation for studying binder burnout in an immobilized plutonium ceramic wasteform

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

Mitchell, M; Pugh, D; Herman, C

The Plutonium Immobilization Program produces a ceramic wasteform that utilizes organic binders. Several techniques and instruments were developed to study binder burnout on full size ceramic samples in a production environment. This approach provides a method for developing process parameters on production scale to optimize throughput, product quality, offgas behavior, and plant emissions. These instruments allow for offgas analysis, large-scale TGA, product quality observation, and thermal modeling. Using these tools, results from lab-scale techniques such as laser dilametry studies and traditional TGA/DTA analysis can be integrated. Often, the sintering step of a ceramification process is the limiting process step thatmore » controls the production throughput. Therefore, optimization of sintering behavior is important for overall process success. Furthermore, the capabilities of this instrumentation allows better understanding of plant emissions of key gases: volatile organic compounds (VOCs), volatile inorganics including some halide compounds, NO{sub x}, SO{sub x}, carbon dioxide, and carbon monoxide.« less

Thin Gauge Twin-Roll Casting, Process Capabilities and Product Quality

NASA Astrophysics Data System (ADS)

Daaland, O.; Espedal, A. B.; Nedreberg, M. L.; Alvestad, I.

Traditionally industrial twin roll casters have been operated at gauges 6-10 mm, depending on the type of caster and the final product requirements. Over the past few years it has become apparent that a significant increase in productivity can be achieved when the casting gauge is reduced. Hydro Aluminium embarked on an extensive research and development, thin gauge casting programme, in the beginning of the 1990's and this paper presents some results from a five year lasting project (joint programme between Hydro Aluminium a.s. and Lauener Engineering). Based on more than 400 casting trials the major benefits and limitations of casting at reduced gauge and increased speed are outlined. Important aspects related to process development and product quality are discussed including: productivity and limitations, surface defects, microstructural characteristics, cooling rates and dendrite structure, segregation behaviour and mechanical properties after thermo-mechanical processing. Results for casting of several alloys are given. Additionally, numerical modelling results of the strip casting process are included.

Recent patents for detecting the species of origin in animal feedstuff, and raw and processed meat products.

PubMed

Rogberg-Muñoz, Andrés; Posik, Diego M; Rípoli, María V; Falomir Lockhart, Agustín H; Peral-García, Pilar; Giovambattista, Guillermo

2013-04-01

The value of the traceability and labeling of food is attributable to two main aspects: health safety and/or product or process certification. The identification of the species related to meat production is still a major concern for economic, religious and health reasons. Many approaches and technologies have been used for species identification in animal feedstuff and food. The early methods for meat products identification include physical, anatomical, histological and chemical. Since 1970, a variety of methods were developed, these include electrophoresis (i.e. isoelectrofocusing), chromatography (i.e. HPLC), immunological techniques (i.e. ELISA), Nuclear Magnetic Resonance, Mass Spectrometry and PCR (DNA and RNA based methods). The recent patents on species detection in animal feedstuffs, raw meat and meat processed products, listed in this work, are mainly based on monoclonal antibodies and PCR, especially RT-PCR. The new developments under research are looking for more sensible, specific, less time consuming and quantitatively detection methods, which can be used in highly processed or heated treated meat food.

Recent progress in continuous and semi-continuous processing of solid oral dosage forms: a review.

PubMed

Teżyk, Michał; Milanowski, Bartłomiej; Ernst, Andrzej; Lulek, Janina

2016-08-01

Continuous processing is an innovative production concept well known and successfully used in other industries for many years. The modern pharmaceutical industry is facing the challenge of transition from a traditional manufacturing approach based on batch-wise production to a continuous manufacturing model. The aim of this article is to present technological progress in manufacturing based on continuous and semi-continuous processing of the solid oral dosage forms. Single unit processes possessing an alternative processing pathway to batch-wise technology or, with some modification, an altered approach that may run continuously, and are thus able to seamlessly switch to continuous manufacturing are briefly presented. Furthermore, the concept of semi-continuous processing is discussed. Subsequently, more sophisticated production systems created by coupling single unit processes and comprising all the steps of production, from powder to final dosage form, were reviewed. Finally, attempts of end-to-end production approach, meaning the linking of continuous synthesis of API from intermediates with the production of final dosage form, are described. There are a growing number of scientific articles showing an increasing interest in changing the approach to the production of pharmaceuticals in recent years. Numerous scientific publications are a source of information on the progress of knowledge and achievements of continuous processing. These works often deal with issues of how to modify or replace the unit processes in order to enable seamlessly switching them into continuous processing. A growing number of research papers concentrate on integrated continuous manufacturing lines in which the production concept of "from powder to tablet" is realized. Four main domains are under investigation: influence of process parameters on intermediates or final dosage forms properties, implementation of process analytical tools, control-managing system responsible for keeping continuous materials flow through the whole manufacturing process and the development of new computational methods to assess or simulate these new manufacturing techniques. The attempt to connect the primary and secondary production steps proves that development of continuously operating lines is possible. A mind-set change is needed to be able to face, and fully assess, the advantages and disadvantages of switching from batch to continuous mode production.

SAR Altimetry Processing on Demand Service for CryoSat-2 and Sentinel-3 at ESA G-POD

NASA Astrophysics Data System (ADS)

Dinardo, Salvatore; Lucas, Bruno; Benveniste, Jerome

2015-12-01

The scope of this work is to feature the new ESA service (SARvatore) for the exploitation of the CryoSat-2 data, designed and developed entirely by the Altimetry Team at ESA-ESRIN EOP-SER (Earth Observation - Exploitation, Research and Development). The G-POD Service, SARvatore (SAR Versatile Altimetric Toolkit for Ocean Research & Exploitation) for CryoSat-2, is a web platform that provides the capability to process on-line and on-demand CryoSat-2 SAR/SARIN data, from L1a (FBR) data products until SAR/SARIN Level-2 geophysical data products.. The Processor will make use of the G-POD (Grid-Processing On Demand) distributed computing platform to deliver timely the output data products. These output data products are generated in standard NetCDF format (using CF Convention), and they are compatible with BRAT (Basic Radar Altimetry Toolbox) and other NetCDF tool. Using the G-POD graphic interface, it is easy to select the geographical area of interest along with the time-frame of interest, based on the Cryosat-2 SAR/SARIN FBR data products availability in the service's catalogue. After the task submission, the users can follow, in real time, the status of the processing task. The processor prototype is versatile in the sense that the users can customize and adapt the processing, according their specific requirements, setting a list of configurable options. The processing service is meant to be used for research & development experiments, to support the development contracts awarded confronting the deliverables to ESA, on site demonstrations/training in training courses and workshops, cross-comparison against third party products (CLS/CNES CPP Products for instance), preparation for the Sentinel-3 Topographic mission, producing data and graphics for publications, etc. So far, the processing has been designed and optimized for open ocean studies and is fully functional only over this kind of surface but there are plans to augment this processing capacity over coastal zone, inland water and over land in view of maximizing the exploitation of the upcoming Sentinel-3 Topographic mission over all surfaces. The service is open and free of charge.

Possible monitoring requirements for the disinfectants and disinfection by-products (D/DBP) regulations

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

Not Available

1993-01-01

The monitoring requirements presented in the report were developed by EPA before a negotiated Disinfectants and Disinfection By-Products (D/DBP) rule was considered. The framework described herein may be substantially changed as a result of the negotiated rulemaking process. The document is useful to consider in developing various monitoring options during the negotiated rulemaking process.

Process characterization and Design Space definition.

PubMed

Hakemeyer, Christian; McKnight, Nathan; St John, Rick; Meier, Steven; Trexler-Schmidt, Melody; Kelley, Brian; Zettl, Frank; Puskeiler, Robert; Kleinjans, Annika; Lim, Fred; Wurth, Christine

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 (MAb). This chapter describes the tools used for the characterization and validation of MAb manufacturing process under the QbD paradigm. This comprises risk assessments for the identification of potential Critical Process Parameters (pCPPs), statistically designed experimental studies as well as studies assessing the linkage of the unit operations. Outcome of the studies is the classification of process parameters according to their criticality and the definition of appropriate acceptable ranges of operation. The process and product knowledge gained in these studies can lead to the approval of a Design Space. Additionally, the information gained in these studies are used to define the 'impact' which the manufacturing process can have on the variability of the CQAs, which is used to define the testing and monitoring strategy. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. 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.

Design of high productivity antibody capture by protein A chromatography using an integrated experimental and modeling approach.

PubMed

Ng, Candy K S; Osuna-Sanchez, Hector; Valéry, Eric; Sørensen, Eva; Bracewell, Daniel G

2012-06-15

An integrated experimental and modeling approach for the design of high productivity protein A chromatography is presented to maximize productivity in bioproduct manufacture. The approach consists of four steps: (1) small-scale experimentation, (2) model parameter estimation, (3) productivity optimization and (4) model validation with process verification. The integrated use of process experimentation and modeling enables fewer experiments to be performed, and thus minimizes the time and materials required in order to gain process understanding, which is of key importance during process development. The application of the approach is demonstrated for the capture of antibody by a novel silica-based high performance protein A adsorbent named AbSolute. In the example, a series of pulse injections and breakthrough experiments were performed to develop a lumped parameter model, which was then used to find the best design that optimizes the productivity of a batch protein A chromatographic process for human IgG capture. An optimum productivity of 2.9 kg L⁻¹ day⁻¹ for a column of 5mm diameter and 8.5 cm length was predicted, and subsequently verified experimentally, completing the whole process design approach in only 75 person-hours (or approximately 2 weeks). Copyright © 2012 Elsevier B.V. All rights reserved.

From Safe Nanomanufacturing to Nanosafe-by-Design processes

NASA Astrophysics Data System (ADS)

Schuster, F.; Lomello, F.

2013-04-01

Industrial needs in terms of multifunctional components are increasing. Many sectors are concerned, from the integrated direct nanoparticles production to the emerging combinations which include the metal matrix composites (MMC), ductile ceramics and ceramic matrix composites, polymer matrix composites (PMC) for bulk application and advanced surface coatings in the fields of automotive, aerospace, energy production and building applications. Moreover, domains with a planetary impact such as environmental issues, as well as aspects for instance health (toxicity) and hazard assessment (ignition and explosion severity) were also taken into account. Nanotechnologies play an important role in promoting innovation in design and realization of multifunctional products for the future, either by improving usual products or creating new functions and/or new products. Nevertheless, this huge evolution in terms of materials could only be promoted by increasing the social acceptance and by acting on the different main technological and economic challenges and developing safe oriented processes. Nowadays, a huge number of developments of nanoparticles are potentially industrial up-scalable. However, some doubts exist about the handling's safety of the current technologies. For these reasons, the main purpose was to develop a self-monitored automation in the production line coupling different techniques in order to simplify processes such as in-situ growth nanoparticles into a nanostructured matrix, over different substrates and/or the nanopowders synthesis, functionalization, dry or wet safe recovery system, granulation, consolidation in single-step, by monitoring at real time the processing parameters such as powder stoichiometry. With the aim of assuring the traceability of the product during the whole life, starting from the conception and including the R&D, the distribution and the use were also considered. The optimization in terms of processing, recovery and conditioning, permits to increase its versatility, thus leading to the increase of the added value to the production. This review put in evidence -by different examples- the progress achieved since the beginning of Nanosafe integrated initiative developed by CEA and its partners as well as promoting, firstly the safety at work place, and then extending to an integrated and controlled in-situ production by of Nanosafe-by-Design controlled processes.

47 CFR 6.7 - Product design, development, and evaluation.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Manufacturers and service providers shall evaluate the accessibility, usability, and compatibility of equipment... identify barriers to accessibility and usability as part of such a product design and development process...

47 CFR 6.7 - Product design, development, and evaluation.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Manufacturers and service providers shall evaluate the accessibility, usability, and compatibility of equipment... identify barriers to accessibility and usability as part of such a product design and development process...

High-throughput process development of an alternative platform for the production of virus-like particles in Escherichia coli.

PubMed

Ladd Effio, Christopher; Baumann, Pascal; Weigel, Claudia; Vormittag, Philipp; Middelberg, Anton; Hubbuch, Jürgen

2016-02-10

The production of safe vaccines against untreatable or new diseases has pushed the research in the field of virus-like particles (VLPs). Currently, a large number of commercial VLP-based human vaccines and vaccine candidates are available or under development. A promising VLP production route is the controlled in vitro assembly of virus proteins into capsids. In the study reported here, a high-throughput screening (HTS) procedure was implemented for the upstream process development of a VLP platform in bacterial cell systems. Miniaturized cultivations were carried out in 48-well format in the BioLector system (m2p-Labs, Germany) using an Escherichia coli strain with a tac promoter producing the murine polyomavirus capsid protein (VP1). The screening procedure incorporated micro-scale cultivations, HTS cell disruption by sonication and HTS-compatible analytics by capillary gel electrophoresis. Cultivation temperatures, shaking speeds, induction and medium conditions were varied to optimize the product expression in E. coli. The most efficient system was selected based on an evaluation of soluble and insoluble product concentrations as well as on the percentage of product in the total soluble protein fraction. The optimized system was scaled up to cultivation 2.5L shaker flask scale and purified using an anion exchange chromatography membrane adsorber, followed by a size exclusion chromatography polishing procedure. For proof of concept, purified VP1 capsomeres were assembled under defined buffer conditions into empty capsids and characterized using transmission electron microscopy (TEM). The presented HTS procedure allowed for a fast development of an efficient production process of VLPs in E. coli. Under optimized cultivation conditions, the VP1 product totalled up to 43% of the total soluble protein fraction, yielding 1.63 mg VP1 per mL of applied cultivation medium. The developed production process strongly promotes the murine polyoma-VLP platform, moving towards an industrially feasible technology for new chimeric vaccines. Copyright © 2015 Elsevier B.V. All rights reserved.

Conventional and Innovative Processing of Milk for Yogurt Manufacture; Development of Texture and Flavor: A Review.

PubMed

Sfakianakis, Panagiotis; Tzia, Constatnina

2014-03-11

Milk and yogurt are important elements of the human diet, due to their high nutritional value and their appealing sensory properties. During milk processing (homogenization, pasteurization) and further yogurt manufacture (fermentation) physicochemical changes occur that affect the flavor and texture of these products while the development of standardized processes contributes to the development of desirable textural and flavor characteristics. The processes that take place during milk processing and yogurt manufacture with conventional industrial methods, as well as with innovative methods currently proposed (ultra-high pressure, ultrasound, microfluidization, pulsed electric fields), and their effect on the texture and flavor of the final conventional or probiotic/prebiotic products will be presented in this review.

Conventional and Innovative Processing of Milk for Yogurt Manufacture; Development of Texture and Flavor: A Review

PubMed Central

Sfakianakis, Panagiotis; Tzia, Constatnina

2014-01-01

Milk and yogurt are important elements of the human diet, due to their high nutritional value and their appealing sensory properties. During milk processing (homogenization, pasteurization) and further yogurt manufacture (fermentation) physicochemical changes occur that affect the flavor and texture of these products while the development of standardized processes contributes to the development of desirable textural and flavor characteristics. The processes that take place during milk processing and yogurt manufacture with conventional industrial methods, as well as with innovative methods currently proposed (ultra-high pressure, ultrasound, microfluidization, pulsed electric fields), and their effect on the texture and flavor of the final conventional or probiotic/prebiotic products will be presented in this review. PMID:28234312

Contemporary issues in HIM. Software engineering--what does it mean to you?

PubMed

Wear, L L

1994-02-01

There have been significant advances in the way we develop software in the last two decades. Many companies are using the new process oriented approach to software development. Companies that use the new techniques and tools have reported improvements in both productivity and quality, but there are still companies developing software the way we did 30 years ago. If you saw the movie Jurassic Park, you saw the perfect way not to develop software. The programmer in the movie was the only person who knew the details of the system. No processes were followed, and there was no documentation. This was an absolutely perfect prescription for failure. Some of you are probably familiar with the term hacker which describes a person who spends hours sitting at a terminal hacking out code. Hackers have created some outstanding software products, but with today's complex systems, most companies are trying to get away from their dependence on hackers. They are instead turning to the process-oriented approach. When selecting software vendors, don't just look at the functionality of a product. Try to determine how the vendor develops software, and determine if you are dealing with hackers or a process-driven company. In the long run, you should get better, more reliable products from the latter.

DREAMS and IMAGE: A Model and Computer Implementation for Concurrent, Life-Cycle Design of Complex Systems

NASA Technical Reports Server (NTRS)

Hale, Mark A.; Craig, James I.; Mistree, Farrokh; Schrage, Daniel P.

1995-01-01

Computing architectures are being assembled that extend concurrent engineering practices by providing more efficient execution and collaboration on distributed, heterogeneous computing networks. Built on the successes of initial architectures, requirements for a next-generation design computing infrastructure can be developed. These requirements concentrate on those needed by a designer in decision-making processes from product conception to recycling and can be categorized in two areas: design process and design information management. A designer both designs and executes design processes throughout design time to achieve better product and process capabilities while expanding fewer resources. In order to accomplish this, information, or more appropriately design knowledge, needs to be adequately managed during product and process decomposition as well as recomposition. A foundation has been laid that captures these requirements in a design architecture called DREAMS (Developing Robust Engineering Analysis Models and Specifications). In addition, a computing infrastructure, called IMAGE (Intelligent Multidisciplinary Aircraft Generation Environment), is being developed that satisfies design requirements defined in DREAMS and incorporates enabling computational technologies.

Teaching Design in Television Production Technology: The Twelve Steps of Preproduction

ERIC Educational Resources Information Center

Harrison, Henry L. (Hal), III; Loveland, Thomas

2009-01-01

Extensive planning must be used to produce television programs. Students must develop sound design practices and understand these attributes of design in their production planning. Through the design and planning processes involved in television production, students learn that design is a creative process, and that there is no perfect design, but…

Near Infrared Spectroscopy in the Forest Products Industry, Forest Products Journal

Treesearch

Chi-Leung So; Brian K. Via; Leslie H. Groom; Laurence R. Schimleck; Todd F. Shupe; Stephen S. Kelley; Timothy G. Rials

2004-01-01

Improving manufacturing efficiency and increasing product worth requires the right combination of actions throughout the manufacturing process. Many innovations have been developed over the last several decades to achieve these goals. Innovations typically work their way backwards in the manufacturing process, with an increasing level of monitoring occurring at the...

Review of Manganese Processing for Production of TRIP/TWIP Steels, Part 2: Reduction Studies

NASA Astrophysics Data System (ADS)

Elliott, R.; Coley, K.; Mostaghel, S.; Barati, M.

2018-02-01

Production of ultrahigh-manganese steels is expected to result in significant increase in demand for low-carbon (LC) ferromanganese (FeMn) and silicomanganese (SiMn). Current manganese processing techniques are energy intensive and typically yield a high-carbon product. The present work therefore reviews available literature regarding carbothermic reduction of Mn oxides and ores, with the objective of identifying opportunities for future process development to mitigate the cost of LC FeMn and SiMn. In general, there is consensus that carbothermic reduction of Mn oxides and ores is limited by gasification of carbon. Conditions which enhance or bypass this step (e.g., by application of CH4) show higher rates of reduction at lower temperatures. This phenomenon has potential application in solid-state reduction of Mn ore. Other avenues for process development include optimization of the prereduction step in conventional FeMn production and metallothermic reduction as a secondary reduction step.

Implementing AORN recommended practices for product selection.

PubMed

Conrardy, Julie A

2012-06-01

This article focuses on the revised AORN "Recommended practices for product selection in perioperative practice settings." Hospitals and ambulatory surgery facilities should have protocols in place for product evaluation that includes a multidisciplinary team approach. The process for product evaluation and selection includes gathering information; establishing consistent requirements for product evaluation; performing a financial impact analysis; investigating a plan to standardize products; conducting an environmental impact analysis; determining whether to purchase single-use, reposable, or reusable products or reprocess single-use devices; developing an evaluation process based on objective criteria; and developing and implementing a comprehensive plan to introduce and use new products. Use of an evaluation tool that is based on objective criteria is one way to obtain valuable input during product evaluations. Because of varied roles and experiences, the perioperative RN is an integral member of the product selection committee. Published by Elsevier Inc.

A nutribusiness strategy for processing and marketing animal-source foods for children.

PubMed

Mills, Edward W; Seetharaman, Koushik; Maretzki, Audrey N

2007-04-01

Nutritional benefits of animal source foods in the diets of children in developing countries indicate a need to increase the availability of such foods to young children. A nutribusiness strategy based on a dried meat and starch product could be used to increase children's access to such foods. The "Chiparoo" was developed at The Pennsylvania State University with this objective in mind. Plant-based and meat ingredients of the Chiparoo are chosen based on regional availability and cultural acceptability. Chiparoo processing procedures, including solar drying, are designed to ensure product safety and to provide product properties that allow them to be eaten as a snack or crumbled into a weaning porridge. Continued work is needed to develop formulation and processing variations that accommodate the needs of cultures around the world.

Laser processes and system technology for the production of high-efficient crystalline solar cells

NASA Astrophysics Data System (ADS)

Mayerhofer, R.; Hendel, R.; Zhu, Wenjie; Geiger, S.

2012-10-01

The laser as an industrial tool is an essential part of today's solar cell production. Due to the on-going efforts in the solar industry, to increase the cell efficiency, more and more laser-based processes, which have been discussed and tested at lab-scale for many years, are now being implemented in mass production lines. In order to cope with throughput requirements, standard laser concepts have to be improved continuously with respect to available average power levels, repetition rates or beam profile. Some of the laser concepts, that showed high potential in the past couple of years, will be substituted by other, more economic laser types. Furthermore, requirements for processing with less-heat affected zones fuel the development of industry-ready ultra short pulsed lasers with pulse widths even below the picosecond range. In 2011, the German Ministry of Education and Research (BMBF) had launched the program "PV-Innovation Alliance", with the aim to support the rapid transfer of high-efficiency processes out of development departments and research institutes into solar cell production lines. Here, lasers play an important role as production tools, allowing the fast implementation of high-performance solar cell concepts. We will report on the results achieved within the joint project FUTUREFAB, where efficiency optimization, throughput enhancement and cost reduction are the main goals. Here, the presentation will focus on laser processes like selective emitter doping and ablation of dielectric layers. An indispensable part of the efforts towards cost reduction in solar cell production is the improvement of wafer handling and throughput capabilities of the laser processing system. Therefore, the presentation will also elaborate on new developments in the design of complete production machines.

Development of Solvent Extraction Approach to Recycle Enriched Molybdenum Material

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

Tkac, Peter; Brown, M. Alex; Sen, Sujat

2016-06-01

Argonne National Laboratory, in cooperation with Oak Ridge National Laboratory and NorthStar Medical Technologies, LLC, is developing a recycling process for a solution containing valuable Mo-100 or Mo-98 enriched material. Previously, Argonne had developed a recycle process using a precipitation technique. However, this process is labor intensive and can lead to production of large volumes of highly corrosive waste. This report discusses an alternative process to recover enriched Mo in the form of ammonium heptamolybdate by using solvent extraction. Small-scale experiments determined the optimal conditions for effective extraction of high Mo concentrations. Methods were developed for removal of ammonium chloridemore » from the molybdenum product of the solvent extraction process. In large-scale experiments, very good purification from potassium and other elements was observed with very high recovery yields (~98%).« less

Development of new critical fluid-based processing methods for nutraceuticals and natural products

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

King, J. W.

2004-01-01

The development of new supercritical fluid processing technology as applied to nutraceuticals and natural products is no longer confined to using just supercritical fluid extraction (SFE) and supercritical carbon dioxide (SC-CO{sub 2}). Recently reported advances have been focused on modifying natural products and improving functionality of an end product using newer experimental techniques and fluid phases. In this presentation four focus areas will be emphasized: (1) control of particle size/morphology and encapsulation of the nutraceutical ingredients, (2) the use of combinatorial methodology to optimize critical fluid processing, (3) application of sub-critical water as a complementary medium for processing natural products,more » and (4) an assessment of the current state of products and processing which use critical fluid to produce nutraceutical and natural products for the food and cosmetic marketplace. Application of the various particle fomiation processes conducted in the presence of critical fluid media, such as: CPF, SAS, DELOS, RESS, PGSS, and GAS, can be used to produce particles of small and uniform distribution, having unique morphologies, that facilitate rapid dissolution or sustained release of many nutraceutical ingredients. These substances have included: therapeutic spices, phystosterols, vitamins, phospholpids, and carotenoids. Accelerating the development of critical fluid processing has been the application of combinatorial methodology to optimize extraction, fractionation, and/or reactions in near-, SC-, or subcritical fluid media. This is frequently accomplished by using sequential or multichannel automated instrumentation that was originally designed for analytical purposes. Several examples will be provided of rapidly assessing the extraction of anthocyanins with sub-critical water and the SFE of natural products. However, differences do exist in conducting experiments on the above instrumentation vs. scaled-up continuous processes, which will be noted. Sub-critical water is finding increase use as an extraction/fractionation or reaction medium. The literature reports applications for the extraction spices, natural antioxidants (rosemary, anthocyanins, etc.), and herbal components (tea and coffee ingredients), Our studies and the literature provide adequate correlations of solute solubility in sub-critical water as well as models for the kinetics of extraction in this medium. Finally, the current state of critical fluid technology as applied to natural products and nutraceuticals will be assessed; noting specific processes, organizations, and products that exist.« less

Advances in multi-scale modeling of solidification and casting processes

NASA Astrophysics Data System (ADS)

Liu, Baicheng; Xu, Qingyan; Jing, Tao; Shen, Houfa; Han, Zhiqiang

2011-04-01

The development of the aviation, energy and automobile industries requires an advanced integrated product/process R&D systems which could optimize the product and the process design as well. Integrated computational materials engineering (ICME) is a promising approach to fulfill this requirement and make the product and process development efficient, economic, and environmentally friendly. Advances in multi-scale modeling of solidification and casting processes, including mathematical models as well as engineering applications are presented in the paper. Dendrite morphology of magnesium and aluminum alloy of solidification process by using phase field and cellular automaton methods, mathematical models of segregation of large steel ingot, and microstructure models of unidirectionally solidified turbine blade casting are studied and discussed. In addition, some engineering case studies, including microstructure simulation of aluminum casting for automobile industry, segregation of large steel ingot for energy industry, and microstructure simulation of unidirectionally solidified turbine blade castings for aviation industry are discussed.

Utilization of protein-rich residues in biotechnological processes.

PubMed

Pleissner, Daniel; Venus, Joachim

2016-03-01

A drawback of biotechnological processes, where microorganisms convert biomass constituents, such as starch, cellulose, hemicelluloses, lipids, and proteins, into wanted products, is the economic feasibility. Particularly the cost of nitrogen sources in biotechnological processes can make up a large fraction of total process expenses. To further develop the bioeconomy, it is of considerable interest to substitute cost-intensive by inexpensive nitrogen sources. The aim of this mini-review was to provide a comprehensive insight of utilization methods of protein-rich residues, such as fish waste, green biomass, hairs, and food waste. The methods described include (i) production of enzymes, (ii) recovery of bioactive compounds, and/or (iii) usage as nitrogen source for microorganisms in biotechnological processes. In this aspect, the utilization of protein-rich residues, which are conventionally considered as waste, allows the development of value-adding processes for the production of bioactive compounds, biomolecules, chemicals, and materials.

Continuous Flow in Labour-Intensive Manufacturing Process

NASA Astrophysics Data System (ADS)

Pacheco Eng., Jhonny; Carbajal MSc., Eduardo; Stoll-Ing., Cesar, Dr.

2017-06-01

A continuous-flow manufacturing represents the peak of standard production, and usually it means high production in a strict line production. Furthermore, low-tech industry demands high labour-intensive, in this context the efficient of the line production is tied at the job shop organization. Labour-intensive manufacturing processes are a common characteristic for developing countries. This research aims to propose a methodology for production planning in order to fulfilment a variable monthly production quota. The main idea is to use a clock as orchestra director in order to synchronize the rate time (takt time) of customer demand with the manufacturing time. In this way, the study is able to propose a stark reduction of stock in process, over-processing, and unnecessary variability.

Environmentally Responsible Microbiological Production of Energetic Ingredients

DTIC Science & Technology

2007-11-01

effort was to develop an environmentally benign and economical microbial process for nitro-energetics production . The specific targets of this method...microbial production of nitro-based EM. As the processes and compounds of choice, RDX/HMX (nitramine) generation was selected. Microorganisms capable of...Current synthetic methods for the production of RDX and HMX utilize hexamine as the precursor. Hexamine is an industrial chemical available on a large

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

Childers, M.; Barnes, J.

The phased field development of the Lion and Panthere fields, offshore the Ivory Coast, includes a small floating production, storage, and offloading (FPSO) tanker with minimal processing capability as an early oil production system (EPS). For the long-term production scheme, the FPSO will be replaced by a converted jack up mobile offshore production system (MOPS) with full process equipment. The development also includes guyed-caisson well platforms, pipeline export for natural gas to fuel an onshore power plant, and a floating storage and offloading (FSO) tanker for oil export. Pipeline export for oil is a future possibility. This array of innovativemore » strategies and techniques seldom has been brought together in a single project. The paper describes the development plan, early oil, jack up MOPS, and transport and installation.« less

Process intensification of biodiesel production by using microwave and ionic liquids as catalyst

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

Handayani, Prima Astuti; Chemical Engineering Program, Faculty of Engineering, Semarang State University; Abdullah

The energy crisis pushes the development and intensification of biodiesel production process. Biodiesel is produced by transesterification of vegetable oils or animal fats and conventionally produced by using acid/base catalyst. However, the conventional method requires longer processing time and obtains lower yield of biodiesel. The microwave has been intensively used to accelerate production process and ionic liquids has been introduced as source of catalyst. This paper discusses the overview of the development of biodiesel production through innovation using microwave irradiation and ionic liquids catalyst to increase the yield of biodiesel. The potential microwave to reduce the processing time will bemore » discussed and compared with other energy power, while the ionic liquids as a new generation of catalysts in the chemical industry will be also discussed for its use. The ionic liquids has potential to enhance the economic and environmental aspects because it has a low corrosion effect, can be recycled, and low waste form.« less

Process intensification of biodiesel production by using microwave and ionic liquids as catalyst

NASA Astrophysics Data System (ADS)

Handayani, Prima Astuti; Abdullah, dan Hadiyanto

2015-12-01

The energy crisis pushes the development and intensification of biodiesel production process. Biodiesel is produced by transesterification of vegetable oils or animal fats and conventionally produced by using acid/base catalyst. However, the conventional method requires longer processing time and obtains lower yield of biodiesel. The microwave has been intensively used to accelerate production process and ionic liquids has been introduced as source of catalyst. This paper discusses the overview of the development of biodiesel production through innovation using microwave irradiation and ionic liquids catalyst to increase the yield of biodiesel. The potential microwave to reduce the processing time will be discussed and compared with other energy power, while the ionic liquids as a new generation of catalysts in the chemical industry will be also discussed for its use. The ionic liquids has potential to enhance the economic and environmental aspects because it has a low corrosion effect, can be recycled, and low waste form.

Crew interface specification development study for in-flight maintenance and stowage functions

NASA Technical Reports Server (NTRS)

Carl, J. G.

1971-01-01

The need and potential solutions for an orderly systems engineering approach to the definition, management and documentation requirements for in-flight maintenance, assembly, servicing, and stowage process activities of the flight crews of future spacecraft were investigated. These processes were analyzed and described using a new technique (mass/function flow diagramming), developed during the study, to give visibility to crew functions and supporting requirements, including data products. This technique is usable by NASA for specification baselines and can assist the designer in identifying both upper and lower level requirements associated with these processes. These diagrams provide increased visibility into the relationships between functions and related equipments being utilized and managed and can serve as a common communicating vehicle between the designer, program management, and the operational planner. The information and data product requirements to support the above processes were identified along with optimum formats and contents of these products. The resulting data product concepts are presented to support these in-flight maintenance and stowage processes.

Development and efficiency assessment of process lubrication for hot forging

NASA Astrophysics Data System (ADS)

Kargin, S.; Artyukh, Viktor; Ignatovich, I.; Dikareva, Varvara

2017-10-01

The article considers innovative technologies in testing and production of process lubricants for hot bulk forging. There were developed new compositions of eco-friendly water-graphite process lubricants for hot extrusion and forging. New approaches to efficiency assessment of process lubricants are developed and described in the following article. Laboratory and field results are presented.

FuzzyCLIPS from research to product

NASA Technical Reports Server (NTRS)

Bochsler, Dan; Dohmann, Edgar

1994-01-01

This paper describes the commercial productization of FuzzyCLIPS which was developed under a NASA Phase 2 SBIR contract. The intent of this paper is to provide a general roadmap of the processes that are required to make a viable, marketable product once its concept and development are complete.

76 FR 37774 - Announcement of Value-Added Producer Grant Application Deadlines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

...-Based Business Ventures develop strategies to create marketing opportunities and to help develop Business Plans for viable marketing opportunities regarding production of bio-based products from... Capital Grants directly related to the processing and/or marketing of value-added products. In order to...

Life cycle impacts of ethanol production from spruce wood chips under high-gravity conditions.

PubMed

Janssen, Matty; Xiros, Charilaos; Tillman, Anne-Marie

2016-01-01

Development of more sustainable biofuel production processes is ongoing, and technology to run these processes at a high dry matter content, also called high-gravity conditions, is one option. This paper presents the results of a life cycle assessment (LCA) of such a technology currently in development for the production of bio-ethanol from spruce wood chips. The cradle-to-gate LCA used lab results from a set of 30 experiments (or process configurations) in which the main process variable was the detoxification strategy applied to the pretreated feedstock material. The results of the assessment show that a process configuration, in which washing of the pretreated slurry is the detoxification strategy, leads to the lowest environmental impact of the process. Enzyme production and use are the main contributors to the environmental impact in all process configurations, and strategies to significantly reduce this contribution are enzyme recycling and on-site enzyme production. Furthermore, a strong linear correlation between the ethanol yield of a configuration and its environmental impact is demonstrated, and the selected environmental impacts show a very strong cross-correlation ([Formula: see text] in all cases) which may be used to reduce the number of impact categories considered from four to one (in this case, global warming potential). Lastly, a comparison with results of an LCA of ethanol production under high-gravity conditions using wheat straw shows that the environmental performance does not significantly differ when using spruce wood chips. For this comparison, it is shown that eutrophication potential also needs to be considered due to the fertilizer use in wheat cultivation. The LCA points out the environmental hotspots in the ethanol production process, and thus provides input to the further development of the high-gravity technology. Reducing the number of impact categories based only on cross-correlations should be done with caution. Knowledge of the analyzed system provides further input to the choice of impact categories.

Development of reactor configurations for an electrofuels platform utilizing genetically modified iron oxidizing bacteria for the reduction of CO2 to biochemicals.

PubMed

Guan, Jingyang; Berlinger, Sarah A; Li, Xiaozheng; Chao, Zhongmou; Sousa E Silva, Victor; Banta, Scott; West, Alan C

2017-03-10

Electrofuels processes are potentially promising platforms for biochemical production from CO 2 using renewable energy. When coupled to solar panels, this approach could avoid the inefficiencies of photosynthesis and there is no competition with food agriculture. In addition, these systems could potentially be used to store intermittent or stranded electricity generated from other renewable sources. Here we develop reactor configurations for continuous electrofuels processes to convert electricity and CO 2 to isobutyric acid (IBA) using genetically modified (GM) chemolithoautotrophic Acidithiobacillus ferrooxidans. These cells oxidize ferrous iron which can be electrochemically reduced. During two weeks of cultivation on ferrous iron, stable cell growth and continuous IBA production from CO 2 were achieved in a process where media was circulated between electrochemical and biochemical rectors. An alternative process with an additional electrochemical cell for accelerated ferrous production was developed, and this system achieved an almost three-fold increase in steady state cell densities, and an almost 4-fold increase in the ferrous iron oxidation rate. Combined, this led to an almost 8-fold increase in the steady state volumetric productivity of IBA up to 0.063±0.012mg/L/h, without a decline in energy efficiency from previous work. Continued development of reactor configurations which can increase the delivery of energy to the genetically modified cells will be required to increase product titers and volumetric productivities. Copyright © 2017 Elsevier B.V. All rights reserved.

Process Research ON Semix Silicon Materials (PROSSM)

NASA Astrophysics Data System (ADS)

Wohlgemuth, J. H.; Warfield, D. B.

1982-02-01

A cost effective process sequence was identified, equipment was designed to implement a 6.6 MW per year automated production line, and a cost analysis projected a $0.56 per watt cell add-on cost for this line. Four process steps were developed for this program: glass beads back clean-up, hot spray antireflective coating, wave soldering of fronts, and ion milling for edging. While spray dopants were advertised as an off the shelf developed product, they were unreliable with shorter than advertised shelf life.

Process Research ON Semix Silicon Materials (PROSSM)

NASA Technical Reports Server (NTRS)

Wohlgemuth, J. H.; Warfield, D. B.

1982-01-01

A cost effective process sequence was identified, equipment was designed to implement a 6.6 MW per year automated production line, and a cost analysis projected a $0.56 per watt cell add-on cost for this line. Four process steps were developed for this program: glass beads back clean-up, hot spray antireflective coating, wave soldering of fronts, and ion milling for edging. While spray dopants were advertised as an off the shelf developed product, they were unreliable with shorter than advertised shelf life.

Developments and potential of radiation processing in the Philippines

NASA Astrophysics Data System (ADS)

Singson, C.; Carmona, C.

This paper describes the research and development activities in three areas of radiation processing, namely: food irradiation, medical product sterilization and wood plastic combination. Plans and efforts exerted to acquire a larger gamma source to augment our present 5,000 curie source are discussed. Cost estimates for a radiation facility is presented on the basis of the market potential of food irradiation and medical product sterilization. Existing local industries that can benefit from the adaptation of irradiation technology in their processing requirements is described.

QbD for pediatric oral lyophilisates development: risk assessment followed by screening and optimization.

PubMed

Casian, Tibor; Iurian, Sonia; Bogdan, Catalina; Rus, Lucia; Moldovan, Mirela; Tomuta, Ioan

2017-12-01

This study proposed the development of oral lyophilisates with respect to pediatric medicine development guidelines, by applying risk management strategies and DoE as an integrated QbD approach. Product critical quality attributes were overviewed by generating Ishikawa diagrams for risk assessment purposes, considering process, formulation and methodology related parameters. Failure Mode Effect Analysis was applied to highlight critical formulation and process parameters with an increased probability of occurrence and with a high impact on the product performance. To investigate the effect of qualitative and quantitative formulation variables D-optimal designs were used for screening and optimization purposes. Process parameters related to suspension preparation and lyophilization were classified as significant factors, and were controlled by implementing risk mitigation strategies. Both quantitative and qualitative formulation variables introduced in the experimental design influenced the product's disintegration time, mechanical resistance and dissolution properties selected as CQAs. The optimum formulation selected through Design Space presented ultra-fast disintegration time (5 seconds), a good dissolution rate (above 90%) combined with a high mechanical resistance (above 600 g load). Combining FMEA and DoE allowed the science based development of a product with respect to the defined quality target profile by providing better insights on the relevant parameters throughout development process. The utility of risk management tools in pharmaceutical development was demonstrated.

Status summary of chemical processing development in plutonium-238 supply program

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

Collins, Emory D.; Benker, Dennis; Wham, Robert M.

This document summarizes the status of development of chemical processing in the Plutonium-238 Supply Program (PSP) near the end of Demonstration 1. The objective of the PSP is “to develop, demonstrate, and document a production process that meets program objectives and to prepare for its operation” (Frazier et al. 2016). Success in the effort includes establishing capability using the current infrastructure to produce Np targets for irradiation in Department of Energy research reactors, chemically processing the irradiated targets to separate and purify the produced Pu and transferring the PuO 2 product to Los Alamos National Laboratory (LANL) at an averagemore » rate of 1.5 kg/y.« less

Overview of processing activities aimed at higher efficiencies and economical production

NASA Technical Reports Server (NTRS)

Bickler, D. B.

1985-01-01

An overview of processing activities aimed at higher efficiencies and economical production were presented. Present focus is on low-cost process technology for higher-efficiency cells of up to 18% or higher. Process development concerns center on the use of less than optimum silicon sheet, the control of production yields, and making uniformly efficient large-area cells. High-efficiency cell factors that require process development are bulk material perfection, very shallow junction formation, front-surface passivation, and finely detailed metallization. Better bulk properties of the silicon sheet and the keeping of those qualities throughout large areas during cell processing are required so that minority carrier lifetimes are maintained and cell performance is not degraded by high doping levels. When very shallow junctions are formed, the process must be sensitive to metallizatin punch-through, series resisitance in the cell, and control of dopant leaching during surface passivation. There is a need to determine the sensitivity to processing by mathematical modeling and experimental activities.

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.

Platform based design of EAP transducers in Danfoss PolyPower A/S

NASA Astrophysics Data System (ADS)

Sarban, Rahimullah; Gudlaugsson, Tómas V.

2013-04-01

Electroactive Polymer (EAP) has gained increasing focus, in research communities, in last two decades. Research within the field of EAP has, so far, been mainly focused on material improvements, characterization, modeling and developing demonstrators. As the EAP technology matures, the need for a new area of research namely product development emerges. Product development can be based on an isolated design and production for a single product or platform design where a product family is developed. In platform design the families of products exploits commonality of platform modules while satisfying a variety of different market segments. Platform based approach has the primary benefit of being cost efficient and short lead time to market when new products emerges. Products development based on EAP technology is challenging both technologically as well as from production and processing point of view. Both the technological and processing challenges need to be addressed before a successful implementation of EAP technology into products. Based on this need Danfoss PolyPower A/S has, in 2011, launched a EAP platform project in collaboration with three Danish universities and three commercial organizations. The aim of the project is to develop platform based designs and product family for the EAP components to be used in variety of applications. This paper presents the structure of the platform project as a whole and specifically the platform based designs of EAP transducers. The underlying technologies, essential for EAP transducers, are also presented. Conceptual design and solution for the concepts are presented as well.

Recombinant organisms for production of industrial products.

PubMed

Adrio, Jose-Luis; Demain, Arnold L

2010-01-01

A revolution in industrial microbiology was sparked by the discoveries of ther double-stranded structure of DNA and the development of recombinant DNA technology. Traditional industrial microbiology was merged with molecular biology to yield improved recombinant processes for the industrial production of primary and secondary metabolites, protein biopharmaceuticals and industrial enzymes. Novel genetic techniques such as metabolic engineering, combinatorial biosynthesis and molecular breeding techniques and their modifications are contributing greatly to the development of improved industrial processes. In addition, functional genomics, proteomics and metabolomics are being exploited for the discovery of novel valuable small molecules for medicine as well as enzymes for catalysis. The sequencing of industrial microbal genomes is being carried out which bodes well for future process improvement and discovery of new industrial products. © 2010 Landes Bioscience

Manufacturing challenges in the commercial production of recombinant coagulation factor VIII.

PubMed

Jiang, R; Monroe, T; McRogers, R; Larson, P J

2002-03-01

Advances in gene technology have led to the development of a method to manufacture recombinant coagulation Factor VIII (rFVIII) for haemophilia A. Because rFVIII is a large and complex protein, its commercialization has required that many challenges in manufacturing, purification and processing be overcome. In order to license the first generation of rFVIII (Kogenate) in 1993, Bayer Corporation invested over 10 years in research and manufacturing development. Seven additional years were subsequently devoted to research and manufacturing improvements in order to accomplish the recent licensing of a second rFVIII product (KOGENATE Bayer or Kogenate FS). This product differs from its predecessor, in that human albumin is removed from the purification and the formulation steps. In addition, fewer chromatography steps are involved resulting in greater yields per mL of conditioned medium, and a solvent-detergent viral inactivation step replaces the heat-processing step used for the previous product. Despite these changes in the manufacturing, the protein backbone and carbohydrate structure of the final rFVIII molecule are identical. The complexity of the production processes is reflected by over 100 000 manufacturing data entries and by 600 quality control tests for each batch of rFVIII. Manufacturers are continuing to develop the next generation of rFVIII, which will be produced without the addition of any human or animal proteins or byproducts. Investments in research, development and manufacturing technology are expected to result in the development of new products with enhanced safety profiles, and in an increase in the production capacity for products that are chronically in short supply.

Research recommendations

NASA Technical Reports Server (NTRS)

1979-01-01

The research and development sequences and priorities for CELSS development were established for each of the following areas: nutrition and food processing, food production, waste processing, systems engineering/modeling, and ecology-systems safety.

A Decision Tool that Combines Discrete Event Software Process Models with System Dynamics Pieces for Software Development Cost Estimation and Analysis

NASA Technical Reports Server (NTRS)

Mizell, Carolyn Barrett; Malone, Linda

2007-01-01

The development process for a large software development project is very complex and dependent on many variables that are dynamic and interrelated. Factors such as size, productivity and defect injection rates will have substantial impact on the project in terms of cost and schedule. These factors can be affected by the intricacies of the process itself as well as human behavior because the process is very labor intensive. The complex nature of the development process can be investigated with software development process models that utilize discrete event simulation to analyze the effects of process changes. The organizational environment and its effects on the workforce can be analyzed with system dynamics that utilizes continuous simulation. Each has unique strengths and the benefits of both types can be exploited by combining a system dynamics model and a discrete event process model. This paper will demonstrate how the two types of models can be combined to investigate the impacts of human resource interactions on productivity and ultimately on cost and schedule.

Optical surface analysis: a new technique for the inspection and metrology of optoelectronic films and wafers

NASA Astrophysics Data System (ADS)

Bechtler, Laurie; Velidandla, Vamsi

2003-04-01

In response to demand for higher volumes and greater product capability, integrated optoelectronic device processing is rapidly increasing in complexity, benefiting from techniques developed for conventional silicon integrated circuit processing. The needs for high product yield and low manufacturing cost are also similar to the silicon wafer processing industry. This paper discusses the design and use of an automated inspection instrument called the Optical Surface Analyzer (OSA) to evaluate two critical production issues in optoelectronic device manufacturing: (1) film thickness uniformity, and (2) defectivity at various process steps. The OSA measurement instrument is better suited to photonics process development than most equipment developed for conventional silicon wafer processing in two important ways: it can handle both transparent and opaque substrates (unlike most inspection and metrology tools), and it is a full-wafer inspection method that captures defects and film variations over the entire substrate surface (unlike most film thickness measurement tools). Measurement examples will be provided in the paper for a variety of films and substrates used for optoelectronics manufacturing.

Valorisation of fish by-products against waste management treatments--Comparison of environmental impacts.

PubMed

Lopes, Carla; Antelo, Luis T; Franco-Uría, Amaya; Alonso, Antonio A; Pérez-Martín, Ricardo

2015-12-01

Reuse and valorisation of fish by-products is a key process for marine resources conservation. Usually, fishmeal and oil processing factories collect the by-products generated by fishing port and industry processing activities, producing an economical benefit to both parts. In the same way, different added-value products can be recovered by the valorisation industries whereas fishing companies save the costs associated with the management of those wastes. However, it is important to estimate the advantages of valorisation processes not only in terms of economic income, but also considering the environmental impacts. This would help to know if the valorisation of a residue provokes higher impact than other waste management options, which means that its advantages are probably not enough for guarantying a sustainable waste reuse. To that purpose, there are several methodologies to evaluate the environmental impacts of processes, including those of waste management, providing different indicators which give information on relevant environmental aspects. In the current study, a comparative environmental assessment between a valorisation process (fishmeal and oil production) and different waste management scenarios (composting, incineration and landfilling) was developed. This comparison is a necessary step for the development and industrial implementation of these processes as the best alternative treatment for fish by-products. The obtained results showed that both valorisation process and waste management treatments presented similar impacts. However, a significant benefit can be achieved through valorisation of fish by-products. Additionally, the implications of the possible presence of pollutants were discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Integrated process development-a robust, rapid method for inclusion body harvesting and processing at the microscale level.

PubMed

Walther, Cornelia; Kellner, Martin; Berkemeyer, Matthias; Brocard, Cécile; Dürauer, Astrid

2017-10-21

Escherichia coli stores large amounts of highly pure product within inclusion bodies (IBs). To take advantage of this beneficial feature, after cell disintegration, the first step to optimal product recovery is efficient IB preparation. This step is also important in evaluating upstream optimization and process development, due to the potential impact of bioprocessing conditions on product quality and on the nanoscale properties of IBs. Proper IB preparation is often neglected, due to laboratory-scale methods requiring large amounts of materials and labor. Miniaturization and parallelization can accelerate analyses of individual processing steps and provide a deeper understanding of up- and downstream processing interdependencies. Consequently, reproducible, predictive microscale methods are in demand. In the present study, we complemented a recently established high-throughput cell disruption method with a microscale method for preparing purified IBs. This preparation provided results comparable to laboratory-scale IB processing, regarding impurity depletion, and product loss. Furthermore, with this method, we performed a "design of experiments" study to demonstrate the influence of fermentation conditions on the performance of subsequent downstream steps and product quality. We showed that this approach provided a 300-fold reduction in material consumption for each fermentation condition and a 24-fold reduction in processing time for 24 samples.

Film and television in Croatia today: production, new technologies and the relationship with visual anthropology.

PubMed

Svilicić, Niksa; Vidacković, Zlatko

2013-03-01

This paper seeks to explain some of the most important recent production and technological changes that have affected the relationship between television and film, especially in Croatia, from the aspect of the development of visual anthropology. In the production segment, special attention was given to the role of Croatian television stations in the production of movies, "splitting" the movies into mini-series, interrupting movies with commercial breaks, and to television movies turned into feature films. This paper tries to perceive and define the structure of methodical processes of visual anthropology (reactive process). The development of photographic and film technology and the events which led to the rapid development of visual culture also point to the inseparable duality of observing visual anthropology within reactive and proactive processes, which are indirectly closely related to the technical aspects of these processes. Defining the technical aspect of visual anthropology as such "service" necessarily interferes with the author's approach in the domain of the script and direction related procedures during pre-production, on the field and during post-production of the movie. The author's approach is important because in dependence on it, the desired spectrum of information "output", susceptible to subsequent scientific analysis, is achieved. Lastly, another important segment is the "distributive-technological process" because, regardless of the approach to the anthropologically relevant phenomenon which is being dealt with in an audio-visual piece of work, it is essential that the work be presented and viewed adequately.

Process development of a New Haemophilus influenzae type b conjugate vaccine and the use of mathematical modeling to identify process optimization possibilities.

PubMed

Hamidi, Ahd; Kreeftenberg, Hans; V D Pol, Leo; Ghimire, Saroj; V D Wielen, Luuk A M; Ottens, Marcel

2016-05-01

Vaccination is one of the most successful public health interventions being a cost-effective tool in preventing deaths among young children. The earliest vaccines were developed following empirical methods, creating vaccines by trial and error. New process development tools, for example mathematical modeling, as well as new regulatory initiatives requiring better understanding of both the product and the process are being applied to well-characterized biopharmaceuticals (for example recombinant proteins). The vaccine industry is still running behind in comparison to these industries. A production process for a new Haemophilus influenzae type b (Hib) conjugate vaccine, including related quality control (QC) tests, was developed and transferred to a number of emerging vaccine manufacturers. This contributed to a sustainable global supply of affordable Hib conjugate vaccines, as illustrated by the market launch of the first Hib vaccine based on this technology in 2007 and concomitant price reduction of Hib vaccines. This paper describes the development approach followed for this Hib conjugate vaccine as well as the mathematical modeling tool applied recently in order to indicate options for further improvements of the initial Hib process. The strategy followed during the process development of this Hib conjugate vaccine was a targeted and integrated approach based on prior knowledge and experience with similar products using multi-disciplinary expertise. Mathematical modeling was used to develop a predictive model for the initial Hib process (the 'baseline' model) as well as an 'optimized' model, by proposing a number of process changes which could lead to further reduction in price. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:568-580, 2016. © 2016 American Institute of Chemical Engineers.

Culture Medium Development for Microbial-Derived Surfactants Production-An Overview.

PubMed

Nurfarahin, Abdul Hamid; Mohamed, Mohd Shamzi; Phang, Lai Yee

2018-05-01

Surfactants are compounds that can reduce the surface tension between two different phases or the interfacial tension of the liquid between water and oil, possessing both hydrophilic and hydrophobic moieties. Biosurfactants have traits that have proven to be advantageous over synthetic surfactants, but these compounds do not compete economically with synthetic surfactants. Different alternatives increase the yield of biosurfactants; development of an economical production process and the usage of cheaper substrates during process have been employed. One of the solutions relies on the suitable formulation of a production medium by including alternative raw materials sourced from agro-wastes, hydrocarbons, or by-products of a process might help in boosting the biosurfactant production. Since the nutritional factors required will be different among microorganisms, the establishment of a suitable formulation for biosurfactant production will be challenging. The present review describes various nutrients and elements considered in the formulation of a production medium with an approach focusing on the macronutrient (carbon, nitrogen source, and C/N ratio), minerals, vitamins, metabolic regulators, and salinity levels which may aid in the study of biosurfactant production in the future.

Toward a unified account of comprehension and production in language development.

PubMed

McCauley, Stewart M; Christiansen, Morten H

2013-08-01

Although Pickering & Garrod (P&G) argue convincingly for a unified system for language comprehension and production, they fail to explain how such a system might develop. Using a recent computational model of language acquisition as an example, we sketch a developmental perspective on the integration of comprehension and production. We conclude that only through development can we fully understand the intertwined nature of comprehension and production in adult processing.

Process feasibility study in support of silicon material task 1

NASA Technical Reports Server (NTRS)

Yaws, C. L.; Li, K. Y.; Hopper, J. R.; Fang, C. S.; Hansen, K. C.

1981-01-01

Results for process system properties, chemical engineering and economic analyses of the new technologies and processes being developed for the production of lower cost silicon for solar cells are presented. Analyses of process system properties are important for chemical materials involved in the several processes under consideration for semiconductor and solar cell grade silicon production. Major physical, thermodynamic and transport property data are reported for silicon source and processing chemical materials.

Development of Integrated Programs for Aerospace-vehicle Design (IPAD): Product manufacture interactions with the design process

NASA Technical Reports Server (NTRS)

Crowell, H. A.

1979-01-01

The product manufacturing interactions with the design process and the IPAD requirements to support the interactions are described. The data requirements supplied to manufacturing by design are identified and quantified. Trends in computer-aided manufacturing are discussed and the manufacturing process of the 1980's is anticipated.

Framework for Design of Traceability System on Organic Rice Certification

NASA Astrophysics Data System (ADS)

Purwandoko, P. B.; Seminar, K. B.; Sutrisno; Sugiyanta

2018-05-01

Nowadays, the preferences of organic products such as organic rice have been increased. It because of the people awareness of the healthy and eco-friendly food product consumption has grown. Therefore, it is very important to ensure organic quality of the product that will be produced. Certification is a series of process that holds to ensure the quality of products meets all criteria of organic standards. Currently, there is a problem that traceability information system for organic rice certification has been not available. The current system still conducts manually caused the loss of information during storage process. This paper aimed at developing a traceability framework on organic rice certification process. First, the main discussed issues are organic certification process. Second, unified modeling language (UML) is used to build the model of user requirement in order to develop traceability system for all actors in the certification process. Furthermore, the information captured model along certification process will be explained in this paper. The model shows the information flow that has to be recorded for each actor. Finally, the challenges in the implementation system will be discussed in this paper.

Systematic development of technical textiles

NASA Astrophysics Data System (ADS)

Beer, M.; Schrank, V.; Gloy, Y.-S.; Gries, T.

2016-07-01

Technical textiles are used in various fields of applications, ranging from small scale (e.g. medical applications) to large scale products (e.g. aerospace applications). The development of new products is often complex and time consuming, due to multiple interacting parameters. These interacting parameters are production process related and also a result of the textile structure and used material. A huge number of iteration steps are necessary to adjust the process parameter to finalize the new fabric structure. A design method is developed to support the systematic development of technical textiles and to reduce iteration steps. The design method is subdivided into six steps, starting from the identification of the requirements. The fabric characteristics vary depending on the field of application. If possible, benchmarks are tested. A suitable fabric production technology needs to be selected. The aim of the method is to support a development team within the technology selection without restricting the textile developer. After a suitable technology is selected, the transformation and correlation between input and output parameters follows. This generates the information for the production of the structure. Afterwards, the first prototype can be produced and tested. The resulting characteristics are compared with the initial product requirements.

Loblolly pine foliar patterns and growth dynamics at age 12 in response to planting density and cultural intensity

Treesearch

Madison Katherine Akers; Michael Kane; Dehai Zhao; Richard F. Daniels; Robert O. Teskey

2015-01-01

Examining the role of foliage in stand development across a range of stand structures provides a more detailed understanding of the processes driving productivity and allows further development of process-based models for prediction. Productivity changes observed at the stand scale will be the integration of changes at the individual tree scale, but few studies have...

High-throughput process development: I. Process chromatography.

PubMed

Rathore, Anurag S; Bhambure, Rahul

2014-01-01

Chromatographic separation serves as "a workhorse" for downstream process development and plays a key role in removal of product-related, host cell-related, and process-related impurities. Complex and poorly characterized raw materials and feed material, low feed concentration, product instability, and poor mechanistic understanding of the processes are some of the critical challenges that are faced during development of a chromatographic step. Traditional process development is performed as trial-and-error-based evaluation and often leads to a suboptimal process. High-throughput process development (HTPD) platform involves an integration of miniaturization, automation, and parallelization and provides a systematic approach for time- and resource-efficient chromatography process development. Creation of such platforms requires integration of mechanistic knowledge of the process with various statistical tools for data analysis. The relevance of such a platform is high in view of the constraints with respect to time and resources that the biopharma industry faces today. This protocol describes the steps involved in performing HTPD of process chromatography step. It described operation of a commercially available device (PreDictor™ plates from GE Healthcare). This device is available in 96-well format with 2 or 6 μL well size. We also discuss the challenges that one faces when performing such experiments as well as possible solutions to alleviate them. Besides describing the operation of the device, the protocol also presents an approach for statistical analysis of the data that is gathered from such a platform. A case study involving use of the protocol for examining ion-exchange chromatography of granulocyte colony-stimulating factor (GCSF), a therapeutic product, is briefly discussed. This is intended to demonstrate the usefulness of this protocol in generating data that is representative of the data obtained at the traditional lab scale. The agreement in the data is indeed very significant (regression coefficient 0.93). We think that this protocol will be of significant value to those involved in performing high-throughput process development of process chromatography.

Biofuels from food processing wastes.

PubMed

Zhang, Zhanying; O'Hara, Ian M; Mundree, Sagadevan; Gao, Baoyu; Ball, Andrew S; Zhu, Nanwen; Bai, Zhihui; Jin, Bo

2016-04-01

Food processing industry generates substantial high organic wastes along with high energy uses. The recovery of food processing wastes as renewable energy sources represents a sustainable option for the substitution of fossil energy, contributing to the transition of food sector towards a low-carbon economy. This article reviews the latest research progress on biofuel production using food processing wastes. While extensive work on laboratory and pilot-scale biosystems for energy production has been reported, this work presents a review of advances in metabolic pathways, key technical issues and bioengineering outcomes in biofuel production from food processing wastes. Research challenges and further prospects associated with the knowledge advances and technology development of biofuel production are discussed. Copyright © 2016. Published by Elsevier Ltd.

A critical review on factors influencing fermentative hydrogen production.

PubMed

Kothari, Richa; Kumar, Virendra; Pathak, Vinayak V; Ahmad, Shamshad; Aoyi, Ochieng; Tyagi, V V

2017-03-01

Biohydrogen production by dark fermentation of different waste materials is a promising approach to produce bio-energy in terms of renewable energy exploration. This communication has reviewed various influencing factors of dark fermentation process with detailed account of determinants in biohydrogen production. It has also focused on different factors such as improved bacterial strain, reactor design, metabolic engineering and two stage processes to enhance the bioenergy productivity from substrate. The study also suggest that complete utilization of substrates for biological hydrogen production requires the concentrated research and development for efficient functioning of microorganism with integrated application for energy production and bioremediation. Various studies have been taken into account here, to show the comparative efficiency of different substrates and operating conditions with inhibitory factors and pretreatment option for biohydrogen production. The study reveals that an extensive research is needed to observe field efficiency of process using low cost substrates and integration of dark and photo fermentation process. Integrated approach of fermentation process will surely compete with conventional hydrogen process and replace it completely in future.

Biological potential of microalgae in China for biorefinery-based production of biofuels and high value compounds.

PubMed

Li, Jingjing; Liu, Ying; Cheng, Jay J; Mos, Michal; Daroch, Maurycy

2015-12-25

Microalgae abundance and diversity in China shows promise for identifying suitable strains for developing algal biorefinery. Numerous strains of microalgae have already been assessed as feedstocks for bioethanol and biodiesel production, but commercial scale algal biofuel production is yet to be demonstrated, most likely due to huge energy costs associated with algae cultivation, harvesting and processing. Biorefining, integrated processes for the conversion of biomass into a variety of products, can improve the prospects of microalgal biofuels by combining them with the production of high value co-products. Numerous microalgal strains in China have been identified as producers of various high value by-products with wide application in the medicine, food, and cosmetics industries. This paper reviews microalgae resources in China and their potential in producing liquid biofuels (bioethanol and biodiesel) and high value products in an integrated biorefinery approach. Implementation of a 'high value product first' principle should make the integrated process of fuels and chemicals production economically feasible and will ensure that public and private interest in the development of microalgal biotechnology is maintained. Copyright © 2015 Elsevier B.V. All rights reserved.

Identification of Pork Adulteration in Processed Meat Products Using the Developed Mitochondrial DNA-Based Primers

PubMed Central

Ha, Jimyeong; Kim, Sejeong; Lee, Jeeyeon; Lee, Soomin; Lee, Heeyoung; Choi, Yukyung; Oh, Hyemin; Yoon, Yohan

2017-01-01

The identification of pork in commercially processed meats is one of the most crucial issues in the food industry because of religious food ethics, medical purposes, and intentional adulteration to decrease production cost. This study therefore aimed to develop a method for the detection of pork adulteration in meat products using primers specific for pig mitochondrial DNA. Mitochondrial DNA sequences for pig, cattle, chicken, and sheep were obtained from GenBank and aligned. The 294-bp mitochondrial DNA D-loop region was selected as the pig target DNA sequence and appropriate primers were designed using the MUSCLE program. To evaluate primer sensitivity, pork-beef-chicken mixtures were prepared as follows: i) 0% pork-50% beef-50% chicken, ii) 1% pork-49.5% beef-49.5% chicken, iii) 2% pork-49% beef-49% chicken, iv) 5% pork-47.5% beef-47.5% chicken, v) 10% pork-45% beef-45% chicken, and vi) 100% pork-0% beef-0% chicken. In addition, a total of 35 commercially packaged products, including patties, nuggets, meatballs, and sausages containing processed chicken, beef, or a mixture of various meats, were purchased from commercial markets. The primers developed in our study were able to detect as little as 1% pork in the heat treated pork-beef-chicken mixtures. Of the 35 processed products, three samples were pork positive despite being labeled as beef or chicken only or as a beef-chicken mix. These results indicate that the developed primers could be used to detect pork adulteration in various processed meat products for application in safeguarding religious food ethics, detecting allergens, and preventing food adulteration. PMID:28747833

Career Preparation in Agricultural Products (Food Processing): A Curriculum Guide for High School Vocational Agriculture. Test Edition.

ERIC Educational Resources Information Center

Moore, Eddie A.

This curriculum guide in agricultural products (food processing) is one of 10 guides developed as part of a vocational project stressing agribusiness, natural resources, and environmental protection. The scope of this guide includes three occupational subgroups: meat, fish, poultry; dairy (milk) products; fruits and vegetables. It is meant as an…

"Are You Talking to Me?"--Teaching User-Centered Design

ERIC Educational Resources Information Center

Kemnitzer, Ronald B.

2005-01-01

User-centered design (UCD) is an approach to design that grounds the process in information about the people who will use the product. UCD processes focus on users through the planning, design and development of a product. Establishing a User Profile is certainly a key element in user-centered design. For many products, such as an automobile, a…

Saturn S-2 production operations techniques: Production welding. Volume 1: Bulkhead welding

NASA Technical Reports Server (NTRS)

Abel, O. G.

1970-01-01

The complex Saturn S-2 welding processes and procedures required considerable development and refinement to establish a production capability that could consistently produce aluminum alloy welds within specified requirements. The special processes and techniques are defined that were established for the welding of gore-to-gore and manhole- or closeout-to-gore.

Manufacturing methods of a composite cell case for a Ni-Cd battery

NASA Technical Reports Server (NTRS)

Bauer, J. L.; Bogner, R. S.; Lowe, E. P.; Orlowski, E.

1979-01-01

Graphite epoxy material for a nickel cadmium battery cell case has been evaluated and determined to perform in the simulated environment of the battery. The basic manufacturing method requires refinement to demonstrate production feasibility. The various facets of production scale-up, i.e., process and tooling development together with material and process control, have been integrated into a comprehensive manufacturing process that assures production reproducibility and product uniformity. Test results substantiate that a battery cell case produced from graphite epoxy pre-impregnated material utilizing internal pressure bag fabrication method is feasible.

An intelligent factory-wide optimal operation system for continuous production process

NASA Astrophysics Data System (ADS)

Ding, Jinliang; Chai, Tianyou; Wang, Hongfeng; Wang, Junwei; Zheng, Xiuping

2016-03-01

In this study, a novel intelligent factory-wide operation system for a continuous production process is designed to optimise the entire production process, which consists of multiple units; furthermore, this system is developed using process operational data to avoid the complexity of mathematical modelling of the continuous production process. The data-driven approach aims to specify the structure of the optimal operation system; in particular, the operational data of the process are used to formulate each part of the system. In this context, the domain knowledge of process engineers is utilised, and a closed-loop dynamic optimisation strategy, which combines feedback, performance prediction, feed-forward, and dynamic tuning schemes into a framework, is employed. The effectiveness of the proposed system has been verified using industrial experimental results.

Manufacturing of Smart Structures Using Fiber Placement Manufacturing Processes

NASA Technical Reports Server (NTRS)

Thomas, Matthew M.; Glowasky, Robert A.; McIlroy, Bruce E.; Story, Todd A.

1996-01-01

Smart structures research and development, with the ultimate aim of rapid commercial and military production of these structures, are at the forefront of the Synthesis and Processing of Intelligent Cost-Effective Structures (SPICES) program. As part of this ARPA-sponsored program, MDA-E is using fiber placement processes to manufacture integrated smart structure systems. These systems comprise advanced composite structures with embedded fiber optic sensors, shape memory alloys, piezoelectric actuators, and miniature accelerometers. Cost-effective approaches and solutions to smart material synthesis in the fiber-placement process, based upon integrated product development, are discussed herein.

A high volume cost efficient production macrostructuring process. [for silicon solar cell surface treatment

NASA Technical Reports Server (NTRS)

Chitre, S. R.

1978-01-01

The paper presents an experimentally developed surface macro-structuring process suitable for high volume production of silicon solar cells. The process lends itself easily to automation for high throughput to meet low-cost solar array goals. The tetrahedron structure observed is 0.5 - 12 micron high. The surface has minimal pitting with virtually no or very few undeveloped areas across the surface. This process has been developed for (100) oriented as cut silicon. Chemi-etched, hydrophobic and lapped surfaces were successfully texturized. A cost analysis as per Samics is presented.

Computer Aided Process Planning for Non-Axisymmetric Deep Drawing Products

NASA Astrophysics Data System (ADS)

Park, Dong Hwan; Yarlagadda, Prasad K. D. V.

2004-06-01

In general, deep drawing products have various cross-section shapes such as cylindrical, rectangular and non-axisymmetric shapes. The application of the surface area calculation to non-axisymmetric deep drawing process has not been published yet. In this research, a surface area calculation for non-axisymmetric deep drawing products with elliptical shape was constructed for a design of blank shape of deep drawing products by using an AutoLISP function of AutoCAD software. A computer-aided process planning (CAPP) system for rotationally symmetric deep drawing products has been developed. However, the application of the system to non-axisymmetric components has not been reported yet. Thus, the CAPP system for non-axisymmetric deep drawing products with elliptical shape was constructed by using process sequence design. The system developed in this work consists of four modules. The first is recognition of shape module to recognize non-axisymmetric products. The second is a three-dimensional (3-D) modeling module to calculate the surface area for non-axisymmetric products. The third is a blank design module to create an oval-shaped blank with the identical surface area. The forth is a process planning module based on the production rules that play the best important role in an expert system for manufacturing. The production rules are generated and upgraded by interviewing field engineers. Especially, the drawing coefficient, the punch and die radii for elliptical shape products are considered as main design parameters. The suitability of this system was verified by applying to a real deep drawing product. This CAPP system constructed would be very useful to reduce lead-time for manufacturing and improve an accuracy of products.

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

Extrusion and Extruded Products: Changes in Quality Attributes as Affected by Extrusion Process Parameters: A Review.

PubMed

Alam, M S; Kaur, Jasmeen; Khaira, Harjot; Gupta, Kalika

2016-01-01

Extrusion of foods is an emerging technology for the food industries to process and market a large number of products of varying size, shape, texture, and taste. Extrusion cooking technology has led to production of wide variety of products like pasta, breakfast cereals, bread crumbs, biscuits, crackers, croutons, baby foods, snack foods, confectionery items, chewing gum, texturized vegetable protein (TVP), modified starch, pet foods, dried soups, dry beverage mixes etc. The functional properties of extruded foods plays an important role for their acceptability which include water absorption, water solubility, oil absorption indexes, expansion index, bulk density and viscosity of the dough. The aim of this review is to give the detailed outlines about the potential of extrusion technology in development of different types of products and the role of extrusion-operating conditions and their effect on product development resulting in quality changes i.e physical, chemical, and nutritional, experienced during the extrusion process.

Biomass, strain engineering, and fermentation processes for butanol production by solventogenic clostridia.

PubMed

Lee, Sang-Hyun; Yun, Eun Ju; Kim, Jungyeon; Lee, Sang Jun; Um, Youngsoon; Kim, Kyoung Heon

2016-10-01

Butanol is considered an attractive biofuel and a commercially important bulk chemical. However, economical production of butanol by solventogenic clostridia, e.g., via fermentative production of acetone-butanol-ethanol (ABE), is hampered by low fermentation performance, mainly as a result of toxicity of butanol to microorganisms and high substrate costs. Recently, sugars from marine macroalgae and syngas were recognized as potent carbon sources in biomass feedstocks that are abundant and do not compete for arable land with edible crops. With the aid of systems metabolic engineering, many researchers have developed clostridial strains with improved performance on fermentation of these substrates. Alternatively, fermentation strategies integrated with butanol recovery processes such as adsorption, gas stripping, liquid-liquid extraction, and pervaporation have been designed to increase the overall titer of butanol and volumetric productivity. Nevertheless, for economically feasible production of butanol, innovative strategies based on recent research should be implemented. This review describes and discusses recent advances in the development of biomass feedstocks, microbial strains, and fermentation processes for butanol production.

Commercial space opportunities - Advanced concepts and technology overview

NASA Technical Reports Server (NTRS)

Reck, Gregory M.

1993-01-01

The paper discusses the status of current and future commercial space opportunities. The goal is to pioneer innovative, customer-focused space concepts and technologies, leveraged through industrial, academic, and government alliance, to ensure U.S. commercial competitiveness and preeminence in space. The strategy is to develop technologies which enable new products and processes, deploy existing technology into commercial and military products and processes, and integrate military and commercial research and production activities. Technology development areas include information infrastructure, electronics design and manufacture, health care technology, environment technology, and aeronautical technologies.

CdSe TFT AMLCDE manufacturing process

NASA Astrophysics Data System (ADS)

Pritchard, Annette M.

1995-06-01

Active Matrix Liquid Crystal Displays, AMLCDs, based on Cadmium Selenide Thin Film Transistors, have been developed by Litton for a number of defence/avionics applications. Fabrication processed for the thin film transistor (TFT) arrays, color filters and liquid crystal cell assembly have been developed which enable the end product to meet the difficult environmental and performance specifications of military applications, while maintaining focus on cost and yield issues. The fabrication of the AMLCD products is now transitioning into a new production facility which has been designed specifically to meet the requirements of the defence/avionics marketplace.

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.

NATO/CCMS PILOT STUDY ON CLEAN PRODUCTS & PROCESSES

EPA Science Inventory

Led by the United States, represented by the U.S. Environmental Protection Agency's (EPA's) National Risk Management Research Laboratory, the Pilot Study on Clean Products and Processes was instituted to create an international forum where current trends, developments, and expert...

In situ Transesterification of Microalgal Oil to Produce Algal Biodiesel

DOT National Transportation Integrated Search

2012-06-01

This research was to process whole microalgae cells for biodiesel production without first extracting lipids. The ultimate : goal is develop a novel process for algal biodiesel production directly from microalgae cells in a single step, i.e., in situ...

Results of SEI Independent Research and Development Projects

DTIC Science & Technology

2008-12-01

contained there. When laptops with a dual-core processor came out, ITunes fails crashed. ITunes was designed as multi-threaded application, but until...involving product portfolio, in-bound technical marketing, research and development, product engineering, supply chain, and out-bound sales and marketing...of quality and process improvement professionals to the marketing, product engineering, supply chain, product test and sales professionals. 3

Creativity Enhancement in a Product Development Course through Entrepreneurship Learning and Intellectual Property Awareness

ERIC Educational Resources Information Center

Silva, Arlindo; Henriques, Elsa; Carvalho, Aldina

2009-01-01

Product development is the set of activities starting with the perception of a market need and ending in the production and sale of a new product satisfying that need. Broadly speaking, it is a process that should follow a structured methodology, if a certain level of effectiveness and efficacy is envisaged. In the Portuguese industrial…

Engineered Chloroplast Genome just got Smarter

PubMed Central

Jin, Shuangxia; Daniell, Henry

2015-01-01

Chloroplasts are known to sustain life on earth by providing food, fuel and oxygen through the process of photosynthesis. However, the chloroplast genome has also been smartly engineered to confer valuable agronomic traits and/or serve as bioreactors for production of industrial enzymes, biopharmaceuticals, bio-products or vaccines. The recent breakthrough in hyper-expression of biopharmaceuticals in edible leaves has facilitated the advancement to clinical studies by major pharmaceutical companies. This review critically evaluates progress in developing new tools to enhance or simplify expression of targeted genes in chloroplasts. These tools hold the promise to further the development of novel fuels and products, enhance the photosynthetic process, and increase our understanding of retrograde signaling and cellular processes. PMID:26440432

Quick generation of Raman spectroscopy based in-process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture.

PubMed

Berry, Brandon N; Dobrowsky, Terrence M; Timson, Rebecca C; Kshirsagar, Rashmi; Ryll, Thomas; Wiltberger, Kelly

2016-01-01

Mitigating risks to biotherapeutic protein production processes and products has driven the development of targeted process analytical technology (PAT); however implementing PAT during development without significantly increasing program timelines can be difficult. The development of a monoclonal antibody expressed in a Chinese hamster ovary (CHO) cell line via fed-batch processing presented an opportunity to demonstrate capabilities of altering percent glycated protein product. Glycation is caused by pseudo-first order, non-enzymatic reaction of a reducing sugar with an amino group. Glucose is the highest concentration reducing sugar in the chemically defined media (CDM), thus a strategy controlling glucose in the production bioreactor was developed utilizing Raman spectroscopy for feedback control. Raman regions for glucose were determined by spiking studies in water and CDM. Calibration spectra were collected during 8 bench scale batches designed to capture a wide glucose concentration space. Finally, a PLS model capable of translating Raman spectra to glucose concentration was built using the calibration spectra and spiking study regions. Bolus feeding in mammalian cell culture results in wide glucose concentration ranges. Here we describe the development of process automation enabling glucose setpoint control. Glucose-free nutrient feed was fed daily, however glucose stock solution was fed as needed according to online Raman measurements. Two feedback control conditions were executed where glucose was controlled at constant low concentration or decreased stepwise throughout. Glycation was reduced from ∼9% to 4% using a low target concentration but was not reduced in the stepwise condition as compared to the historical bolus glucose feeding regimen. © 2015 American Institute of Chemical Engineers.

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.

Selection of an Alternative Production Part Approval Process to Improve Weapon Systems Production Readiness

DTIC Science & Technology

2017-09-01

production outcomes: 1) knowledge gaps in technology, 2) design instability and 3) manufacturing knowledge gaps. Only manufacturing knowledge gaps...ability to produce at a desired production rate. Each item produced under this manufacturing development is to meet that item’s design requirements. The...represented with respect to assessing manufacturing design and development with a verification and demonstration. DOD acquisition waits to assess production

An Evolutionary History of Oriented Strandboard (OSB)

Treesearch

John I. Zerbe; Zhiyong Cai; George B. Harpole

2015-01-01

To improve wood utilization efficiency, oriented strandboard (OSB) was developed; 80% of the wood removed from the forest can now be processed into marketable products. This manuscript describes the history of developing this most profitable wood product, OSB, and the early FPL contribution in development.

Evolutionary process development towards next generation crystalline silicon solar cells : a semiconductor process toolbox application

NASA Astrophysics Data System (ADS)

John, J.; Prajapati, V.; Vermang, B.; Lorenz, A.; Allebe, C.; Rothschild, A.; Tous, L.; Uruena, A.; Baert, K.; Poortmans, J.

2012-08-01

Bulk crystalline Silicon solar cells are covering more than 85% of the world's roof top module installation in 2010. With a growth rate of over 30% in the last 10 years this technology remains the working horse of solar cell industry. The full Aluminum back-side field (Al BSF) technology has been developed in the 90's and provides a production learning curve on module price of constant 20% in average. The main reason for the decrease of module prices with increasing production capacity is due to the effect of up scaling industrial production. For further decreasing of the price per wattpeak silicon consumption has to be reduced and efficiency has to be improved. In this paper we describe a successive efficiency improving process development starting from the existing full Al BSF cell concept. We propose an evolutionary development includes all parts of the solar cell process: optical enhancement (texturing, polishing, anti-reflection coating), junction formation and contacting. Novel processes are benchmarked on industrial like baseline flows using high-efficiency cell concepts like i-PERC (Passivated Emitter and Rear Cell). While the full Al BSF crystalline silicon solar cell technology provides efficiencies of up to 18% (on cz-Si) in production, we are achieving up to 19.4% conversion efficiency for industrial fabricated, large area solar cells with copper based front side metallization and local Al BSF applying the semiconductor toolbox.

Setting new standards in MEMS

NASA Astrophysics Data System (ADS)

Rimskog, Magnus; O'Loughlin, Brian J.

2007-02-01

Silex Microsystems handles a wide range of customized MEMS components. This speech will be describing Silex's MEMS foundry work model for providing customized solutions based on MEMS in a cost effective and well controlled manner. Factors for success are the capabilities to reformulate a customer product concept to manufacturing processes in the wafer fab, using standard process modules and production equipment. A well-controlled system increases the likelihood of a first batch success and enables fast ramp-up into volume production. The following success factors can be listed: strong enduring relationships with the customers; highly qualified well-experienced specialists working close with the customer; process solutions and building blocks ready to use out of a library; addressing manufacturing issues in the early design phase; in-house know how to meet demands for volume manufacturing; access to a wafer fab with high capacity, good organization, high availability of equipment, and short lead times; process development done in the manufacturing environment using production equipment for easy ramp-up to volume production. The article covers a method of working to address these factors: to have a long and enduring relationships with customers utilizing MEMS expertise and working close with customers, to translate their product ideas to MEMS components; to have stable process solutions for features such as Low ohmic vias, Spiked electrodes, Cantilevers, Silicon optical mirrors, Micro needles, etc, which can be used and modified for the customer needs; to use a structured development and design methodology in order to handle hundreds of process modules, and setting up standard run sheets. It is also very important to do real time process development in the manufacturing line. It minimizes the lead-time for the ramp-up of production; to have access to a state of the art Wafer Fab which is well organized, controlled and flexible, with high capacity and short lead-time for prototypes. It is crucial to have intimate control of processes, equipment, organization, production flow control and WIP. This has been addressed by using a fully computerized control and reporting system.

Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System.

PubMed

Jenke, Dennis

2012-01-01

An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered. Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

Automated assembly of VECSEL components

NASA Astrophysics Data System (ADS)

Brecher, C.; Pyschny, N.; Haag, S.; Mueller, T.

2013-02-01

Due to the architectural advantage of an external cavity architecture that enables the integration of additional elements into the cavity (e.g. for mode control, frequency conversion, wavelength tuning or passive mode-locking) VECSELs are a rapidly developing laser technology. Nevertheless they often have to compete with direct (edge) emitting laser diodes which can have significant cost advantages thanks to their rather simple structure and production processes. One way to compensate the economical disadvantages of VECSELs is to optimize each component in terms of quality and costs and to apply more efficient (batch) production processes. In this context, the paper presents recent process developments for the automated assembly of VECSELs using a new type of desktop assembly station with an ultra-precise micromanipulator. The core concept is to create a dedicated process development environment from which implemented processes can be transferred fluently to production equipment. By now two types of processes have been put into operation on the desktop assembly station: 1.) passive alignment of the pump optics implementing a camera-based alignment process, where the pump spot geometry and position on the semiconductor chip is analyzed and evaluated; 2.) active alignment of the end mirror based on output power measurements and optimization algorithms. In addition to the core concept and corresponding hardware and software developments, detailed results of both processes are presented explaining measurement setups as well as alignment strategies and results.

Economics of recombinant antibody production processes at various scales: Industry-standard compared to continuous precipitation.

PubMed

Hammerschmidt, Nikolaus; Tscheliessnig, Anne; Sommer, Ralf; Helk, Bernhard; Jungbauer, Alois

2014-06-01

Standard industry processes for recombinant antibody production employ protein A affinity chromatography in combination with other chromatography steps and ultra-/diafiltration. This study compares a generic antibody production process with a recently developed purification process based on a series of selective precipitation steps. The new process makes two of the usual three chromatographic steps obsolete and can be performed in a continuous fashion. Cost of Goods (CoGs) analyses were done for: (i) a generic chromatography-based antibody standard purification; (ii) the continuous precipitation-based purification process coupled to a continuous perfusion production system; and (iii) a hybrid process, coupling the continuous purification process to an upstream batch process. The results of this economic analysis show that the precipitation-based process offers cost reductions at all stages of the life cycle of a therapeutic antibody, (i.e. clinical phase I, II and III, as well as full commercial production). The savings in clinical phase production are largely attributed to the fact that expensive chromatographic resins are omitted. These economic analyses will help to determine the strategies that are best suited for small-scale production in parallel fashion, which is of importance for antibody production in non-privileged countries and for personalized medicine. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Final Technical Report - Advanced Optical Sensors to Minimize Energy Consumption in Polymer Extrusion Processes

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

Susan J. Foulk

Project Objective: The objectives of this study are to develop an accurate and stable on-line sensor system to monitor color and composition on-line in polymer melts, to develop a scheme for using the output to control extruders to eliminate the energy, material and operational costs of off-specification product, and to combine or eliminate some extrusion processes. Background: Polymer extrusion processes are difficult to control because the quality achieved in the final product is complexly affected by the properties of the extruder screw, speed of extrusion, temperature, polymer composition, strength and dispersion properties of additives, and feeder system properties. Extruder systemsmore » are engineered to be highly reproducible so that when the correct settings to produce a particular product are found, that product can be reliably produced time after time. However market conditions often require changes in the final product, different products or grades may be processed in the same equipment, and feed materials vary from lot to lot. All of these changes require empirical adjustment of extruder settings to produce a product meeting specifications. Optical sensor systems that can continuously monitor the composition and color of the extruded polymer could detect process upsets, drift, blending oscillations, and changes in dispersion of additives. Development of an effective control algorithm using the output of the monitor would enable rapid corrections for changes in materials and operating conditions, thereby eliminating most of the scrap and recycle of current processing. This information could be used to identify extruder systems issues, diagnose problem sources, and suggest corrective actions in real-time to help keep extruder system settings within the optimum control region. Using these advanced optical sensor systems would give extruder operators real-time feedback from their process. They could reduce the amount of off-spec product produced and significantly reduce energy consumption. Also, because blending and dispersion of additives and components in the final product could be continuously verified, we believe that, in many cases, intermediate compounding steps could be eliminated (saving even more time and energy).« less

Conversion of bioprocess ethanol to industrial chemical products - Applications of process models for energy-economic assessments

NASA Technical Reports Server (NTRS)

Rohatgi, Naresh K.; Ingham, John D.

1992-01-01

An assessment approach for accurate evaluation of bioprocesses for large-scale production of industrial chemicals is presented. Detailed energy-economic assessments of a potential esterification process were performed, where ethanol vapor in the presence of water from a bioreactor is catalytically converted to ethyl acetate. Results show that such processes are likely to become more competitive as the cost of substrates decreases relative to petrolium costs. A commercial ASPEN process simulation provided a reasonably consistent comparison with energy economics calculated using JPL developed software. Detailed evaluations of the sensitivity of production cost to material costs and annual production rates are discussed.

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).

Recent advances in microbial production of mannitol: utilization of low-cost substrates, strain development and regulation strategies.

PubMed

Zhang, Min; Gu, Lei; Cheng, Chao; Ma, Jiangfeng; Xin, Fengxue; Liu, Junli; Wu, Hao; Jiang, Min

2018-02-26

Mannitol has been widely used in fine chemicals, pharmaceutical industries, as well as functional foods due to its excellent characteristics, such as antioxidant protecting, regulation of osmotic pressure and non-metabolizable feature. Mannitol can be naturally produced by microorganisms. Compared with chemical manufacturing, microbial production of mannitol provides high yield and convenience in products separation; however the fermentative process has not been widely adopted yet. A major obstacle to microbial production of mannitol under industrial-scale lies in the low economical efficiency, owing to the high cost of fermentation medium, leakage of fructose, low mannitol productivity. In this review, recent advances in improving the economical efficiency of microbial production of mannitol were reviewed, including utilization of low-cost substrates, strain development for high mannitol yield and process regulation strategies for high productivity.

Electronics manufacturing and assembly in Japan

NASA Technical Reports Server (NTRS)

Kukowski, John A.; Boulton, William R.

1995-01-01

In the consumer electronics industry, precision processing technology is the basis for enhancing product functions and for minimizing components and end products. Throughout Japan, manufacturing technology is seen as critical to the production and assembly of advanced products. While its population has increased less than 30 percent over twenty-five years, Japan's gross national product has increase thirtyfold; this growth has resulted in large part from rapid replacement of manual operations with innovative, high-speed, large-scale, continuously running, complex machines that process a growing number of miniaturized components. The JTEC panel found that introduction of next-generation electronics products in Japan goes hand-in-hand with introduction of new and improved production equipment. In the panel's judgment, Japan's advanced process technologies and equipment development and its highly automated factories are crucial elements of its domination of the consumer electronics marketplace - and Japan's expertise in manufacturing consumer electronics products gives it potentially unapproachable process expertise in all electronics markets.

Modeling and simulation of enzymatic gluconic acid production using immobilized enzyme and CSTR-PFTR circulation reaction system.

PubMed

Li, Can; Lin, Jianqun; Gao, Ling; Lin, Huibin; Lin, Jianqiang

2018-04-01

Production of gluconic acid by using immobilized enzyme and continuous stirred tank reactor-plug flow tubular reactor (CSTR-PFTR) circulation reaction system. A production system is constructed for gluconic acid production, which consists of a continuous stirred tank reactor (CSTR) for pH control and liquid storage and a plug flow tubular reactor (PFTR) filled with immobilized glucose oxidase (GOD) for gluconic acid production. Mathematical model is developed for this production system and simulation is made for the enzymatic reaction process. The pH inhibition effect on GOD is modeled by using a bell-type curve. Gluconic acid can be efficiently produced by using the reaction system and the mathematical model developed for this system can simulate and predict the process well.

Intelligent methods for the process parameter determination of plastic injection molding

NASA Astrophysics Data System (ADS)

Gao, Huang; Zhang, Yun; Zhou, Xundao; Li, Dequn

2018-03-01

Injection molding is one of the most widely used material processing methods in producing plastic products with complex geometries and high precision. The determination of process parameters is important in obtaining qualified products and maintaining product quality. This article reviews the recent studies and developments of the intelligent methods applied in the process parameter determination of injection molding. These intelligent methods are classified into three categories: Case-based reasoning methods, expert system- based methods, and data fitting and optimization methods. A framework of process parameter determination is proposed after comprehensive discussions. Finally, the conclusions and future research topics are discussed.

An integration architecture for the automation of a continuous production complex.

PubMed

Chacón, Edgar; Besembel, Isabel; Narciso, Flor; Montilva, Jonás; Colina, Eliezer

2002-01-01

The development of integrated automation systems for continuous production plants is a very complicated process. A variety of factors must be taken into account, such as their different components (e.g., production units control systems, planning systems, financial systems, etc.), the interaction among them, and their different behavior (continuous or discrete). Moreover, the difficulty of this process is increased by the fact that each component can be viewed in a different way depending on the kind of decisions to be made, and its specific behavior. Modeling continuous production complexes as a composition of components, where, in turn, each component may also be a composite, appears to be the simplest and safest way to develop integrated automation systems. In order to provide the most versatile way to develop this kind of system, this work proposes a new approach for designing and building them, where process behavior, operation conditions and equipment conditions are integrated into a hierarchical automation architecture.

Traceability System For Agricultural Productsbased on Rfid and Mobile Technology

NASA Astrophysics Data System (ADS)

Sugahara, Koji

In agriculture, it is required to establish and integrate food traceability systems and risk management systems in order to improve food safety in the entire food chain. The integrated traceability system for agricultural products was developed, based on innovative technology of RFID and mobile computing. In order to identify individual products on the distribution process efficiently,small RFID tags with unique ID and handy RFID readers were applied. On the distribution process, the RFID tags are checked by using the readers, and transit records of the products are stored to the database via wireless LAN.Regarding agricultural production, the recent issues of pesticides misuse affect consumer confidence in food safety. The Navigation System for Appropriate Pesticide Use (Nouyaku-navi) was developed, which is available in the fields by Internet cell-phones. Based on it, agricultural risk management systems have been developed. These systems collaborate with traceability systems and they can be applied for process control and risk management in agriculture.

EARSEC SAR processing system

NASA Astrophysics Data System (ADS)

Protheroe, Mark; Sloggett, David R.; Sieber, Alois J.

1994-12-01

Traditionally, the production of high quality Synthetic Aperture Radar imagery has been an area where a potential user would have to expend large amounts of money in either the bespoke development of a processing chain dedicated to his requirements or in the purchase of a dedicated hardware platform adapted using accelerator boards and enhanced memory management. Whichever option the user adopted there were limitations based on the desire for a realistic throughput in data load and time. The user had a choice, made early in the purchase, for either a system that adopted innovative algorithmic manipulation, to limit the processing time of the purchase of expensive hardware. The former limits the quality of the product, while the latter excludes the user from any visibility into the processing chain. Clearly there was a need for a SAR processing architecture that gave the user a choice into the methodology to be adopted for a particular processing sequence, allowing him to decide on either a quick (lower quality) product or a detailed slower (high quality) product, without having to change the algorithmic base of his processor or the hardware platform. The European Commission, through the Advanced Techniques unit of the Joint Research Centre (JRC) Institute for Remote Sensing at Ispra in Italy, realizing the limitations on current processing abilities, initiated its own program to build airborne SAR and Electro-Optical (EO) sensor systems. This program is called the European Airborne Remote Sensing Capabilities (EARSEC) program. This paper describes the processing system developed for the airborne SAR sensor system. The paper considers the requirements for the system and the design of the EARSEC Airborne SAR Processing System. It highlights the development of an open SAR processing architecture where users have full access to intermediate products that arise from each of the major processing stages. It also describes the main processing stages in the overall architecture and illustrates the results of each of the key stages in the processor.

The Airborne Ocean Color Imager - System description and image processing

NASA Technical Reports Server (NTRS)

Wrigley, Robert C.; Slye, Robert E.; Klooster, Steven A.; Freedman, Richard S.; Carle, Mark; Mcgregor, Lloyd F.

1992-01-01

The Airborne Ocean Color Imager was developed as an aircraft instrument to simulate the spectral and radiometric characteristics of the next generation of satellite ocean color instrumentation. Data processing programs have been developed as extensions of the Coastal Zone Color Scanner algorithms for atmospheric correction and bio-optical output products. The latter include several bio-optical algorithms for estimating phytoplankton pigment concentration, as well as one for the diffuse attenuation coefficient of the water. Additional programs have been developed to geolocate these products and remap them into a georeferenced data base, using data from the aircraft's inertial navigation system. Examples illustrate the sequential data products generated by the processing system, using data from flightlines near the mouth of the Mississippi River: from raw data to atmospherically corrected data, to bio-optical data, to geolocated data, and, finally, to georeferenced data.

Methyl chloride via oxyhydrochlorination of methane: A building block for chemicals and fuels from natural gas

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

Benson, R.L.; Brown, S.S.D.; Ferguson, S.P.

1995-12-31

The objectives of this program are to (a) develop a process for converting natural gas to methyl chloride via an oxyhydrochlorination route using highly selective, stable catalysts in a fixed-bed, (b) design a reactor capable of removing the large amount of heat generated in the process so as to control the reaction, (c) develop a recovery system capable of removing the methyl chloride from the product stream and (d) determine the economics and commercial viability of the process. The general approach has been as follows: (a) design and build a laboratory scale reactor, (b) define and synthesize suitable OHC catalystsmore » for evaluation, (c) select first generation OHC catalyst for Process Development Unit (PDU) trials, (d) design, construct and startup PDU, (e) evaluate packed bed reactor design, (f) optimize process, in particular, product recovery operations, (g) determine economics of process, (h) complete preliminary engineering design for Phase II and (i) make scale-up decision and formulate business plan for Phase II. Conclusions regarding process development and catalyst development are presented.« less

Optical Gripper

NASA Astrophysics Data System (ADS)

Jalba, C. K.; Muminovic, A.; Epple, S.; Barz, C.; Nasui, V.

2017-05-01

With increasing automation, many work processes become more and more complex. Most technical products can no longer be developed and manufactured by a single department. They are often the product of different divisions and require cooperation from different specialist areas. For example, in the Western world, a simple coffee maker is no longer so much in demand. If the buyer has the possibility to choose between a simple coffee maker and a coffee machine with very complex functions, the choice will probably fall to the more complex variant. Technical progress also applies to other technical products, such as grippers and manipulators. In this paper, it is shown how grasping processes can be redefined and developed with interdisciplinary technical approaches. Both conventional and latest developments in mechanical engineering, production technology, mechatronics and sensor technology will be considered.

Technologies for Extracting Valuable Metals and Compounds from Geothermal Fluids

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

Harrison, Stephen

2014-04-30

Executive Summary Simbol Materials studied various methods of extracting valuable minerals from geothermal brines in the Imperial Valley of California, focusing on the extraction of lithium, manganese, zinc and potassium. New methods were explored for managing the potential impact of silica fouling on mineral extraction equipment, and for converting silica management by-products into commercial products.` Studies at the laboratory and bench scale focused on manganese, zinc and potassium extraction and the conversion of silica management by-products into valuable commercial products. The processes for extracting lithium and producing lithium carbonate and lithium hydroxide products were developed at the laboratory scale andmore » scaled up to pilot-scale. Several sorbents designed to extract lithium as lithium chloride from geothermal brine were developed at the laboratory scale and subsequently scaled-up for testing in the lithium extraction pilot plant. Lithium The results of the lithium studies generated the confidence for Simbol to scale its process to commercial operation. The key steps of the process were demonstrated during its development at pilot scale: 1. Silica management. 2. Lithium extraction. 3. Purification. 4. Concentration. 5. Conversion into lithium hydroxide and lithium carbonate products. Results show that greater than 95% of the lithium can be extracted from geothermal brine as lithium chloride, and that the chemical yield in converting lithium chloride to lithium hydroxide and lithium carbonate products is greater than 90%. The product purity produced from the process is consistent with battery grade lithium carbonate and lithium hydroxide. Manganese and zinc Processes for the extraction of zinc and manganese from geothermal brine were developed. It was shown that they could be converted into zinc metal and electrolytic manganese dioxide after purification. These processes were evaluated for their economic potential, and at the present time Simbol Materials is evaluating other products with greater commercial value. Potassium Silicotitanates, zeolites and other sorbents were evaluated as potential reagents for the extraction of potassium from geothermal brines and production of potassium chloride (potash). It was found that zeolites were effective at removing potassium but the capacity of the zeolites and the form that the potassium is in does not have economic potential. Iron-silica by-product The conversion of iron-silica by-product produced during silica management operations into more valuable materials was studied at the laboratory scale. Results indicate that it is technically feasible to convert the iron-silica by-product into ferric chloride and ferric sulfate solutions which are precursors to a ferric phosphate product. However, additional work to purify the solutions is required to determine the commercial viability of this process. Conclusion Simbol Materials is in the process of designing its first commercial plant based on the technology developed to the pilot scale during this project. The investment in the commercial plant is hundreds of millions of dollars, and construction of the commercial plant will generate hundreds of jobs. Plant construction will be completed in 2016 and the first lithium products will be shipped in 2017. The plant will have a lithium carbonate equivalent production capacity of 15,000 tonnes per year. The gross revenues from the project are expected to be approximately $ 80 to 100 million annually. During this development program Simbol grew from a company of about 10 people to over 60 people today. Simbol is expected to employ more than 100 people once the plant is constructed. Simbol Materials’ business is scalable in the Imperial Valley region because there are eleven geothermal power plants already in operation, which allows Simbol to expand its business from one plant to multiple plants. Additionally, the scope of the resource is vast in terms of potential products such as lithium, manganese and zinc and potentially potassium.« less

Study of CNSL Processing Plants Located in Cuddalore District of Tamil Nadu, India

NASA Astrophysics Data System (ADS)

Bhaskaran, E.

2017-06-01

Basic chemicals and their related products like petrochemicals, fertilisers, paints, varnishes, glass, perfumes, toiletries, pharmaceuticals, etc. form a very significant part of the Indian economy and account for about 3% of India's GDP. Among the most diversified industrial sectors, it covers an array of more than 70,000 commercial products. The chemicals sector accounts for about 14% in overall index of industrial production, 11% of total exports and about 7.2% of total imports. The total Foreign Direct Investment in Chemicals (excluding fertilizers) was US 7252 million from April 2011 to March 2012. For inclusive growth and sustainable development most of the Chemical manufacturers should adopt the Cluster Development Approach. The objective is to Study the Occupational Hazards in Cashew Nut Shell Liquid (CNSL) Oil Processing Industries in Panruti Block of Cuddalore District. The methodology adopted is collection of primary processing data during November 2012 from 14 CNSL Processing Industries in Panruti Block of Cuddalore District. Majority of Industries has not processed the CNSL oil as per standards and there is much scope for occupational hazards. In two processes the CNSL oil is let out in the tank constructed equal to ground height where there is possibility of workers getting trapped inside the high temperature CNSL oil. The electric motor is also placed in the ground so that there is possibility of current passing in the ground which leads to occupational hazards for the workers. To conclude, Cashew Shell Oil Processing Industries in Panruti Block of Cuddalore District needs is re-engineering in design and operation starting from Cashew Shell storage, extraction of shell oil from expeller, processing and packaging of CNSL in barrels for better safety from occupational hazards and Cyclones. Moreover for sustainable development, they should adopt cluster development approach, so that infrastructure interrelationships, technology interrelationships, procurement interrelationships, production interrelationships and marketing interrelationships will take place among CNSL manufacturers to decrease cost, increase quality, productivity and efficiency to compete in the world market.

Biological hydrogen production by dark fermentation: challenges and prospects towards scaled-up production.

PubMed

RenNanqi; GuoWanqian; LiuBingfeng; CaoGuangli; DingJie

2011-06-01

Among different technologies of hydrogen production, bio-hydrogen production exhibits perhaps the greatest potential to replace fossil fuels. Based on recent research on dark fermentative hydrogen production, this article reviews the following aspects towards scaled-up application of this technology: bioreactor development and parameter optimization, process modeling and simulation, exploitation of cheaper raw materials and combining dark-fermentation with photo-fermentation. Bioreactors are necessary for dark-fermentation hydrogen production, so the design of reactor type and optimization of parameters are essential. Process modeling and simulation can help engineers design and optimize large-scale systems and operations. Use of cheaper raw materials will surely accelerate the pace of scaled-up production of biological hydrogen. And finally, combining dark-fermentation with photo-fermentation holds considerable promise, and has successfully achieved maximum overall hydrogen yield from a single substrate. Future development of bio-hydrogen production will also be discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Spray-congealed microparticles for drug delivery - an overview of factors influencing their production and characteristics.

PubMed

Oh, Ching Mien; Guo, Qiyun; Wan Sia Heng, Paul; Chan, Lai Wah

2014-07-01

In any manufacturing process, the success of producing an end product with the desired properties and yield depends on a range of factors that include the equipment, process and formulation variables. It is the interest of manufacturers and researchers to understand each manufacturing process better and ascertain the effects of various manufacturing-associated factors on the properties of the end product. Unless the manufacturing process is well understood, it would be difficult to set realistic limits for the process variables and raw material specifications to ensure consistently high-quality and reproducible end products. Over the years, spray congealing has been used to produce particulates by the food and pharmaceutical industries. The latter have used this technology to develop specialized drug delivery systems. In this review, basic principles as well as advantages and disadvantages of the spray congealing process will be covered. Recent developments in spray congealing equipment, process variables and formulation variables such as the matrix material, encapsulated material and additives will also be discussed. Innovative equipment designs and formulations for spray congealing have emerged. Judicious choice of atomizers, polymers and additives is the key to achieve the desired properties of the microparticles for drug delivery.

Microscale to Manufacturing Scale-up of Cell-Free Cytokine Production—A New Approach for Shortening Protein Production Development Timelines

PubMed Central

Zawada, James F; Yin, Gang; Steiner, Alexander R; Yang, Junhao; Naresh, Alpana; Roy, Sushmita M; Gold, Daniel S; Heinsohn, Henry G; Murray, Christopher J

2011-01-01

Engineering robust protein production and purification of correctly folded biotherapeutic proteins in cell-based systems is often challenging due to the requirements for maintaining complex cellular networks for cell viability and the need to develop associated downstream processes that reproducibly yield biopharmaceutical products with high product quality. Here, we present an alternative Escherichia coli-based open cell-free synthesis (OCFS) system that is optimized for predictable high-yield protein synthesis and folding at any scale with straightforward downstream purification processes. We describe how the linear scalability of OCFS allows rapid process optimization of parameters affecting extract activation, gene sequence optimization, and redox folding conditions for disulfide bond formation at microliter scales. Efficient and predictable high-level protein production can then be achieved using batch processes in standard bioreactors. We show how a fully bioactive protein produced by OCFS from optimized frozen extract can be purified directly using a streamlined purification process that yields a biologically active cytokine, human granulocyte-macrophage colony-stimulating factor, produced at titers of 700 mg/L in 10 h. These results represent a milestone for in vitro protein synthesis, with potential for the cGMP production of disulfide-bonded biotherapeutic proteins. Biotechnol. Bioeng. 2011; 108:1570–1578. © 2011 Wiley Periodicals, Inc. PMID:21337337

Advances in Polyhydroxyalkanoate (PHA) Production.

PubMed

Koller, Martin

2017-11-02

This editorial paper provides a synopsis of the contributions to the Bioengineering special issue "Advances in Polyhydroxyalkanoate (PHA) Production". It illustrates the embedding of the issue's individual research articles in the current global research and development landscape related to polyhydroxyalkanoates (PHA). The article shows how these articles are interrelated to each other, reflecting the entire PHA process chain including strain selection, metabolic and genetic considerations, feedstock evaluation, fermentation regimes, process engineering, and polymer processing towards high-value marketable products.

Bioreactors for high cell density and continuous multi-stage cultivations: options for process intensification in cell culture-based viral vaccine production.

PubMed

Tapia, Felipe; Vázquez-Ramírez, Daniel; Genzel, Yvonne; Reichl, Udo

2016-03-01

With an increasing demand for efficacious, safe, and affordable vaccines for human and animal use, process intensification in cell culture-based viral vaccine production demands advanced process strategies to overcome the limitations of conventional batch cultivations. However, the use of fed-batch, perfusion, or continuous modes to drive processes at high cell density (HCD) and overextended operating times has so far been little explored in large-scale viral vaccine manufacturing. Also, possible reductions in cell-specific virus yields for HCD cultivations have been reported frequently. Taking into account that vaccine production is one of the most heavily regulated industries in the pharmaceutical sector with tough margins to meet, it is understandable that process intensification is being considered by both academia and industry as a next step toward more efficient viral vaccine production processes only recently. Compared to conventional batch processes, fed-batch and perfusion strategies could result in ten to a hundred times higher product yields. Both cultivation strategies can be implemented to achieve cell concentrations exceeding 10(7) cells/mL or even 10(8) cells/mL, while keeping low levels of metabolites that potentially inhibit cell growth and virus replication. The trend towards HCD processes is supported by development of GMP-compliant cultivation platforms, i.e., acoustic settlers, hollow fiber bioreactors, and hollow fiber-based perfusion systems including tangential flow filtration (TFF) or alternating tangential flow (ATF) technologies. In this review, these process modes are discussed in detail and compared with conventional batch processes based on productivity indicators such as space-time yield, cell concentration, and product titers. In addition, options for the production of viral vaccines in continuous multi-stage bioreactors such as two- and three-stage systems are addressed. While such systems have shown similar virus titers compared to batch cultivations, keeping high yields for extended production times is still a challenge. Overall, we demonstrate that process intensification of cell culture-based viral vaccine production can be realized by the consequent application of fed-batch, perfusion, and continuous systems with a significant increase in productivity. The potential for even further improvements is high, considering recent developments in establishment of new (designer) cell lines, better characterization of host cell metabolism, advances in media design, and the use of mathematical models as a tool for process optimization and control.

Production of oxygen from lunar ilmenite

NASA Technical Reports Server (NTRS)

Zhao, Y.; Shadman, F.

1990-01-01

The following subjects are addressed: (1) the mechanism and kinetics of carbothermal reduction of simulated lunar ilmenite using carbon and, particularly, CO as reducing agents; (2) the determination of the rate-limiting steps; (3) the investigation of the effect of impurities, particularly magnesium; (4) the search for catalysts suitable for enhancement of the rate-limiting step; (5) the comparison of the kinetics of carbothermal reduction with those of hydrogen reduction; (6) the study of the combined use of CO and hydrogen as products of gasification of carbonaceous solids; (7) the development of reduction methods based on the use of waste carbonaceous compounds for the process; (8) the development of a carbothermal reaction path that utilizes gasification of carbonaceous solids to reducing gaseous species (hydrocarbons and carbon monoxide) to facilitate the reduction reaction kinetics and make the process more flexible in using various forms of carbonaceous feeds; (9) the development of advanced gas separation techniques, including the use of high-temperature ceramic membranes; (10) the development of an optimum process flow sheet for carbothermal reduction, and comparison of this process with the hydrogen reduction scheme, as well as a general comparison with other leading oxygen production schemes; and (11) the use of new and advanced material processing and separation techniques.

Automated information system for analysis and prediction of production situations in blast furnace plant

NASA Astrophysics Data System (ADS)

Lavrov, V. V.; Spirin, N. A.

2016-09-01

Advances in modern science and technology are inherently connected with the development, implementation, and widespread use of computer systems based on mathematical modeling. Algorithms and computer systems are gaining practical significance solving a range of process tasks in metallurgy of MES-level (Manufacturing Execution Systems - systems controlling industrial process) of modern automated information systems at the largest iron and steel enterprises in Russia. This fact determines the necessity to develop information-modeling systems based on mathematical models that will take into account the physics of the process, the basics of heat and mass exchange, the laws of energy conservation, and also the peculiarities of the impact of technological and standard characteristics of raw materials on the manufacturing process data. Special attention in this set of operations for metallurgic production is devoted to blast-furnace production, as it consumes the greatest amount of energy, up to 50% of the fuel used in ferrous metallurgy. The paper deals with the requirements, structure and architecture of BF Process Engineer's Automated Workstation (AWS), a computer decision support system of MES Level implemented in the ICS of the Blast Furnace Plant at Magnitogorsk Iron and Steel Works. It presents a brief description of main model subsystems as well as assumptions made in the process of mathematical modelling. Application of the developed system allows the engineering and process staff to analyze online production situations in the blast furnace plant, to solve a number of process tasks related to control of heat, gas dynamics and slag conditions of blast-furnace smelting as well as to calculate the optimal composition of blast-furnace slag, which eventually results in increasing technical and economic performance of blast-furnace production.

Koji--where East meets West in fermentation.

PubMed

Zhu, Yang; Tramper, Johannes

2013-12-01

Almost all biotechnological processes originate from traditional food fermentations, i.e. the many indigenous processes that can be found already in the written history of thousands of years ago. We still consume many of these fermented foods and beverages on a daily basis today. The evolution of these traditional processes, in particular since the 19th century, stimulated and influenced the development of modern biotechnological processes. In return, the development of modern biotechnology and related advanced techniques will no doubt improve the process, the product quality and the safety of our favourite fermented foods and beverages. In this article, we describe the relationship between these traditional food fermentations and modern biotechnology. Using Koji and its derived product soy sauce as examples, we address the mutual influences that will provide us with a better future concerning the quality, safety and nutritional effect of many fermented food products. © 2013.

The new role of HSE in chemical product development

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

Purinton, R.J. Jr.; Manning, T.S.; Dowell, S.

1996-11-01

Today, Health, Safety, and Environmental issues take a more prominent role than ever before in chemical product development for the global oilfield service industry. Prior to widespread regulatory guidelines, technical problems were solved and well treatment programs were developed using the chemicals which performed the best and were the least expensive for the application. HSE concerns were sometimes addressed from a remedial standpoint, rather than a preventive one throughout the process. With a clearer understanding of the potential impact of chemicals upon people and the environment, along with the ever-increasing array of government regulations, service companies are taking a newmore » approach to product development. HSE-related risks and costs are being assessed early and continued throughout chemical development, with both product and treatment process features then designed accordingly. One service company reflects this approach with its {open_quotes}cradle-to-grave{close_quotes} Product Development and Stewardship program. Integral to this program are planned HSE assessments at each step of development, including Feasibility, Lab Development, Field Testing, Manufacturing, and Commercial Field Introduction. These assessments provide the data necessary to {open_quotes}engineer-in{close_quotes} solutions to potential HSE-related problems, produce viable Risk Management Plans, and promote a smoother path to commercialization. This avoids arriving at the commercial launch point with a product which poses unacceptably high personal or environmental risks, may be restricted or banned in key markets, or requires lengthy and expensive government registrations. In order to optimize R&E resources and ensure continuous evaluation, decision points (to continue, modify, or abandon) are built into the process. Early HSE screenings must be accurate but also relatively quick and inexpensive to be meaningful and economical.« less

Emission factor development for the malt beverage, wine, and distilled spirits industries

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

Lapp, T.; Shrager, B.; Safriet, D.

Midwest Research Institute is currently developing emission factors for inclusion in AP-42 Chapter 9, Food and Agricultural Industries. Three of the sections cover the production of malt beverages, wine, and distilled spirits. The malt beverage segment focuses on the development of ethanol emission factors for filling operations, which were recently identified as the large source of brewery ethanol emissions. The discussion includes a description of the production process and emissions factors for breweries, a history of emission factories for breweries, a description of emission testing conducted at two large breweries, and a presentation of some of the emission factors formore » malt beverage production. The wine industry segment focuses on emissions from the fermentation stage for red and white wines, the pomace screen and pomace press for red wines, and bottling of white wine. Emission factors are presented for ethanol emissions from each of these sources as well as other VOC emissions from the fermentation process. A discussion of the wine production process is presented. A discussion of the emission sources and available emission factors is presented for the distilled spirits industry segment. Factors are presented for the fermentation and aging stages. A process description is presented for the production of Bourbon whisky.« less

The process defines the product: what really matters in biosimilar design and production?

PubMed

Vulto, Arnold G; Jaquez, Orlando A

2017-08-01

Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized for the originator molecule and systematically matched as closely as possible by the biosimilar developer to ensure bio-similarity. The close matching of the originator fingerprint is the foundation of the biosimilarity exercise, as the analytical tools designed to measure differences at the molecular level are far more sensitive and specific than tools available to physicians during clinical trials. Biosimilar development, therefore, has a greater focus on preclinical attributes compared with the development of an original biological agent. As changes in CQAs can occur at different stages of the manufacturing process, even small modifications to the process can alter biosimilar attributes beyond the point of similarity and impact clinical effectiveness and safety. The manufacturer's ability to provide consistent production and quality control will greatly influence the acceptance of biosimilars. To this end, preventing drift from the required specifications over time and avoiding the various implications brought by product shortage will enhance biosimilar integration into daily practice. As most prescribers are not familiar with this new drug development paradigm, educational programmes will be needed so that prescribers see biosimilars as fully equivalent, efficacious and safe medicines when compared with originator products. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

The process defines the product: what really matters in biosimilar design and production?

PubMed Central

Jaquez, Orlando A.

2017-01-01

Abstract Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized for the originator molecule and systematically matched as closely as possible by the biosimilar developer to ensure bio-similarity. The close matching of the originator fingerprint is the foundation of the biosimilarity exercise, as the analytical tools designed to measure differences at the molecular level are far more sensitive and specific than tools available to physicians during clinical trials. Biosimilar development, therefore, has a greater focus on preclinical attributes compared with the development of an original biological agent. As changes in CQAs can occur at different stages of the manufacturing process, even small modifications to the process can alter biosimilar attributes beyond the point of similarity and impact clinical effectiveness and safety. The manufacturer’s ability to provide consistent production and quality control will greatly influence the acceptance of biosimilars. To this end, preventing drift from the required specifications over time and avoiding the various implications brought by product shortage will enhance biosimilar integration into daily practice. As most prescribers are not familiar with this new drug development paradigm, educational programmes will be needed so that prescribers see biosimilars as fully equivalent, efficacious and safe medicines when compared with originator products. PMID:28903544

Media fill for validation of a good manufacturing practice-compliant cell production process.

PubMed

Serra, Marta; Roseti, Livia; Bassi, Alessandra

2015-01-01

According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process.

Development of pulsed processes for the manufacture of solar cells. Quarterly progress report No. 3, April--July 1978

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

Not Available

1978-07-01

Third quarter results under a program to develop ion implantation and specialized, associated processes necessary to achieve automated production of silicon solar cells are described. An ion implantation facility development for solar cell production is described, and a design for an automated production implanter is presented. Also, solar cell development efforts using combined ion implantation and pulsed energy techniques are discussed. Cell performance comparisons have also been made in which junctions and back surface fields were prepared by diffusion and ion implantation. A model is presented to explain the mechanism of ion implantation damage annealing using pulsed energy sources. Functionalmore » requirements have been determined for a pulsed electron beam processor for annealing ion implantation damage at a rate compatible with a 100 milliampere ion implanter. These rates result in a throughput of 100 megawatts of solar cell product per year.« less

Life-cycle assessment of corn-based butanol as a potential transportation fuel.

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

Wu, M.; Wang, M.; Liu, J.

2007-12-31

Butanol produced from bio-sources (such as corn) could have attractive properties as a transportation fuel. Production of butanol through a fermentation process called acetone-butanol-ethanol (ABE) has been the focus of increasing research and development efforts. Advances in ABE process development in recent years have led to drastic increases in ABE productivity and yields, making butanol production worthy of evaluation for use in motor vehicles. Consequently, chemical/fuel industries have announced their intention to produce butanol from bio-based materials. The purpose of this study is to estimate the potential life-cycle energy and emission effects associated with using bio-butanol as a transportation fuel.more » The study employs a well-to-wheels analysis tool--the Greenhouse Gases, Regulated Emissions and Energy Use in Transportation (GREET) model developed at Argonne National Laboratory--and the Aspen Plus{reg_sign} model developed by AspenTech. The study describes the butanol production from corn, including grain processing, fermentation, gas stripping, distillation, and adsorption for products separation. The Aspen{reg_sign} results that we obtained for the corn-to-butanol production process provide the basis for GREET modeling to estimate life-cycle energy use and greenhouse gas emissions. The GREET model was expanded to simulate the bio-butanol life cycle, from agricultural chemical production to butanol use in motor vehicles. We then compared the results for bio-butanol with those of conventional gasoline. We also analyzed the bio-acetone that is coproduced with bio-butanol as an alternative to petroleum-based acetone. Our study shows that, while the use of corn-based butanol achieves energy benefits and reduces greenhouse gas emissions, the results are affected by the methods used to treat the acetone that is co-produced in butanol plants.« less

A Practical Framework Toward Prediction of Breaking Force and Disintegration of Tablet Formulations Using Machine Learning Tools.

PubMed

Akseli, Ilgaz; Xie, Jingjin; Schultz, Leon; Ladyzhynsky, Nadia; Bramante, Tommasina; He, Xiaorong; Deanne, Rich; Horspool, Keith R; Schwabe, Robert

2017-01-01

Enabling the paradigm of quality by design requires the ability to quantitatively correlate material properties and process variables to measureable product performance attributes. Conventional, quality-by-test methods for determining tablet breaking force and disintegration time usually involve destructive tests, which consume significant amount of time and labor and provide limited information. Recent advances in material characterization, statistical analysis, and machine learning have provided multiple tools that have the potential to develop nondestructive, fast, and accurate approaches in drug product development. In this work, a methodology to predict the breaking force and disintegration time of tablet formulations using nondestructive ultrasonics and machine learning tools was developed. The input variables to the model include intrinsic properties of formulation and extrinsic process variables influencing the tablet during manufacturing. The model has been applied to predict breaking force and disintegration time using small quantities of active pharmaceutical ingredient and prototype formulation designs. The novel approach presented is a step forward toward rational design of a robust drug product based on insight into the performance of common materials during formulation and process development. It may also help expedite drug product development timeline and reduce active pharmaceutical ingredient usage while improving efficiency of the overall process. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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

Romm, J.J.

Many American companies have found that saving energy and cutting pollution dramatically improves the bottom line. But beyond these gains, businesses that launch energy efficiency programs to save money are often astonished to discover unforeseen benefits: energy efficient lighting, heating, cooling, motors, and industrial processes can increase worker productivity, decrease absenteeism, and improve the quality of work performed. Profits created by the jump in worker productivity can exceed energy savings by a factor of ten. Energy efficiency and pollution prevention represent the next wave in manufacturing, following the quality revolution launched by the Japanese in the 1960s. Unless America leadsmore » the lean and clean revolution, economic health will be undermined as other countries develop clean processes and products and US companies suffer competitively. Also, developing countries will leapfrog their wasteful model and buy products and manufacturing processes from foreign firms already practicing lean and clean.« less

Contaminant Removal from Oxygen Production Systems for In Situ Resource Utilization

NASA Technical Reports Server (NTRS)

Anthony, Stephen M.; Santiago-Maldonado, Edgardo; Captain, James G.; Pawate, Ashtamurthy S.; Kenis, Paul J. A.

2012-01-01

The In Situ Resource Utilization (ISRU) project has been developing technologies to produce oxygen from lunar regolith to provide consumables to a lunar outpost. The processes developed reduce metal oxides in the regolith to produce water, which is then electrolyzed to produce oxygen. Hydrochloic and hydrofluoric acids are byproducts of the reduction processes, as halide minerals are also reduced at oxide reduction conditions. Because of the stringent water quality requirements for electrolysis, there is a need for a contaminant removal process. The Contaminant Removal from Oxygen Production Systems (CROPS) team has been developing a separation process to remove these contaminants in the gas and liquid phase that eliminates the need for consumables. CROPS has been using Nafion, a highly water selective polymeric proton exchange membrane, to recover pure water from the contaminated solution. Membrane thickness, product stream flow rate, and acid solution temperature and concentration were varied with the goal of maximizing water permeation and acid rejection. The results show that water permeation increases with increasing solution temperature and product stream flow rate, while acid rejection increases with decreasing solution temperature and concentration. Thinner membranes allowed for higher water flux and acid rejection than thicker ones. These results were used in the development of the hardware built for the most recent Mars ISRU demonstration project.

Economic analysis of fuel ethanol production from hulled barley by the EDGE (Enhanced Dry Grind Enzymatic) process

USDA-ARS?s Scientific Manuscript database

A cost model was developed for fuel ethanol production from barley based on the EDGE (Enhanced Dry Grind Enzymatic) process (Nghiem, et al., 2008). In this process, in addition to beta-glucanases, which is added to reduce the viscosity of the barley mash for efficient mixing, another enzyme, beta-...

Production and use of metals and oxygen for lunar propulsion

NASA Technical Reports Server (NTRS)

Hepp, Aloysius F.; Linne, Diane L.; Landis, Geoffrey A.; Groth, Mary F.; Colvin, James E.

1991-01-01

Production, power, and propulsion technologies for using oxygen and metals derived from lunar resources are discussed. The production process is described, and several of the more developed processes are discussed. Power requirements for chemical, thermal, and electrical production methods are compared. The discussion includes potential impact of ongoing power technology programs on lunar production requirements. The performance potential of several possible metal fuels including aluminum, silicon, iron, and titanium are compared. Space propulsion technology in the area of metal/oxygen rocket engines is discussed.

Design of CGMP Production of 18F- and 68Ga-Radiopharmaceuticals

PubMed Central

Chu, Pei-Chun; Chao, Hao-Yu; Shieh, Wei-Chen; Chen, Chuck C.

2014-01-01

Objective. Radiopharmaceutical production process must adhere to current good manufacturing process (CGMP) compliance to ensure the quality of precursor, prodrug (active pharmaceutical ingredient, API), and the final drug product that meet acceptance criteria. We aimed to develop an automated system for production of CGMP grade of PET radiopharmaceuticals. Methods. The hardware and software of the automated synthesizer that fit in the hot cell under cGMP requirement were developed. Examples of production yield and purity for 68Ga-DOTATATE and 18F-FDG at CGMP facility were optimized. Analytical assays and acceptance criteria for cGMP grade of 68Ga-DOTATATE and 18F-FDG were established. Results. CGMP facility for the production of PET radiopharmaceuticals has been established. Radio-TLC and HPLC analyses of 68Ga-DOTATATE and 18F-FDG showed that the radiochemical purity was 92% and 96%, respectively. The products were sterile and pyrogenic-free. Conclusion. CGMP compliance of radiopharmaceuticals has been reviewed. 68Ga-DOTATATE and 18F-FDG were synthesized with high radiochemical yield under CGMP process. PMID:25276810

The experience factory: Can it make you a 5? or what is its relationship to other quality and improvement concepts?

NASA Technical Reports Server (NTRS)

Basili, Victor R.

1992-01-01

The concepts of quality improvements have permeated many businesses. It is clear that the nineties will be the quality era for software and there is a growing need to develop or adapt quality improvement approaches to the software business. Thus we must understand software as an artifact and software as a business. Since the business we are dealing with is software, we must understand the nature of software and software development. The software discipline is evolutionary and experimental; it is a laboratory science. Software is development not production. The technologies of the discipline are human based. There is a lack of models that allow us to reason about the process and the product. All software is not the same; process is a variable, goals are variable, etc. Packaged, reusable, experiences require additional resources in the form of organization, processes, people, etc. There have been a variety of organizational frameworks proposed to improve quality for various businesses. The ones discussed in this presentation include: Plan-Do-Check-Act, a quality improvement process based upon a feedback cycle for optimizing a single process model/production line; the Experience Factory/Quality Improvement Paradigm, continuous improvements through the experimentation, packaging, and reuse of experiences based upon a business's needs; Total Quality Management, a management approach to long term success through customer satisfaction based on the participation of all members of an organization; the SEI capability maturity model, a staged process improvement based upon assessment with regard to a set of key process areas until you reach a level 5 which represents a continuous process improvement; and Lean (software) Development, a principle supporting the concentration of the production on 'value added' activities and the elimination of reduction of 'not value added' activities.

A Low-cost, High-yield Process for the Direct Productin of High Energy Density Liquid Fuel from Biomass

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

Agrawal, Rakesh; Delgass, W. N.; Ribeiro, F.

2013-08-31

The primary objective and outcome of this project was the development and validation of a novel, low-cost, high-pressure fast-hydropyrolysis/hydrodeoxygenation (HDO) process (H 2Bioil) using supplementary hydrogen (H 2) to produce liquid hydrocarbons from biomass. The research efforts under the various tasks of the project have culminated in the first experimental demonstration of the H 2Bioil process, producing 100% deoxygenated >C4+ hydrocarbons containing 36-40% of the carbon in the feed of pyrolysis products from biomass. The demonstrated H{sub 2}Bioil process technology (i.e. reactor, catalyst, and downstream product recovery) is scalable to a commercial level and is estimated to be economically competitivemore » for the cases when supplementary H 2 is sourced from coal, natural gas, or nuclear. Additionally, energy systems modeling has revealed several process integration options based on the H 2Bioilprocess for energy and carbon efficient liquid fuel production. All project tasks and milestones were completed or exceeded. Novel, commercially-scalable, high-pressure reactors for both fast-hydropyrolysis and hydrodeoxygenation were constructed, completing Task A. These reactors were capable of operation under a wide-range of conditions; enabling process studies that lead to identification of optimum process conditions. Model compounds representing biomass pyrolysis products were studied, completing Task B. These studies were critical in identifying and developing HDO catalysts to target specific oxygen functional groups. These process and model compound catalyst studies enabled identification of catalysts that achieved 100% deoxygenation of the real biomass feedstock, sorghum, to form hydrocarbons in high yields as part of Task C. The work completed during this grant has identified and validated the novel and commercially scalable H 2Bioil process for production of hydrocarbon fuels from biomass. Studies on model compounds as well as real biomass feedstocks were utilized to identify optimized process conditions and selective HDO catalyst for high yield production of hydrocarbons from biomass. In addition to these experimental efforts, in Tasks D and E, we have developed a mathematical optimization framework to identify carbon and energy efficient biomass-to-liquid fuel process designs that integrate the use of different primary energy sources along with biomass (e.g. solar, coal or natural gas) for liquid fuel production. Using this tool, we have identified augmented biomass-to-liquid fuel configurations based on the fast-hydropyrolysis/HDO pathway, which was experimentally studied in this project. The computational approach used for screening alternative process configurations represents a unique contribution to the field of biomass processing for liquid fuel production.« less

Development of the Fray-Farthing-Chen Cambridge Process: Towards the Sustainable Production of Titanium and Its Alloys

NASA Astrophysics Data System (ADS)

Hu, Di; Dolganov, Aleksei; Ma, Mingchan; Bhattacharya, Biyash; Bishop, Matthew T.; Chen, George Z.

2018-02-01

The Kroll process has been employed for titanium extraction since the 1950s. It is a labour and energy intensive multi-step semi-batch process. The post-extraction processes for making the raw titanium into alloys and products are also excessive, including multiple remelting steps. Invented in the late 1990s, the Fray-Farthing-Chen (FFC) Cambridge process extracts titanium from solid oxides at lower energy consumption via electrochemical reduction in molten salts. Its ability to produce alloys and powders, while retaining the cathode shape also promises energy and material efficient manufacturing. Focusing on titanium and its alloys, this article reviews the recent development of the FFC-Cambridge process in two aspects, (1) resource and process sustainability and (2) advanced post-extraction processing.

Production of Hydrogen by Superadiabatic Decomposition of Hydrogen Sulfide - Final Technical Report for the Period June 1, 1999 - September 30, 2000

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

Rachid B. Slimane; Francis S. Lau; Javad Abbasian

2000-10-01

The objective of this program is to develop an economical process for hydrogen production, with no additional carbon dioxide emission, through the thermal decomposition of hydrogen sulfide (H{sub 2}S) in H{sub 2}S-rich waste streams to high-purity hydrogen and elemental sulfur. The novel feature of the process being developed is the superadiabatic combustion (SAC) of part of the H{sub 2}S in the waste stream to provide the thermal energy required for the decomposition reaction such that no additional energy is required. The program is divided into two phases. In Phase 1, detailed thermochemical and kinetic modeling of the SAC reactor withmore » H{sub 2}S-rich fuel gas and air/enriched air feeds is undertaken to evaluate the effects of operating conditions on exit gas products and conversion efficiency, and to identify key process parameters. Preliminary modeling results are used as a basis to conduct a thorough evaluation of SAC process design options, including reactor configuration, operating conditions, and productivity-product separation schemes, with respect to potential product yields, thermal efficiency, capital and operating costs, and reliability, ultimately leading to the preparation of a design package and cost estimate for a bench-scale reactor testing system to be assembled and tested in Phase 2 of the program. A detailed parametric testing plan was also developed for process design optimization and model verification in Phase 2. During Phase 2 of this program, IGT, UIC, and industry advisors UOP and BP Amoco will validate the SAC concept through construction of the bench-scale unit and parametric testing. The computer model developed in Phase 1 will be updated with the experimental data and used in future scale-up efforts. The process design will be refined and the cost estimate updated. Market survey and assessment will continue so that a commercial demonstration project can be identified.« less

Suomi NPP VIIRS active fire product status

NASA Astrophysics Data System (ADS)

Ellicott, E. A.; Csiszar, I. A.; Schroeder, W.; Giglio, L.; Wind, B.; Justice, C. O.

2012-12-01

We provide an overview of the evaluation and development of the Active Fires product derived from the Visible Infrared Imager Radiometer Suite (VIIRS) sensor on the Suomi National Polar-orbiting Partnership (SNPP) satellite during the first year of on-orbit data. Results from the initial evaluation of the standard SNPP Active Fires product, generated by the SNPP Interface Data Processing System (IDPS), supported the stabilization of the VIIRS Sensor Data Record (SDR) product. This activity focused in particular on the processing of the dual-gain 4 micron VIIRS M13 radiometric measurements into 750m aggregated data, which are fundamental for active fire detection. Following the VIIRS SDR product's Beta maturity status in April 2012, correlative analysis between VIIRS and near-simultaneous fire detections from the Moderate Resolution Imaging Spectroradiometer (MODIS) on the NASA Earth Observing System Aqua satellite confirmed the expected relative detection rates driven primarily by sensor differences. The VIIRS Active Fires Product Development and Validation Team also developed a science code that is based on the latest MODIS Collection 6 algorithm and provides a full spatially explicit fire mask to replace the sparse array output of fire locations from a MODIS Collection 4 equivalent algorithm in the current IDPS product. The Algorithm Development Library (ADL) was used to support the planning for the transition of the science code into IDPS operations in the future. Product evaluation and user outreach was facilitated by a product website that provided end user access to fire data in user-friendly format over North America as well as examples of VIIRS-MODIS comparisons. The VIIRS fire team also developed an experimental product based on 375m VIIRS Imagery band measurements and provided high quality imagery of major fire events in US. By August 2012 the IDPS product achieved Beta maturity, with some known and documented shortfalls related to the processing of incorrect SDR input data and to apparent algorithm deficiencies in select observing and environmental conditions.

Pharmaceutical Product Lead Optimization for Better In vivo Bioequivalence Performance: A case study of Diclofenac Sodium Extended Release Matrix Tablets.

PubMed

Shahiwala, Aliasgar; Zarar, Aisha

2018-01-01

In order to prove the validity of a new formulation, a considerable amount of effort is required to study bioequivalence, which not only increases the burden of carrying out a number of bioequivalence studies but also eventually increases the cost of the optimization process. The aim of the present study was to develop sustained release matrix tablets containing diclofenac sodium using natural polymers and to demonstrate step by step process of product development till the prediction of in vivo marketed product equivalence of the developed product. Different batches of tablets were prepared by direct compression. In vitro drug release studies were performed as per USP. The drug release data were assessed using model-dependent, modelindependent and convolution approaches. Drug release profiles showed that extended release action were in the following order: Gum Tragacanth > Sodium Alginate > Gum Acacia. Amongst the different batches prepared, only F1 and F8 passed the USP criteria of drug release. Developed formulas were found to fit Higuchi kinetics model with Fickian (case I) diffusion-mediated release mechanism. Model- independent kinetics confirmed that total of four batches were passed depending on the similarity factors based on the comparison with the marketed Diclofenac. The results of in vivo predictive convolution model indicated that predicted AUC, Cmax and Tmax values for batch F8 were similar to that of marketed product. This study provides simple yet effective outline of pharmaceutical product development process that will minimize the formulation development trials and maximize the product success in bioequivalence studies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Effect of Humidity of Poly-Cereal Flour Mixture and Screw Rotation Rate on Efficiency of Extrusion Process

ERIC Educational Resources Information Center

Ospanov, ?bdymanap ?.; Muslimov, Nurzhan Zh.; Timurbekova, ?igul ?.; Jumabekova, Gulnar? B.

2016-01-01

The food industry is an important constituent of a country's economy, which provides the population with food. The development of the food industry and the supply of food products to the entire population requires improving food-manufacturing technologies, such as the process for production of extruded poly-cereal food products using…

Process integration for simultaneous saccharification, fermentation, and recovery (SSFR): Production of butanol from corn stover using Clostridium beijerinckii P260

USDA-ARS?s Scientific Manuscript database

A simultaneous saccharification, fermentation, and recovery (SSFR) process was developed for production of acetone butanol ethanol (AB or ABE), of which butanol is the main product, from corn stover employing Clostridium beijerinckii P260. Of the 86 gL^-1^ corn stover, over 97% of the sugars were r...

I-NERI Annual Technical Progress Report 2007-004-K Development and Characterization of New High-Level Waste Forms for Achieving Waste Minimization from Pyroprocessing

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

S. Frank

The current method for the immobilization of fission products that accumulate in electrorefiner salt during the electrochemical processing of used metallic nuclear fuel is to encapsulate the electrorefiner salt in a glass-bonded sodalite ceramic waste form. This process was developed by Argonne National Laboratory in the USA and is currently performed at the Idaho National Laboratory for the treatment of Experimental Breeder Reactor-II (EBR-II) used fuel. This process utilizes a “once-through” option for the disposal of spent electrorefiner salt; where, after the treatment of the EBR-II fuel, the electrorefiner salt containing the active fission products will be disposed of inmore » the ceramic waste form (CWF). The CWF produced will have low fission product loading of approximately 2 to 5 weight percent due to the limited fuel inventory currently being processed. However; the design and implementation of advanced electrochemical processing facilities to treat used fuel would process much greater quantities fuel. With an advanced processing facility, it would be necessary to selectively remove fission products from the electrorefiner salt for salt recycle and to concentrate the fission products to reduce the volume of high-level waste from the treatment facility. The Korean Atomic Energy Research Institute and the Idaho National Laboratory have been collaborating on I-NERI research projects for a number of years to investigate both aspects of selective fission product separation from electrorefiner salt, and to develop advanced waste forms for the immobilization of the collected fission products. The first joint KAERI/INL I-NERI project titled: 2006-002-K, Separation of Fission Products from Molten LiCl-KCl Salt Used for Electrorefining of Metal Fuels, was successfully completed in 2009 by concentrating and isolating fission products from actual electrorefiner salt used for the treated used EBR-II fuel. Two separation methods were tested and from these tests were produced concentrated salt products that acted as the feed material for development of advanced waste forms investigated in this proposal. Accomplishments from the first year activities associated with this I-NERI project included the down selection of candidate waste forms to immobilize fission products separated from electrorefiner salt, and the design of equipment to fabricate actual waste forms in the Hot Fuels Examination Facility (HFEF) at the INL. Reported in this document are accomplishments from the second year (FY10) work performed at the INL, and includes the testing of waste form fabrication equipment, repeating the fission product precipitation experiment, and initial waste form fabrication efforts.« less

Dropwise additive manufacturing of pharmaceutical products for melt-based dosage forms.

PubMed

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

2015-05-01

The US Food and Drug Administration introduced the quality by design approach and process analytical technology guidance to encourage innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. As part of this renewed emphasis on the improvement of manufacturing, the pharmaceutical industry has begun to develop more efficient production processes with more intensive use of online measurement and sensing, real-time quality control, and process control tools. Here, we present dropwise additive manufacturing of pharmaceutical products (DAMPP) as an alternative to conventional pharmaceutical manufacturing methods. This mini-manufacturing process for the production of pharmaceuticals utilizes drop on demand printing technology for automated and controlled deposition of melt-based formulations onto edible substrates. The advantages of drop-on-demand technology, including reproducible production of small droplets, adjustable drop sizing, high placement accuracy, and flexible use of different formulations, enable production of individualized dosing even for low-dose and high-potency drugs. In this work, DAMPP is used to produce solid oral dosage forms from hot melts of an active pharmaceutical ingredient and a polymer. The dosage forms are analyzed to show the reproducibility of dosing and the dissolution behavior of different formulations. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

A practical and scalable manufacturing process for an anti-fungal agent, Nikkomycin Z.

PubMed

Stenland, Christopher J; Lis, Lev G; Schendel, Frederick J; Hahn, Nicholas J; Smart, Mary A; Miller, Amy L; von Keitz, Marc G; Gurvich, Vadim J

2013-02-15

A scalable and reliable manufacturing process for Nikkomycin Z HCl on a 170 g scale has been developed and optimized. The process is characterized by a 2.3 g/L fermentation yield, 79% purification yield, and >98% relative purity of the final product. This method is suitable for further scale up and cGMP production. The Streptomyces tendae ΔNikQ strain developed during the course of this study is superior to any previously reported strain in terms of higher yield and purity of Nikkomycin Z.

Second Aerospace Environmental Technology Conference

NASA Technical Reports Server (NTRS)

Whitaker, A. F. (Editor); Clark-Ingram, M. (Editor)

1997-01-01

The mandated elimination of CFC'S, Halons, TCA, and other ozone depleting chemicals and specific hazardous materials has required changes and new developments in aerospace materials and processes. The aerospace industry has been involved for several years in providing product substitutions, redesigning entire production processes, and developing new materials that minimize or eliminate damage to the environment. These activities emphasize replacement cleaning solvents and their application, verification, compliant coatings including corrosion protection system and removal techniques, chemical propulsion effects on the environment, and the initiation of modifications to relevant processing and manufacturing specifications and standards.

Second Aerospace Environmental Technology Conference

NASA Technical Reports Server (NTRS)

Whitaker, A. F.; Clark-Ingram, M.; Hessler, S. L.

1997-01-01

The mandated elimination of CFC's, Halons, TCA, and other ozone depleting chemicals and specific hazardous materials has required changes and new developments in aerospace materials and processes. The aerospace industry has been involved for several years in providing product substitutions, redesigning entire production processes, and developing new materials that minimize or eliminate damage to the environment. These activities emphasize replacement cleaning solvents and their application verifications, compliant coatings including corrosion protection systems, and removal techniques, chemical propulsion effects on the environment, and the initiation of modifications to relevant processing and manufacturing specifications and standards.

Omega-3 production by fermentation of Yarrowia lipolytica: From fed-batch to continuous.

PubMed

Xie, Dongming; Miller, Edward; Sharpe, Pamela; Jackson, Ethel; Zhu, Quinn

2017-04-01

The omega-3 fatty acid, cis-5,8,11,14,17-eicosapentaenoic acid (C20:5; EPA) has wide-ranging benefits in improving heart health, immune function, and mental health. A sustainable source of EPA production through fermentation of metabolically engineered Yarrowia lipolytica has been developed. In this paper, key fed-batch fermentation conditions were identified to achieve 25% EPA in the yeast biomass, which is so far the highest EPA titer reported in the literature. Dynamic models of the EPA fermentation process were established for analyzing, optimizing, and scaling up the fermentation process. In addition, model simulations were used to develop a two-stage continuous process and compare to single-stage continuous and fed- batch processes. The two stage continuous process, which is equipped with a smaller growth fermentor (Stage 1) and a larger production fermentor (Stage 2), was found to be a superior process to achieve high titer, rate, and yield of EPA. A two-stage continuous fermentation experiment with Y. lipolytica strain Z7334 was designed using the model simulation and then tested in a 2 L and 5 L fermentation system for 1,008 h. Compared with the standard 2 L fed-batch process, the two-stage continuous fermentation process improved the overall EPA productivity by 80% and EPA concentration in the fermenter by 40% while achieving comparable EPA titer in biomass and similar conversion yield from glucose. During the long-term experiment it was also found that the Y. lipolytica strain evolved to reduce byproduct and increase lipid production. This is one of the few continuous fermentation examples that demonstrated improved productivity and concentration of a final product with similar conversion yield compared with a fed-batch process. This paper suggests the two-stage continuous fermentation could be an effective process to achieve improved production of omega-3 and other fermentation products where non-growth or partially growth associated kinetics characterize the process. Biotechnol. Bioeng. 2017;114: 798-812. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Technology Development of Salak (Salacca Zalacca) Chips With Vacuum Frying Machine Base On Expert System In Kramat-Bangkalan Regency

NASA Astrophysics Data System (ADS)

Rosida, D. F.; Happyanto; Anggraeni; Sugiarto; Hapsari

2018-01-01

Agropolitan Program is one form of regional development to improve agribusiness system and effort to improve the welfare of the community. One of the leading commodities in Bangkalan agroclimates is salak which is a potentially very large commodity to be developed. Salak commodities in Kramat Bangkalan Indonesia have developed varous salak produced such as dates of salak, syrup and dodol salak. Salak chips was the target of innovation from processed salak. The Production of salak chips using frying technology with vacuum system to obtain crunchy chips. To get the results need to be developed synergy technology to combine the process conditions and the right system in producing good quality salak chips. Bangkalan Regency is the potential to continue to develop products using a variety of salak to the processed form of vacuum frying machine based on expert system so that the resulting product would be great texture, aroma and taste. This will make the area of Bangkalan, Indonesia be more independent in producing and increasing revenue.

Process optimization for the preparation of antioxidant rich ginger candy using beetroot pomace extract.

PubMed

Kumar, Vikas; Kushwaha, Rinku; Goyal, Ankit; Tanwar, Beenu; Kaur, Jaspreet

2018-04-15

Now-a-days, there is an increased interest in fruits and vegetables processing by-products due to potential source of phytochemicals and pigments. Beetroot (Beta vulgaris) pomace extract is a rich source of betalain, phenolics and other bioactive components, which possess significant antioxidant activities. In the present study, process optimization was performed for developing ginger (Zingiber officinale) candy enriched with beetroot pomace extract using response surface methodology (RSM). The effect of two process variables: blanching time (0-10 min) and beetroot pomace extract (0-10%) was evaluated on physicochemical characteristics and phytochemicals content of the developed product. Maximum phytochemicals' activities were obtained under optimum conditions of 7.81 min blanching time and 9.24% beetroot pomace extract. FTIR analysis also confirmed the significant effect of beetroot pomace extract and it's blanching on the phytochemical potential of ginger candy. The study would be useful for developing similar novel and antioxidants rich food products supplemented with beetroot pomace extract. Copyright © 2017 Elsevier Ltd. All rights reserved.

Space Shuttle ET Friction Stir Weld Machines

NASA Technical Reports Server (NTRS)

Thompson, Jack M.

2003-01-01

NASA and Lockheed-Martin approached the FSW machine vendor community with a specification for longitudinal barrel production FSW weld machines and a shorter travel process development machine in June of 2000. This specification was based on three years of FSW process development on the Space Shuttle External Tank alloys, AL2 195-T8M4 and AL22 19-T87. The primary motivations for changing the ET longitudinal welds from the existing variable polarity Plasma Arc plasma weld process included: (1) Significantly reduced weld defect rates and related reduction in cycle time and uncertainty; (2) Many fewer process variables to control (5 vs. 17); (3) Fewer manufacturing steps; (4) Lower residual stresses and distortion; (5) Improved weld strengths, particularly at cryogenic temperatures; (6) Fewer hazards to production personnel. General Tool was the successful bidder. The equipment is at this writing installed and welding flight hardware. This paper is a means of sharing with the rest of the FSW community the unique features developed to assure NASA/L-M of successful production welds.

Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements.

PubMed

Burggraeve, A; Van den Kerkhof, T; Hellings, M; Remon, J P; Vervaet, C; De Beer, T

2011-04-18

Fluid bed granulation is a batch process, which is characterized by the processing of raw materials for a predefined period of time, consisting of a fixed spraying phase and a subsequent drying period. The present study shows the multivariate statistical modeling and control of a fluid bed granulation process based on in-line particle size distribution (PSD) measurements (using spatial filter velocimetry) combined with continuous product temperature registration using a partial least squares (PLS) approach. Via the continuous in-line monitoring of the PSD and product temperature during granulation of various reference batches, a statistical batch model was developed allowing the real-time evaluation and acceptance or rejection of future batches. Continuously monitored PSD and product temperature process data of 10 reference batches (X-data) were used to develop a reference batch PLS model, regressing the X-data versus the batch process time (Y-data). Two PLS components captured 98.8% of the variation in the X-data block. Score control charts in which the average batch trajectory and upper and lower control limits are displayed were developed. Next, these control charts were used to monitor 4 new test batches in real-time and to immediately detect any deviations from the expected batch trajectory. By real-time evaluation of new batches using the developed control charts and by computation of contribution plots of deviating process behavior at a certain time point, batch losses or reprocessing can be prevented. Immediately after batch completion, all PSD and product temperature information (i.e., a batch progress fingerprint) was used to estimate some granule properties (density and flowability) at an early stage, which can improve batch release time. Individual PLS models relating the computed scores (X) of the reference PLS model (based on the 10 reference batches) and the density, respectively, flowabililty as Y-matrix, were developed. The scores of the 4 test batches were used to examine the predictive ability of the model. Copyright © 2011 Elsevier B.V. All rights reserved.

Nanotechnology in meat processing and packaging: potential applications - a review.

PubMed

Ramachandraiah, Karna; Han, Sung Gu; Chin, Koo Bok

2015-02-01

Growing demand for sustainable production, increasing competition and consideration of health concerns have led the meat industries on a path to innovation. Meat industries across the world are focusing on the development of novel meat products and processes to meet consumer demand. Hence, a process innovation, like nanotechnology, can have a significant impact on the meat processing industry through the development of not only novel functional meat products, but also novel packaging for the products. The potential benefits of utilizing nanomaterials in food are improved bioavailability, antimicrobial effects, enhanced sensory acceptance and targeted delivery of bioactive compounds. However, challenges exist in the application of nanomaterials due to knowledge gaps in the production of ingredients such as nanopowders, stability of delivery systems in meat products and health risks caused by the same properties which also offer the benefits. For the success of nanotechnology in meat products, challenges in public acceptance, economics and the regulation of food processed with nanomaterials which may have the potential to persist, accumulate and lead to toxicity need to be addressed. So far, the most promising area for nanotechnology application seems to be in meat packaging, but the long term effects on human health and environment due to migration of the nanomaterials from the packaging needs to be studied further. The future of nanotechnology in meat products depends on the roles played by governments, regulatory agencies and manufacturers in addressing the challenges related to the application of nanomaterials in food.

Nanotechnology in Meat Processing and Packaging: Potential Applications — A Review

PubMed Central

Ramachandraiah, Karna; Han, Sung Gu; Chin, Koo Bok

2015-01-01

Growing demand for sustainable production, increasing competition and consideration of health concerns have led the meat industries on a path to innovation. Meat industries across the world are focusing on the development of novel meat products and processes to meet consumer demand. Hence, a process innovation, like nanotechnology, can have a significant impact on the meat processing industry through the development of not only novel functional meat products, but also novel packaging for the products. The potential benefits of utilizing nanomaterials in food are improved bioavailability, antimicrobial effects, enhanced sensory acceptance and targeted delivery of bioactive compounds. However, challenges exist in the application of nanomaterials due to knowledge gaps in the production of ingredients such as nanopowders, stability of delivery systems in meat products and health risks caused by the same properties which also offer the benefits. For the success of nanotechnology in meat products, challenges in public acceptance, economics and the regulation of food processed with nanomaterials which may have the potential to persist, accumulate and lead to toxicity need to be addressed. So far, the most promising area for nanotechnology application seems to be in meat packaging, but the long term effects on human health and environment due to migration of the nanomaterials from the packaging needs to be studied further. The future of nanotechnology in meat products depends on the roles played by governments, regulatory agencies and manufacturers in addressing the challenges related to the application of nanomaterials in food. PMID:25557827

Enriching the biological space of natural products and charting drug metabolites, through real time biotransformation monitoring: The NMR tube bioreactor.

PubMed

Chatzikonstantinou, Alexandra V; Chatziathanasiadou, Maria V; Ravera, Enrico; Fragai, Marco; Parigi, Giacomo; Gerothanassis, Ioannis P; Luchinat, Claudio; Stamatis, Haralambos; Tzakos, Andreas G

2018-01-01

Natural products offer a wide range of biological activities, but they are not easily integrated in the drug discovery pipeline, because of their inherent scaffold intricacy and the associated complexity in their synthetic chemistry. Enzymes may be used to perform regioselective and stereoselective incorporation of functional groups in the natural product core, avoiding harsh reaction conditions, several protection/deprotection and purification steps. Herein, we developed a three step protocol carried out inside an NMR-tube. 1st-step: STD-NMR was used to predict the: i) capacity of natural products as enzyme substrates and ii) possible regioselectivity of the biotransformations. 2nd-step: The real-time formation of multiple-biotransformation products in the NMR-tube bioreactor was monitored in-situ. 3rd-step: STD-NMR was applied in the mixture of the biotransformed products to screen ligands for protein targets. Herein, we developed a simple and time-effective process, the "NMR-tube bioreactor", that is able to: (i) predict which component of a mixture of natural products can be enzymatically transformed, (ii) monitor in situ the transformation efficacy and regioselectivity in crude extracts and multiple substrate biotransformations without fractionation and (iii) simultaneously screen for interactions of the biotransformation products with pharmaceutical protein targets. We have developed a green, time-, and cost-effective process that provide a simple route from natural products to lead compounds for drug discovery. This process can speed up the most crucial steps in the early drug discovery process, and reduce the chemical manipulations usually involved in the pipeline, improving the environmental compatibility. Copyright © 2017 Elsevier B.V. All rights reserved.

SAR Altimetry Processing on Demand Service for Cryosat-2 and Sentinel-3 at ESA G-Pod

NASA Astrophysics Data System (ADS)

Dinardo, Salvatore; Benveniste, Jérôme; Ambrózio, Américo; Restano, Marco

2016-07-01

The G-POD SARvatore service to users for the exploitation of CryoSat-2 data was designed and developed by the Altimetry Team at ESA-ESRIN EOP-SER (Earth Observation - Exploitation, Research and Development). The G-POD service coined SARvatore (SAR Versatile Altimetric Toolkit for Ocean Research & Exploitation) is a web platform that allows any scientist to process on-line, on-demand and with user-selectable configuration CryoSat-2 SAR/SARIN data, from L1a (FBR) data products up to SAR/SARin Level-2 geophysical data products. The Processor takes advantage of the G-POD (Grid Processing On Demand) distributed computing platform (350 CPUs in ~70 Working Nodes) to timely deliver output data products and to interface with ESA-ESRIN FBR data archive (155'000 SAR passes and 41'000 SARin passes). The output data products are generated in standard NetCDF format (using CF Convention), therefore being compatible with the Multi-Mission Radar Altimetry Toolbox (BRAT) and other NetCDF tools. By using the G-POD graphical interface, it is straightforward to select a geographical area of interest within the time-frame related to the Cryosat-2 SAR/SARin FBR data products availability in the service catalogue. The processor prototype is versatile, allowing users to customize and to adapt the processing according to their specific requirements by setting a list of configurable options. After the task submission, users can follow, in real time, the status of the processing, which can be lengthy due to the required intense number-crunching inherent to SAR processing. From the web interface, users can choose to generate experimental SAR data products as stack data and RIP (Range Integrated Power) waveforms. The processing service, initially developed to support the awarded development contracts by confronting the deliverables to ESA's prototype, is now made available to the worldwide SAR Altimetry Community for research & development experiments, for on-site demonstrations/training in training courses and workshops, for cross-comparison to third party products (e.g. CLS/CNES CPP or ESA SAR COP data products), for the preparation of the Sentinel-3 Surface Topography Mission, for producing data and graphics for publications, etc. Initially, the processing was designed and uniquely optimized for open ocean studies. It was based on the SAMOSA model developed for the Sentinel-3 Ground Segment using CryoSat data (Cotton et al., 2008; Ray et al., 2014). However, since June 2015, a new retracker (SAMOSA+) is offered within the service as a dedicated retracker for coastal zone, inland water and sea-ice/ice-sheet. In view of the Sentinel-3 launch, a new flavor of the service will be initiated, exclusively dedicated to the processing of Sentinel-3 mission data products. The scope of this new service will be to maximize the exploitation of the upcoming Sentinel-3 Surface Topography Mission's data over all surfaces. The service is open, free of charge (supported by the ESA SEOM Programme Element) for worldwide scientific applications and available at https://gpod.eo.esa.int/services/CRYOSAT_SAR/

A national research & development strategy for biomass crop feedstocks

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

Wright, L.L.; Cushman, J.H.

Planning was initiated in 1996 with the objective of reevaluating current biomass feedstock research and development strategies to: (1) assure that by 2005, one or more commercial lignocellulosic to ethanol projects will be able to acquire a dependable supply of biomass crop feedstocks; (2) assure that recently initiated demonstrations of crops to electricity will be successful and; (3) assure that the research base needed to support future biomass industry expansion is being developed. Multiple trends and analyses indicate that biomass energy research and development strategies must take into account the fact that competition for land will define the upper limitsmore » of available biomass energy crop supplies and will largely dictate the price of those supplies. Only crop production and utilization strategies which contribute profit to the farmer or landowner and to energy producers will be used commercially for biomass energy production. Strategies for developing biomass {open_quotes}energy{close_quotes} crop supplies must take into consideration all of the methods by which biomass crops will enter biomass energy markets. The lignocellulosic materials derived from crops can be available as primary residues or crop by-products; secondary residues or processing by-products; co-products (at both the crop production and processing stages); or, as dedicated energy crops. Basic research and development (R&D) leading to yield improvement continues to be recommended as a major long-term focus for dedicated energy crops. Many additional near term topics need attention, some of which are also applicable to by-products and co-products. Switchgrass R&D should be expanded and developed with greater collaboration of USDA and state extension groups. Woody crop research should continue with significant cost-share from industries developing the crops for other commercial products. Co-product options need more investigation.« less

Development of an agricultural biotechnology crop product: testing from discovery to commercialization.

PubMed

Privalle, Laura S; Chen, Jingwen; Clapper, Gina; Hunst, Penny; Spiegelhalter, Frank; Zhong, Cathy X

2012-10-17

"Genetically modified" (GM) or "biotech" crops have been the most rapidly adopted agricultural technology in recent years. The development of a GM crop encompasses trait identification, gene isolation, plant cell transformation, plant regeneration, efficacy evaluation, commercial event identification, safety evaluation, and finally commercial authorization. This is a lengthy, complex, and resource-intensive process. Crops produced through biotechnology are the most highly studied food or food component consumed. Before commercialization, these products are shown to be as safe as conventional crops with respect to feed, food, and the environment. This paper describes this global process and the various analytical tests that must accompany the product during the course of development, throughout its market life, and beyond.

Production of long chain alkyl esters from carbon dioxide and electricity by a two-stage bacterial process.

PubMed

Lehtinen, Tapio; Efimova, Elena; Tremblay, Pier-Luc; Santala, Suvi; Zhang, Tian; Santala, Ville

2017-11-01

Microbial electrosynthesis (MES) is a promising technology for the reduction of carbon dioxide into value-added multicarbon molecules. In order to broaden the product profile of MES processes, we developed a two-stage process for microbial conversion of carbon dioxide and electricity into long chain alkyl esters. In the first stage, the carbon dioxide is reduced to organic compounds, mainly acetate, in a MES process by Sporomusa ovata. In the second stage, the liquid end-products of the MES process are converted to the final product by a second microorganism, Acinetobacter baylyi in an aerobic bioprocess. In this proof-of-principle study, we demonstrate for the first time the bacterial production of long alkyl esters (wax esters) from carbon dioxide and electricity as the sole sources of carbon and energy. The process holds potential for the efficient production of carbon-neutral chemicals or biofuels. Copyright © 2017 Elsevier Ltd. All rights reserved.

Connected vehicle impacts on transportation planning technical memorandum #2 : connected vehicle planning processes and products and stakeholder roles and responsibilities.

DOT National Transportation Integrated Search

2015-01-01

The objective of this project, Connected Vehicle Impacts on Transportation Planning, is to comprehensively assess how connected vehicles should be considered across the range of transportation planning processes and products developed by States...

78 FR 21912 - Proposed Information Collection; Comment Request; Processed Products Family of Forms

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-12

... Collection; Comment Request; Processed Products Family of Forms AGENCY: National Oceanic and Atmospheric... NOAA in the economic and social analyses developed when proposing and evaluating fishery management... collection). Affected Public: Business or other for-profit organizations. Estimated Number of Respondents...

The BioDyn facility on ISS: Advancing biomaterial production in microgravity for commercial applications

NASA Astrophysics Data System (ADS)

Myers, Niki; Wessling, Francis; Deuser, Mark; Anderson, C. D.; Lewis, Marian

1999-01-01

The primary goals of the BioDyn program are to foster use of the microgravity environment for commercial production of bio-materials from cells, and to develop services and processes for obtaining these materials through space processing. The scope of products includes commercial bio-molecules such as cytokines, other cell growth regulatory proteins, hormones, monoclonal antibodies and enzymes; transplantable cells or tissues which can be improved by low-G processes, or which cannot be obtained through standard processes in earth gravity; agriculture biotechnology products from plant cells; microencapsulation for diabetes treatment; and factors regulating cellular aging. To facilitate BioDyn's commercial science driven goals, hardware designed for ISS incorporates the flexibility for interchange between the different ISS facilities including the glovebox, various thermal units and centrifuges. By providing a permanent research facility, ISS is the critical space-based platform required by scientists for carrying out the long-term experiments necessary for developing bio-molecules and tissues using several cell culture modalities including suspension and anchorage-dependent cell types.

Product development: the making of the Abbott ARCHITECT.

PubMed

Kisner, H J

1997-01-01

Many laboratorians have a limited perspective on what is involved in developing an instrument and bringing it to market. This article traces the product development process used by Abbott Diagnostics Division that resulted in Abbott being named the 1996 Concurrent Engineering Company of the Year for the design of the ARCHITECT.

Medical device development.

PubMed

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

A Time Series of Sea Surface Nitrate and Nitrate based New Production in the Global Oceans

NASA Astrophysics Data System (ADS)

Goes, J. I.; Fargion, G. S.; Gomes, H. R.; Franz, B. A.

2014-12-01

With support from NASA's MEaSUREs program, we are developing algorithms for two innovative satellite-based Earth Science Data Records (ESDRs), one Sea Surface Nitrate (SSN) and the other, Nitrate based new Production (NnP). Newly developed algorithms will be applied to mature ESDRs of Chlorophyll a and SST available from NASA, to generate maps of SSN and NnP. Our proposed ESDRs offer the potential of greatly improving our understanding of the role of the oceans in global carbon cycling, earth system processes and climate change, especially for regions and seasons which are inaccessible to traditional shipboard studies. They also provide an innovative means for validating and improving coupled ecosystem models that currently rely on global maps of nitrate generated from multi-year data sets. To aid in our algorithm development efforts and to ensure that our ESDRs are truly global in nature, we are currently in the process of assembling a large database of nutrients from oceanographic institutions all over the world. Once our products are developed and our algorithms are fine-tuned, large-scale data production will be undertaken in collaboration with NASA's Ocean Biology Processing Group (OPBG), who will make the data publicly available first as evaluation products and then as mature ESDRs.

Separation of Zirconium and Hafnium: A Review

NASA Astrophysics Data System (ADS)

Xu, L.; Xiao, Y.; van Sandwijk, A.; Xu, Q.; Yang, Y.

Zirconium is an ideal material for nuclear reactors due to its low absorption cross-section for thermal neutrons, whereas the typically contained hafnium with strong neutron-absorption is very harmful for zirconium. This paper provides an overview of the processes for separating hafnium from zirconium. The separation processes are roughly classified into hydro- and pyrometallurgical routes. The current dominant zirconium production route involves pyrometallurgical ore cracking, multi-step hydrometallurgical liquid-liquid extraction for hafnium removal and the reduction of zirconium tetrachloride to the pure metal by the Kroll process. The lengthy hydrometallurgical Zr-Hf separation operations leads to high production cost, intensive labour and heavy environmental burden. Using a compact pyrometallurgical separation method can simplify the whole production flowsheet with a higher process efficiency. The known separation methods are discussed based on the following reaction features: redox characteristics, volatility, electrochemical properties and molten salt extraction. The commercially operating extractive distillation process is a significant advance in Zr-Hf separation technology but it suffers from high process maintenance cost. The recently developed new process based on molten salt-metal equilibrium for Zr-Hf separation shows a great potential for industrial application, which is compact for nuclear grade zirconium production starting from crude ore. In the present paper, the available separation technologies are compared. The advantages and disadvantages as well as future directions of research and development for nuclear grade zirconium production are discussed.

Quality data collection and management technology of aerospace complex product assembly process

NASA Astrophysics Data System (ADS)

Weng, Gang; Liu, Jianhua; He, Yongxi; Zhuang, Cunbo

2017-04-01

Aiming at solving problems of difficult management and poor traceability for discrete assembly process quality data, a data collection and management method is proposed which take the assembly process and BOM as the core. Data collection method base on workflow technology, data model base on BOM and quality traceability of assembly process is included in the method. Finally, assembly process quality data management system is developed and effective control and management of quality information for complex product assembly process is realized.

Integrated microbial processes for biofuels and high value-added products: the way to improve the cost effectiveness of biofuel production.

PubMed

da Silva, Teresa Lopes; Gouveia, Luísa; Reis, Alberto

2014-02-01

The production of microbial biofuels is currently under investigation, as they are alternative sources to fossil fuels, which are diminishing and their use has a negative impact on the environment. However, so far, biofuels derived from microbes are not economically competitive. One way to overcome this bottleneck is the use of microorganisms to transform substrates into biofuels and high value-added products, and simultaneously taking advantage of the various microbial biomass components to produce other products of interest, as an integrated process. In this way, it is possible to maximize the economic value of the whole process, with the desired reduction of the waste streams produced. It is expected that this integrated system makes the biofuel production economically sustainable and competitive in the near future. This review describes the investigation on integrated microbial processes (based on bacteria, yeast, and microalgal cultivations) that have been experimentally developed, highlighting the importance of this approach as a way to optimize microbial biofuel production process.

The JSC Engineering Directorate Product Peer Review Process

NASA Technical Reports Server (NTRS)

Jenks, Kenneth C.

2009-01-01

The JSC Engineering Directorate has developed a Product Peer Review process in support of NASA policies for project management and systems engineering. The process complies with the requirements of NPR 7120.5, NPR 7123.1 and NPR 7150.2 and follows the guidance in NASA/SP-2007-6105. This presentation will give an overview of the process followed by a brief demonstration of an actual peer review, with audience participation.

Recombinant protein production and insect cell culture and process

NASA Technical Reports Server (NTRS)

Spaulding, Glenn (Inventor); Prewett, Tacey (Inventor); Goodwin, Thomas (Inventor); Francis, Karen (Inventor); Andrews, Angela (Inventor); Oconnor, Kim (Inventor)

1993-01-01

A process has been developed for recombinant production of selected polypeptides using transformed insect cells cultured in a horizontally rotating culture vessel modulated to create low shear conditions. A metabolically transformed insect cell line is produced using the culture procedure regardless of genetic transformation. The recombinant polypeptide can be produced by an alternative process using the cultured insect cells as host for a virus encoding the described polypeptide such as baculovirus. The insect cells can also be a host for viral production.

Recombinant Protein Production and Insect Cell Culture and Process

NASA Technical Reports Server (NTRS)

Spaulding, Glenn F. (Inventor); Goodwin, Thomas J. (Inventor); OConnor, Kim C. (Inventor); Francis, Karen M. (Inventor); Andrews, Angela D. (Inventor); Prewett, Tracey L. (Inventor)

1997-01-01

A process has been developed for recombinant production of selected polypeptides using transformed insect cells cultured in a horizontally rotating culture vessel modulated to create low shear conditions. A metabolically transformed insect cell line is produced using the culture procedure regardless of genetic transformation. The recombinant polypeptide can be produced by an alternative process using virtually infected or stably transformed insect cells containing a gene encoding the described polypeptide. The insect cells can also be a host for viral production.

Expanding lean thinking to the product and process design and development within the framework of sustainability

NASA Astrophysics Data System (ADS)

Sorli, M.; Sopelana, A.; Salgado, M.; Pelaez, G.; Ares, E.

2012-04-01

Companies require tools to change towards a new way of developing and producing innovative products to be manufactured considering the economic, social and environmental impact along the product life cycle. Based on translating Lean principles in Product Development (PD) from the design stage and, along the entire product life cycle, it is aimed to address both sustainability and environmental issues. The drivers of sustainable culture within a lean PD have been identified and a baseline for future research on the development of appropriate tools and techniques has been provided. This research provide industry with a framework which balance environmental and sustainable factors with lean principles to be considered and incorporated from the beginning of product design and development covering the entire product lifecycle.

Study of Hydrogen Production Method using Latent Heat of Liquefied Natural Gas

NASA Astrophysics Data System (ADS)

Ogawa, Masaru; Seki, Tatsuyoshi; Honda, Hiroshi; Nakamura, Motomu; Takatani, Yoshiaki

In recent years, Fuel Cell Electrical Vehicle is expected to improve urban environment. Particularly a hydrogen fuel type FCEV expected for urban use, because its excellent characters such as short startup time, high responsibility and zero emission. On the other hand, as far as hydrogen production is concerned, large amount of CO2 is exhausted into the atmosphere by the process of LNG reforming. In our research, we studied the utilization of LNG latent heat for hydrogen gas production process as well as liquefied hydrogen process. Furthermore, CO2---Capturing as liquid state or solid state from hydrogen gas production process by LNG is also studied. Results of research shows that LNG latent heat is very effect to cool hydrogen gas for conventional hydrogen liquefied process. However, the LNG latent heat is not available for LNG reforming process. If we want to use LNG latent heat for this process, we have to develop new hydrogen gas produce process. In this new method, both hydrogen and CO2 is cooled by LNG directly, and CO2 is removed from the reforming gas. In order to make this method practical, we should develop a new type heat-exchanger to prevent solid CO2 from interfering the performance of it.

CELSS research and development program

NASA Technical Reports Server (NTRS)

Bubenheim, David

1990-01-01

Research in Controlled Ecological Life Support Systems (CELSS) conducted by NASA indicate that plant based systems are feasible candidates for human support in space. Ames has responsibility for research and development, systems integration and control, and space flight experiment portions of the CELSS program. Important areas for development of new methods and technologies are biomass production, waste processing, water purification, air revitalization, and food processing. For the plant system, the approach was to identify the flexibility and response time for the food, water, and oxygen production, and carbon dioxide consumption processes. Tremendous increases in productivity, compared with terrestrial agriculture, were realized. Waste processing research emphasizes recycle (transformation) of human wastes, trash, and inedible biomass to forms usable as inputs to the plant production system. Efforts to improve efficiency of the plant system, select new CELSS crops for a balanced diet, and initiate closed system research with the Crop Growth Research Chambers continue. The System Control and Integration program goal is to insure orchestrated system operation of the biological, physical, and chemical operation of the biological, physical, and chemical component processors of the CELSS. Space flight studies are planned to verify adequate operation of the system in reduced gravity or microgravity environments.

Modernized Techniques for Dealing with Quality Data and Derived Products

NASA Astrophysics Data System (ADS)

Neiswender, C.; Miller, S. P.; Clark, D.

2008-12-01

"I just want a picture of the ocean floor in this area" is expressed all too often by researchers, educators, and students in the marine geosciences. As more sophisticated systems are developed to handle data collection and processing, the demand for quality data, and standardized products continues to grow. Data management is an invisible bridge between science and researchers/educators. The SIOExplorer digital library presents more than 50 years of ocean-going research. Prior to publication, all data is checked for quality using standardized criterion developed for each data stream. Despite the evolution of data formats and processing systems, SIOExplorer continues to present derived products in well- established formats. Standardized products are published for each cruise, and include a cruise report, MGD77 merged data, multi-beam flipbook, and underway profiles. Creation of these products is made possible by processing scripts, which continue to change with ever-evolving data formats. We continue to explore the potential of database-enabled creation of standardized products, such as the metadata-rich MGD77 header file. Database-enabled, automated processing produces standards-compliant metadata for each data and derived product. Metadata facilitates discovery and interpretation of published products. This descriptive information is stored both in an ASCII file, and a searchable digital library database. SIOExplorer's underlying technology allows focused search and retrieval of data and products. For example, users can initiate a search of only multi-beam data, which includes data-specific parameters. This customization is made possible with a synthesis of database, XML, and PHP technology. The combination of standardized products and digital library technology puts quality data and derived products in the hands of scientists. Interoperable systems enable distribution these published resources using technology such as web services. By developing modernized strategies to deal with data, Scripps Institution of Oceanography is able to produce and distribute well-formed, and quality-tested derived products, which aid research, understanding, and education.

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

Simpson, L.; Britt, J.; Birkmire, R.

ITN Energy Systems, Inc., and Global Solar Energy, Inc., assisted by NREL's PV Manufacturing R&D program, have continued to advance CIGS production technology by developing trajectory-oriented predictive/control models, fault-tolerance control, control platform development, in-situ sensors, and process improvements. Modeling activities included developing physics-based and empirical models for CIGS and sputter-deposition processing, implementing model-based control, and applying predictive models to the construction of new evaporation sources and for control. Model-based control is enabled by implementing reduced or empirical models into a control platform. Reliability improvement activities include implementing preventive maintenance schedules; detecting failed sensors/equipment and reconfiguring to tinue processing; and systematicmore » development of fault prevention and reconfiguration strategies for the full range of CIGS PV production deposition processes. In-situ sensor development activities have resulted in improved control and indicated the potential for enhanced process status monitoring and control of the deposition processes. Substantial process improvements have been made, including significant improvement in CIGS uniformity, thickness control, efficiency, yield, and throughput. In large measure, these gains have been driven by process optimization, which in turn have been enabled by control and reliability improvements due to this PV Manufacturing R&D program.« less

Separation science and technology. Semiannual progress report, October 1993--March 1994

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

Vandegrift, G.F.; Aase, S.B.; Buchholz, B.

1997-12-01

This document reports on the work done by the Separations Science and Technology Programs of the Chemical Technology Division, Argonne National Laboratory (ANL), in the period October 1993-March 1994. This effort is mainly concerned with developing the TRUEX process for removing and concentrating actinides from acidic waste streams contaminated with transuranic (TRU) elements. The objectives of TRUEX processing are to recover valuable TRU elements and to lower disposal costs for the nonTRU waste product of the process. Other projects are underway with the objective of developing (1) evaporation technology for concentrating radioactive waste and product streams such as those generatedmore » by the TRUEX process, (2) treatment schemes for liquid wastes stored are being generated at ANL, (3) a process based on sorbing modified TRUEX solvent on magnetic beads to be used for separation of contaminants from radioactive and hazardous waste streams, and (4) a process that uses low-enriched uranium targets for production of {sup 99}Mo for nuclear medicine uses.« less

Readiness Assessment Towards Smart Manufacturing System for Tuna Processing Industry in Indonesia

NASA Astrophysics Data System (ADS)

Anggrahini, D.; Kurniati, N.; Karningsih, P. D.; Parenreng, S. M.; Syahroni, N.

2018-04-01

Marine product processing is one of the top priority clusters in the national development. Tuna, as a kind of deep ocean fishes, has the highest number of production that significantly increased throughout the years. Indonesia government encourages tuna processing industry, which are mostly dominated by small to medium enterprises, to grow continuously. Nowadays, manufacturers are facing substantial challenges in adopting modern system and technology that will lead a significant improvement through the internet of things (IoT). A smart factory transform integrated manufacturing process, in a high speed processing to respond customer needs. It has some positive impacts, such as increasing productivity, reducing set up time, shortening marketing and other support activities, hence the process is being more flexible and efficient. To implement smart manufacturing system, factories should know the readiness at any level of them, technology capability and strategy appropriateness. This exploratory study aims to identify the criterias, and develop an assessment tools to measure the level towards smart factory.

Systems engineering and integration processes involved with manned mission operations

NASA Technical Reports Server (NTRS)

Kranz, Eugene F.; Kraft, Christopher C.

1993-01-01

This paper will discuss three mission operations functions that are illustrative of the key principles of operations SE&I and of the processes and products involved. The flight systems process was selected to illustrate the role of the systems product line in developing the depth and cross disciplinary skills needed for SE&I and providing the foundation for dialogue between participating elements. FDDD was selected to illustrate the need for a structured process to assure that SE&I provides complete and accurate results that consistently support program needs. The flight director's role in mission operations was selected to illustrate the complexity of the risk/gain tradeoffs involved in the development of the flight techniques and flight rules process as well as the absolute importance of the leadership role in developing the technical, operational, and political trades.

Advanced optical manufacturing digital integrated system

NASA Astrophysics Data System (ADS)

Tao, Yizheng; Li, Xinglan; Li, Wei; Tang, Dingyong

2012-10-01

It is necessarily to adapt development of advanced optical manufacturing technology with modern science technology development. To solved these problems which low of ration, ratio of finished product, repetition, consistent in big size and high precision in advanced optical component manufacturing. Applied business driven and method of Rational Unified Process, this paper has researched advanced optical manufacturing process flow, requirement of Advanced Optical Manufacturing integrated System, and put forward architecture and key technology of it. Designed Optical component core and Manufacturing process driven of Advanced Optical Manufacturing Digital Integrated System. the result displayed effective well, realized dynamic planning Manufacturing process, information integration improved ratio of production manufactory.

Industrial production of acetone and butanol by fermentation-100 years later.

PubMed

Sauer, Michael

2016-07-01

Microbial production of acetone and butanol was one of the first large-scale industrial fermentation processes of global importance. During the first part of the 20th century, it was indeed the second largest fermentation process, superseded in importance only by the ethanol fermentation. After a rapid decline after the 1950s, acetone-butanol-ethanol (ABE) fermentation has recently gained renewed interest in the context of biorefinery approaches for the production of fuels and chemicals from renewable resources. The availability of new methods and knowledge opens many new doors for industrial microbiology, and a comprehensive view on this process is worthwhile due to the new interest. This thematic issue of FEMS Microbiology Letters, dedicated to the 100th anniversary of the first industrial exploitation of Chaim Weizmann's ABE fermentation process, covers the main aspects of old and new developments, thereby outlining a model development in biotechnology. All major aspects of industrial microbiology are exemplified by this single process. This includes new technologies, such as the latest developments in metabolic engineering, the exploitation of biodiversity and discoveries of new regulatory systems such as for microbial stress tolerance, as well as technological aspects, such as bio- and down-stream processing. © FEMS 2016.

Product development using process monitoring and NDE data fusion

NASA Astrophysics Data System (ADS)

Peterson, Todd; Bossi, Richard H.

1998-03-01

Composite process/product development relies on both process monitoring information and nondestructive evaluation measurements for determining application suitability. In the past these activities have been performed and analyzed independently. Our present approach is to present the process monitoring and NDE data together in a data fusion workstation. This methodology leads to final product acceptance based on a combined process monitoring and NDE criteria. The data fusion work station combines process parameter and NDE data in a single workspace enabling all the data to be used in the acceptance/rejection decision process. An example application is the induction welding process, a unique joining method for assembling primary composite structure, that offers significant cost and weight advantages over traditional fasted structure. The determination of the required time, temperature and pressure conditions used in the process to achieve a complete weld is being aided by the use of ultrasonic inspection techniques. Full waveform ultrasonic inspection data is employed to evaluate the quality of spar cap to skin fit, an essential element of the welding process, and is processed to find a parameter that can be used for weld acceptance. Certification of the completed weld incorporates the data fusion methodology.

Designing a ruggedisation lab to characterise materials for harsh environments.

PubMed

Frazzette, Nicholas; Jethva, Janak; Mehta, Khanjan; Stapleton, Joshua J; Randall, Clive

Designing products for use in developing countries presents a unique set of challenges including harsh operating environments, costly repairs and maintenance, and users with varying degrees of education and device familiarity. For products to be robust, adaptable and durable, they need to be ruggedised for environmental factors such as high temperature and humidity as well as different operational conditions such as shock and chemical exposure. The product characterisation and ruggedisation processes require specific expertise and resources that are seldom available outside of large corporations and elite national research labs. There is no standardised process since product needs strongly depend on the context and user base, making it particularly onerous for underfunded start-ups and academic groups. Standardised protocols that identify essential lab testing regimens for specific contexts and user groups can complement field-testing and accelerate the product development process while reducing costs. This article synthesises current methods and strategies for product testing employed by large corporations as well as defence-related entities. A technological and organisational framework for a service-for-fee product characterisation and ruggedisation lab that reduces costs and shortens the timespan from product invention to commercial launch in harsh settings is presented.

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.

How inverse solver technologies can support die face development and process planning in the automotive industry

NASA Astrophysics Data System (ADS)

Huhn, Stefan; Peeling, Derek; Burkart, Maximilian

2017-10-01

With the availability of die face design tools and incremental solver technologies to provide detailed forming feasibility results in a timely fashion, the use of inverse solver technologies and resulting process improvements during the product development process of stamped parts often is underestimated. This paper presents some applications of inverse technologies that are currently used in the automotive industry to streamline the product development process and greatly increase the quality of a developed process and the resulting product. The first focus is on the so-called target strain technology. Application examples will show how inverse forming analysis can be applied to support the process engineer during the development of a die face geometry for Class `A' panels. The drawing process is greatly affected by the die face design and the process designer has to ensure that the resulting drawn panel will meet specific requirements regarding surface quality and a minimum strain distribution to ensure dent resistance. The target strain technology provides almost immediate feedback to the process engineer during the die face design process if a specific change of the die face design will help to achieve these specific requirements or will be counterproductive. The paper will further show how an optimization of the material flow can be achieved through the use of a newly developed technology called Sculptured Die Face (SDF). The die face generation in SDF is more suited to be used in optimization loops than any other conventional die face design technology based on cross section design. A second focus in this paper is on the use of inverse solver technologies for secondary forming operations. The paper will show how the application of inverse technology can be used to accurately and quickly develop trim lines on simple as well as on complex support geometries.

Integrating the results of user research into medical device development: insights from a case study.

PubMed

Martin, Jennifer L; Barnett, Julie

2012-07-19

It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product.

Integrating the results of user research into medical device development: insights from a case study

PubMed Central

2012-01-01

Background It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product. PMID:22812565

Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm.

PubMed

Zalai, Dénes; Dietzsch, Christian; Herwig, Christoph

2013-01-01

In the last few years, several quality by design (QbD) studies demonstrated the benefit of systematic approaches for biopharmaceutical development. However, only very few studies identified biosimilars as a special case of product development. The targeted quality profile of biosimilars is strictly defined by the originator's product characteristic. Moreover, the major source of prior knowledge is the experience with the originator product itself. Processing this information in biosimilar development has a major effect on risk management and process development strategies. The main objective of this contribution is to demonstrate how risk management can facilitate the implementation of QbD in early-stage product development with special emphasis on fitting the reported approaches to biosimilars. Risk assessments were highlighted as important tools to integrate prior knowledge in biosimilar development. The risk assessment process as suggested by the International Conference on Harmonization (ICH Q9) was reviewed and three elements were identified to play a key role in targeted risk assessment approaches: proper understanding of target linkage, risk assessment tool compliance, and criticality threshold value. Adjusting these steps to biosimilar applications helped to address some unique challenges of these products such as a strictly defined quality profile or a lack of process knowledge. This contribution demonstrates the need for tailored risk management approaches for the risk-based development of biosimilars and provides novel tools for the integration of additional knowledge available for these products. The pharmaceutical industry is facing challenges such as profit loss and price competition. Companies are forced to rationalize business models and to cut costs in development as well as manufacturing. These trends recently hinder the implementation of any concepts that do not offer certain financial benefit or promise a long return of investment. Quality by design (QbD) is a concept that is currently struggling for more acceptance from the side of the pharmaceutical industry. To achieve this, the major goals of QbD have to be revisited and QbD tools have to be subsequently developed. This contribution offers an example as to how implement risk management in early-stage biosimilar development as part of the QbD concept. The main goal was to go beyond the conventional QbD workflow and to adjust risk management to the challenges of biosimilar products. Accordingly, instead of using methods like failure mode and effects analysis, recommendations of the ICH Q9 guideline were reviewed and put into practice by creating tailored risk assessment tools. The novelty of this contribution is to report those tailored tools ready-to-use for early bioprocess development of biosimilars along QbD principles.

Concise Review: Guidance in Developing Commercializable Autologous/Patient-Specific Cell Therapy Manufacturing

PubMed Central

Armant, Myriam; Brandwein, Harvey; Burger, Scott; Campbell, Andrew; Carpenito, Carmine; Clarke, Dominic; Fong, Timothy; Karnieli, Ohad; Niss, Knut; Van't Hof, Wouter; Wagey, Ravenska

2013-01-01

Cell therapy is poised to play an enormous role in regenerative medicine. However, little guidance is being made available to academic and industrial entities in the start-up phase. In this technical review, members of the International Society for Cell Therapy provide guidance in developing commercializable autologous and patient-specific manufacturing strategies from the perspective of process development. Special emphasis is placed on providing guidance to small academic or biotech researchers as to what simple questions can be addressed or answered at the bench in order to make their cell therapy products more feasible for commercial-scale production. We discuss the processes that are required for scale-out at the manufacturing level, and how many questions can be addressed at the bench level. The goal of this review is to provide guidance in the form of topics that can be addressed early in the process of development to better the chances of the product being successful for future commercialization. PMID:24101671

Development of a 3-step straight-through purification strategy combining membrane adsorbers and resins.

PubMed

Hughson, Michael D; Cruz, Thayana A; Carvalho, Rimenys J; Castilho, Leda R

2017-07-01

The pressures to efficiently produce complex biopharmaceuticals at reduced costs are driving the development of novel techniques, such as in downstream processing with straight-through processing (STP). This method involves directly and sequentially purifying a particular target with minimal holding steps. This work developed and compared six different 3-step STP strategies, combining membrane adsorbers, monoliths, and resins, to purify a large, complex, and labile glycoprotein from Chinese hamster ovary cell culture supernatant. The best performing pathway was cation exchange chromatography to hydrophobic interaction chromatography to affinity chromatography with an overall product recovery of up to 88% across the process and significant clearance of DNA and protein impurities. This work establishes a platform and considerations for the development of STP of biopharmaceutical products and highlights its suitability for integration with single-use technologies and continuous production methods. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:931-940, 2017. © 2017 American Institute of Chemical Engineers.

Architecture for distributed design and fabrication

NASA Astrophysics Data System (ADS)

McIlrath, Michael B.; Boning, Duane S.; Troxel, Donald E.

1997-01-01

We describe a flexible, distributed system architecture capable of supporting collaborative design and fabrication of semi-conductor devices and integrated circuits. Such capabilities are of particular importance in the development of new technologies, where both equipment and expertise are limited. Distributed fabrication enables direct, remote, physical experimentation in the development of leading edge technology, where the necessary manufacturing resources are new, expensive, and scarce. Computational resources, software, processing equipment, and people may all be widely distributed; their effective integration is essential in order to achieve the realization of new technologies for specific product requirements. Our architecture leverages is essential in order to achieve the realization of new technologies for specific product requirements. Our architecture leverages current vendor and consortia developments to define software interfaces and infrastructure based on existing and merging networking, CIM, and CAD standards. Process engineers and product designers access processing and simulation results through a common interface and collaborate across the distributed manufacturing environment.

Quarterly Report: Microchannel-Assisted Nanomaterial Deposition Technology for Photovoltaic Material Production

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

Palo, Daniel R.

2011-04-26

Quarterly report to ITP for Nanomanufacturing program. Report covers FY11 Q2. The primary objective of this project is to develop a nanomanufacturing process which will reduce the manufacturing energy, environmental discharge, and production cost associated with current nano-scale thin-film photovoltaic (PV) manufacturing approaches. The secondary objective is to use a derivative of this nanomanufacturing process to enable greener, more efficient manufacturing of higher efficiency quantum dot-based photovoltaic cells now under development. The work is to develop and demonstrate a scalable (pilot) microreactor-assisted nanomaterial processing platform for the production, purification, functionalization, and solution deposition of nanomaterials for photovoltaic applications. The highmore » level task duration is shown. Phase I consists of a pilot platform for Gen II PV films along with parallel efforts aimed at Gen III PV quantum dot materials. Status of each task is described.« less

Recovery of succinic acid produced by fermentation of a metabolically engineered Mannheimia succiniciproducens strain.

PubMed

Song, Hyohak; Huh, Yun Suk; Lee, Sang Yup; Hong, Won Hi; Hong, Yeon Ki

2007-12-01

There have recently been much advances in the production of succinic acid, an important four-carbon dicarboxylic acid for many industrial applications, by fermentation of several natural and engineered bacterial strains. Mannheimia succiniciproducens MBEL55E isolated from bovine rumen is able to produce succinic acid with high efficiency, but also produces acetic, formic and lactic acids just like other anaerobic succinic acid producers. We recently reported the development of an engineered M. succiniciproducens LPK7 strain which produces succinic acid as a major fermentation product while producing much reduced by-products. Having an improved succinic acid producer developed, it is equally important to develop a cost-effective downstream process for the recovery of succinic acid. In this paper, we report the development of a simpler and more efficient method for the recovery of succinic acid. For the recovery of succinic acid from the fermentation broth of LPK7 strain, a simple process composed of a single reactive extraction, vacuum distillation, and crystallization yielded highly purified succinic acid (greater than 99.5% purity, wt%) with a high yield of 67.05wt%. When the same recovery process or even multiple reactive extraction steps were applied to the fermentation broth of MBEL55E, lower purity and yield of succinic acid were obtained. These results suggest that succinic acid can be purified in a cost-effective manner by using the fermentation broth of engineered LPK7 strain, showing the importance of integrating the strain development, fermentation and downstream process for optimizing the whole processes for succinic acid production.

Automated Metrology System for Pu 238

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

Wunderlich, Richard J.

Under a collaborative partnership between the NASA and DOE, a new automated measurement system developed by ORNL will ensure quality production of plutonium-238 while reducing handling by workers. NASA has funded ORNL and other national laboratories to develop a process that will restore US production capability of Pu-238 for the first time since the late 1980s when the Savannah River Plant ceased production. ORNL has produced and separated about 100 grams of the material and plans to scale up the process over the next several years to meet demand to power NASA deep space missions.

Development of mathematical models for automation of strength calculation during plastic deformation processing

NASA Astrophysics Data System (ADS)

Steposhina, S. V.; Fedonin, O. N.

2018-03-01

Dependencies that make it possible to automate the force calculation during surface plastic deformation (SPD) processing and, thus, to shorten the time for technological preparation of production have been developed.

Scale-up bioprocess development for production of the antibiotic valinomycin in Escherichia coli based on consistent fed-batch cultivations.

PubMed

Li, Jian; Jaitzig, Jennifer; Lu, Ping; Süssmuth, Roderich D; Neubauer, Peter

2015-06-12

Heterologous production of natural products in Escherichia coli has emerged as an attractive strategy to obtain molecules of interest. Although technically feasible most of them are still constrained to laboratory scale production. Therefore, it is necessary to develop reasonable scale-up strategies for bioprocesses aiming at the overproduction of targeted natural products under industrial scale conditions. To this end, we used the production of the antibiotic valinomycin in E. coli as a model system for scalable bioprocess development based on consistent fed-batch cultivations. In this work, the glucose limited fed-batch strategy based on pure mineral salt medium was used throughout all scales for valinomycin production. The optimal glucose feed rate was initially detected by the use of a biocatalytically controlled glucose release (EnBase® technology) in parallel cultivations in 24-well plates with continuous monitoring of pH and dissolved oxygen. These results were confirmed in shake flasks, where the accumulation of valinomycin was highest when the specific growth rate decreased below 0.1 h(-1). This correlation was also observed for high cell density fed-batch cultivations in a lab-scale bioreactor. The bioreactor fermentation produced valinomycin with titers of more than 2 mg L(-1) based on the feeding of a concentrated glucose solution. Valinomycin production was not affected by oscillating conditions (i.e. glucose and oxygen) in a scale-down two-compartment reactor, which could mimic similar situations in industrial bioreactors, suggesting that the process is very robust and a scaling of the process to a larger industrial scale appears a realistic scenario. Valinomycin production was scaled up from mL volumes to 10 L with consistent use of the fed-batch technology. This work presents a robust and reliable approach for scalable bioprocess development and represents an example for the consistent development of a process for a heterologously expressed natural product towards the industrial scale.

Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

PubMed

Avalle, P; Pollitt, M J; Bradley, K; Cooper, B; Pearce, G; Djemai, A; Fitzpatrick, S

2014-07-01

This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps, development of a Process Analytical Technology (PAT) method is discussed and also a novel application of automated microscopy as the reference method. Ultimately, PAT methods should link to product performance and the two key Critical Quality Attributes (CQAs) for this CR product are assay and release rate, linked to the API and CR coating steps respectively. In this work, the link between near infra-red (NIR) spectra and those attributes was explored by chemometrics over the course of the coating process in a pilot scale industrial environment. Correlations were built between the NIR spectra and coating weight (for API amount), CR coating thickness and dissolution performance. These correlations allow the coating process to be monitored at-line and so better control of the product performance in line with QbD requirements. Copyright © 2014 Elsevier B.V. All rights reserved.

Tracking blood products in blood centres using radio frequency identification: a comprehensive assessment.

PubMed

Davis, Rodeina; Geiger, Bradley; Gutierrez, Alfonso; Heaser, Julie; Veeramani, Dharmaraj

2009-07-01

Radio frequency identification (RFID) can be a key enabler for enhancing productivity and safety of the blood product supply chain. This article describes a systematic approach developed by the RFID Blood Consortium for a comprehensive feasibility and impact assessment of RFID application in blood centre operations. Our comprehensive assessment approach incorporates process-orientated and technological perspectives as well as impact analysis. Assessment of RFID-enabled process redesign is based on generic core processes derived from the three participating blood centres. The technological assessment includes RFID tag readability and performance evaluation, testing of temperature and biological effects of RF energy on blood products, and RFID system architecture design and standards. The scope of this article is limited to blood centre processes (from donation to manufacturing/distribution) for selected mainstream blood products (red blood cells and platelets). Radio frequency identification can help overcome a number of common challenges and process inefficiencies associated with identification and tracking of blood products. High frequency-based RFID technology performs adequately and safely for red blood cell and platelet products. Productivity and quality improvements in RFID-enabled blood centre processes can recoup investment cost in a 4-year payback period. Radio frequency identification application has significant process-orientated and technological implications. It is feasible and economically justifiable to incorporate RFID into blood centre processes.

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

Object positioning in storages of robotized workcells using LabVIEW Vision

NASA Astrophysics Data System (ADS)

Hryniewicz, P.; Banaś, W.; Sękala, A.; Gwiazda, A.; Foit, K.; Kost, G.

2015-11-01

During the manufacturing process, each performed task is previously developed and adapted to the conditions and the possibilities of the manufacturing plant. The production process is supervised by a team of specialists because any downtime causes great loss of time and hence financial loss. Sensors used in industry for tracking and supervision various stages of a production process make it much easier to maintain it continuous. One of groups of sensors used in industrial applications are non-contact sensors. This group includes: light barriers, optical sensors, rangefinders, vision systems, and ultrasonic sensors. Through to the rapid development of electronics the vision systems were widespread as the most flexible type of non-contact sensors. These systems consist of cameras, devices for data acquisition, devices for data analysis and specialized software. Vision systems work well as sensors that control the production process itself as well as the sensors that control the product quality level. The LabVIEW program as well as the LabVIEW Vision and LabVIEW Builder represent the application that enables program the informatics system intended to process and product quality control. The paper presents elaborated application for positioning elements in a robotized workcell. Basing on geometric parameters of manipulated object or on the basis of previously developed graphical pattern it is possible to determine the position of particular manipulated elements. This application could work in an automatic mode and in real time cooperating with the robot control system. It allows making the workcell functioning more autonomous.

The Role of Knowledge Acquisition in Facilitating Customer Involvement in Product Development: Examining the Mediation Effect of Absorptive Capacity

ERIC Educational Resources Information Center

Dahiyat, Samer E.; Al-Zu'bi, Zu'bi M. F.

2012-01-01

Knowledge management has often been linked to product development, innovation, and customisation. In particular, effective exploitation of customer knowledge, through engaging customers in a process of co-creation of products, exemplifies such a link. Accordingly, this research aims to identify those dimensions of knowledge management activities…

Development and application of process-based simulation models for cotton production: A review of past, present, and future directions

USDA-ARS?s Scientific Manuscript database

The development and application of cropping system simulation models for cotton production has a long and rich history, beginning in the southeast United States in the 1960's and now expanded to major cotton production regions globally. This paper briefly reviews the history of cotton simulation mo...

ETO - ENGINEERING TRADE-OFFS (SYSTEMS ANALYSIS BRANCH, SUSTAINABLE TECHNOLOGY DIVISION, NRMRL)

EPA Science Inventory

The ETO - Engineering Trade-Offs program is to develop a new, integrated decision-making approach to compare/contrast two or more states of being: a benchmark and an alternative, a change in a production process, alternative processes or products. ETO highlights the difference in...

Fueling the future with fungal genomics

Treesearch

Igor.V. Grigoriev; Daniel Cullen; Stephen B. Goodwin; David Hibbett; Thomas W. Jeffries; Christian P. Kubicek; Cheryl Kuske; Jon K. Magnuson; Francis Martin; Joseph W. Spatafora; Adrian Tsang; Scott E. Baker

2011-01-01

Fungi play important roles across the range of current and future biofuel production processes. From crop/feedstock health to plant biomass saccharification, enzyme production to bioprocesses for producing ethanol, higher alcohols, or future hydrocarbon biofuels, fungi are involved. Research and development are underway to understand the underlying biological processes...

Establishment of the roadmap for chlorination process development for zirconium recovery and recycle

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

Collins, E.D.; Del Cul, G.D.; Spencer, B.B.

Process development studies are being conducted to recover, purify, and reuse the zirconium (about 98.5% by mass) in used nuclear fuel (UNF) zirconium alloy cladding. Feasibility studies began in FY 2010 using empty cladding hulls that were left after fuel dissolution or after oxidation to a finely divided oxide powder (voloxidation). In FY 2012, two industrial teams (AREVA and Shaw-Westinghouse) were contracted by the Department of Energy Office of Nuclear Energy (NE) to provide technical assistance to the project. In FY 2013, the NE Fuel Cycle Research and Development Program requested development of a technology development roadmap to guide futuremore » work. The first step in the roadmap development was to assess the starting point, that is, the current state of the technology and the end goal. Based on previous test results, future work is to be focused on first using chlorine as the chlorinating agent and secondly on the use of a process design that utilizes a chlorination reactor and dual ZrCl{sub 4} product salt condensers. The likely need for a secondary purification step was recognized. Completion of feasibility testing required an experiment on the chemical decladding flowsheet option. This was done during April 2013. The roadmap for process development will continue through process chemistry optimization studies, the chlorinated reactor design configuration, product salt condensers, and the off-gas trapping of tritium or other volatile fission products from the off-gas stream. (authors)« less

The Hyperspectral Imager for the Coastal Ocean (HICO): Sensor and Data Processing Overview

DTIC Science & Technology

2010-01-20

backscattering coefficients, and others. Several of these software modules will be developed within the Automated Processing System (APS), a data... Automated Processing System (APS) NRL developed APS, which processes satellite data into ocean color data products. APS is a collection of methods...used for ocean color processing which provide the tools for the automated processing of satellite imagery [1]. These tools are in the process of

Biography for Todd Shollenberger | NREL

Science.gov Websites

Shollenberger Photo of Todd Shollenberger Todd Shollenberger Research Technician III-Biological biocatalyst fermentation. He has worked on professional research and development projects such as the fermentation production process development, pilot plant to full production scale-up, and quantitative

Biodiesel Production using Heterogeneous Catalyst in CSTR: Sensitivity Analysis and Optimization

NASA Astrophysics Data System (ADS)

Keong, L. S.; Patle, D. S.; Shukor, S. R.; Ahmad, Z.

2016-03-01

Biodiesel as a renewable fuel has emerged as a potential replacement for petroleum-based diesels. Heterogeneous catalyst has become the focus of researches in biodiesel production with the intention to overcome problems associated with homogeneous catalyzed processes. The simulation of heterogeneous catalyzed biodiesel production has not been thoroughly studied. Hence, a simulation of carbon-based solid acid catalyzed biodiesel production from waste oil with high FFA content (50 weight%) was developed in the present work to study the feasibility and potential of the simulated process. The simulated process produces biodiesel through simultaneous transesterification and esterification with the consideration of reaction kinetics. The developed simulation is feasible and capable to produce 2.81kmol/hr of FAME meeting the international standard (EN 14214). Yields of 68.61% and 97.19% are achieved for transesterification and esterification respectively. Sensitivity analyses of FFA composition in waste oil, methanol to oil ratio, reactor pressure and temperature towards FAME yield from both reactions were carried out. Optimization of reactor temperature was done to maximize FAME products.