15 CFR 16.2 - Description and goal of program.

Code of Federal Regulations, 2012 CFR

2012-01-01

... standardized test methods by which selected product performance characteristics can be measured; (2) Developing... voluntarily to test and label their products according to the selected or developed methods; and (4...

Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system.

PubMed

Patel, Jayshree; Mulhall, Brian; Wolf, Heinz; Klohr, Steven; Guazzo, Dana Morton

2011-01-01

A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated for container-closure integrity verification of a lyophilized product in a parenteral vial package system. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Method development and optimization challenge studies incorporated artificially defective packages representing a range of glass vial wall and sealing surface defects, as well as various elastomeric stopper defects. Method validation required 3 days of random-order replicate testing of a test sample population of negative-control, no-defect packages and positive-control, with-defect packages. Positive-control packages were prepared using vials each with a single hole laser-drilled through the glass vial wall. Hole creation and hole size certification was performed by Lenox Laser. Validation study results successfully demonstrated the vacuum decay leak test method's ability to accurately and reliably detect those packages with laser-drilled holes greater than or equal to approximately 5 μm in nominal diameter. All development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work. A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated to detect defects in stoppered vial packages containing lyophilized product for injection. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Test method validation study results proved the method capable of detecting holes laser-drilled through the glass vial wall greater than or equal to 5 μm in nominal diameter. Total test time is less than 1 min per package. All method development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work.

Pesticide Analytical Methods

EPA Pesticide Factsheets

Pesticide manufacturers must develop and submit analytical methods for their pesticide products to support registration of their products under FIFRA. Learn about these methods as well as SOPs for testing of antimicrobial products against three organisms.

Using a fuzzy comprehensive evaluation method to determine product usability: A test case

PubMed Central

Zhou, Ronggang; Chan, Alan H. S.

2016-01-01

BACKGROUND: In order to take into account the inherent uncertainties during product usability evaluation, Zhou and Chan [1] proposed a comprehensive method of usability evaluation for products by combining the analytic hierarchy process (AHP) and fuzzy evaluation methods for synthesizing performance data and subjective response data. This method was designed to provide an integrated framework combining the inevitable vague judgments from the multiple stages of the product evaluation process. OBJECTIVE AND METHODS: In order to illustrate the effectiveness of the model, this study used a summative usability test case to assess the application and strength of the general fuzzy usability framework. To test the proposed fuzzy usability evaluation framework [1], a standard summative usability test was conducted to benchmark the overall usability of a specific network management software. Based on the test data, the fuzzy method was applied to incorporate both the usability scores and uncertainties involved in the multiple components of the evaluation. Then, with Monte Carlo simulation procedures, confidence intervals were used to compare the reliabilities among the fuzzy approach and two typical conventional methods combining metrics based on percentages. RESULTS AND CONCLUSIONS: This case study showed that the fuzzy evaluation technique can be applied successfully for combining summative usability testing data to achieve an overall usability quality for the network software evaluated. Greater differences of confidence interval widths between the method of averaging equally percentage and weighted evaluation method, including the method of weighted percentage averages, verified the strength of the fuzzy method. PMID:28035942

Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

PubMed Central

Li, Jing-Jing; Gao, Qi; Liu, Zhi-Dong; Kang, Qiong-Hua; Hou, Yi-Jun; Zhang, Luo-Chuan; Hu, Xiao-Mei; Li, Jie; Zhang, Juan

2015-01-01

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world. PMID:26488582

Using a fuzzy comprehensive evaluation method to determine product usability: A test case.

PubMed

Zhou, Ronggang; Chan, Alan H S

2017-01-01

In order to take into account the inherent uncertainties during product usability evaluation, Zhou and Chan [1] proposed a comprehensive method of usability evaluation for products by combining the analytic hierarchy process (AHP) and fuzzy evaluation methods for synthesizing performance data and subjective response data. This method was designed to provide an integrated framework combining the inevitable vague judgments from the multiple stages of the product evaluation process. In order to illustrate the effectiveness of the model, this study used a summative usability test case to assess the application and strength of the general fuzzy usability framework. To test the proposed fuzzy usability evaluation framework [1], a standard summative usability test was conducted to benchmark the overall usability of a specific network management software. Based on the test data, the fuzzy method was applied to incorporate both the usability scores and uncertainties involved in the multiple components of the evaluation. Then, with Monte Carlo simulation procedures, confidence intervals were used to compare the reliabilities among the fuzzy approach and two typical conventional methods combining metrics based on percentages. This case study showed that the fuzzy evaluation technique can be applied successfully for combining summative usability testing data to achieve an overall usability quality for the network software evaluated. Greater differences of confidence interval widths between the method of averaging equally percentage and weighted evaluation method, including the method of weighted percentage averages, verified the strength of the fuzzy method.

Prediction of acute inhalation toxicity using in vitro lung surfactant inhibition.

PubMed

Sørli, Jorid B; Huang, Yishi; Da Silva, Emilie; Hansen, Jitka S; Zuo, Yi Y; Frederiksen, Marie; Nørgaard, Asger W; Ebbehøj, Niels E; Larsen, Søren T; Hougaard, Karin S

2018-01-01

Private consumers and professionals may experience acute inhalation toxicity after inhaling aerosolized impregnation products. The distinction between toxic and non-toxic products is difficult to make for producers and product users alike, as there is no clearly described relationship between the chemical composition of the products and induction of toxicity. The currently accepted method for determination of acute inhalation toxicity is based on experiments on animals; it is time-consuming, expensive and causes stress for the animals. Impregnation products are present on the market in large numbers and amounts and exhibit great variety. Therefore, an alternative method to screen for acute inhalation toxicity is needed. The aim of our study was to determine if inhibition of lung surfactant by impregnation products in vitro could accurately predict toxicity in vivo in mice. We tested 21 impregnation products using the constant flow through set-up of the constrained drop surfactometer to determine if the products inhibited surfactant function or not. The same products were tested in a mouse inhalation bioassay to determine their toxicity in vivo. The sensitivity was 100%, i.e., the in vitro method predicted all the products that were toxic for mice to inhale. The specificity of the in vitro test was 63%, i.e., the in vitro method found three false positives in the 21 tested products. Six of the products had been involved in accidental human inhalation where they caused acute inhalation toxicity. All of these six products inhibited lung surfactant function in vitro and were toxic to mice.

Instruments for the nondestructive testing of materials and products: Handbook. Volumes 1 & 2 (2nd revised and enlarged edition)

NASA Astrophysics Data System (ADS)

Kliuev, V. V.

Data on the general design and principles of operation of various instruments and systems for the nondestructive testing of materials and products of various kinds are presented, and test procedures are described. Methods discussed include optical, thermal, capillary, RF, and X-ray testing techniques. The discussion also covers magnetic, electromagnetic, eddy-current, acoustic, and combined nondestructive testing methods.

HILIS - A HIGH INTENSITY LIGHT SYSTEM FOR ALGAE FOOD PRODUCTION,

DTIC Science & Technology

ALGAE, PRODUCTION CONTROL), (*FOOD, FEASIBILITY STUDIES), CHLORELLA , CALORIMETRY, NUTRITION, MODEL TESTS, ILLUMINATION, BRIGHTNESS, TEMPERATURE CONTROL, HEAT TRANSFER, SPECTRUM SIGNATURES, TEST METHODS, TEST EQUIPMENT.

The evaluation of the optimization design and application effect of same-well-injection-production technique’s injection-production circulatory system

NASA Astrophysics Data System (ADS)

Guoxing, Zheng; Minghu, Jiang; Hongliang, Gong; Nannan, Zhang; Jianguang, Wei

2018-02-01

According to basic principles of combining series of strata and demands of same-well injection-production technique, the optimization designing method of same-well injection-production technique’s injection-production circulatory system is given. Based on oil-water two-phase model with condition of arbitrarily well network, a dynamic forecast method for the application of same-well injection-production reservoir is established with considering the demands and capacity of same-well injection-production technique, sample wells are selected to launch the forecast evaluation and analysis of same-well injection-production reservoir application’s effect. Results show: single-test-well composite water cut decreases by 4.7% and test-well-group composite water cut decreases by 1.56% under the condition of basically invariant ground water injection rate. The method provides theoretical support for the proof of same-well injection-production technique’s reservoir development improving effect and further tests.

The TASS Method for Scoring Production Work

ERIC Educational Resources Information Center

Orsborn, Karen J.

1977-01-01

Describes and recommends to typing teachers the Time and Speed Scoring (TASS) method for testing typewriting production and figuring production rates. This method measures speed and quality as two separate items, because proficiency in production typewriting should reflect the student's skill in typing both accurately and quickly. (MF)

[Interlaboratory Study on Evaporation Residue Test for Food Contact Products (Report 1)].

PubMed

Ohno, Hiroyuki; Mutsuga, Motoh; Abe, Tomoyuki; Abe, Yutaka; Amano, Homare; Ishihara, Kinuyo; Ohsaka, Ikue; Ohno, Haruka; Ohno, Yuichiro; Ozaki, Asako; Kakihara, Yoshiteru; Kobayashi, Hisashi; Sakuragi, Hiroshi; Shibata, Hiroshi; Shirono, Katsuhiro; Sekido, Haruko; Takasaka, Noriko; Takenaka, Yu; Tajima, Yoshiyasu; Tanaka, Aoi; Tanaka, Hideyuki; Tonooka, Hiroyuki; Nakanishi, Toru; Nomura, Chie; Haneishi, Nahoko; Hayakawa, Masato; Miura, Toshihiko; Yamaguchi, Miku; Watanabe, Kazunari; Sato, Kyoko

2018-01-01

An interlaboratory study was performed to evaluate the equivalence between an official method and a modified method of evaporation residue test using three food-simulating solvents (water, 4% acetic acid and 20% ethanol), based on the Japanese Food Sanitation Law for food contact products. Twenty-three laboratories participated, and tested the evaporation residues of nine test solutions as blind duplicates. For evaporation, a water bath was used in the official method, and a hot plate in the modified method. In most laboratories, the test solutions were heated until just prior to evaporation to dryness, and then allowed to dry under residual heat. Statistical analysis revealed that there was no significant difference between the two methods, regardless of the heating equipment used. Accordingly, the modified method provides performance equal to the official method, and is available as an alternative method.

The isolated chicken eye test as a suitable in vitro method for determining the eye irritation potential of household cleaning products.

PubMed

Schutte, K; Prinsen, M K; McNamee, P M; Roggeband, R

2009-08-01

Eye irritation is an important endpoint in the safety evaluation of consumer products and their ingredients. Several in vitro methods have been developed and are used by different industry sectors to assess eye irritation. One such in vitro method in use for some time already is the isolated chicken eye test (ICE). This investigation focuses on assessing the ICE as a method to determine the eye irritation potential of household cleaning products, both for product safety assurance prior to marketing and for classification and labeling decisions. The ICE involves a single application of test substances onto the cornea of isolated chicken eyes. Endpoints are corneal swelling, corneal opacity and fluorescein retention. The ICE results were compared to historic LVET data in this study due to availability of such in vivo data and the ability to correlate LVET to human experience data on the outcome of accidental exposures to household cleaning products in general. The results of this study indicate that the ICE test is a useful in vitro method for evaluating the eye irritation/corrosion potential and establishing classification and labeling for household cleaning products. For new product formulations, it is best used as part of a weight-of-evidence approach and benchmarked against data from comparable formulations with known eye irritation/corrosion profiles and market experience.

Non-destructive testing method for determining the solvent diffusion coefficient in the porous materials products

NASA Astrophysics Data System (ADS)

Belyaev, V. P.; Mishchenko, S. V.; Belyaev, P. S.

2018-01-01

Ensuring non-destructive testing of products in industry is an urgent task. Most of the modern methods for determining the diffusion coefficient in porous materials have been developed for bodies of a given configuration and size. This leads to the need for finished products destruction to make experimental samples from them. The purpose of this study is the development of a dynamic method that allows operatively determine the diffusion coefficient in finished products from porous materials without destroying them. The method is designed to investigate the solvents diffusion coefficient in building constructions from materials having a porous structure: brick, concrete and aerated concrete, gypsum, cement, gypsum or silicate solutions, gas silicate blocks, heat insulators, etc. A mathematical model of the method is constructed. The influence of the design and measuring device operating parameters on the method accuracy is studied. The application results of the developed method for structural porous products are presented.

The Development of Testing Methods for Characterizing Emissions and Sources of Exposures from Polyurethane Products

EPA Science Inventory

The relationship between onsite manufacture of spray polyurethane foam insulation (SPFI) and potential exposures is not well understood. Currently, no comprehensive standard test methods exist for characterizing and quantifying product emissions. Exposures to diisocyanate compoun...

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

PubMed

Simonetti, Andrea; Amari, Filippo

2015-01-01

In reaction to the limitations of the traditional sterility test methods, in 2008, the U.S. Food and Drug Administration issued the guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" encouraging sterile drug manufacturers to use properly validated physical methods, apart from conventional microbial challenge testing, to confirm container closure integrity as part of the stability protocol. The case study presented in this article investigated the capability of four container closure integrity testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, Novartis Vaccines, Siena, Italy). Vacuum decay, pharmacopoeial dye ingress test, Novartis specific dye ingress test, and high-voltage leak detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference prefilled syringes, classified, respectively, as examples of conforming to closure integrity requirements (negative controls) and as defective (positive controls). Positive controls were, in turn, split in six groups, three of with holes laser-drilled through the prefilled syringe glass barrel, while the other three with capillary tubes embedded in the prefilled syringe plunger. These reference populations were then investigated by means of validated equipment used for container closure integrity testing of prefilled syringe commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that the vacuum decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical solution, preventing possible prefilled syringe plunger movement during container closure integrity testing execution, is presented as well. The growing need to meet sterile drug products' regulatory, quality, and safety expectations has progressively driven new developments and improvements both in container closure integrity testing methods and in the respective equipment, over the last years. Indeed, container closure integrity testing establishes the container closure system capability to provide required protection to the drug product and to demonstrate maintenance of product sterility over its shelf life. This article describes the development of four container closure integrity testing approaches for the evaluation of glass prefilled syringe closure integrity, including two destructive (pharmacopoeial and Novartis specific dye ingress test) and two non-destructive (vacuum decay and high-voltage leak detection) methods. The important finding from the validation of comparative studies was that the vacuum decay method resulted in the most effective, reliable and repeatable detection of defective samples, whether the defect was exposed to sterile water, to drug product, or to air. Complete sets of known defects were created for this purpose (5 μm, 10 μm, 20 μm certified leakages by laser drilled holes and capillary tubes). All investigations and studies were conducted at Bonfiglioli Engineering S.r.l. (Vigarano Pieve, Ferrara, Italy) and at Novartis Vaccines (Sovicille, Siena, Italy). © PDA, Inc. 2015.

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

30 CFR 27.31 - Testing methods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Testing methods. 27.31 Section 27.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.31 Testing methods. A methane...

The use and interpretation of in vitro data in regulatory toxicology: cosmetics, toiletries and household products.

PubMed

Indans, Ian

2002-02-28

There is currently a drive to eliminate animal testing for cosmetics, toiletries and household products; indeed, the European Union Cosmetics Directive aims to prohibit the use of experimental animals for the testing of finished cosmetic products after 2002. At present, national prohibitions are in place in the UK, Germany, Austria and the Netherlands, for the testing of finished cosmetic products and cosmetic ingredients. In the USA animal testing for certain types of finished products is mandatory. Against this background, the currently available regulatory in vitro tests comprise methods for eye irritation, skin corrosivity, genotoxicity, dermal penetration and photoirritation. The draft updates to the Organisation for Economic Co-operation and Development guidelines for eye and skin irritation advocate the use of in vitro or ex vivo methods prior to the commencement of animal studies. At present, testing for these endpoints cannot be completed in vitro, but potentially corrosive substances and products can be classified without the need for animal studies. Regulatory genotoxicity testing can be completed using only in vitro methods, provided that a clear negative outcome is obtained for each test. Data from dermal penetration studies may be used to refine risk assessments. Current developments in areas such as skin sensitisation and skin irritation promise that in the reasonably near future such information may be generated without the use of animals.

77 FR 21038 - Energy Conservation Program: Test Procedures for Light-Emitting Diode Lamps

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-09

... Photometric Measurements of Solid-State Lighting Products'' for determining lumen output, input power, and CCT.... Test Method 5. Test Calculations and Rounding C. Proposed Approach for Rated Lifetime Measurements 1... Test Method to Project Rated Lifetime 4. Test Conditions 5. Test Setup 6. Test Method and Measurements...

Modernization of AOAC Nutrient Methods by Stakeholder Panel on Infant Formula and Adult Nutritionals.

PubMed

Sullivan, Darryl

2016-01-01

Infant formula is one of the most highly regulated products in the world. To comply with global regulations and to ensure the products are manufactured within product specifications, accurate analytical testing is required. Most of the AOAC INTERNATIONAL legacy test methods for infant formula were developed and validated in the 1980s and 1990s. Although these methods performed very well for many years, infant formulas have been updated, and today's products contain many new and novel ingredients. There were a number of cases in which the legacy AOAC methods began to result in problems with the analysis of modern infant formulas, and the use of these methods caused some disputes with regulatory agencies. In 2010, AOAC reached an agreement with the International Formula Council, which has changed its name to the Infant Nutrition Council of America, regarding a project to modernize these AOAC infant-formula test methods. This agreement led to the development of Standard Method Performance Requirements (SMPRs(®)) for 28 nutrients. After SMPR approval, methods were collected, evaluated, validated, and approved through the AOAC Official Methods(SM) process. Forty-seven methods have been approved as AOAC First Action Methods, and eight have been approved as Final Action.

Validation of laboratory-scale recycling test method of paper PSA label products

Treesearch

Carl Houtman; Karen Scallon; Richard Oldack

2008-01-01

Starting with test methods and a specification developed by the U.S. Postal Service (USPS) Environmentally Benign Pressure Sensitive Adhesive Postage Stamp Program, a laboratory-scale test method and a specification were developed and validated for pressure-sensitive adhesive labels, By comparing results from this new test method and pilot-scale tests, which have been...

Non-destructive inspection of polymer composite products

NASA Astrophysics Data System (ADS)

Anoshkin, A. N.; Sal'nikov, A. F.; Osokin, V. M.; Tretyakov, A. A.; Luzin, G. S.; Potrakhov, N. N.; Bessonov, V. B.

2018-02-01

The paper considers the main types of defects encountered in products made of polymer composite materials for aviation use. The analysis of existing methods of nondestructive testing is carried out, features of their application are considered taking into account design features, geometrical parameters and internal structure of objects of inspection. The advantages and disadvantages of the considered methods of nondestructive testing used in industrial production are shown.

[Comparison of various topical sun protection formulations, based on cosmetic vs medical device status, using in vitro methods to assess their efficacy, photo-stability and water resistance].

PubMed

Couteau, C; Paparis, E; Coiffard, L-J-M

2016-02-01

Within the European Union, sun protection products have long been considered cosmetics whereas in other parts of the world, such as the United States, they are considered as medicinal products. In France, sun protection products with medical device status have recently appeared. Our aim was to compare medical and cosmetic sun protection products. We subjected 4 sun protection products to in vitro testing in order to determine their efficacy in the UVB and UVA ranges, as well as their photo-stability and water resistance. We tested two cosmetic products (Dépiwhite S Soin photoprotecteur(®) SPF 50+ and Urgo cicatrices(®) SPF 30) and two class I medical devices (MD) (Actinica lotion(®) and Kelocote UV(®) Gel for scars). The main in vitro method used involved measuring the transmittance of a sample of each product applied to a dish containing poly(methyl methacrylate) using a spectrophotometer with integrating spheres. This method enabled us to determine the SPF of the various products as well as their photo-stability and degree of water resistance. Regarding efficacy, three of the four test products met the European recommendations governing sun protection products, i.e. a ratio between UVB and UVA protection of 3 or less, and a critical wavelength (λc) of 370 nm or higher. Actinica lotion(®) was the more effective of the two medical devices tested, and was also the most photo-stable, at least within the UVB range. All four products tested were water-resistant. The products tested, while having different status and different claims, exhibited equivalent filtration properties under the study conditions. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

The application of uniplex, duplex, and multiplex PCR for the absence of specified microorganism testing of pharmaceutical excipients and drug products.

PubMed

Ragheb, Suzan M; Yassin, Aymen S; Amin, Magdy A

2012-01-01

Notable progress has been made in methods that encourage the use of polymerase chain reaction (PCR) as a rapid and accurate tool in microbiological testing of pharmaceuticals. In this study, the detection of the four main specified microorganisms according to the pharmacopeial recommendations, Salmonella spp, Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus, was optimized in different pharmaceutical dosage forms and raw materials. Uniplex PCR was performed for the detection of each microorganism individually targeting the conserved region in each bacterial genome. Further optimizations were done to perform duplex and multiplex PCR assays considering relative concentrations of competitor primers used in the reaction. The uniplex PCR amplicons were successfully sequenced, confirming the conservation of used primers. Other validation parameters such as specificity, sensitivity, and robustness were examined closely. The method provides a high-throughput screening method to test different pharmaceutical preparations for specified microorganisms for the detection of microbiological contamination. Strict regulations govern the production of pharmaceutical products whether they are sterile or nonsterile. Certain official tests are carried out in microbiology testing laboratory in any pharmaceutical production facility to ensure the pharmaceuticals microbiological quality according to the standard pharmacopeial recommendations. Nonsterile products must be free of specified microorganisms that are used as a check for their quality. Topical preparations must be free of Pseudomonas aeruginosa and Staphylococcus aureus, and oral preparations must be free of Salmonella spp and Escherichia coli. Conventional microbiological methods are time-consuming, labor-intensive, and require long incubation times, resulting in delaying the release of the products. In this study, we tested and validated a polymerase chain reaction identification approach to detect indicator bacteria in pharmaceutical preparations. The method depends on amplification of certain conserved genes located in the four specified bacteria. The method is optimized to be carried out individually or collectively to detect all indicator bacteria in a single reaction in different forms of pharmaceutical products.

Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques.

PubMed

Westenberger, Benjamin J; Ellison, Christopher D; Fussner, Andrew S; Jenney, Susan; Kolinski, Richard E; Lipe, Terra G; Lyon, Robbe C; Moore, Terry W; Revelle, Larry K; Smith, Anjanette P; Spencer, John A; Story, Kimberly D; Toler, Duckhee Y; Wokovich, Anna M; Buhse, Lucinda F

2005-12-08

This work investigated the use of non-traditional analytical methods to evaluate the quality of a variety of pharmaceutical products purchased via internet sites from foreign sources and compared the results with those obtained from conventional quality assurance methods. Traditional analytical techniques employing HPLC for potency, content uniformity, chromatographic purity and drug release profiles were used to evaluate the quality of five selected drug products (fluoxetine hydrochloride, levothyroxine sodium, metformin hydrochloride, phenytoin sodium, and warfarin sodium). Non-traditional techniques, such as near infrared spectroscopy (NIR), NIR imaging and thermogravimetric analysis (TGA), were employed to verify the results and investigate their potential as alternative testing methods. Two of 20 samples failed USP monographs for quality attributes. The additional analytical methods found 11 of 20 samples had different formulations when compared to the U.S. product. Seven of the 20 samples arrived in questionable containers, and 19 of 20 had incomplete labeling. Only 1 of the 20 samples had final packaging similar to the U.S. products. The non-traditional techniques complemented the traditional techniques used and highlighted additional quality issues for the products tested. For example, these methods detected suspect manufacturing issues (such as blending), which were not evident from traditional testing alone.

Soft wheat and flour products methods review: solvent retention capacity equation correction

USDA-ARS?s Scientific Manuscript database

This article discusses the results of a significant change to calculations made within AACCI Approved methods 56-10 and 56-11, the Alkaline Water Retention Capacity (AWRC) test and the Solvent Retention Capacity (SRC) test. The AACCI Soft Wheat and Flour Products Technical Committee reviewed propos...

40 CFR 60.133 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 6 2010-07-01 2010-07-01 false Test methods and procedures. 60.133 Section 60.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... and Bronze Production Plants § 60.133 Test methods and procedures. (a) In conducting performance tests...

40 CFR 60.133 - Test methods and procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 7 2012-07-01 2012-07-01 false Test methods and procedures. 60.133 Section 60.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... and Bronze Production Plants § 60.133 Test methods and procedures. (a) In conducting performance tests...

40 CFR 60.133 - Test methods and procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 6 2011-07-01 2011-07-01 false Test methods and procedures. 60.133 Section 60.133 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... and Bronze Production Plants § 60.133 Test methods and procedures. (a) In conducting performance tests...

In vitro methods for evaluating skin hydration under diapers and incontinence products.

PubMed

Tate, M L; Wright, A S

2017-11-01

Excessive skin hydration from wearing wet undergarments, such as infant diapers and adult incontinence products, has been historically problematic. Skin damage occurs from wetness (urine) and limited product breathability. Evaporative water loss has been measured on adult arms (armband method) or infant torsos (on-baby method), after wearing a saline-insulted diaper product. The current study developed a reliable in vitro method of evaluating diaper and incontinence products for improvements in skin dryness. A simulated skin substrate was applied to a heated mechanical arm or baby torso. A disposable diaper or incontinence product was wrapped around the arm or baby torso, and loaded with saline. Hydration of the simulated skin was measured by evaporimetry and compared with clinical data from adult armband evaluations. The heated mechanical arm and baby torso accurately distinguished products for skin dryness. Eight diaper products were evaluated and compared to human test results. The torso in vitro and mechanical arm evaluations demonstrated strong correlations to human epidermal water loss evaluations, with repeatable results. Additionally, the bench test has been used for adult incontinence products, and it proved to differentiate those products as well as infant products. A rapid and reliable means of evaluation has been developed, and it is predictive of human subject testing. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Surfactant irritation: in vitro corneosurfametry and in vivo bioengineering.

PubMed

Gabard, B; Chatelain, E; Bieli, E; Haas, S

2001-02-01

Irritant reactions to surfactants, cleansing products, soaps and detergents are common in clinical and occupational dermatology. Mildness has become a major benefit claimed, and testing for mildness now ranks among the first concerns of the manufacturing industry. A wealth of publications deals with this problem, trying to improve the methodology, reduce the costs of testing and facilitate decision-making. Differences in vivo can be measured clinically and/or instrumentally. This is difficult, as commercially available products are generally safe to use and none are harsh in the absolute sense. Nineteen different products (syndets, shampoos, personal cleansers), all claiming to be mild, were tested in vitro by a newly introduced method, corneosurfametry. For evaluating the aggressiveness of the products, the calculation of an index of irritation (IOI) was proposed. A concentration-effect curve of sodium lauryl sulfate (SLS) as standard and model surfactant was obtained. Some of the products were further tested in vivo with a flex wash test and with a soap chamber test and compared to SLS. Bioengineering methods (transepidermal water loss TEWL, skin color) were used to evaluate the results. The results of the corneosurfametry allowed us to classify the products in three categories, with increasing aggressiveness towards the stratum corneum, according to their IOIs. The in vivo tests were not able to discriminate between the products, but ranks from the results of the bioengineering measurements showed a good correlation between TEWL changes, but not between colour changes, and IOIs from corneosurfametry. Corneosurfametry emerged as a simple, low-cost and fast method for ranking commercial products according to their mildness. However, the skin bioengineering techniques showed that some products could lead to skin reactions, such as erythema, that could not be detected by the in vitro technique.

Chemical test for mammalian feces in grain products: collaborative study.

PubMed

Gerber, H R

1989-01-01

A collaborative study was conducted to validate the use of the AOAC alkaline phosphatase method for mammalian feces in corn meal, 44.B01-44.B06, for 7 additional products: brown rice cream, oat bran, grits, semolina, pasta flour, farina, and barley plus (a mixture of barley, oat bran, and brown rice). The proposed method determines the presence of alkaline phosphatase, an enzyme contained in mammalian feces, by using phenolphthalein diphosphate as the enzyme substrate in a test agar medium. Fecal matter is separated from the grain products by specific gravity differences in 1% test agar. As the product is distributed on liquid test agar, fecal fragments float while the grain products sink. The alkaline phosphatase cleaves phosphate radicals from phenolphthalein diphosphate, generating free phenolphthalein, which produces a pink to red-purple color around the fecal particles in the previously colorless medium. Collaborators' recovery averages ranged from 21.7 particles (72.3%) for oat bran to 25.3 particles (84.3%) for semolina at the 30 particle spike level. Overall average background was 0.4 positive reactions per food type. The collaborators reported that the method was quick, simple, and easy to use. The method has been approved interim official first action for all 7 grain products.

Stimulus Characteristics of Single-Word Tests of Children's Speech Sound Production

ERIC Educational Resources Information Center

Macrae, Toby

2017-01-01

Purpose: This clinical focus article provides readers with a description of the stimulus characteristics of 12 popular tests of speech sound production. Method: Using significance testing and descriptive analyses, stimulus items were compared in terms of the number of opportunities for production of all consonant singletons, clusters, and rhotic…

Absorbing Software Testing into the Scrum Method

NASA Astrophysics Data System (ADS)

Tuomikoski, Janne; Tervonen, Ilkka

In this paper we study, how to absorb software testing into the Scrum method. We conducted the research as an action research during the years 2007-2008 with three iterations. The result showed that testing can and even should be absorbed to the Scrum method. The testing team was merged into the Scrum teams. The teams can now deliver better working software in a shorter time, because testing keeps track of the progress of the development. Also the team spirit is higher, because the Scrum team members are committed to the same goal. The biggest change from test manager’s point of view was the organized Product Owner Team. Test manager don’t have testing team anymore, and in the future all the testing tasks have to be assigned through the Product Backlog.

High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 1. Method development and validation.

PubMed

Damgaard, Rasmus; Rasmussen, Mats; Buus, Peter; Mulhall, Brian; Guazzo, Dana Morton

2013-01-01

In Part 1 of this three-part research series, a leak test performed using high-voltage leak detection (HVLD) technology, also referred to as an electrical conductivity and capacitance leak test, was developed and validated for container-closure integrity verification of a small-volume laminate plastic bag containing an aqueous solution for injection. The sterile parenteral product is the rapid-acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®, by Novo Nordisk A/S, Bagsværd, Denmark). The aseptically filled and sealed package is designed to preserve product sterility through expiry. Method development and validation work incorporated positive control packages with a single hole laser-drilled through the laminate film of each bag. A unique HVLD method characterized by specific high-voltage and potentiometer set points was established for testing bags positioned in each of three possible orientations as they are conveyed through the instrument's test zone in each of two possible directions-resulting in a total of six different test method options. Validation study results successfully demonstrated the ability of all six methods to accurately and reliably detect those packages with laser-drilled holes from 2.5-11.2 μm in nominal diameter. Part 2 of this series will further explore HVLD test results as a function of package seal and product storage variables. The final Part 3 will report the impact of HVLD exposure on product physico-chemical stability. In this Part 1 of a three-part research series, a leak test method based on electrical conductivity and capacitance, called high voltage leak detection (HVLD), was used to find leaks in small plastic bags filled with an insulin pharmaceutical solution for human injection by Novo Nordisk A/S (Bagsværd, Denmark). To perform the test, the package is electrically grounded while being conveyed past an electrode linked to a high-voltage, low-amperage transformer. The instrument measures the current that passes from the transformer to the electrode, through the packaged product and along the package walls, to the ground. Plastic packages without defect are relatively nonconductive and yield a low voltage reading; a leaking package with electrically conductive solution located in or near the leak triggers a spike in voltage reading. Test methods were optimized and validated, enabling the detection of leaking packages with holes as small as 2.5 μm in diameter. Part 2 of this series will further explore HVLD test results as a function of package seal and product storage variables. The final Part 3 will report the impact of HVLD exposure on product stability.

Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing.

PubMed

Weber, Benjamin; Lee, Sau L; Delvadia, Renishkumar; Lionberger, Robert; Li, Bing V; Tsong, Yi; Hochhaus, Guenther

2015-03-01

Equivalence testing of aerodynamic particle size distribution (APSD) through multi-stage cascade impactors (CIs) is important for establishing bioequivalence of orally inhaled drug products. Recent work demonstrated that the median of the modified chi-square ratio statistic (MmCSRS) is a promising metric for APSD equivalence testing of test (T) and reference (R) products as it can be applied to a reduced number of CI sites that are more relevant for lung deposition. This metric is also less sensitive to the increased variability often observed for low-deposition sites. A method to establish critical values for the MmCSRS is described here. This method considers the variability of the R product by employing a reference variance scaling approach that allows definition of critical values as a function of the observed variability of the R product. A stepwise CI equivalence test is proposed that integrates the MmCSRS as a method for comparing the relative shapes of CI profiles and incorporates statistical tests for assessing equivalence of single actuation content and impactor sized mass. This stepwise CI equivalence test was applied to 55 published CI profile scenarios, which were classified as equivalent or inequivalent by members of the Product Quality Research Institute working group (PQRI WG). The results of the stepwise CI equivalence test using a 25% difference in MmCSRS as an acceptance criterion provided the best matching with those of the PQRI WG as decisions of both methods agreed in 75% of the 55 CI profile scenarios.

The development and standardization of testing methods for genetically modified organisms and their derived products.

PubMed

Zhang, Dabing; Guo, Jinchao

2011-07-01

As the worldwide commercialization of genetically modified organisms (GMOs) increases and consumers concern the safety of GMOs, many countries and regions are issuing labeling regulations on GMOs and their products. Analytical methods and their standardization for GM ingredients in foods and feed are essential for the implementation of labeling regulations. To date, the GMO testing methods are mainly based on the inserted DNA sequences and newly produced proteins in GMOs. This paper presents an overview of GMO testing methods as well as their standardization. © 2011 Institute of Botany, Chinese Academy of Sciences.

Antimicrobial Testing Methods & Procedures: MB-31

EPA Pesticide Factsheets

Information about ATMP - SOP Quantitative Disk Carrier Test Method (QCT-2) Modified for Testing Antimicrobial Products Against Spores of Clostridium difficile (ATCC 43598) on Inanimate, Hard, Non-porous Surfaces - MB-31-Final

Hybrid analysis (barcode-high resolution melting) for authentication of Thai herbal products, Andrographis paniculata (Burm.f.) Wall.ex Nees.

PubMed

Osathanunkul, Maslin; Suwannapoom, Chatmongkon; Khamyong, Nuttaluck; Pintakum, Danupol; Lamphun, Santisuk Na; Triwitayakorn, Kanokporn; Osathanunkul, Kitisak; Madesis, Panagiotis

2016-01-01

Andrographis paniculata Nees is a medicinal plant with multiple pharmacological properties. It has been used over many centuries as a household remedy. A. paniculata products sold on the markets are in processed forms so it is difficult to authenticate. Therefore buying the herbal products poses a high-risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. High resolution melting analysis coupled with DNA barcoding (Bar-HRM) was applied to detect adulteration in commercial herbal products. The rbcL barcode was selected to use in primers design for HRM analysis to produce standard melting profile of A. paniculata species. DNA of the tested commercial products was isolated and their melting profiles were then generated and compared with the standard A. paniculata. The melting profiles of the rbcL amplicons of the three closely related herbal species (A. paniculata, Acanthus ebracteatus and Rhinacanthus nasutus) are clearly separated so that they can be distinguished by the developed method. The method was then used to authenticate commercial herbal products. HRM curves of all 10 samples tested are similar to A. paniculata which indicated that all tested products were contained the correct species as labeled. The method described in this study has been proved to be useful in aiding identification and/or authenticating A. paniculata. This Bar-HRM analysis has allowed us easily to determine the A. paniculata species in herbal products on the markets even they are in processed forms. We propose the use of DNA barcoding combined with High Resolution Melting analysis for authenticating of Andrographis paniculata products.The developed method can be used regardless of the type of the DNA template (fresh or dried tissue, leaf, and stem).rbcL region was chosen for the analysis and work well with our samplesWe can easily determine the A. paniculata species in herbal products tested. Abbreviations used: bp: Base pair, Tm: Melting temperature.

77 FR 4544 - CPSC Symposium on Phthalates Screening and Testing Methods

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-30

... Screening and Testing Methods AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The... symposium on phthalates screening and testing methods. The symposium will be held at the CPSC's National... submit comments, identified by Docket No. CPSC-2012-0008, by any of the following methods: Electronic...

Major advances in testing of dairy products: milk component and dairy product attribute testing.

PubMed

Barbano, D M; Lynch, J M

2006-04-01

Milk component analysis is relatively unusual in the field of quantitative analytical chemistry because an analytical test result determines the allocation of very large amounts of money between buyers and sellers of milk. Therefore, there is high incentive to develop and refine these methods to achieve a level of analytical performance rarely demanded of most methods or laboratory staff working in analytical chemistry. In the last 25 yr, well-defined statistical methods to characterize and validate analytical method performance combined with significant improvements in both the chemical and instrumental methods have allowed achievement of improved analytical performance for payment testing. A shift from marketing commodity dairy products to the development, manufacture, and marketing of value added dairy foods for specific market segments has created a need for instrumental and sensory approaches and quantitative data to support product development and marketing. Bringing together sensory data from quantitative descriptive analysis and analytical data from gas chromatography olfactometry for identification of odor-active compounds in complex natural dairy foods has enabled the sensory scientist and analytical chemist to work together to improve the consistency and quality of dairy food flavors.

Antimicrobial Testing Methods & Procedures: MB-17-04

EPA Pesticide Factsheets

Information about ATMP - SOP Neutralization Confirmation Procedures for the AOAC Use-dilution method (UDM), the AOAC Germicidal Spray Products as Disinfectants Test (GSPT) and the Disinfectant Towelette Test (DTT) - MB-17-04

Antimicrobial Testing Methods & Procedures: MB-31-03

EPA Pesticide Factsheets

Information about ATMP - SOP Quantitative Disk Carrier Test Method (QCT-2) Modified for Testing Antimicrobial Products Against Spores of Clostridium difficile (ATCC 43598) on Inanimate, Hard, Non-porous Surfaces - MB-31-03

Exact test-based approach for equivalence test with parameter margin.

PubMed

Cassie Dong, Xiaoyu; Bian, Yuanyuan; Tsong, Yi; Wang, Tianhua

2017-01-01

The equivalence test has a wide range of applications in pharmaceutical statistics which we need to test for the similarity between two groups. In recent years, the equivalence test has been used in assessing the analytical similarity between a proposed biosimilar product and a reference product. More specifically, the mean values of the two products for a given quality attribute are compared against an equivalence margin in the form of ±f × σ R , where ± f × σ R is a function of the reference variability. In practice, this margin is unknown and is estimated from the sample as ±f × S R . If we use this estimated margin with the classic t-test statistic on the equivalence test for the means, both Type I and Type II error rates may inflate. To resolve this issue, we develop an exact-based test method and compare this method with other proposed methods, such as the Wald test, the constrained Wald test, and the Generalized Pivotal Quantity (GPQ) in terms of Type I error rate and power. Application of those methods on data analysis is also provided in this paper. This work focuses on the development and discussion of the general statistical methodology and is not limited to the application of analytical similarity.

40 CFR 59.207 - Test methods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 6 2012-07-01 2012-07-01 false Test methods. 59.207 Section 59.207 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL... Compound Emission Standards for Consumer Products § 59.207 Test methods. Each manufacturer or importer...

40 CFR 59.207 - Test methods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 5 2010-07-01 2010-07-01 false Test methods. 59.207 Section 59.207 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL... Compound Emission Standards for Consumer Products § 59.207 Test methods. Each manufacturer or importer...

40 CFR 59.207 - Test methods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 6 2014-07-01 2014-07-01 false Test methods. 59.207 Section 59.207 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL... Compound Emission Standards for Consumer Products § 59.207 Test methods. Each manufacturer or importer...

40 CFR 59.207 - Test methods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 5 2011-07-01 2011-07-01 false Test methods. 59.207 Section 59.207 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL... Compound Emission Standards for Consumer Products § 59.207 Test methods. Each manufacturer or importer...

40 CFR 59.207 - Test methods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 6 2013-07-01 2013-07-01 false Test methods. 59.207 Section 59.207 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL... Compound Emission Standards for Consumer Products § 59.207 Test methods. Each manufacturer or importer...

Biofilm and metallo beta-lactamase production among the strains of Pseudomonas aeruginosa and Acinetobacter spp. at a Tertiary Care Hospital in Kathmandu, Nepal.

PubMed

Baniya, Bandana; Pant, Narayan Dutt; Neupane, Sanjeev; Khatiwada, Saroj; Yadav, Uday Narayan; Bhandari, Nisha; Khadka, Rama; Bhatta, Sabita; Chaudhary, Raina

2017-11-02

Pseudomonas aeruginosa and Acinetobacter spp. are found to be associated with biofilm and metallo-β-lactamase production and are the common causes of serious infections mainly in hospitalized patients. So, the main aims of this study were to determine the rates of biofilm production and metallo beta-lactamase production (MBL) among the strains of Pseudomonas aeruginosa and Acinetobacter spp. isolated from hospitalized patients. A total of 85 P. aeruginosa isolates and 50 Acinetobacter spp. isolates isolated from different clinical specimens from patients admitted to Shree Birendra Hospital, Kathmandu, Nepal from July 2013 to May 2014 were included in this study. The bacterial isolates were identified with the help of biochemical tests. Modified Kirby-Bauer disc diffusion technique was used for antimicrobial susceptibility testing. Combined disc diffusion technique was used for the detection of MBL production, while Congo red agar method and tube adherence method were used for detection of biofilm production. Around 16.4% of P. aeruginosa isolates and 22% of the strains of Acinetobacter spp. were metallo β-lactamase producers. Out of 85 P. aeruginosa isolates, 23 (27.05%) were biofilm producers according to tube adherence test while, only 13 (15.29%) were biofilm producers as per Congo red agar method. Similarly, out of 50 Acinetobacter spp. 7 (14%) isolates were biofilm producers on the basis of tube adherence test, while only 5 (10%) were positive for biofilm production by Congo red agar method. Highest rates of susceptibility of P. aeruginosa as well as Acinetobacter spp. were seen toward colistin. In our study, biofilm production and metallo beta-lactamase production were observed among Pseudomonas aeruginosa and Acinetobacter spp. However, no statistically significant association could be established between biofilm production and metallo beta-lactamase production.

SMART empirical approaches for predicting field performance of PV modules from results of reliability tests

NASA Astrophysics Data System (ADS)

Hardikar, Kedar Y.; Liu, Bill J. J.; Bheemreddy, Venkata

2016-09-01

Gaining an understanding of degradation mechanisms and their characterization are critical in developing relevant accelerated tests to ensure PV module performance warranty over a typical lifetime of 25 years. As newer technologies are adapted for PV, including new PV cell technologies, new packaging materials, and newer product designs, the availability of field data over extended periods of time for product performance assessment cannot be expected within the typical timeframe for business decisions. In this work, to enable product design decisions and product performance assessment for PV modules utilizing newer technologies, Simulation and Mechanism based Accelerated Reliability Testing (SMART) methodology and empirical approaches to predict field performance from accelerated test results are presented. The method is demonstrated for field life assessment of flexible PV modules based on degradation mechanisms observed in two accelerated tests, namely, Damp Heat and Thermal Cycling. The method is based on design of accelerated testing scheme with the intent to develop relevant acceleration factor models. The acceleration factor model is validated by extensive reliability testing under different conditions going beyond the established certification standards. Once the acceleration factor model is validated for the test matrix a modeling scheme is developed to predict field performance from results of accelerated testing for particular failure modes of interest. Further refinement of the model can continue as more field data becomes available. While the demonstration of the method in this work is for thin film flexible PV modules, the framework and methodology can be adapted to other PV products.

Sterilization validation for medical devices at IRASM microbiological laboratory—Practical approaches

NASA Astrophysics Data System (ADS)

Trandafir, Laura; Alexandru, Mioara; Constantin, Mihai; Ioniţă, Anca; Zorilă, Florina; Moise, Valentin

2012-09-01

EN ISO 11137 established regulations for setting or substantiating the dose for achieving the desired sterility assurance level. The validation studies can be designed in particular for different types of products. Each product needs distinct protocols for bioburden determination and sterility testing. The Microbiological Laboratory from Irradiation Processing Center (IRASM) deals with different types of products, mainly for the VDmax25 method. When it comes to microbiological evaluation the most challenging was cotton gauze. A special situation for establishing the sterilization validation method appears in cases of cotton packed in large quantities. The VDmax25 method cannot be applied for items with average bioburden more than 1000 CFU/pack, irrespective of the weight of the package. This is a method limitation and implies increased costs for the manufacturer when choosing other methods. For microbiological tests, culture condition should be selected in both cases of the bioburden and sterility testing. Details about choosing criteria are given.

Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods.

PubMed

Raab, Stephen S; Andrew-Jaja, Carey; Condel, Jennifer L; Dabbs, David J

2006-01-01

The objective of the study was to determine whether the Toyota production system process improves Papanicolaou test quality and patient safety. An 8-month nonconcurrent cohort study that included 464 case and 639 control women who had a Papanicolaou test was performed. Office workflow was redesigned using Toyota production system methods by introducing a 1-by-1 continuous flow process. We measured the frequency of Papanicolaou tests without a transformation zone component, follow-up and Bethesda System diagnostic frequency of atypical squamous cells of undetermined significance, and diagnostic error frequency. After the intervention, the percentage of Papanicolaou tests lacking a transformation zone component decreased from 9.9% to 4.7% (P = .001). The percentage of Papanicolaou tests with a diagnosis of atypical squamous cells of undetermined significance decreased from 7.8% to 3.9% (P = .007). The frequency of error per correlating cytologic-histologic specimen pair decreased from 9.52% to 7.84%. The introduction of the Toyota production system process resulted in improved Papanicolaou test quality.

77 FR 14814 - Tobacco Product Analysis; Scientific Workshop; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... work to develop tobacco reference products that are not currently available for laboratory use. Discuss... methods used to analyze tobacco products. FDA will invite speakers to address scientific and technical matters relating to the testing of tobacco reference products and the analytical methods used to measure...

Hybrid analysis (barcode-high resolution melting) for authentication of Thai herbal products, Andrographis paniculata (Burm.f.) Wall.ex Nees

PubMed Central

Osathanunkul, Maslin; Suwannapoom, Chatmongkon; Khamyong, Nuttaluck; Pintakum, Danupol; Lamphun, Santisuk Na; Triwitayakorn, Kanokporn; Osathanunkul, Kitisak; Madesis, Panagiotis

2016-01-01

Background: Andrographis paniculata Nees is a medicinal plant with multiple pharmacological properties. It has been used over many centuries as a household remedy. A. paniculata products sold on the markets are in processed forms so it is difficult to authenticate. Therefore buying the herbal products poses a high-risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Materials and Methods: High resolution melting analysis coupled with DNA barcoding (Bar-HRM) was applied to detect adulteration in commercial herbal products. The rbcL barcode was selected to use in primers design for HRM analysis to produce standard melting profile of A. paniculata species. DNA of the tested commercial products was isolated and their melting profiles were then generated and compared with the standard A. paniculata. Results: The melting profiles of the rbcL amplicons of the three closely related herbal species (A. paniculata, Acanthus ebracteatus and Rhinacanthus nasutus) are clearly separated so that they can be distinguished by the developed method. The method was then used to authenticate commercial herbal products. HRM curves of all 10 samples tested are similar to A. paniculata which indicated that all tested products were contained the correct species as labeled. Conclusion: The method described in this study has been proved to be useful in aiding identification and/or authenticating A. paniculata. This Bar-HRM analysis has allowed us easily to determine the A. paniculata species in herbal products on the markets even they are in processed forms. SUMMARY We propose the use of DNA barcoding combined with High Resolution Melting analysis for authenticating of Andrographis paniculata products.The developed method can be used regardless of the type of the DNA template (fresh or dried tissue, leaf, and stem).rbcL region was chosen for the analysis and work well with our samplesWe can easily determine the A. paniculata species in herbal products tested. Abbreviations used: bp: Base pair, Tm: Melting temperature PMID:27041863

9 CFR 113.4 - Exemptions to tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Exemptions to tests. 113.4 Section 113.4 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... § 113.4 Exemptions to tests. (a) The test methods and procedures contained in all applicable Standard...

[Testing methods for the characterization of catheter balloons and lumina].

PubMed

Werner, C; Rössler, K; Deckert, F

1995-10-01

The present paper reports on the characterization of catheter balloons and lumina on the basis of such known parameters as residual volume, compliance, burst pressure and flow rate, with the aim of developing standards, test methods and testing equipment as well as standards. These are becoming ever more important with the coming into force of the EC directive on medical products [7] and the law governing medical products in Germany [13], which requires manufacturers to specify the properties of their products. Our testing concept is based on a commercially available machine that subjects materials to alternating extension and compression forces over the long-term, to which we added a special hydraulic module. Using the multimedia technology we achieved a real time superimposition of the volume-diameter curve on the balloon. The function of the testing device and method is demonstrated on dilatation catheters. Our initial results reveal compatibility with the requirements of the 1% accuracy class. Use of this methodology for comparative testing of catheters and quality evaluation is recommended.

Method Analysis of Microbial Resistant Gypsum Products

EPA Science Inventory

Abstract: Several commercially available gypsum products are marketed as microbial-resistant. During previous test method research on a microbial resistant gypsum wallboard study, a common theme from both stakeholders and product vendors was the need for a unified and accepted m...

Methanogenic activity tests by Infrared Tunable Diode Laser Absorption Spectroscopy.

PubMed

Martinez-Cruz, Karla; Sepulveda-Jauregui, Armando; Escobar-Orozco, Nayeli; Thalasso, Frederic

2012-10-01

Methanogenic activity (MA) tests are commonly carried out to estimate the capability of anaerobic biomass to treat effluents, to evaluate anaerobic activity in bioreactors or natural ecosystems, or to quantify inhibitory effects on methanogenic activity. These activity tests are usually based on the measurement of the volume of biogas produced by volumetric, pressure increase or gas chromatography (GC) methods. In this study, we present an alternative method for non-invasive measurement of methane produced during activity tests in closed vials, based on Infrared Tunable Diode Laser Absorption Spectroscopy (MA-TDLAS). This new method was tested during model acetoclastic and hydrogenotrophic methanogenic activity tests and was compared to a more traditional method based on gas chromatography. From the results obtained, the CH(4) detection limit of the method was estimated to 60 ppm and the minimum measurable methane production rate was estimated to 1.09(.)10(-3) mg l(-1) h(-1), which is below CH(4) production rate usually reported in both anaerobic reactors and natural ecosystems. Additionally to sensitivity, the method has several potential interests compared to more traditional methods among which short measurements time allowing the measurement of a large number of MA test vials, non-invasive measurements avoiding leakage or external interferences and similar cost to GC based methods. It is concluded that MA-TDLAS is a promising method that could be of interest not only in the field of anaerobic digestion but also, in the field of environmental ecology where CH(4) production rates are usually very low. Copyright © 2012 Elsevier B.V. All rights reserved.

Abrasion Testing of Products Containing Nanomaterials, SOP-R-2: Scientific Operating Procedure Series: Release (R)

DTIC Science & Technology

2016-04-01

characterized by different methods such as Scanning Electron Microscopy (SEM) or Transmission Electron Microscopy (TEM) and other methods . ERDC SR-16...the surface coating and substrate material used. Adaptations to this test method can be used with a range of nanomaterial / polymer products in which...material rather than the presence of nanomaterial (Golanski et al. 2011). After particles are released, proper characterization is essential to

A Simple Method for Causal Analysis of Return on IT Investment

PubMed Central

Alemi, Farrokh; Zargoush, Manaf; Oakes, James L.; Edrees, Hanan

2011-01-01

This paper proposes a method for examining the causal relationship among investment in information technology (IT) and the organization's productivity. In this method, first a strong relationship among (1) investment in IT, (2) use of IT and (3) organization's productivity is verified using correlations. Second, the assumption that IT investment preceded improved productivity is tested using partial correlation. Finally, the assumption of what may have happened in the absence of IT investment, the so called counterfactual, is tested through forecasting productivity at different levels of investment. The paper applies the proposed method to investment in the Veterans Health Information Systems and Technology Architecture (VISTA) system. Result show that the causal analysis can be done, even with limited data. Furthermore, because the procedure relies on overall organization's productivity, it might be more objective than when the analyst picks and chooses which costs and benefits should be included in the analysis. PMID:23019515

Evaluation of modifications of the traditional patch test in assessing the chemical irritation potential of feminine hygiene products.

PubMed

Farage, Miranda A; Meyer, Sandy; Walter, Dave

2004-05-01

The first main objective of the work presented in this paper was to investigate ways of optimizing the current arm patch test protocol by (1) increasing the sensitivity of the test in order to evaluate more effectively the products that are inherently non-irritating, and/or (2) reducing the costs of these types of studies by shortening the protocol. The second main objective was to use the results of these studies and the results of the parallel studies conducted using the behind-the-knee method to better understand the contribution of mechanical irritation to the skin effects produced by these types of products. In addition, we were interested in continuing the evaluation of sensory effects and their relationship to objective measures of irritation. Test materials were prepared from three, currently marketed feminine protection pads. Wet and dry samples were applied to the upper arm using the standard 24-h patch test. Applications were repeated daily for 4 consecutive days. The test sites were scored for irritation prior to the first patch application, and 30-60 min after removal of each patch. Some test sites were treated by tape stripping the skin prior to the initial patch application. In addition, in one experiment, panelists were asked to keep a daily diary describing any sensory skin effects they noticed at each test site. All protocol variations ([intact skin/dry samples], [compromised skin/dry samples], [intact skin/wet samples], and [compromised skin/wet samples]) gave similar results for the products tested. When compared to the behind-the-knee test method, the standard upper arm patch test gave consistently lower levels of irritation when the test sites were scored shortly after patch removal, even though the sample application was longer (24 vs. 6 h) in the standard patch test. The higher level of irritation in the behind-the-knee method was likely due to mechanical irritation. The sensory skin effects did not appear to be related to a particular test product or a particular protocol variation. However, the mean irritation scores at those sites where a sensory effect was reported were higher than the mean irritation scores at those sites were no sensory effects were reported. All four protocol variations of the standard upper arm patch test can be used to assess the inherent chemical irritant properties of feminine protection products. For these products, which are inherently non-irritating, tape stripping and/or applying wet samples does not increase the sensitivity of the patch test method. Differences in irritation potential were apparent after one to three 24-h applications. Therefore, the standard patch test protocol can be shortened to three applications without compromising our ability to detect differences in the chemical irritation produced by the test materials. The patch test can be used to evaluate effectively the inherent chemical irritation potential of these types of products. However, this method is not suitable for testing the mechanical irritation due to friction that occurs during product use. There is no relationship between specific test conditions, i.e., compromised skin and/or testing wet samples and reports of perceived sensory reactions. However, there seems to be a clear relationship between sensory reactions and objective irritation scores.

16 CFR 1209.7 - Test procedures for smoldering combustion.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Test procedures for smoldering combustion. 1209.7 Section 1209.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... for smoldering combustion. This section provides the test method for determining smoldering combustion...

16 CFR 1209.7 - Test procedures for smoldering combustion.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Test procedures for smoldering combustion. 1209.7 Section 1209.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... for smoldering combustion. This section provides the test method for determining smoldering combustion...

16 CFR 1209.7 - Test procedures for smoldering combustion.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Test procedures for smoldering combustion. 1209.7 Section 1209.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... for smoldering combustion. This section provides the test method for determining smoldering combustion...

16 CFR 1209.7 - Test procedures for smoldering combustion.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Test procedures for smoldering combustion. 1209.7 Section 1209.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... for smoldering combustion. This section provides the test method for determining smoldering combustion...

MULTIPOLLUTANT METHODS - METHODS FOR OZONE AND OZONE PRECURSORS

EPA Science Inventory

This task involves the development and testing of methods for monitoring ozone and compounds associated with the atmospheric chemistry of ozone production both as precursors and reaction products. Although atmospheric gases are the primary interest, separation of gas and particl...

16 CFR 1513.4 - Test methods.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Test methods. 1513.4 Section 1513.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR BUNK BEDS § 1513.4 Test methods. (a) Guardrails (see § 1513.3(a)(6)). With no mattress on the...

16 CFR 1513.4 - Test methods.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Test methods. 1513.4 Section 1513.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR BUNK BEDS § 1513.4 Test methods. (a) Guardrails (see § 1513.3(a)(6)). With no mattress on the...

16 CFR 1513.4 - Test methods.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Test methods. 1513.4 Section 1513.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR BUNK BEDS § 1513.4 Test methods. (a) Guardrails (see § 1513.3(a)(6)). With no mattress on the...

16 CFR 1513.4 - Test methods.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Test methods. 1513.4 Section 1513.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR BUNK BEDS § 1513.4 Test methods. (a) Guardrails (see § 1513.3(a)(6)). With no mattress on the...

16 CFR 1610.3 - Summary of test method.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Summary of test method. 1610.3 Section 1610.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES The Standard § 1610.3 Summary of test method. The Standard...

Evaluation of Electromagnetic Near-Field Measurement Technique as Non-Destructive Testing for Composite Structures

NASA Astrophysics Data System (ADS)

Raad Hussein, Alaa; Badri Albarody, Thar M.; Megat Yusoff, Puteri Sri Melor Bt

2018-05-01

Nowadays there is no viable non-destructive method that could detect flaws in complex composite products. Such a method could provide unique tools to allow engineers to minimize time consumption and cost during the evaluation of various product parameters without disturbing production. The latest research and development on propagation waves introduce micro, radio and millimetre waves as new potential non-destructive test methods for evaluation of mechanical flaws and prediction of failure in a product during production. This paper focuses on recent developments, usage, classification of electromagnetic waves under the range of radio frequency, millimetre and micro-waves. In addition, this paper reviews the application of propagation wave and proposed a new health monitoring technique based on Doppler Effect for vibration measurement in complex composite structures. Doppler Effect is influenced by dynamic behaviour of the composite structures and both are effect by flaws occurred inside the structure. Composite manufacturers, especially Aerospace industry are demanding these methods comprehensively inspect and evaluate the damages and defects in their products.

Effectiveness of creative and productive instructional method towards students' learning achievement in steel structure course

NASA Astrophysics Data System (ADS)

Sugiyanto, Pribadi, Supriyanto, Bambang

2017-09-01

The purpose of this study was to investigate the effectiveness of Creative & Productive instructional method compared with conventional method. This research was a quasi-experimental study involving all Civil Engineering students at Universitas Negeri Malang who were taking a course of Steel Structure. The students were randomly assigned to two different treatment groups, 30 students in experimental group and 37 students in the control group. It was assumed that these groups were equal in all relevant aspects; they differed only in the treatment administered. We used the t-test to test the hypothesis. The results of this research suggest that: (l) the use of Creative & Productive instructional method can significantly improve students' learning achievement, (2) the use of Creative & Productive instructional method can significantly improve students' retention, (3) students' motivation has a significant effect on their learning achievement, and (4) students' motivation has a significant effect on their retention.

Stability indicating methods for the analysis of cefprozil in the presence of its alkaline induced degradation product

NASA Astrophysics Data System (ADS)

Attia, Khalid A. M.; Nassar, Mohammed W. I.; El-Zeiny, Mohamed B.; Serag, Ahmed

2016-04-01

Three simple, specific, accurate and precise spectrophotometric methods were developed for the determination of cefprozil (CZ) in the presence of its alkaline induced degradation product (DCZ). The first method was the bivariate method, while the two other multivariate methods were partial least squares (PLS) and spectral residual augmented classical least squares (SRACLS). The multivariate methods were applied with and without variable selection procedure (genetic algorithm GA). These methods were tested by analyzing laboratory prepared mixtures of the above drug with its alkaline induced degradation product and they were applied to its commercial pharmaceutical products.

Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.

PubMed

Lu, Xujin; Lloyd, David K; Klohr, Steven E

2016-01-01

A feasibility study was conducted for a sensitive and robust dye immersion method for the measurement of container closure integrity of unopened prefilled syringes using fluorescence spectrophotometry as the detection method. A Varian Cary Eclipse spectrofluorometer was used with a custom-made sample holder to position the intact syringe in the sample compartment for fluorescence measurements. Methylene blue solution was initially evaluated as the fluorophore in a syringe with excitation at 607 nm and emission at 682 nm, which generated a limit of detection of 0.05 μg/mL. Further studies were conducted using rhodamine 123, a dye with stronger fluorescence. Using 480 nm excitation and 525 nm emission, the dye in the syringe could be easily detected at levels as low as 0.001 μg/mL. The relative standard deviation for 10 measurements of a sample of 0.005 μg/mL (with repositioning of the syringe after each measurement) was less than 1.1%. A number of operational parameters were optimized, including the photomultiplier tube voltage, excitation, and emission slit widths. The specificity of the testing was challenged by using marketed drug products and a protein sample, which showed no interference to the rhodamine detection. Results obtained from this study demonstrated that using rhodamine 123 for container closure integrity testing with in-situ (in-syringe) fluorescence measurements significantly enhanced the sensitivity and robustness of the testing and effectively overcame limitations of the traditional methylene blue method with visual or UV-visible absorption detection. Ensuring container closure integrity of injectable pharmaceutical products is necessary to maintain quality throughout the shelf life of a sterile drug product. Container closure integrity testing has routinely been used to evaluate closure integrity during product development and production line qualification of prefilled syringes, vials, and devices. However, container closure integrity testing has recently gained industry attention due to increased regulatory agency scrutiny regarding the analytical rigor of container closure integrity testing methods and expectations to use container closure integrity testing in lieu of sterility tests in stability programs. Methylene blue dye is often used for dye ingress testing of container closure integrity, but we found it unsuitable for reliable detection of small breaches in prefilled syringes of drug product. This work describes the suitability and advantages of using a fluorescent dye and spectroscopic detection for a robust, sensitive, and quality control-friendly container closure integrity testing method for prefilled syringes. © PDA, Inc. 2016.

Tobacco and Nicotine Product Testing

PubMed Central

Biener, Lois; Leischow, Scott J.; Zeller, Mitch R.

2012-01-01

Introduction: Tobacco product testing is a critical component of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which grants the Food and Drug Administration the authority to regulate tobacco products. The availability of methods and measures that can provide accurate data on the relative health risks across types of tobacco products, brands, and subbrands of tobacco products on the validity of any health claims associated with a product, and on how consumers perceive information on products toxicity or risks is crucial for making decisions on the product's potential impact on public health. These tools are also necessary for making assessments of the impact of new indications for medicinal products (other than cessation) but more importantly of tobacco products that may in the future be marketed as cessation tools. Objective: To identify research opportunities to develop empirically based and comprehensive methods and measures for testing tobacco and other nicotine-containing products so that the best science is available when decisions are made about products or policies. Methods: Literature was reviewed to address sections of the FSPTCA relevant to tobacco product evaluation; research questions were generated and then reviewed by a committee of research experts. Results: A research agenda was developed for tobacco product evaluation in the general areas of toxicity and health risks, abuse liability, consumer perception, and population effects. Conclusion: A cohesive, systematic, and comprehensive assessment of tobacco products is important and will require building consensus and addressing some crucial research questions. PMID:21460383

77 FR 73345 - Safety Standard for Bedside Sleepers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-10

... product-related issues, such as non- levelness of the product (two reports), instability of leg extensions...) Segmented Mattress Flatness Requirement and Test Method; (2) Removable Bassinet Bed Stability; and (3) Stability Test Dummy. Because bedside sleepers are already required to be tested to the bassinet standard...

21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What must I do to ensure the stability of my PET... the stability of my PET drug products through expiry? (a) Stability testing program. You must... PET drug products. The test methods must be reliable, meaningful, and specific. The samples tested for...

Comprehensive validation scheme for in situ fiber optics dissolution method for pharmaceutical drug product testing.

PubMed

Mirza, Tahseen; Liu, Qian Julie; Vivilecchia, Richard; Joshi, Yatindra

2009-03-01

There has been a growing interest during the past decade in the use of fiber optics dissolution testing. Use of this novel technology is mainly confined to research and development laboratories. It has not yet emerged as a tool for end product release testing despite its ability to generate in situ results and efficiency improvement. One potential reason may be the lack of clear validation guidelines that can be applied for the assessment of suitability of fiber optics. This article describes a comprehensive validation scheme and development of a reliable, robust, reproducible and cost-effective dissolution test using fiber optics technology. The test was successfully applied for characterizing the dissolution behavior of a 40-mg immediate-release tablet dosage form that is under development at Novartis Pharmaceuticals, East Hanover, New Jersey. The method was validated for the following parameters: linearity, precision, accuracy, specificity, and robustness. In particular, robustness was evaluated in terms of probe sampling depth and probe orientation. The in situ fiber optic method was found to be comparable to the existing manual sampling dissolution method. Finally, the fiber optic dissolution test was successfully performed by different operators on different days, to further enhance the validity of the method. The results demonstrate that the fiber optics technology can be successfully validated for end product dissolution/release testing. (c) 2008 Wiley-Liss, Inc. and the American Pharmacists Association

Measuring healthcare productivity - from unit to system level.

PubMed

Kämäräinen, Vesa Johannes; Peltokorpi, Antti; Torkki, Paulus; Tallbacka, Kaj

2016-04-18

Purpose - Healthcare productivity is a growing issue in most Western countries where healthcare expenditure is rapidly increasing. Therefore, accurate productivity metrics are essential to avoid sub-optimization within a healthcare system. The purpose of this paper is to focus on healthcare production system productivity measurement. Design/methodology/approach - Traditionally, healthcare productivity has been studied and measured independently at the unit, organization and system level. Suggesting that productivity measurement should be done in different levels, while simultaneously linking productivity measurement to incentives, this study presents the challenges of productivity measurement at the different levels. The study introduces different methods to measure productivity in healthcare. In addition, it provides background information on the methods used to measure productivity and the parameters used in these methods. A pilot investigation of productivity measurement is used to illustrate the challenges of measurement, to test the developed measures and to prove the practical information for managers. Findings - The study introduces different approaches and methods to measure productivity in healthcare. Practical implications - A pilot investigation of productivity measurement is used to illustrate the challenges of measurement, to test the developed measures and to prove the practical benefits for managers. Originality/value - The authors focus on the measurement of the whole healthcare production system and try to avoid sub-optimization. Additionally considering an individual patient approach, productivity measurement is examined at the unit level, the organizational level and the system level.

10 CFR Appendix D to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Clothes Dryers

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Energy Consumption... CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. D Appendix D to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Clothes...

10 CFR Appendix D to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Clothes Dryers

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Uniform Test Method for Measuring the Energy Consumption... CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. D Appendix D to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Clothes...

10 CFR Appendix D to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Clothes Dryers

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Energy Consumption... CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. D Appendix D to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Clothes...

10 CFR Appendix B to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Freezers

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Energy Consumption... ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. B Appendix B to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Freezers The provisions...

10 CFR Appendix B to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Freezers

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Energy Consumption... ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. B Appendix B to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Freezers The provisions...

10 CFR Appendix B to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Freezers

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Energy Consumption... ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. B Appendix B to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Freezers The provisions...

Automatic test comes to focal plane array production

NASA Astrophysics Data System (ADS)

Skaggs, Frank L.; Barton, T. D.

1992-08-01

To meet the needs of military and commercial markets, the infrared focal plane array industry must develop new, effective and low cost methods of fabricating and testing imaging detectors. This paper describes Texas Instruments new concepts in automated testing and cold probe technology as they apply to volume production.

A new test method for the evaluation of total antioxidant activity of herbal products.

PubMed

Zaporozhets, Olga A; Krushynska, Olena A; Lipkovska, Natalia A; Barvinchenko, Valentina N

2004-01-14

A new test method for measuring the antioxidant power of herbal products, based on solid-phase spectrophotometry using tetrabenzo-[b,f,j,n][1,5,9,13]-tetraazacyclohexadecine-Cu(II) complex immobilized on silica gel, is proposed. The absorbance of the modified sorbent (lambda(max) = 712 nm) increases proportionally to the total antioxidant activity of the sample solution. The method represents an attractive alternative to the mostly used radical scavenging capacity assays, because they generally require complex long-lasting stages to be carried out. The proposed test method is simple ("drop and measure" procedure is applied), rapid (10 min/sample), requires only the monitoring of time and absorbance, and provides good statistical parameters (s(r)

24 CFR 3280.406 - Air chamber test method for certification and qualification of formaldehyde emission levels.

Code of Federal Regulations, 2010 CFR

2010-04-01

... particleboard is produced or surface-finished, whichever is later, the panels must be dead-stacked or air-tight... with the Standard Test Method for Determining Formaldehyde Levels from Wood Products Under Defined Test...

Accelerated weathering of fire-retardant-treated wood for fire testing

Treesearch

Robert H. White

2009-01-01

Fire-retardant-treated products for exterior applications must be subjected to actual or accelerated weathering prior to fire testing. For fire-retardant-treated wood, the two accelerated weathering methods have been Method A and B of ASTM D 2898. The rain test is Method A of ASTM D 2898. Method B includes exposures to ultraviolet (UV) sunlamps in addition to water...

76 FR 2056 - Incorporation of Revised ASTM Standards That Provide Flexibility in the Use of Alternatives to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

... Sulfur in Petroleum Products (General Bomb Method); ASTM D2622-98, Standard Test Method for Sulfur in...; ASTM D240-00, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb... Liquid Hydrocarbon Fuels by Bomb Calorimeter, ASTM D4809-00, Standard Test Method for Heat of Combustion...

Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products.

PubMed

Velaga, Sitaram P; Djuris, Jelena; Cvijic, Sandra; Rozou, Stavroula; Russo, Paola; Colombo, Gaia; Rossi, Alessandra

2018-02-15

In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated. This review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhalers, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug. Dissolution mechanisms of respirable particles as well as kinetic models have been presented. A more recent biorelevant dissolution set-ups and media for studying inhalation biopharmaceutics were also reviewed. In addition, factors affecting interplay between dissolution and absorption of deposited particles in the context of biopharmaceutical considerations of inhalation products were examined. Copyright © 2017 Elsevier B.V. All rights reserved.

Characterisation of the joining zone of serially arranged hybrid semi-finished components

NASA Astrophysics Data System (ADS)

Behrens, B.-A.; Chugreev, A.; Matthias, T.

2018-05-01

Forming of already joined semi-finished products is an innovative approach to manufacture components which are well-adapted to external loads. This approach results in an economically and ecologically improved production by the targeted use of high-quality materials in component areas, which undergo high stresses. One possible production method for hybrid semi-finished products is friction welding. This welding method allows for the production of hybrid semi-finished products made of aluminium and steel as well as steel and steel. In this paper, the thermomechanical tensile and shear stresses causing a failure of the joined zone are experimentally determined through tension tests. These tests are performed with specimens whose joint zones are aligned with different angles to the load direction.

An assessment of individualized technical ear training for audio production.

PubMed

Kim, Sungyoung

2015-07-01

An individualized technical ear training method is compared to a non-individualized method. The efficacy of the individualized method is assessed using a standardized test conducted before and after the training period. Participants who received individualized training improved better than the control group on the test. Results indicate the importance of individualized training for acquisition of spectrum-identification and spectrum-matching skills. Individualized training, therefore, should be implemented by default into technical ear training programs used in audio production industry and education.

Introduction of a method for presenting health-based impacts of the emission from products, based on emission measurements of materials used in manufacturing of the products

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

Jørgensen, Rikke Bramming, E-mail: rikke.jorgensen@iot.ntnu.no

A method for presenting the health impact of emissions from furniture is introduced, which could be used in the context of environmental product declarations. The health impact is described by the negative indoor air quality potential, the carcinogenic potential, the mutagenic and reprotoxic potential, the allergenic potential, and the toxicological potential. An experimental study of emissions from four pieces of furniture is performed by testing both the materials used for production of the furniture and the complete piece of furniture, in order to compare the results gained by adding emissions of material with results gained from testing the finished piecemore » of furniture. Calculating the emission from a product based on the emission from materials used in the manufacture of the product is a new idea. The relation between calculated results and measured results from the same products differ between the four pieces of furniture tested. Large differences between measured and calculated values are seen for leather products. More knowledge is needed to understand why these differences arise. Testing materials allows us to compare different suppliers of the same material. Four different foams and three different timber materials are tested, and the results vary between materials of the same type. If the manufacturer possesses this type of knowledge of the materials from the subcontractors it could be used as a selection criterion according to production of low emission products. -- Highlights: • A method for presenting health impact of emissions is introduced. • An experimental study of emissions from four pieces of furniture is performed. • Health impact is calculated based on sum of contribution from the materials used. • Calculated health impact is compared to health impact of the manufactured product. • The results show that health impact could be useful in product development and for presentation in EPDs.« less

Antimicrobial Testing Methods & Procedures: MB-09-06

EPA Pesticide Factsheets

Describes the methodology used to determine the efficacy of towelette-based disinfectants against microbes on hard surfaces. The test is based on AOAC Method 961.02 (Germicidal Spray Products as Disinfectants).

Validation of 15 kGy as a radiation sterilisation dose for bone allografts manufactured at the Queensland Bone Bank: application of the VDmax 15 method.

PubMed

Nguyen, Huynh; Morgan, David A F; Sly, Lindsay I; Benkovich, Morris; Cull, Sharon; Forwood, Mark R

2008-06-01

ISO 11137-2006 (ISO 11137-2a 2006) provides a VDmax 15 method for substantiation of 15 kGy as radiation sterilisation dose (RSD) for health care products with a relatively low sample requirement. Moreover, the method is also valid for products in which the bioburden level is less than or equal to 1.5. In the literature, the bioburden level of processed bone allografts is extremely low. Similarly, the Queensland Bone Bank (QBB) usually recovers no viable organisms from processed bone allografts. Because bone allografts are treated as a type of health care product, the aim of this research was to substantiate 15 kGy as a RSD for frozen bone allografts at the QBB using method VDmax 15-ISO 11137-2: 2006 (ISO 11137-2e, Procedure for method VDmax 15 for multiple production batches. Sterilisation of health care products - radiation - part 2: establishing the sterilisation dose, 2006; ISO 11137-2f, Procedure for method VDmax 15 for a single production batch. Sterilisation of health care products - radiation - part 2: establishing the sterilisation dose, 2006). 30 femoral heads, 40 milled bone allografts and 40 structural bone allografts manufactured according to QBB standard operating procedures were used. Estimated bioburdens for each bone allograft group were used to calculate the verification doses. Next, 10 samples per group were irradiated at the verification dose, sterility was tested and the number of positive tests of sterility recorded. If the number of positive samples was no more than 1, from the 10 tests carried out in each group, the verification was accepted and 15 kGy was substantiated as RSD for those bone allografts. The bioburdens in all three groups were 0, and therefore the verification doses were 0 kGy. Sterility tests of femoral heads and milled bones were all negative (no contamination), and there was one positive test of sterility in the structural bone allograft. Accordingly, the verification was accepted. Using the ISO validated protocol, VDmax 15, 15 kGy was substantiated as RSD for frozen bone allografts manufactured at the QBB.

Development of friction and wear full-scale testing for TKR prostheses with reliable low cost apparatus

NASA Astrophysics Data System (ADS)

Suwandi, Agri; Soemardi, Tresna P.; Kiswanto, Gandjar; Kusumaningsih, Widjajalaksmi; I. Gusti Agung I. G., W.

2018-02-01

Prostheses products must undergo simulation and physical testing, before clinical testing. Finite element method is a preliminary simulation for in vivo test. The method visualizes the magnitude of the compressive force and the critical location of the Total Knee Replacement (TKR) prostheses design. In vitro testing is classified as physical testing for prostheses product. The test is conducted to evaluate the potential failure of the product and the characteristics of the prostheses TKR material. Friction and wear testing are part of the in vivo test. Motion of knee joints, which results in the phenomena of extension and deflection in the femoral and tibia insert, is represented by friction and wear testing. Friction and wear tests aim to obtain an approximate lifetime in normal and extreme load patterns as characterized by the shape of the friction surface area. The lifetime estimation requires friction and wear full-scale testing equipments for TKR prostheses products. These are necessary in obtaining initial data on potential product failures and characterizing of the material based on the ASTM F2724-08 standards. Based on the testing result and statistical analysis data, the average wear rate value per year is 2.19 × 10-3 mg/MC, with a 10 % safety limit of volume and 14,400 cycles times, for 15 hours moving nonstop then the prediction of wear life of the component tibia insert is ± 10 years.

Validation and Recommendation of Methods to Measure Biogas Production Potential of Animal Manure

PubMed Central

Pham, C. H.; Triolo, J. M.; Cu, T. T. T.; Pedersen, L.; Sommer, S. G.

2013-01-01

In developing countries, biogas energy production is seen as a technology that can provide clean energy in poor regions and reduce pollution caused by animal manure. Laboratories in these countries have little access to advanced gas measuring equipment, which may limit research aimed at improving local adapted biogas production. They may also be unable to produce valid estimates of an international standard that can be used for articles published in international peer-reviewed science journals. This study tested and validated methods for measuring total biogas and methane (CH4) production using batch fermentation and for characterizing the biomass. The biochemical methane potential (BMP) (CH4 NL kg−1 VS) of pig manure, cow manure and cellulose determined with the Moller and VDI methods was not significantly different in this test (p>0.05). The biodegradability using a ratio of BMP and theoretical BMP (TBMP) was slightly higher using the Hansen method, but differences were not significant. Degradation rate assessed by methane formation rate showed wide variation within the batch method tested. The first-order kinetics constant k for the cumulative methane production curve was highest when two animal manures were fermented using the VDI 4630 method, indicating that this method was able to reach steady conditions in a shorter time, reducing fermentation duration. In precision tests, the repeatability of the relative standard deviation (RSDr) for all batch methods was very low (4.8 to 8.1%), while the reproducibility of the relative standard deviation (RSDR) varied widely, from 7.3 to 19.8%. In determination of biomethane concentration, the values obtained using the liquid replacement method (LRM) were comparable to those obtained using gas chromatography (GC). This indicates that the LRM method could be used to determine biomethane concentration in biogas in laboratories with limited access to GC. PMID:25049861

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

PubMed

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

2013-04-01

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

Evalution of DNA extraction methods in order to monitor genetically modified materials in soy foodstuffs and feeds commercialised in Turkey by multiplex real-time PCR.

PubMed

Turkec, Aydin; Kazan, Hande; Baykut, Aykut; Lucas, Stuart J

2015-01-01

Soybean is one of the most important biotech crops, widely used as an ingredient in both foodstuffs and feed. DNA extraction methods have been evaluated to detect the presence of genetically modified (GM) materials in soya-containing food and feed products commercialised in Turkey. All extraction methods performed well for the majority of soya foods and feed products analysed. However, the most successful method varied between different products; the Foodproof, Genespin and the cetyltrimethylammonium bromide (CTAB) methods each produced the highest DNA yield and purity for different soya foodstuffs and feeds. Of the samples tested, 20% were positive for the presence of at least two GM elements (35S/NOS) while 11% contained an additional GM element (35S/NOS/FMV). Of the tested products, animal feeds showed a larger prevalence of GM material (50%) than the soya-containing foodstuffs (13%). The best performing extraction methods proved to be the Foodproof, Genespin and CTAB methods for soya-containing food and feed products. The results obtained herein clearly demonstrate the presence of GM soybean in the Turkish market, and that the Foodproof GMO Screening Kit provides reliable screening of soy-containing food and feed products. © 2014 Society of Chemical Industry.

Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel.

PubMed

Mahaguna, Vorapann; McDermott, J Mario; Zhang, Feng; Ochoa, Felipe

2004-01-01

The purpose of this investigation was to compare quality parameters, including product appearance, content uniformity, pH, weight uniformity, microbial limit testing and preservative effectiveness testing on extemporaneously compounded progesterone vaginal suppositories obtained from 10 randomly chosen compounding pharmacies (90 suppositories each) across the United States, to the Food and Drug Administration (FDA) approved prescription progesterone gel product (Prochieve/Crinone) which is manufactured in a cGMP regulated facility. The content uniformity and pH were determined using qualified methods. The microbial limits testing and preservative effectiveness testing were conducted according to compendial methods. Only one pharmacy provided suppositories that were all within the potency limits required for the prescription progesterone gel product. The other pharmacies provided at least some suppositories where progesterone content was either subpotent or superpotent for progesterone. The pH of most of the compounded suppository products was in the range of 4.22 to 7.68 with a median of 6.30 (normal vaginal pH is <5), whereas the gel product was 2.80. For compounded product from one of the pharmacies, microbial limits testing indicated CDC group IVC-2 and Comamonas acidovorans were detected. This data indicates that pharmacy compounded delivery systems for progesterone should be used with caution.

Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products.

PubMed

Gordon, Oliver; Goverde, Marcel; Staerk, Alexandra; Roesti, David

2017-01-01

This article reports the validation strategy used to demonstrate that the Milliflex ® Quantum yielded non-inferior results to the traditional bioburden method. It was validated according to USP <1223>, European Pharmacopoeia 5.1.6, and Parenteral Drug Association Technical Report No. 33 and comprised the validation parameters robustness, ruggedness, repeatability, specificity, limit of detection and quantification, accuracy, precision, linearity, range, and equivalence in routine operation. For the validation, a combination of pharmacopeial ATCC strains as well as a broad selection of in-house isolates were used. In-house isolates were used in stressed state. Results were statistically evaluated regarding the pharmacopeial acceptance criterion of ≥70% recovery compared to the traditional method. Post-hoc test power calculations verified the appropriateness of the used sample size to detect such a difference. Furthermore, equivalence tests verified non-inferiority of the rapid method as compared to the traditional method. In conclusion, the rapid bioburden on basis of the Milliflex ® Quantum was successfully validated as alternative method to the traditional bioburden test. LAY ABSTRACT: Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms). Bioburden testing measures the levels of microbes present in the bulk solution of a drug before sterilization, and thus it provides important information for manufacturing a safe product. In general, bioburden testing has to be performed using the methods described in the pharmacopoeias (membrane filtration or plate count). These methods are well established and validated regarding their effectiveness; however, the incubation time required to visually identify microbial colonies is long. Thus, alternative methods that detect microbial contamination faster will improve control over the manufacturing process and speed up product release. Before alternative methods may be used, they must undergo a side-by-side comparison with pharmacopeial methods. In this comparison, referred to as validation, it must be shown in a statistically verified manner that the effectiveness of the alternative method is at least equivalent to that of the pharmacopeial methods. Here we describe the successful validation of an alternative bioburden testing method based on fluorescent staining of growing microorganisms applying the Milliflex ® Quantum system by MilliporeSigma. © PDA, Inc. 2017.

7 CFR 58.133 - Methods for quality and wholesomeness determination.

Code of Federal Regulations, 2013 CFR

2013-01-01

... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection... any other method approved by Standard Methods for the Examination of Dairy Products (confirmatory test... and Applied Nutrition, 200 C Street SW., Washington, DC 20204. (2) Individual producer milk samples...

7 CFR 58.133 - Methods for quality and wholesomeness determination.

Code of Federal Regulations, 2012 CFR

2012-01-01

... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection... any other method approved by Standard Methods for the Examination of Dairy Products (confirmatory test... and Applied Nutrition, 200 C Street SW., Washington, DC 20204. (2) Individual producer milk samples...

7 CFR 58.133 - Methods for quality and wholesomeness determination.

Code of Federal Regulations, 2014 CFR

2014-01-01

... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection... any other method approved by Standard Methods for the Examination of Dairy Products (confirmatory test... and Applied Nutrition, 200 C Street SW., Washington, DC 20204. (2) Individual producer milk samples...

Agreement among the Productivity Components of Eight Presenteeism Tests in a Sample of Health Care Workers.

PubMed

Thompson, Angus H; Waye, Arianna

2018-06-01

Presenteeism (reduced productivity at work) is thought to be responsible for large economic costs. Nevertheless, much of the research supporting this is based on self-report questionnaires that have not been adequately evaluated. To examine the level of agreement among leading tests of presenteeism and to determine the inter-relationship of the two productivity subcategories, amount and quality, within the context of construct validity and method variance. Just under 500 health care workers from an urban health area were asked to complete a questionnaire containing the productivity items from eight presenteeism instruments. The analysis included an examination of test intercorrelations, separately for amount and quality, supplemented by principal-component analyses to determine whether either construct could be described by a single factor. A multitest, multiconstruct analysis was performed on the four tests that assessed both amount and quality to test for the relative contributions of construct and method variance. A total of 137 questionnaires were completed. Agreement among tests was positive, but modest. Pearson r ranges were 0 to 0.64 (mean = 0.32) for Amount and 0.03 to 0.38 (mean = 0.25) for Quality. Further analysis suggested that agreement was influenced more by method variance than by the productivity constructs the tests were designed to measure. The results suggest that presenteeism tests do not accurately assess work performance. Given their importance in the determination of policy-relevant conclusions, attention needs to be given to test improvement in the context of criterion validity assessment. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Future Food Production System Development Pulling From Space Biology Crop Growth Testing in Veggie

NASA Technical Reports Server (NTRS)

Massa, Gioia; Romeyn, Matt; Fritsche, Ralph

2017-01-01

Preliminary crop testing using Veggie indicates the environmental conditions provided by the ISS are generally suitable for food crop production. When plant samples were returned to Earth for analysis, their levels of nutrients were comparable to Earth-grown ground controls. Veggie-grown produce food safety microbiology analysis indicated that space-grown crops are safe to consume. Produce sanitizing wipes were used on-orbit to further reduce risk of foodborne illness. Validation growth tests indicated abiotic challenges of insufficient or excess fluid delivery, potentially reduced air flow leading to excess water, elevated CO2 leading to physiological responses, and microorganisms that became opportunistic pathogens. As NASA works to develop future space food production, several areas of research to define these systems pull from the Veggie technology validation tests. Research into effective, reusable water delivery and water recovery methods for future food production systems arises from abiotic challenges observed. Additionally, impacts of elevated CO2 and refinement of fertilizer and light recipes for crops needs to be assessed. Biotic pulls include methods or technologies to effectively sanitize produce with few consumables and low inputs; work to understand the phytomicrobiome and potentially use it to protect crops or enhance growth; selection of crops with high harvest index and desirable flavors for supplemental nutrition; crops that provide psychosocial benefits, and custom space crop development. Planning for future food production in a deep space gateway or a deep space transit vehicle requires methods of handling and storing seeds, and ensuring space seeds are free of contaminants and long-lived. Space food production systems may require mechanization and autonomous operation, with preliminary testing initiated to identify operations and capabilities that are candidates for automation. Food production design is also pulling from Veggie logistics lessons, as we learn about growing at different scales and move toward developing systems that require less launch mass. Veggie will be used as a test bed for novel food production technologies. Veggie is a relatively simple precursor food production system but the knowledge gained from space biology validation tests in Veggie will have far reaching repercussions on future exploration food production. This work is supported by NASA.

Future Food Production System Development Pulling from Space Biology Crop Growth Testing in Veggie

NASA Technical Reports Server (NTRS)

Massa, G. D.; Romeyn, M. W.; Fritsche, R. F.

2017-01-01

Preliminary crop testing using Veggie indicates the environmental conditions provided by the ISS are generally suitable for food crop production. When plant samples were returned to Earth for analysis, their levels of nutrients were comparable to Earth-grown ground controls. Veggie-grown produce food safety microbiology analysis indicated that space-grown crops are safe to consume. Produce sanitizing wipes were used on-orbit to further reduce risk of foodborne illness. Validation growth tests indicated abiotic challenges of insufficient or excess fluid delivery, potentially reduced air flow leading to excess water, elevated CO2 leading to physiological responses, and microorganisms that became opportunistic pathogens. As NASA works to develop future space food production, several areas of research to define these systems pull from the Veggie technology validation tests. Research into effective, reusable water delivery and water recovery methods for future food production systems arises from abiotic challenges observed. Additionally, impacts of elevated CO2 and refinement of fertilizer and light recipes for crops needs to be assessed. Biotic pulls include methods or technologies to effectively sanitize produce with few consumables and low inputs; work to understand the phytomicrobiome and potentially use it to protect crops or enhance growth; selection of crops with high harvest index and desirable flavors for supplemental nutrition; crops that provide psychosocial benefits, and custom space crop development. Planning for future food production in a deep space gateway or a deep space transit vehicle requires methods of handling and storing seeds, and ensuring space seeds are free of contaminants and long-lived. Space food production systems may require mechanization and autonomous operation, with preliminary testing initiated to identify operations and capabilities that are candidates for automation. Food production design is also pulling from Veggie logistics lessons, as we learn about growing at different scales and move toward developing systems that require less launch mass. Veggie will be used as a test bed for novel food production technologies. Veggie is a relatively simple precursor food production system but the knowledge gained from space biology validation tests in Veggie will have far reaching repercussions on future exploration food production.

Performance of the AOAC use-dilution method with targeted modifications: collaborative study.

PubMed

Tomasino, Stephen F; Parker, Albert E; Hamilton, Martin A; Hamilton, Gordon C

2012-01-01

The U.S. Environmental Protection Agency (EPA), in collaboration with an industry work group, spearheaded a collaborative study designed to further enhance the AOAC use-dilution method (UDM). Based on feedback from laboratories that routinely conduct the UDM, improvements to the test culture preparation steps were prioritized. A set of modifications, largely based on culturing the test microbes on agar as specified in the AOAC hard surface carrier test method, were evaluated in a five-laboratory trial. The modifications targeted the preparation of the Pseudomonas aeruginosa test culture due to the difficulty in separating the pellicle from the broth in the current UDM. The proposed modifications (i.e., the modified UDM) were compared to the current UDM methodology for P. aeruginosa and Staphylococcus aureus. Salmonella choleraesuis was not included in the study. The goal was to determine if the modifications reduced method variability. Three efficacy response variables were statistically analyzed: the number of positive carriers, the log reduction, and the pass/fail outcome. The scope of the collaborative study was limited to testing one liquid disinfectant (an EPA-registered quaternary ammonium product) at two levels of presumed product efficacies, high and low. Test conditions included use of 400 ppm hard water as the product diluent and a 5% organic soil load (horse serum) added to the inoculum. Unfortunately, the study failed to support the adoption of the major modification (use of an agar-based approach to grow the test cultures) based on an analysis of method's variability. The repeatability and reproducibility standard deviations for the modified method were equal to or greater than those for the current method across the various test variables. However, the authors propose retaining the frozen stock preparation step of the modified method, and based on the statistical equivalency of the control log densities, support its adoption as a procedural change to the current UDM. The current UDM displayed acceptable responsiveness to changes in product efficacy; acceptable repeatability across multiple tests in each laboratory for the control counts and log reductions; and acceptable reproducibility across multiple laboratories for the control log density values and log reductions. Although the data do not support the adoption of all modifications, the UDM collaborative study data are valuable for assessing sources of method variability and a reassessment of the performance standard for the UDM.

Allergic contact dermatitis from ophthalmic products: can pre-treatment with sodium lauryl sulfate increase patch test sensitivity?

PubMed

Corazza, Monica; Virgili, Annarosa

2005-05-01

In patients suspected of allergic contact dermatitis because of topical ophthalmic medicaments, patch tests performed with patients' own products are often negative. The irritant anionic surfactant sodium lauryl sulfate (SLS) may alter the stratum corneum and increase antigen penetration. Pre-treatment of the skin with SLS 0.5% for 24 h was performed in the sites of patch tests with patients' own products in 15 selected patients. In patients previously negative to their own products tested with conventional patch tests, SLS pre-treatment showed 6 new relevant positive reactions and induced a stronger positive reaction in 1 patient. SLS pre-treatment could be proposed as an alternative promising method, which may increase sensitivity of patch tests with patients' own products.

Evaluation of culture- and PCR-based detection methods for Escherichia coli O157:H7 in inoculated ground beeft.

PubMed

Arthur, Terrance M; Bosilevac, Joseph M; Nou, Xiangwu; Koohmaraie, Mohammad

2005-08-01

Currently, several beef processors employ test-and-hold systems for increased quality control of ground beef. In such programs, each lot of product must be tested and found negative for Escherichia coli O157:H7 prior to release of the product into commerce. Optimization of three testing attributes (detection time, specificity, and sensitivity) is critical to the success of such strategies. Because ground beef is a highly perishable product, the testing methodology used must be as rapid as possible. The test also must have a low false-positive result rate so product is not needlessly discarded. False-negative results cannot be tolerated because they would allow contaminated product to be released and potentially cause disease. In this study, two culture-based and three PCR-based methods for detecting E. coli O157:H7 in ground beef were compared for their abilities to meet the above criteria. Ground beef samples were individually spiked with five genetically distinct strains of E. coli O157: H7 at concentrations of 17 and 1.7 CFU/65 g and then subjected to the various testing methodologies. There was no difference (P > 0.05) in the abilities of the PCR-based methods to detect E. coli O157:H7 inoculated in ground beef at 1.7 CFU/65 g. The culture-based systems detected more positive samples than did the PCR-based systems, but the detection times (21 to 48 h) were at least 9 h longer than those for the PCR-based methods (7.5 to 12 h). Ground beef samples were also spiked with potentially cross-reactive strains. The PCR-based systems that employed an immunomagnetic separation step prior to detection produced fewer false-positive results.

16 CFR § 1513.4 - Test methods.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Test methods. § 1513.4 Section § 1513.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR BUNK BEDS § 1513.4 Test methods. (a) Guardrails (see § 1513.3(a)(6)). With no mattress on the...

16 CFR 1508.5 - Component spacing test method for § 1508.4(b).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Component spacing test method for § 1508.4(b). 1508.5 Section 1508.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR FULL-SIZE BABY CRIBS § 1508.5 Component spacing test method for...

40 CFR 1033.325 - Maintenance of records; submittal of information.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Production Line Testing and Audit Programs § 1033.325 Maintenance of records; submittal of information. (a... production line test or audit including: (i) The date, time, and location of each test or audit. (ii) The method by which the Green Engine Factor was calculated or the number of hours of service accumulated on...

Prototype Testing in Instructional Development. SWRL Working Papers: 1972.

ERIC Educational Resources Information Center

Niedermeyer, Fred C., Ed.

When properly implemented, prototype testing appears to provide one of the most direct and economical methods for identifying means to optimize the effectiveness of a product, and ultimately to validate a product's effect. The nine papers in this volume exemplify several categories of protytype testing conducted at different stages of the…

24 CFR 3280.403 - Standard for windows and sliding glass doors used in manufactured homes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Manufactured Housing, except the exterior and interior pressure tests must be conducted at the design wind... the products, an independent quality assurance agency shall conduct pre-production specimen tests in... meet ANSI Z97.1-1984, “Safety Performance Specifications and Methods of Test for Safety Glazing...

24 CFR 3280.403 - Standard for windows and sliding glass doors used in manufactured homes.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Manufactured Housing, except the exterior and interior pressure tests must be conducted at the design wind... the products, an independent quality assurance agency shall conduct pre-production specimen tests in... meet ANSI Z97.1-1984, “Safety Performance Specifications and Methods of Test for Safety Glazing...

24 CFR 3280.403 - Standard for windows and sliding glass doors used in manufactured homes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Manufactured Housing, except the exterior and interior pressure tests must be conducted at the design wind... the products, an independent quality assurance agency shall conduct pre-production specimen tests in... meet ANSI Z97.1-1984, “Safety Performance Specifications and Methods of Test for Safety Glazing...

24 CFR 3280.403 - Standard for windows and sliding glass doors used in manufactured homes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Manufactured Housing, except the exterior and interior pressure tests must be conducted at the design wind... the products, an independent quality assurance agency shall conduct pre-production specimen tests in... meet ANSI Z97.1-1984, “Safety Performance Specifications and Methods of Test for Safety Glazing...

An Investigation on Formaldehyde Emission Characteristics of Wood Building Materials in Chinese Standard Tests: Product Emission Levels, Measurement Uncertainties, and Data Correlations between Various Tests

PubMed Central

Song, Wei; Cao, Yang; Wang, Dandan; Hou, Guojun; Shen, Zaihua; Zhang, Shuangbao

2015-01-01

As a large producer and consumer of wood building materials, China suffers product formaldehyde emissions (PFE) but lacks systematic investigations and basic data on Chinese standard emission tests (CST), so this paper presented a first effort on this issue. The PFE of fiberboards, particleboards, blockboards, floorings, and parquets manufactured in Beijing region were characterized by the perforator extraction method (PE), 9–11 L and 40 L desiccator methods (D9, D40), and environmental chamber method (EC) of the Chinese national standard GB 18580; based on statistics of PFE data, measurement uncertainties in CST were evaluated by the Monte Carlo method; moreover, PFE data correlations between tests were established. Results showed: (1) Different tests may give slightly different evaluations on product quality. In PE and D9 tests, blockboards and parquets reached E1 grade for PFE, which can be directly used in indoor environment; but in D40 and EC tests, floorings and parquets achieved E1. (2) In multiple tests, PFE data characterized by PE, D9, and D40 complied with Gaussian distributions, while those characterized by EC followed log-normal distributions. Uncertainties in CST were overall low, with uncertainties for 20 material-method combinations all below 7.5%, and the average uncertainty for each method under 3.5%, thus being acceptable in engineering application. A more complicated material structure and a larger test scale caused higher uncertainties. (3) Conventional linear models applied to correlating PFE values between PE, D9, and EC, with R2 all over 0.840, while novel logarithmic (exponential) models can work better for correlations involving D40, with R2 all beyond 0.901. This research preliminarily demonstrated the effectiveness of CST, where results for D40 presented greater similarities to EC—the currently most reliable test for PFE, thus highlighting the potential of Chinese D40 as a more practical approach in production control and risk assessment. PMID:26656316

40 CFR 63.14 - Incorporations by reference.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Testing and Materials (ASTM), 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428... (Reapproved 2010), Standard Test Method for Water in Petroleum Products and Bituminous Materials by...-09 Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter...

Evaluation of different methods to detect microbial hygiene indicators relevant in the dairy industry.

PubMed

Hervert, C J; Alles, A S; Martin, N H; Boor, K J; Wiedmann, M

2016-09-01

It is estimated that 19% of the total food loss from retail, food service, and households comes from dairy products. A portion of this loss may be attributed to premature spoilage of products due to lapses in sanitation and postpasteurization contamination at the processing level. Bacterial groups including coliforms, Enterobacteriaceae (EB), and total gram-negative organisms represent indicators of poor sanitation or postpasteurization contamination in dairy products worldwide. Although Petrifilms (3M, St. Paul, MN) and traditional selective media are commonly used for the testing of these indicator organism groups throughout the US dairy industry, new rapid methods are also being developed. This project was designed to evaluate the ability of different methods to detect coliforms, EB, and other gram-negative organisms isolated from various dairy products and dairy processing environments. Using the Food Microbe Tracker database, a collection of 211 coliform, EB, and gram-negative bacterial isolates representing 25 genera associated with dairy products was assembled for this study. We tested the selected isolates in pure culture (at levels of approximately 15 to 300 cells/test) to evaluate the ability of 3M Coliform Petrifilm to detect coliforms, 3M Enterobacteriaceae Petrifilm, violet red bile glucose agar, and an alternative flow cytometry-based method (bioMérieux D-Count, Marcy-l'Étoile, France) to detect EB, and crystal violet tetrazolium agar to detect total gram-negative organisms. Of the 211 gram-negative isolates tested, 82% (174/211) had characteristic growth on crystal violet tetrazolium agar. Within this set of 211 gram-negative organisms, 175 isolates representing 19 EB genera were screened for detection using EB selective/differential testing methods. We observed positive results for 96% (168/175), 90% (158/175), and 86% (151/175) of EB isolates when tested on EB Petrifilm, violet red bile glucose agar, and D-Count, respectively; optimization of the cut-off thresholds for the D-Count may further improve its sensitivity and specificity, but will require additional data and may vary in food matrices. Additionally, 74% (129/175) of the EB isolates tested positive as coliforms. The data obtained from this study identify differences in detection between 5 microbial hygiene indicator tests and highlight the benefits of EB and total gram-negative testing methods. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Formaldehyde emission from particleboard and plywood paneling : measurement, mechanism, and product standards

Treesearch

George E. Myers

1983-01-01

A number of commercial panel products, primarily particleboard and hardwood plywood, were tested for their formaldehyde emission behavior using desiccator, perforator, and dynamic chamber methods. The results were analyzed in terms of the source of formaldehyde observed in the tests (free vs. hydrolytically produced) and the potential utility of the testa as product...

Cleanser, Detergent, Personal Care Product, and Pretreatment Evaluation

NASA Technical Reports Server (NTRS)

Adam, Niklas; Carrier, Chris; Vega, Leticia; Casteel, Michael; Verostko, chuck; Pickering, Karen

2011-01-01

The purpose of the Cleanser, Detergent, Personal Care Product, and Pretreatment Evaluation & Selection task is to identify the optimal combination of personal hygiene products, crew activities, and pretreatment strategies to provide the crew with sustainable life support practices and a comfortable habitat. Minimal energy, mass, and crew time inputs are desired to recycle wastewater during long duration missions. This document will provide a brief background on the work this past year supporting the ELS Distillation Comparison Test, issues regarding use of the hygiene products originally chosen for the test, methods and results used to select alternative products, and lessons learned from testing.

Cleanser, Detergent, Personal Care Product Pretreatment Evaluation

NASA Technical Reports Server (NTRS)

Adam, Niklas

2010-01-01

The purpose of the Cleanser, Detergent, Personal Care Product, and Pretreatment Evaluation & Selection task is to identify the optimal combination of personal hygiene products, crew activities, and pretreatment strategies to provide the crew with sustainable life support practices and a comfortable habitat. Minimal energy, mass, and crew time inputs are desired to recycle wastewater during long duration missions. This document will provide a brief background on the work this past year supporting the ELS Distillation Comparison Test, issues regarding use of the hygiene products originally chosen for the test, methods and results used to select alternative products, and lessons learned from testing.

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.

Need for new technologies for detection of adventitious agents in vaccines and other biological products.

PubMed

Mallet, Laurent; Gisonni-Lex, Lucy

2014-01-01

From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine. This contamination event illustrates the gaps within the existing adventitious agent strategy and the potential use of new broader molecular detection methods. This paper serves to summarize current testing approaches and challenges, along with opportunities for the use of these new technologies. Testing of biological products is required to ensure the safety of patients. Recently, a licensed vaccine was found to be contaminated with a virus. This contamination did not cause a safety concern to the patients; however, it highlights the need for using new testing methods to control our biological products. This paper introduces the benefits of these new tests and outlines the challenges with the current tests. © PDA, Inc. 2014.

10 CFR Appendix A1 to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Electric Refrigerators and Electric...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Energy Consumption... Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. A1 Appendix A1 to Subpart B of Part 430—Uniform Test Method for Measuring...

10 CFR Appendix A1 to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Electric Refrigerators and Electric...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Energy Consumption... Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. A1 Appendix A1 to Subpart B of Part 430—Uniform Test Method for Measuring...

[Interlaboratory Study on Evaporation Residue Test for Food Contact Products (Report 2)].

PubMed

Ohno, Hiroyuki; Mutsuga, Motoh; Abe, Tomoyuki; Abe, Yutaka; Amano, Homare; Ishihara, Kinuyo; Ohsaka, Ikue; Ohno, Haruka; Ohno, Yuichiro; Ozaki, Asako; Kakihara, Yoshiteru; Kobayashi, Hisashi; Sakuragi, Hiroshi; Shibata, Hiroshi; Shirono, Katsuhiro; Sekido, Haruko; Takasaka, Noriko; Takenaka, Yu; Tajima, Yoshiyasu; Tanaka, Aoi; Tanaka, Hideyuki; Nakanishi, Toru; Nomura, Chie; Haneishi, Nahoko; Hayakawa, Masato; Miura, Toshihiko; Yamaguchi, Miku; Yamada, Kyohei; Watanabe, Kazunari; Sato, Kyoko

2018-01-01

An interlaboratory study was performed to evaluate the equivalence between an official method and a modified method of evaporation residue test using heptane as a food-simulating solvent for oily or fatty foods, based on the Japanese Food Sanitation Law for food contact products. Twenty-three laboratories participated, and tested the evaporation residues of nine test solutions as blind duplicates. In the official method, heating for evaporation was done with a water bath. In the modified method, a hot plate was used for evaporation, and/or a vacuum concentration procedure was skipped. In most laboratories, the test solutions were heated until just prior to dryness, and then allowed to dry under residual heat. Statistical analysis revealed that there was no significant difference between the two methods. Accordingly, the modified method provides performance equal to the official method, and is available as an alternative method. Furthermore, an interlaboratory study was performed to evaluate and compare two leaching solutions (95% ethanol and isooctane) used as food-simulating solvents for oily or fatty foods in the EU. The results demonstrated that there was no significant difference between heptane and these two leaching solutions.

Consumer vinegar test for determining calcium disintegration.

PubMed

Mason, N A; Patel, J D; Dressman, J B; Shimp, L A

1992-09-01

A consumer test and standardized methods were compared for measuring the disintegration of calcium tablets, and the disintegration results were compared with results of dissolution testing to determine the ability of the consumer test of disintegration to predict bioavailability of calcium. Disintegration of 17 calcium supplement products, in tablet form, was studied in Simulated Gastric Fluid Test Solution, USP, without pepsin (GF), in distilled water, and in white distilled vinegar. For disintegration testing with GF and with distilled water, six tablets of each product were placed in an apparatus and immersed in the solution at 37 degrees C for 60 minutes. Six tablets of each product were tested in 200 mL of vinegar at room temperature for 30 minutes. Disintegration was determined by visual observation. Seven products were tested for dissolution in GF or water. Three samples of each product were tested at intervals over 120 minutes for calcium content. Results of testing with an ion-selective electrode were converted to milligrams and compared with the calcium content of the tablets (as claimed on the package label). The mean disintegration times of various calcium products in vinegar ranged from 1.8 to greater than 30 minutes. The mean time in distilled water and GF ranged from 1.6 to greater than 60 minutes and from 1.0 to greater than 60 minutes, respectively. Results were in agreement in 87% to 93% of cases between the consumer vinegar test and the standardized disintegration test methods, a significant correlation. No correlation was found between disintegration time and the extent of dissolution. The disintegration and dissolution of commercially available calcium tablets was highly variable.(ABSTRACT TRUNCATED AT 250 WORDS)

The Behind-the-Knee test: an efficient model for evaluating mechanical and chemical irritation.

PubMed

Farage, Miranda A

2006-05-01

The 'Behind-the-Knee' method (BTK test), using the popliteal fossa as a test site, evaluates both the inherent chemical irritation, and the potential for mechanical irritation of substrates and products. This approach eliminates some of the difficulties of in-use clinical test systems while still providing reliable results. In this publication, examples of the results of BTK tests on several materials are presented with direct comparisons, where possible, with results of in-use clinical testing conducted on the same materials. In in-use clinical tests, volunteer panelists were provided with catamenial products to use in place of their normal product. In the BTK test, samples were applied daily to the popliteal fossa using an elastic athletic band. In both studies, irritation reactions were scored visually. Levels of irritation in the BTK test are consistently higher than those of standard patch tests, illustrating the contribution of mechanical irritation to the overall irritant potential of materials and products. Repeated tests on identical test materials demonstrated that the BTK test results are reproducible. Side-by-side comparisons of the BTK test and in-use clinical tests demonstrated that the BTK test produces results of similar quality to the in-use clinical. By using several concurrent panels with a common test material, it is possible to compare the irritant properties of several materials at once. We have tested over 25 different materials in over 35 BTK studies. The test method has proven reliable and versatile in testing a wide variety of materials, including menstrual pads, topsheets, interlabial pads, pantiliners, tampons and lotion coatings on products. Unlike in-use clinicals, the BTK test allows the direct comparison of two products at one time on the same individual, and is easily adapted to investigative programs. It is subject to fewer confounding factors, is much easier to implement, has a shorter turnaround time, and is less expensive than in-use clinical testing. Importantly, unlike standard patch tests, the BTK test evaluates both the inherent chemical irritation associated with materials and the mechanical irritation owing to friction. Although the BTK test was developed using catamenial products, the test system provides a valuable alternative for evaluating any material where mechanical irritation may play a role, including textiles, facial tissues, baby and adult diapers, and laundry products that may leave residues on fabrics.

40 CFR 75.6 - Incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., Standard Test Method for Sulfur in Petroleum Products (General Bomb Method), for appendices A and D of this part. (2) D240-00, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb... Fuels by Bomb Calorimeter (Precision Method), for appendices D and F of this part. (47) ASTM D5865-01a...

[Examination related to revised test method for determination of formaldehyde, regulated by the law for the control of household products containing harmful substances].

PubMed

Ikarashi, Yoshiaki; Kaniwa, Masa-aki; Tsuchiya, Toshie

2003-01-01

In Japan, the amount of formaldehyde in textile products was regulated by the low for the control of household products containing harmful substances. Formaldehyde was determined by measuring the optical density of acetylacetone derivative of formaldehyde extracted from textiles. The household products low stated that the increase in the optical density of color development of the extract from the textile products for babies or infants within 24 months after birth should not be more than 0.05. Collaborative study decided the amount of formaldehyde equivalent to the increase in absorbance described above, and the amount was 16 ppm. There are some reports that formaldehyde causes an allergic reaction even at a very low concentration, so continuous regulation for formaldehyde in the textiles was desirable using this level of amount. We developed HPLC method for the determination of formaldehyde in textile products. Formaldehyde was determined by the direct injection of acetylacetone derivative of samples into the system equipped with ODS column and UV-VIS detector (detection wavelength 413 nm) using the mixture of acetonitrile and water as mobile phase. The linearity was obtained between a peak area or height and the concentrations of formaldehyde solution in the range of 0.0625-2 micrograms/ml. The regulation level was sufficiently detected by the present HPLC method. We recommended that the HPLC test was adopted as a reexamination method for the products may violate the regulation as well as a dimedone test.

Flammability tests for regulation of building and construction materials

Treesearch

K. Sumathipala

2006-01-01

The regulation of building materials and products for flammability is critical to ensure the safety of occupants in buildings and other structures. The involvement of exposed building materials and products in fires resulting in the loss of human life often spurs an increase in regulation and new test methods to address the problem. Flammability tests range from those...

Horizontal environmental assessment of building products in relation to the construction products directive (CPD).

PubMed

Schiopu, Nicoleta; Jayr, Emmanuel; Méhu, Jacques; Barna, Ligia; Moszkowicz, Pierre

2007-01-01

According to the European Construction Products Directive (89/106/EC), construction products must satisfy specified essential requirements (ER). To comply with ER 3, on hygiene, health and environment, the construction works must be designed and built in such a way that they will not be a threat to the hygiene and health of the occupants and neighbours, nor to the environment. Standardised test methods for the release of substances that are hazardous to health and environment need to be developed at the European level. A horizontal approach is considered the best route for such test development and consists of the development of a test method applicable for different products used in a certain scenario (across the fields of different Technical Committees). The work presented here regards the emission of pollutants towards soil and water and has been carried out on monolith products, based on three types of matrices: concrete, wood and metal (zinc). The aim of the work is to study the parameters (nature of leachant, temperature, liquid-to-solid ratio) that could influence the release behaviour of substances in water. The knowledge acquired from these tests will allow the identification of some parameters needed for the development of a horizontal test.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform FDA Regulation of Snus.

PubMed

Berman, Micah L; Bickel, Warren K; Harris, Andrew C; LeSage, Mark G; O'Connor, Richard J; Stepanov, Irina; Shields, Peter G; Hatsukami, Dorothy K

2017-10-04

The U.S. Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this paper is to describe these assessment methods using a U.S. manufactured "snus" as the test product. In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This paper integrates COMET's findings over the last 4 years. Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, and consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The use of fatigue tests in the manufacture of automotive steel wheels.

NASA Astrophysics Data System (ADS)

Drozyner, P.; Rychlik, A.

2016-08-01

Production for the automotive industry must be particularly sensitive to the aspect of safety and reliability of manufactured components. One of such element is the rim, where durability is a feature which significantly affects the safety of transport. Customer complaints regarding this element are particularly painful for the manufacturer because it is almost always associated with the event of accident or near-accident. Authors propose original comprehensive method of quality control at selected stages of rims production: supply of materials, production and pre-shipment inspections. Tests by the proposed method are carried out on the originally designed inertial fatigue machine The machine allows bending fatigue tests in the frequency range of 0 to 50 Hz at controlled increments of vibration amplitude. The method has been positively verified in one of rims factory in Poland. Implementation resulted in an almost complete elimination of complaints resulting from manufacturing and material errors.

Development of real-time PCR tests for the detection of Tenebrio molitor in food and feed.

PubMed

Debode, Frédéric; Marien, Aline; Gérard, Amaury; Francis, Frédéric; Fumière, Olivier; Berben, Gilbert

2017-08-01

Insects are rich in proteins and could be an alternative source of proteins to feed animals and humans. Numerous companies have started the production of insects for feed purposes. In Europe, these processed animal proteins are not yet authorised by legislation as many questions still need to be answered concerning this 'novel food'. Authorisations will be possible when methods of authentication of the products are available. In this study we propose real-time PCR methods for the specific detection of the mealworm (Tenebriomolitor), one of the most widely used insects for food and feed production. Two PCR assays are proposed: the first based on the wingless gene and the second based on the cadherin gene. The PCR tests amplify fragments of 87 bp. These qualitative methods were tested according to several performance criteria. The specificity was tested on 34 insect species' DNA, but also on non-insect species including crustacean, mammals, birds and plants. The limit of detection was determined and was below 20 copies for the two PCR tests. The applicability of the tests was demonstrated by the analysis of real-life processed samples containing T. molitor.

40 CFR 92.5 - Reference materials.

Code of Federal Regulations, 2010 CFR

2010-07-01

...: (1) ASTM material. The following table sets forth material from the American Society for Testing and...., Philadelphia, PA 19103. The table follows: Document number and name 40 CFR part 92 reference ASTM D 86-95, Standard Test Method for Distillation of Petroleum Products § 92.113 ASTM D 93-94, Standard Test Methods...

Resampling and Distribution of the Product Methods for Testing Indirect Effects in Complex Models

ERIC Educational Resources Information Center

Williams, Jason; MacKinnon, David P.

2008-01-01

Recent advances in testing mediation have found that certain resampling methods and tests based on the mathematical distribution of 2 normal random variables substantially outperform the traditional "z" test. However, these studies have primarily focused only on models with a single mediator and 2 component paths. To address this limitation, a…

Hyperbaric Oxygen Therapy and Oxygen Compatibility of Skin and Wound Care Products

PubMed Central

Bernatchez, Stéphanie F.; Tucker, Joseph; Chiffoleau, Gwenael

2017-01-01

Objective: Use test methods to assess the oxygen compatibility of various wound care products. Approach: There are currently no standard test methods specifically for evaluating the oxygen compatibility and safety of materials under hyperbaric oxygen (HBO) conditions. However, tests such as the oxygen index (OI), oxygen exposure (OE), and autogenous ignition temperature (AIT) can provide useful information. Results: The OI test measures the minimum oxygen concentration that will support candle-like burning, and it was used to test 44 materials. All but two exhibited an OI equal to or greater (safer) than a control material commonly used in HBO. The OE test exposes each material to an oxygen-enriched atmosphere (>99.5% oxygen) to monitor temperature and pressure for an extended duration. The results of the OE testing indicated that none of the 44 articles tested with this method self-ignited within the 60°C, 3 atm pressurized oxygen atmosphere. The AIT test exposes materials to a rapid ramp up in temperature in HBO conditions at 3 atm until ignition occurs. Ten wound care materials and seven materials usually avoided in HBO chambers were tested. The AIT ranged from 138°C to 384°C for wound care products and from 146°C to 420°C for the other materials. Innovation: This work provides useful data and recommendations to help develop a new standard approach for evaluating the HBO compatibility of wound care products to ensure safety for patients and clinicians. Conclusion: The development of an additional test to measure the risk of electrostatic discharge of materials in HBO conditions is needed. PMID:29098113

Evaluation of detection methods for screening meat and poultry products for the presence of foodborne pathogens.

PubMed

Bohaychuk, Valerie M; Gensler, Gary E; King, Robin K; Wu, John T; McMullen, Lynn M

2005-12-01

Rapid and molecular technologies such as enzyme-linked immunosorbent assay (ELISA), PCR, and lateral flow immunoprecipitation can reduce the time and labor involved in screening food products for the presence of pathogens. These technologies were compared with conventional culture methodology for the detection of Salmonella, Campylobacter, Listeria, and Escherichia coli O157:H7 inoculated in raw and processed meat and poultry products. Recommended protocols were modified so that the same enrichment broths used in the culture methods were also used in the ELISA, PCR, and lateral flow immunoprecipitation assays. The percent agreement between the rapid technologies and culture methods ranged from 80 to 100% depending on the pathogen detected and the method used. ELISA, PCR, and lateral flow immunoprecipitation all performed well, with no statistical difference, compared with the culture method for the detection of E. coli O157:H7. ELISA performed better for the detection of Salmonella, with sensitivity and specificity rates of 100%. PCR performed better for the detection of Campylobacter jejuni, with 100% agreement to the culture method. PCR was highly sensitive for the detection of all the foodborne pathogens tested except Listeria monocytogenes. Although the lateral flow immunoprecipitation tests were statistically different from the culture methods for Salmonella and Listeria because of false-positive results, the tests did not produce any false negatives, indicating that this method would be suitable for screening meat and poultry products for these pathogens.

Test-retest stability of the Task and Ego Orientation Questionnaire.

PubMed

Lane, Andrew M; Nevill, Alan M; Bowes, Neal; Fox, Kenneth R

2005-09-01

Establishing stability, defined as observing minimal measurement error in a test-retest assessment, is vital to validating psychometric tools. Correlational methods, such as Pearson product-moment, intraclass, and kappa are tests of association or consistency, whereas stability or reproducibility (regarded here as synonymous) assesses the agreement between test-retest scores. Indexes of reproducibility using the Task and Ego Orientation in Sport Questionnaire (TEOSQ; Duda & Nicholls, 1992) were investigated using correlational (Pearson product-moment, intraclass, and kappa) methods, repeated measures multivariate analysis of variance, and calculating the proportion of agreement within a referent value of +/-1 as suggested by Nevill, Lane, Kilgour, Bowes, and Whyte (2001). Two hundred thirteen soccer players completed the TEOSQ on two occasions, 1 week apart. Correlation analyses indicated a stronger test-retest correlation for the Ego subscale than the Task subscale. Multivariate analysis of variance indicated stability for ego items but with significant increases in four task items. The proportion of test-retest agreement scores indicated that all ego items reported relatively poor stability statistics with test-retest scores within a range of +/-1, ranging from 82.7-86.9%. By contrast, all task items showed test-retest difference scores ranging from 92.5-99%, although further analysis indicated that four task subscale items increased significantly. Findings illustrated that correlational methods (Pearson product-moment, intraclass, and kappa) are influenced by the range in scores, and calculating the proportion of agreement of test-retest differences with a referent value of +/-1 could provide additional insight into the stability of the questionnaire. It is suggested that the item-by-item proportion of agreement method proposed by Nevill et al. (2001) should be used to supplement existing methods and could be especially helpful in identifying rogue items in the initial stages of psychometric questionnaire validation.

Production integrated nondestructive testing of composite materials and material compounds - an overview

NASA Astrophysics Data System (ADS)

Straß, B.; Conrad, C.; Wolter, B.

2017-03-01

Composite materials and material compounds are of increasing importance, because of the steadily rising relevance of resource saving lightweight constructions. Quality assurance with appropriate Nondestructive Testing (NDT) methods is a key aspect for reliable and efficient production. Quality changes have to be detected already in the manufacturing flow in order to take adequate corrective actions. For materials and compounds the classical NDT methods for defectoscopy, like X-ray and Ultrasound (US) are still predominant. Nevertheless, meanwhile fast, contactless NDT methods, like air-borne ultrasound, dynamic thermography and special Eddy-Current techniques are available in order to detect cracks, voids, pores and delaminations but also for characterizing fiber content, distribution and alignment. In Metal-Matrix Composites US back-scattering can be used for this purpose. US run-time measurements allow the detection of thermal stresses at the metal-matrix interface. Another important area is the necessity for NDT in joining. To achieve an optimum material utilization and product safety as well as the best possible production efficiency, there is a need for NDT methods for in-line inspection of the joint quality while joining or immediately afterwards. For this purpose EMAT (Electromagnetic Acoustic Transducer) technique or Acoustic Emission testing can be used.

Accelerated in-vitro release testing methods for extended-release parenteral dosage forms.

PubMed

Shen, Jie; Burgess, Diane J

2012-07-01

This review highlights current methods and strategies for accelerated in-vitro drug release testing of extended-release parenteral dosage forms such as polymeric microparticulate systems, lipid microparticulate systems, in-situ depot-forming systems and implants. Extended-release parenteral dosage forms are typically designed to maintain the effective drug concentration over periods of weeks, months or even years. Consequently, 'real-time' in-vitro release tests for these dosage forms are often run over a long time period. Accelerated in-vitro release methods can provide rapid evaluation and therefore are desirable for quality control purposes. To this end, different accelerated in-vitro release methods using United States Pharmacopeia (USP) apparatus have been developed. Different mechanisms of accelerating drug release from extended-release parenteral dosage forms, along with the accelerated in-vitro release testing methods currently employed are discussed. Accelerated in-vitro release testing methods with good discriminatory ability are critical for quality control of extended-release parenteral products. Methods that can be used in the development of in-vitro-in-vivo correlation (IVIVC) are desirable; however, for complex parenteral products this may not always be achievable. © 2012 The Authors. JPP © 2012 Royal Pharmaceutical Society.

Accelerated in vitro release testing methods for extended release parenteral dosage forms

PubMed Central

Shen, Jie; Burgess, Diane J.

2012-01-01

Objectives This review highlights current methods and strategies for accelerated in vitro drug release testing of extended release parenteral dosage forms such as polymeric microparticulate systems, lipid microparticulate systems, in situ depot-forming systems, and implants. Key findings Extended release parenteral dosage forms are typically designed to maintain the effective drug concentration over periods of weeks, months or even years. Consequently, “real-time” in vitro release tests for these dosage forms are often run over a long time period. Accelerated in vitro release methods can provide rapid evaluation and therefore are desirable for quality control purposes. To this end, different accelerated in vitro release methods using United States Pharmacopoeia (USP) apparatus have been developed. Different mechanisms of accelerating drug release from extended release parenteral dosage forms, along with the accelerated in vitro release testing methods currently employed are discussed. Conclusions Accelerated in vitro release testing methods with good discriminatory ability are critical for quality control of extended release parenteral products. Methods that can be used in the development of in vitro-in vivo correlation (IVIVC) are desirable, however for complex parenteral products this may not always be achievable. PMID:22686344

10 CFR Appendix E to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Water Heaters

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Energy Consumption of Water Heaters E Appendix E to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. E Appendix E to Subpart B of Part 430—Uniform Test Method...

Allergy to cosmetics: a literature review.

PubMed

Alani, Jennifer I; Davis, Mark Denis P; Yiannias, James A

2013-01-01

The term cosmetic has a broad definition and includes personal care products, hair care products, nail care products, and sunscreens. Modern cosmetics are safe for most users, and adverse reactions are very rare because the manufacturers invest heavily in safety, quality control, and product testing before releasing the product to the market. Despite these efforts, adverse reactions occur. Skin care products are major contributors to cosmetic allergic contact dermatitis (ACD), followed by hair care and nail care products. The most common allergens are fragrances and preservatives. The diagnosis of cosmetic allergy is established by reviewing the patient's clinical history and physical examination findings and confirmed with skin patch testing. Patch testing is the standard method for detecting allergens responsible for eliciting ACD. The purpose of this article was to review the prevalence, legislative laws, and role of patch testing in ACD.

Genotoxicity of drinking water treated with different disinfectants and effects of disinfection conditions detected by umu-test.

PubMed

Nie, Xuebiao; Liu, Wenjun; Zhang, Liping; Liu, Qing

2017-06-01

The genotoxicity of drinking water treated with 6 disinfection methods and the effects of disinfection conditions were investigated using the umu-test. The pretreatment procedure of samples for the umu-test was optimized for drinking water analysis. The results of the umu-test were in good correlation with those of the Ames-test. The genotoxicity and production of haloacetic acids (HAAs) were the highest for chlorinated samples. UV+chloramination is the safest disinfection method from the aspects of genotoxicity, HAA production and inactivation effects. For chloramination, the effects of the mass ratio of Cl 2 to N of chloramine on genotoxicity were also studied. The changes of genotoxicity were different from those of HAA production, which implied that HAA production cannot represent the genotoxic potential of water. The genotoxicity per chlorine decay of chlorination and chloramination had similar trends, indicating that the reaction of organic matters and chlorine made a great contribution to the genotoxicity. The results of this study are of engineering significance for optimizing the operation of waterworks. Copyright © 2016. Published by Elsevier B.V.

DNA barcoding detects contamination and substitution in North American herbal products

PubMed Central

2013-01-01

Background Herbal products available to consumers in the marketplace may be contaminated or substituted with alternative plant species and fillers that are not listed on the labels. According to the World Health Organization, the adulteration of herbal products is a threat to consumer safety. Our research aimed to investigate herbal product integrity and authenticity with the goal of protecting consumers from health risks associated with product substitution and contamination. Methods We used DNA barcoding to conduct a blind test of the authenticity for (i) 44 herbal products representing 12 companies and 30 different species of herbs, and (ii) 50 leaf samples collected from 42 herbal species. Our laboratory also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples. Results We recovered DNA barcodes from most herbal products (91%) and all leaf samples (100%), with 95% species resolution using a tiered approach (rbcL + ITS2). Most (59%) of the products tested contained DNA barcodes from plant species not listed on the labels. Although we were able to authenticate almost half (48%) of the products, one-third of these also contained contaminants and or fillers not listed on the label. Product substitution occurred in 30/44 of the products tested and only 2/12 companies had products without any substitution, contamination or fillers. Some of the contaminants we found pose serious health risks to consumers. Conclusions Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers. These activities dilute the effectiveness of otherwise useful remedies, lowering the perceived value of all related products because of a lack of consumer confidence in them. We suggest that the herbal industry should embrace DNA barcoding for authenticating herbal products through testing of raw materials used in manufacturing products. The use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for 'best practices? in the manufacturing of herbal products. This would provide consumers with safe, high quality herbal products. PMID:24120035

[Reduction of animal experiments in experimental drug testing].

PubMed

Behrensdorf-Nicol, H; Krämer, B

2014-10-01

In order to ensure the quality of biomedical products, an experimental test for every single manufactured batch is required for many products. Especially in vaccine testing, animal experiments are traditionally used for this purpose. For example, efficacy is often determined via challenge experiments in laboratory animals. Safety tests of vaccine batches are also mostly performed using laboratory animals. However, many animal experiments have clear inherent disadvantages (low accuracy, questionable transferability to humans, unclear significance). Furthermore, for ethical reasons and animal welfare aspects animal experiments are also seen very critical by the public. Therefore, there is a strong trend towards replacing animal experiments with methods in which no animals are used ("replacement"). If a replacement is not possible, the required animal experiments should be improved in order to minimize the number of animals necessary ("reduction") and to reduce pain and suffering caused by the experiment to a minimum ("refinement"). This "3R concept" is meanwhile firmly established in legislature. In recent years many mandatory animal experiments have been replaced by alternative in vitro methods or improved according to the 3R principles; numerous alternative methods are currently under development. Nevertheless, the process from the development of a new method to its legal implementation takes a long time. Therefore, supplementary regulatory measures to facilitate validation and acceptance of new alternative methods could contribute to a faster and more consequent implementation of the 3R concept in the testing of biomedical products.

Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by High-Performance Liquid Chromatography with FMOC-Su Derivatization: Collaborative Study

PubMed Central

Zhou, Joseph Ziqi; Waszkuc, Ted; Mohammed, Felicia

2008-01-01

A collaborative study was conducted for determination of glucosamine in raw materials and dietary supplements containing glucosamine sulfate and/or glucosamine hydrochloride by high-performance liquid Chromatography (HPLC) with N-(9-fluorenyl-methoxycarbonyloxy) succinimide (FMOC-Su) derivatization. Thirteen blind materials, one pair of which were duplicates, were tested by 12 collaborating laboratories. The test samples consisted of various commercial products, including tablets, capsules, drink mix, and liquids as well as raw materials, blanks, and those for spike recovery analyses. The tests with blank products and products spiked with glucosamine showed good specificity of the method. The average recoveries at spike levels of 100 and 150% of the declared amount were 99.0% with a relative standard deviation (RSD) of 2.1%, and 101% with an RSD of 2.3%, respectively. The test results between laboratories on each commercial product were reproducible with RSD values of no more than 4.0%, and the results were repeatable in the same laboratory with an average RSD of 0.7%. HorRat values ranged from 0.5 to 1.7 on both tests of spike recovery and reproducibility between laboratories on commercial products. The average determination coefficient of the calibration curves from the laboratories was 0.9995 with an RSD of 0.03%. All of the 12 collaborating laboratories succeeded in the study and none of their reported test results were outliers, partly indicating the robustness of the method. It is recommended that the method be accepted by AOAC INTERNATIONAL as Official First Action. PMID:16152919

Detection of undeclared animal by-products in commercial canine canned foods: Comparative analyses by ELISA and PCR-RFLP coupled with slab gel electrophoresis or capillary gel electrophoresis.

PubMed

Hsieh, Ming-Kun; Shih, Pei-Yin; Wei, Chia-Fong; Vickroy, Thomas W; Chou, Chi-Chung

2016-03-30

The potential presence of undeclared animal by-products in pet foods is not subject to routine examination. Previously published methods for species-based identification of animal by-products have not been used routinely owing to inconsistent results. The present study evaluated the utility of several approaches for accurate identification of animal by-products in 11 commercial brands of canine canned foods. Canine canned foods from several countries were analysed by ELISA, PCR-RFLP coupled with slab-gel electrophoresis (SGE) and capillary gel electrophoresis (CGE) to test for evidence of by-products derived from cattle, chicken, sheep or pig. While CGE-based analysis detected all (24) animal-derived by-products that were reported for the 11 test samples, SGE and ELISA detected only 22/24 (92%) and 14/24 (58%) of labelled by-products, respectively. In addition, undeclared animal by-products were found using all three analytical approaches with CGE detecting more positives (19) than SGE (17) or ELISA (5). Significant disparities were evident between the labelled contents and the detected content of animal by-products. CGE-based testing for PCR products appears to provide greater sensitivity and accuracy than either SGE or ELISA-based methods. As testing of commercial products becomes more reliable and mainstream, manufacturers will need to develop more thorough and accurate labelling protocols. © 2015 Society of Chemical Industry.

Physical Test Prototypes Based on Microcontroller

NASA Astrophysics Data System (ADS)

Paramitha, S. T.

2017-03-01

The purpose of this study was to produce a prototype of a physical test-based microcontroller. The research method uses the research and development of the Borg and gall. The procedure starts from the study; research and information collecting, planning, develop preliminary form of product, preliminary field testing, main product revision, playing field testing, operational product revision, field operational testing, final product revision, dissemination and implementation. Validation of the product, obtained through expert evaluation; test products of small scale and large scale; effectiveness test; evaluation of respondents. The results showed that the eligibility assessment of prototype products based physical tests microcontroller. Based on the ratings of seven experts showed that 87% included in the category of “very good” and 13% included in the category of “good”. While the effectiveness of the test results showed that 1). The results of the experimental group to test sit-ups increase by 40% and the control group by 15%. 2). The results of the experimental group to test push-ups increased by 30% and the control group by 10%. 3). The results of the experimental group to test the Back-ups increased by 25% and the control group by 10%. With a significant value of 0.002 less than 0.05, product means a physical test prototype microcontroller based, proven effective in improving the results of physical tests. Conclusions and recommendations; Product physical microcontroller-based assays, can be used to measure the physical tests of pushups, sit ups, and back-ups.

Mechanism of ascorbic acid interference in biochemical tests that use peroxide and peroxidase to generate chromophore.

PubMed

Martinello, Flávia; Luiz da Silva, Edson

2006-11-01

Ascorbic acid interferes negatively in peroxidase-based tests (Trinder method). However, the precise mechanism remains unclear for tests that use peroxide, a phenolic compound and 4-aminophenazone (4-AP). We determined the chemical mechanism of this interference, by examining the effects of ascorbic acid in the reaction kinetics of the production and reduction of the oxidized chromophore in urate, cholesterol, triglyceride and glucose tests. Reaction of ascorbic acid with the Trinder method constituents was also verified. Ascorbic acid interfered stoichiometrically with all tests studied. However, it had two distinct effects on the reaction rate. In the urate test, ascorbic acid decreased the chromophore formation with no change in its production kinetics. In contrast, in cholesterol, triglyceride and glucose tests, an increase in the lag phase of color development occurred. Of all the Trinder constituents, only peroxide reverted the interference. In addition, ascorbic acid did not interfere with oxidase activity nor reduce significantly the chromophore formed. Peroxide depletion was the predominant chemical mechanism of ascorbic acid interference in the Trinder method with phenolics and 4-AP. Distinctive effects of ascorbic acid on the reaction kinetics of urate, cholesterol, glucose and triglyceride might be due to the rate of peroxide production by oxidases.

Testing actinide fission yield treatment in CINDER90 for use in MCNP6 burnup calculations

DOE PAGES

Fensin, Michael Lorne; Umbel, Marissa

2015-09-18

Most of the development of the MCNPX/6 burnup capability focused on features that were applied to the Boltzman transport or used to prepare coefficients for use in CINDER90, with little change to CINDER90 or the CINDER90 data. Though a scheme exists for best solving the coupled Boltzman and Bateman equations, the most significant approximation is that the employed nuclear data are correct and complete. Thus, the CINDER90 library file contains 60 different actinide fission yields encompassing 36 fissionable actinides (thermal, fast, high energy and spontaneous fission). Fission reaction data exists for more than 60 actinides and as a result, fissionmore » yield data must be approximated for actinides that do not possess fission yield information. Several types of approximations are used for estimating fission yields for actinides which do not possess explicit fission yield data. The objective of this study is to test whether or not certain approximations of fission yield selection have any impact on predictability of major actinides and fission products. Further we assess which other fission products, available in MCNP6 Tier 3, result in the largest difference in production. Because the CINDER90 library file is in ASCII format and therefore easily amendable, we assess reasons for choosing, as well as compare actinide and major fission product prediction for the H. B. Robinson benchmark for, three separate fission yield selection methods: (1) the current CINDER90 library file method (Base); (2) the element method (Element); and (3) the isobar method (Isobar). Results show that the three methods tested result in similar prediction of major actinides, Tc-99 and Cs-137; however, certain fission products resulted in significantly different production depending on the method of choice.« less

E-learning platform for automated testing of electronic circuits using signature analysis method

NASA Astrophysics Data System (ADS)

Gherghina, Cǎtǎlina; Bacivarov, Angelica; Bacivarov, Ioan C.; Petricǎ, Gabriel

2016-12-01

Dependability of electronic circuits can be ensured only through testing of circuit modules. This is done by generating test vectors and their application to the circuit. Testability should be viewed as a concerted effort to ensure maximum efficiency throughout the product life cycle, from conception and design stage, through production to repairs during products operating. In this paper, is presented the platform developed by authors for training for testability in electronics, in general and in using signature analysis method, in particular. The platform allows highlighting the two approaches in the field namely analog and digital signature of circuits. As a part of this e-learning platform, it has been developed a database for signatures of different electronic components meant to put into the spotlight different techniques implying fault detection, and from this there were also self-repairing techniques of the systems with this kind of components. An approach for realizing self-testing circuits based on MATLAB environment and using signature analysis method is proposed. This paper analyses the benefits of signature analysis method and simulates signature analyzer performance based on the use of pseudo-random sequences, too.

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.

10 CFR Appendix N to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Furnaces and Boilers

Code of Federal Regulations, 2010 CFR

2010-01-01

... furnaces without stack dampers with adjustable fan control—cool-down test. For a furnace with adjustable... 10 Energy 3 2010-01-01 2010-01-01 false Uniform Test Method for Measuring the Energy Consumption... CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. N...

10 CFR Appendix A to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Electric Refrigerators and Electric...

Code of Federal Regulations, 2011 CFR

2011-01-01

... the test for a unit having no defrost provisions (section 4.1). The second part is designed to capture... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Energy Consumption... Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test...

40 CFR 60.17 - Incorporations by reference.

Code of Federal Regulations, 2010 CFR

2010-07-01

... in Petroleum Products (General Bomb Method), IBR approved for §§ 60.106(j)(2), 60.335(b)(10)(i), and... Petroleum Products (General Bomb Method), IBR approved for § 60.4415(a)(1)(i). (10) ASTM D240-76, 92, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, IBR approved...

Nonvolatile, semivolatile, or volatile: redefining volatile for volatile organic compounds.

PubMed

Võ, Uyên-Uyén T; Morris, Michael P

2014-06-01

Although widely used in air quality regulatory frameworks, the term "volatile organic compound" (VOC) is poorly defined. Numerous standardized tests are currently used in regulations to determine VOC content (and thus volatility), but in many cases the tests do not agree with each other, nor do they always accurately represent actual evaporation rates under ambient conditions. The parameters (time, temperature, reference material, column polarity, etc.) used in the definitions and the associated test methods were created without a significant evaluation of volatilization characteristics in real world settings. Not only do these differences lead to varying VOC content results, but occasionally they conflict with one another. An ambient evaporation study of selected compounds and a few formulated products was conducted and the results were compared to several current VOC test methodologies: SCAQMD Method 313 (M313), ASTM Standard Test Method E 1868-10 (E1868), and US. EPA Reference Method 24 (M24). The ambient evaporation study showed a definite distinction between nonvolatile, semivolatile, and volatile compounds. Some low vapor pressure (LVP) solvents, currently considered exempt as VOCs by some methods, volatilize at ambient conditions nearly as rapidly as the traditional high-volatility solvents they are meant to replace. Conversely, bio-based and heavy hydrocarbons did not readily volatilize, though they often are calculated as VOCs in some traditional test methods. The study suggests that regulatory standards should be reevaluated to more accurately reflect real-world emission from the use of VOC containing products. The definition of VOC in current test methods may lead to regulations that exclude otherwise viable alternatives or allow substitutions of chemicals that may limit the environmental benefits sought in the regulation. A study was conducted to examine volatility of several compounds and a few formulated products under several current VOC test methodologies and ambient evaporation. This paper provides ample evidence to warrant a reevaluation of regulatory standards and provides a framework for progressive developments based on reasonable and scientifically justifiable definitions of VOCs.

40 CFR 52.742 - Incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-07-01

... from the American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103. (1) ASTM D1475-85, Standard Test Method for Density of Paint, Varnish, Lacquer, and Related Products, for § 52.741(a)(4)(i)(B)(3)(i). (2) ASTM D2369-87, Standard Test Method for Volatile Content of...

Reduction in in vivo testing at the National Veterinary Services Laboratories of the United States Department of Agriculture.

PubMed

Hyde, R L

1986-01-01

Efforts are being made at the National Veterinary Services Laboratories to reduce in vivo testing of USDA licensed veterinary vaccines. A hemagglutination test for determining potency of killed parvovirus vaccine is currently being used for canine and swine adjuvanted and nonadjuvanted products; a serum neutralization inhibition test (SNIT) is being developed for potency testing of killed adjuvanted infectious bovine rhinotracheitis (IBR), bovine virus diarrhea (BVD) and parainfluenza (PI3) vaccines: and a tissue culture titration method for live avian encephalomyelitis virus vaccine is being pursued as a replacement for the old hatch-out chick embryo titration method. Difficulties in separating the antigen from oil emulsion products are preventing significant advances in developing in vitro testing procedures for poultry killed-virus vaccines.

8. VIEW OF RADIOGRAPHY EQUIPMENT, TEST METHODS INCLUDED RADIOGRAPHY AND ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

8. VIEW OF RADIOGRAPHY EQUIPMENT, TEST METHODS INCLUDED RADIOGRAPHY AND BETA BACKSCATTERING. (7/13/56) - Rocky Flats Plant, Non-Nuclear Production Facility, South of Cottonwood Avenue, west of Seventh Avenue & east of Building 460, Golden, Jefferson County, CO

Testing of the Defense Waste Processing Facility Cold Chemical Dissolution Method in Sludge Batch 9 Qualification

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

Edwards, T.; Pareizs, J.; Coleman, C.

For each sludge batch that is processed in the Defense Waste Processing Facility (DWPF), the Savannah River National Laboratory (SRNL) tests the applicability of the digestion methods used by the DWPF Laboratory for elemental analysis of Sludge Receipt and Adjustment Tank (SRAT) Receipt samples and SRAT Product process control samples. DWPF SRAT samples are typically dissolved using a method referred to as the DWPF Cold Chemical or Cold Chem Method (CC), (see DWPF Procedure SW4- 15.201). Testing indicates that the CC method produced mixed results. The CC method did not result in complete dissolution of either the SRAT Receipt ormore » SRAT Product with some fine, dark solids remaining. However, elemental analyses did not reveal extreme biases for the major elements in the sludge when compared with analyses obtained following dissolution by hot aqua regia (AR) or sodium peroxide fusion (PF) methods. The CC elemental analyses agreed with the AR and PF methods well enough that it should be adequate for routine process control analyses in the DWPF after much more extensive side-by-side tests of the CC method and the PF method are performed on the first 10 SRAT cycles of the Sludge Batch 9 (SB9) campaign. The DWPF Laboratory should continue with their plans for further tests of the CC method during these 10 SRAT cycles.« less

Techniques for control of long-term reliability of complex integrated circuits. I - Reliability assurance by test vehicle qualification.

NASA Technical Reports Server (NTRS)

Van Vonno, N. W.

1972-01-01

Development of an alternate approach to the conventional methods of reliability assurance for large-scale integrated circuits. The product treated is a large-scale T squared L array designed for space applications. The concept used is that of qualification of product by evaluation of the basic processing used in fabricating the product, providing an insight into its potential reliability. Test vehicles are described which enable evaluation of device characteristics, surface condition, and various parameters of the two-level metallization system used. Evaluation of these test vehicles is performed on a lot qualification basis, with the lot consisting of one wafer. Assembled test vehicles are evaluated by high temperature stress at 300 C for short time durations. Stressing at these temperatures provides a rapid method of evaluation and permits a go/no go decision to be made on the wafer lot in a timely fashion.

A 100-Year Review: Sensory analysis of milk.

PubMed

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

2017-12-01

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

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

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

Beckley, D.A.; Stites, J. Jr.

The objective was to characterize several lots of materials used for carbon/carbon and carbon/phenol product manufacture. Volume one is organized into testing categories based on raw material of product form. Each category contains a discussion of the sampling plan, comments and observations on each test method utilized, and a summary of the results obtained each category.

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

Automated screening method for determining optimum preservative systems for personal and home care products.

PubMed

Lenczewski, M E; Kananen, L L

1998-01-01

A procedure was designed to determine the minimum preservative level (MPL) for personal and home care products. A highly preserved sample and an unpreserved sample were combined at different concentrations within a 96-well microtiter plate by using an autodilutor. A unique tip design made it possible to accurately deliver viscous test materials that cannot be dispensed using vacuum- or fluid-filled systems. After inoculation, the sample was evaluated at a specified time interval for the presence of surviving bacteria, yeast, and mold. The lowest concentration of preservative with no microbial growth is the recommended level of preservative for the product. Because sample turbidity may interfere with determination of the endpoint, a colorimetric endpoint was used to indicate growth of microorganisms and to differentiate product from growth. The predicted levels were tested with a modified Cosmetic, Toiletry, and Fragrance Association method. The method successfully predicted effective preservative levels in many personal and home care products with a broad range of viscosities.

DNA extraction techniques compared for accurate detection of genetically modified organisms (GMOs) in maize food and feed products.

PubMed

Turkec, Aydin; Kazan, Hande; Karacanli, Burçin; Lucas, Stuart J

2015-08-01

In this paper, DNA extraction methods have been evaluated to detect the presence of genetically modified organisms (GMOs) in maize food and feed products commercialised in Turkey. All the extraction methods tested performed well for the majority of maize foods and feed products analysed. However, the highest DNA content was achieved by the Wizard, Genespin or the CTAB method, all of which produced optimal DNA yield and purity for different maize food and feed products. The samples were then screened for the presence of GM elements, along with certified reference materials. Of the food and feed samples, 8 % tested positive for the presence of one GM element (NOS terminator), of which half (4 % of the total) also contained a second element (the Cauliflower Mosaic Virus 35S promoter). The results obtained herein clearly demonstrate the presence of GM maize in the Turkish market, and that the Foodproof GMO Screening Kit provides reliable screening of maize food and feed products.

Perspectives and strategies of alternative methods used in the risk assessment of personal care products.

PubMed

Quantin, P; Thélu, A; Catoire, S; Ficheux, H

2015-11-01

Risk assessment for personal care products requires the use of alternative methods since animal testing is now totally banned. Some of these methods are effective and have been validated by the "European Union Reference Laboratory for alternatives to animal testing"; but there is still a need for development and implementation of methods for specific endpoints. In this review, we have focused on dermal risk assessment because it is the prime route of absorption and main target organ for personal care products. Within this field, various areas must be assessed: irritation, sensitisation and toxicokinetic. Personal care product behaviour after use by the consumer and potential effects on the environment are also discussed. The purpose of this review is to show evolution and the prospects of alternative methods for safety dermal assessment. Assessment strategies must be adapted to the different chemical classes of substances studied but also to the way in which they are used. Finally, experimental and theoretical technical parameters that may impact on measured effects have been identified and discussed. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

High resolution identity testing of inactivated poliovirus vaccines

PubMed Central

Mee, Edward T.; Minor, Philip D.; Martin, Javier

2015-01-01

Background Definitive identification of poliovirus strains in vaccines is essential for quality control, particularly where multiple wild-type and Sabin strains are produced in the same facility. Sequence-based identification provides the ultimate in identity testing and would offer several advantages over serological methods. Methods We employed random RT-PCR and high throughput sequencing to recover full-length genome sequences from monovalent and trivalent poliovirus vaccine products at various stages of the manufacturing process. Results All expected strains were detected in previously characterised products and the method permitted identification of strains comprising as little as 0.1% of sequence reads. Highly similar Mahoney and Sabin 1 strains were readily discriminated on the basis of specific variant positions. Analysis of a product known to contain incorrect strains demonstrated that the method correctly identified the contaminants. Conclusion Random RT-PCR and shotgun sequencing provided high resolution identification of vaccine components. In addition to the recovery of full-length genome sequences, the method could also be easily adapted to the characterisation of minor variant frequencies and distinction of closely related products on the basis of distinguishing consensus and low frequency polymorphisms. PMID:26049003

Study of The Vector Product using Three Dimensions Vector Card of Engineering in Pathumwan Institute of Technology

NASA Astrophysics Data System (ADS)

Mueanploy, Wannapa

2015-06-01

The objective of this research was to offer the way to improve engineering students in Physics topic of vector product. The sampling of this research was the engineering students at Pathumwan Institute of Technology during the first semester of academic year 2013. 1) Select 120 students by random sampling are asked to fill in a satisfaction questionnaire scale, to select size of three dimensions vector card in order to apply in the classroom. 2) Select 60 students by random sampling to do achievement test and take the test to be used in the classroom. The methods used in analysis of achievement test by the Kuder-Richardson Method (KR- 20). The results show that 12 items of achievement test are appropriate to be applied in the classroom. The achievement test gets Difficulty (P) = 0.40-0.67, Discrimination = 0.33-0.73 and Reliability (r) = 0.70.The experimental in the classroom. 3) Select 60 students by random sampling divide into two groups; group one (the controlled group) with 30 students was chosen to study in the vector product lesson by the regular teaching method. Group two (the experimental group) with 30 students was chosen to learn the vector product lesson with three dimensions vector card. 4) Analyzed data between the controlled group and the experimental group, the result showed that experimental group got higher achievement test than the controlled group significant at .01 level.

[Simultaneous determination of pesticide residues in agricultural products by LC-MS/MS].

PubMed

Watanabe, Minae; Ueno, Eiji; Inoue, Tomomi; Ohno, Haruka; Ikai, Yoshitomo; Morishita, Toshio; Oshima, Harumi; Hayashi, Rumiko

2013-01-01

A method for the simultaneous determination of multiple pesticide residues in agricultural products was developed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The sample was extracted with acetonitrile. Co-extractives were removed by GPC/graphitized carbon column SPE, and silica gel/PSA cartridge column SPE. Pesticides in the test solution were determined by LC-MS/MS using scheduled MRM. Recoveries of 124 pesticides from spinach, brown rice, soybean, orange and tomato were tested at the level of 0.1 µg/g, and those of 121 pesticides ranged from 70 to 120% (RSD≤15%). Pesticide residues in 239 agricultural products were investigated by this method, and residues of 49 pesticides were detected in 98 agricultural products.

Qualitative risk assessment during polymer mortar test specimens preparation - methods comparison

NASA Astrophysics Data System (ADS)

Silva, F.; Sousa, S. P. B.; Arezes, P.; Swuste, P.; Ribeiro, M. C. S.; Baptista, J. S.

2015-05-01

Polymer binder modification with inorganic nanomaterials (NM) could be a potential and efficient solution to control matrix flammability of polymer concrete (PC) materials without sacrificing other important properties. Occupational exposures can occur all along the life cycle of a NM and “nanoproducts” from research through scale-up, product development, manufacturing, and end of life. The main objective of the present study is to analyse and compare different qualitative risk assessment methods during the production of polymer mortars (PM) with NM. The laboratory scale production process was divided in 3 main phases (pre-production, production and post-production), which allow testing the assessment methods in different situations. The risk assessment involved in the manufacturing process of PM was made by using the qualitative analyses based on: French Agency for Food, Environmental and Occupational Health & Safety method (ANSES); Control Banding Nanotool (CB Nanotool); Ecole Polytechnique Fédérale de Lausanne method (EPFL); Guidance working safely with nanomaterials and nanoproducts (GWSNN); Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, Italy method (ISPESL); Precautionary Matrix for Synthetic Nanomaterials (PMSN); and Stoffenmanager Nano. It was verified that the different methods applied also produce different final results. In phases 1 and 3 the risk assessment tends to be classified as medium-high risk, while for phase 2 the more common result is medium level. It is necessary to improve the use of qualitative methods by defining narrow criteria for the methods selection for each assessed situation, bearing in mind that the uncertainties are also a relevant factor when dealing with the risk related to nanotechnologies field.

10 CFR Appendix O to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Vented Home Heating Equipment

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Energy Consumption..., App. O Appendix O to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of... condition. 1.9“Flue gases” means reaction products resulting from the combustion of a fuel with the oxygen...

10 CFR Appendix O to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Vented Home Heating Equipment

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Energy Consumption..., App. O Appendix O to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of... products resulting from the combustion of a fuel with the oxygen of the air, including the inerts and any...

10 CFR Appendix O to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Vented Home Heating Equipment

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Energy Consumption..., App. O Appendix O to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of... condition. 1.9“Flue gases” means reaction products resulting from the combustion of a fuel with the oxygen...

10 CFR Appendix O to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Vented Home Heating Equipment

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Uniform Test Method for Measuring the Energy Consumption..., App. O Appendix O to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of... condition. 1.9“Flue gases” means reaction products resulting from the combustion of a fuel with the oxygen...

Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products.

PubMed

Bolden, Jay; Smith, Kelly

2017-01-01

Recombinant Factor C (rFC) is non-animal-derived reagent used to detect bacterial endotoxins in pharmaceutical products. Despite the fact that the reagent was first commercially available nearly 15 years ago, the broad use of rFC in pharmaceutical industry has long been lagging, presumably due to historical single-source supplier concerns and the lack of inclusion in worldwide pharmacopeias. Commercial rFC reagents are now available from multiple manufacturers, thus single sourcing is no longer an issue. We report here the successful validation of several pharmaceutical products by an end-point florescence-based endotoxin method using the rFC reagent. The method is equivalent or superior to the compendia bacterial endotoxins test method. Based on the comparability data and extenuating circumstances, the incorporation of the end point fluorescence technique and rFC reagent in global compendia bacterial endotoxins test chapters is desired and warranted. LAY ABSTRACT: Public health has been protected for over 30 years with the use of a purified blood product of the horseshoe crab, limulus amebocyte lysate. More recently, this blood product can be produced in biotech manufacturing processes, which reduces potential impacts to the horseshoe crab and related species dependent upon the crab, for example, migrating shorebirds. The pharmaceutical industry has been slow to adopt the use of this reagent, Recombinant Factor C (rFC), for various reasons. We evaluated the use of rFC across many pharmaceutical products, and in other feasibility demonstration experiments, and found rFC to be a suitable alternative to the animal-derived limulus amebocyte lysate. Incorporation of rFC and its analytical method into national testing standards would provide an equivalent or better test while continuing to maintain patient safety for those who depend on medicines and while securing pharmaceutical supply chains. In addition, widespread use of this method would benefit existing animal conservation efforts. © PDA, Inc. 2017.

Identification of members of the genera Panaeolus and Psilocybe by a DNA test. A preliminary test for hallucinogenic fungi.

PubMed

Lee, J C; Cole, M; Linacre, A

2000-08-14

Abuse of hallucinogens produced by the fungal genera Psilocybe and Panaeolus are a growing problem. Five species from each of the two genera were examined in this preliminary research and a method that will unambiguously identify fungal samples as being of one of these two genera has been developed. The method uses genus specific DNA sequences within the Internal Transcribed Spacer of the ribosomal gene complex. Amplification of a common DNA product and a genus specific product results in two identifiable products, which facilitates the unambiguous identification of material from these two fungi to generic level.

40 CFR 61.137 - Test methods and procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Section 61.137 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS National Emission Standard for Benzene Emissions from Coke By-Product Recovery Plants § 61.137 Test methods and procedures. (a) Each owner or...

7 CFR 58.930 - Official test methods.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Operations and Operating Procedures § 58.930 Official test methods. (a) Chemical. Chemical analysis, except where otherwise prescribed...

7 CFR 58.930 - Official test methods.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Operations and Operating Procedures § 58.930 Official test methods. (a) Chemical. Chemical analysis, except where otherwise prescribed...

7 CFR 58.930 - Official test methods.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Operations and Operating Procedures § 58.930 Official test methods. (a) Chemical. Chemical analysis, except where otherwise prescribed...

7 CFR 58.930 - Official test methods.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Operations and Operating Procedures § 58.930 Official test methods. (a) Chemical. Chemical analysis, except where otherwise prescribed...

7 CFR 58.930 - Official test methods.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Operations and Operating Procedures § 58.930 Official test methods. (a) Chemical. Chemical analysis, except where otherwise prescribed...

16 CFR 1509.6 - Component-spacing test method.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Component-spacing test method. 1509.6 Section 1509.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... applied to the wedge perpendicular to the plane of the crib side. ...

Laboratory and clinical evaluation of on-site urine drug testing.

PubMed

Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

2014-11-01

Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

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

PubMed

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

2014-02-01

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

Semiquantitative determination of mesophilic, aerobic microorganisms in cocoa products using the Soleris NF-TVC method.

PubMed

Montei, Carolyn; McDougal, Susan; Mozola, Mark; Rice, Jennifer

2014-01-01

The Soleris Non-fermenting Total Viable Count method was previously validated for a wide variety of food products, including cocoa powder. A matrix extension study was conducted to validate the method for use with cocoa butter and cocoa liquor. Test samples included naturally contaminated cocoa liquor and cocoa butter inoculated with natural microbial flora derived from cocoa liquor. A probability of detection statistical model was used to compare Soleris results at multiple test thresholds (dilutions) with aerobic plate counts determined using the AOAC Official Method 966.23 dilution plating method. Results of the two methods were not statistically different at any dilution level in any of the three trials conducted. The Soleris method offers the advantage of results within 24 h, compared to the 48 h required by standard dilution plating methods.

Evaluation of different phenotypic tests for detection of metallo-β-lactamases in imipenem-resistant Pseudomonas aeruginosa

PubMed Central

Sachdeva, Rohit; Sharma, Babita; Sharma, Rajni

2017-01-01

PURPOSE: Pseudomonas aeruginosa causes a wide spectrum of infections including bacteremia, pneumonia, urinary tract infection, etc., Metallo-beta-lactamase (MBL) producing P. aeruginosa is an emerging threat and cause of concern as they have emerged as one of the most feared resistance mechanisms. This study was designed to know the prevalence of MBL production in P. aeruginosa and to evaluate the four phenotypic tests for detection of MBL production in imipenem-resistant clinical isolates of P. aeruginosa. METHODS: Totally, 800 isolates of P. aeruginosa isolated from various clinical samples were evaluated for carbapenem resistance and MBL production. All imipenem-resistant strains were tested for carabapenemase production by modified Hodge test. Screening for MBL production was done by double-disc synergy test and combined disc test (CDT). Confirmation of MBL production was done by the E-test (Ab BioDisk, Solna, Sweden). RESULTS: Out of the 800 isolates of P. aeruginosa, 250 isolates were found resistant to imipenem. Based on the results of E-test, 147 (18.37%) isolates of P. aeruginosa were positive for MBL production. The CDT has the highest sensitivity and specificity for the detection of MBL production as compared to other tests. CONCLUSION: The results of this study are indicative that MBL production is an important mechanism of carbapenem resistance among P. aeruginosa. Use of simple screening test like CDT will be crucial step toward large-scale monitoring of these emerging resistant determinants. Phenotypic test for MBL production has to be standardized, and all the isolates should be routinely screened for MBL production. PMID:28966485

Evaluating the Sporicidal Activity of Disinfectants against Clostridium difficile and Bacillus amyloliquefaciens Spores by Using the Improved Methods Based on ASTM E2197-11

PubMed Central

Uwamahoro, Marie Christine; Massicotte, Richard; Hurtubise, Yves; Gagné-Bourque, François; Mafu, Akier Assanta; Yahia, L’Hocine

2018-01-01

Spore-forming pathogenic bacteria, such as Clostridium difficile, are associated with nosocomial infection, leading to the increased use of sporicidal disinfectants, which impacts socioeconomic costs. However, C. difficile can be prevented using microorganisms such as Bacillus amyloliquefaciens, a prophylactic agent that has been proven to be effective against it in recent tests or it can be controlled by sporicidal disinfectants. These disinfectants against spores should be evaluated according to a known and recommended standard. Unfortunately, some newly manufactured disinfectants like Bioxy products have not yet been tested. ASTM E2197-11 is a standard test that uses stainless steel disks (1 cm in diameter) as carriers, and the performance of the test formulation is calculated by comparing the number of viable test organisms to that on the control carriers. Surface tests are preferable for evaluating disinfectants with sporicidal effects on hard surfaces. This study applies improved methods, based on the ASTM E2197-11 standard, for evaluating and comparing the sporicidal efficacies of several disinfectants against spores of C. difficile and B. amyloliquefaciens, which are used as the test organisms. With the improved method, all spores were recovered through vortexing and membrane filtration. The results show that chlorine-based products are effective in 5 min and Bioxy products at 5% w/v are effective in 10 min. Although Bioxy products may take longer to prove their effectiveness, their non-harmful effects to hospital surfaces and people have been well established in the literature. PMID:29459891

Evaluating the Sporicidal Activity of Disinfectants against Clostridium difficile and Bacillus amyloliquefaciens Spores by Using the Improved Methods Based on ASTM E2197-11.

PubMed

Uwamahoro, Marie Christine; Massicotte, Richard; Hurtubise, Yves; Gagné-Bourque, François; Mafu, Akier Assanta; Yahia, L'Hocine

2018-01-01

Spore-forming pathogenic bacteria, such as Clostridium difficile , are associated with nosocomial infection, leading to the increased use of sporicidal disinfectants, which impacts socioeconomic costs. However, C. difficile can be prevented using microorganisms such as Bacillus amyloliquefaciens , a prophylactic agent that has been proven to be effective against it in recent tests or it can be controlled by sporicidal disinfectants. These disinfectants against spores should be evaluated according to a known and recommended standard. Unfortunately, some newly manufactured disinfectants like Bioxy products have not yet been tested. ASTM E2197-11 is a standard test that uses stainless steel disks (1 cm in diameter) as carriers, and the performance of the test formulation is calculated by comparing the number of viable test organisms to that on the control carriers. Surface tests are preferable for evaluating disinfectants with sporicidal effects on hard surfaces. This study applies improved methods, based on the ASTM E2197-11 standard, for evaluating and comparing the sporicidal efficacies of several disinfectants against spores of C. difficile and B. amyloliquefaciens , which are used as the test organisms. With the improved method, all spores were recovered through vortexing and membrane filtration. The results show that chlorine-based products are effective in 5 min and Bioxy products at 5% w/v are effective in 10 min. Although Bioxy products may take longer to prove their effectiveness, their non-harmful effects to hospital surfaces and people have been well established in the literature.

Process analytical technology to understand the disintegration behavior of alendronate sodium tablets.

PubMed

Xu, Xiaoming; Gupta, Abhay; Sayeed, Vilayat A; Khan, Mansoor A

2013-05-01

Various adverse events including esophagus irritations have been reported with the use of alendronate tablets, likely attributed to the rapid tablet disintegration in the mouth or esophagus. Accordingly, the disintegration of six alendronate tablet drug products was studied using a newly developed testing device equipped with in-line sensors, in addition to the official compendial procedure for measuring the disintegration time. The in-line sensors were used to monitor the particle count and solution pH change to assess the onset and duration of disintegration. A relatively large variation was observed in the disintegration time of the tested drug products using the compendial method. The data collected using the in-line sensors suggested that all tested drug products exhibited almost instantaneous onset of disintegration, under 2 s, and a sharp drop in solution pH. The drop in pH was slower for tablets with slower disintegration. The in-house prepared alendronate test tablets also showed similar trends suggesting rapid solubilization of the drug contributed to the fast tablet disintegration. This research highlights the usefulness of the newly developed in-line analytical method in combination with the compendial method in providing a better understanding of the disintegration and the accompanying drug solubilization processes for fast disintegrating tablet drug products. Copyright © 2013 Wiley Periodicals, Inc.

Information Compendium on Nonflammable Hydraulic Fluid and Design Requirements for Its Adoption

DTIC Science & Technology

1990-02-01

Titration. D 892 - Foaming Characteristics of Lubricating Oils. D 1744 - Water in Liquid Petroleum Products by Karl Fischer Reagent. A-2 MI L- H-UrnX... Method Standard 791C, Method 5308. MIL-H-6083 and MIL-H-46170 are tested at 121°C; NFH is tested at 1350C. * MIL-H-6083 and MIL-H-46170 are tested with...demonstrated such improved fire resistance that they were termed nonflammable hydraulic fluids. A new test method for measuring flame/fire propagation

40 CFR 63.5719 - How do I conduct a performance test?

Code of Federal Regulations, 2011 CFR

2011-07-01

... appendix A to 40 CFR part 60, as appropriate, to select the sampling sites. (2) Use Method 2, 2A, 2C, 2D... emissions. (4) You may use American Society for Testing and Materials (ASTM) D6420-99 (available for... parts being made and material application methods. The production conditions during the test must also...

10 CFR Appendix X to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Dehumidifiers

Code of Federal Regulations, 2014 CFR

2014-01-01

... of Dehumidifiers X Appendix X to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. X Appendix X to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of...

10 CFR Appendix X to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Dehumidifiers

Code of Federal Regulations, 2013 CFR

2013-01-01

... of Dehumidifiers X Appendix X to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. X Appendix X to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of...

10 CFR Appendix X to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Dehumidifiers

Code of Federal Regulations, 2012 CFR

2012-01-01

... of Dehumidifiers X Appendix X to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. X Appendix X to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of...

10 CFR Appendix X to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Dehumidifiers

Code of Federal Regulations, 2010 CFR

2010-01-01

... of Dehumidifiers X Appendix X to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. X Appendix X to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of...

10 CFR Appendix X to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Dehumidifiers

Code of Federal Regulations, 2011 CFR

2011-01-01

... of Dehumidifiers X Appendix X to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. X Appendix X to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of...

Nondestructive Testing Eddy Current Equipment, Methods and Applications RQA/M1-5330.12 (V-II).

ERIC Educational Resources Information Center

National Aeronautics and Space Administration, Huntsville, AL. George C. Marshall Space Flight Center.

As one in the series of programmed instruction handbooks, prepared by the U. S. space program, home study material is presented in this volume concerning familiarization and orientation on eddy current testing. The subject is presented under the following headings: Test Coils, Methods and Indications, and Applications. High product quality and…

Validation Study of Rapid Assays of Bioburden, Endotoxins and Other Contamination.

PubMed

Shintani, Hideharu

2016-01-01

Microbial testing performed in support of pharmaceutical and biopharmaceutical production falls into three main categories: detection (qualitative), enumeration (quantitative), and characterization/identification. Traditional microbiological methods are listed in the compendia and discussed by using the conventional growth-based techniques, which are labor intensive and time consuming. In general, such tests require several days of incubation for microbial contamination (bioburden) to be detected, and therefore management seldom is able to take proactive corrective measures. In addition, microbial growth is limited by the growth medium used and incubation conditions, thus impacting testing sensitivity, accuracy, and reproducibility. 　For more than 20 years various technology platforms for rapid microbiological methods (RMM) have been developed, and many have been readily adopted by the food industry and clinical microbiology laboratories. Their use would certainly offer drug companies faster test turnaround times to accommodate the aggressive deadlines for manufacturing processes and product release. Some rapid methods also offer the possibility for real-time microbial analyses, enabling management to respond to microbial contamination events in a more timely fashion, and can provide cost savings and higher efficiencies in quality control testing laboratories. Despite the many proven business and quality benefits and the fact that the FDA's initiative to promote the use of process analytical technology (PAT) includes rapid microbial methods, pharmaceutical and biopharmaceutical industries have been somewhat slow to embrace alternative microbial methodologies for several reasons. The major reason is that the bioburden counts detected by the incubation method and rapid assay are greatly divergent. 　The use of rapid methods is a dynamic field in applied microbiology and one that has gained increased attention nationally and internationally over time. This topic has been extensively addressed at conferences and in published documents around the world. More recently, the use of alternative methods for control of the microbiological quality of pharmaceutical products and materials used in pharmaceutical production has been addressed by the compendia in an attempt to facilitate implementation of these technologies by pharmaceutical companies. The author presents some of the rapid method technologies under evaluation or in use by pharmaceutical microbiologists and the current status of the implementation of alternative microbial methods.

High-frequency productivity estimates for a lake from free-water CO2 concentration measurements

NASA Astrophysics Data System (ADS)

Provenzale, Maria; Ojala, Anne; Heiskanen, Jouni; Erkkilä, Kukka-Maaria; Mammarella, Ivan; Hari, Pertti; Vesala, Timo

2018-04-01

Lakes are important actors in biogeochemical cycles and a powerful natural source of CO2. However, they are not yet fully integrated in carbon global budgets, and the carbon cycle in the water is still poorly understood. In freshwater ecosystems, productivity studies have usually been carried out with traditional methods (bottle incubations, 14C technique), which are imprecise and have a poor temporal resolution. Consequently, our ability to quantify and predict the net ecosystem productivity (NEP) is limited: the estimates are prone to errors and the NEP cannot be parameterised from environmental variables. Here we expand the testing of a free-water method based on the direct measurement of the CO2 concentration in the water. The approach was first proposed in 2008, but was tested on a very short data set (3 days) under specific conditions (autumn turnover); despite showing promising results, this method has been neglected by the scientific community. We tested the method under different conditions (summer stratification, typical summer conditions for boreal dark-water lakes) and on a much longer data set (40 days), and quantitatively validated it comparing our data and productivity models. We were able to evaluate the NEP with a high temporal resolution (minutes) and found a very good agreement (R2 ≥ 0.71) with the models. We also estimated the parameters of the productivity-irradiance (PI) curves that allow the calculation of the NEP from irradiance and water temperature. Overall, our work shows that the approach is suitable for productivity studies under a wider range of conditions, and is an important step towards developing this method so that it becomes more widely used.

A risk-based classification scheme for genetically modified foods. II: Graded testing.

PubMed

Chao, Eunice; Krewski, Daniel

2008-12-01

This paper presents a graded approach to the testing of crop-derived genetically modified (GM) foods based on concern levels in a proposed risk-based classification scheme (RBCS) and currently available testing methods. A graded approach offers the potential for more efficient use of testing resources by focusing less on lower concern GM foods, and more on higher concern foods. In this proposed approach to graded testing, products that are classified as Level I would have met baseline testing requirements that are comparable to what is widely applied to premarket assessment of GM foods at present. In most cases, Level I products would require no further testing, or very limited confirmatory analyses. For products classified as Level II or higher, additional testing would be required, depending on the type of the substance, prior dietary history, estimated exposure level, prior knowledge of toxicity of the substance, and the nature of the concern related to unintended changes in the modified food. Level III testing applies only to the assessment of toxic and antinutritional effects from intended changes and is tailored to the nature of the substance in question. Since appropriate test methods are not currently available for all effects of concern, future research to strengthen the testing of GM foods is discussed.

High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure.

PubMed

Rasmussen, Mats; Damgaard, Rasmus; Buus, Peter; Guazzo, Dana Morton

2013-01-01

This Part 3 of this three-part research series reports the impact of high-voltage leak detection (HVLD) exposure on the physico-chemical stability of the packaged product. The product, intended for human administration by injection, is an aqueous solution formulation of the rapid acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®) by Novo Nordisk A/S, Bagsværd, Denmark. The package is a small-volume form-fill-seal plastic laminate bag. Product-packages exposed to HVLD were compared to unexposed product after storage for 9 months at recommended storage conditions of 5 ± 3 °C. No differences in active ingredient or degradation products assays were noted. No changes in any other stability indicating parameter results were observed. This report concludes this three-part series. Part 1 documented HVLD method development and validation work. Part 2 explored the impact of various package material, package temperature, and package storage conditions on HVLD test results. Detection of leaks in the bag seal area was investigated. In conclusion, HVLD is reported to be a validatable leak test method suitable for rapid, nondestructive container-closure integrity evaluation of the subject product-package. In Part 1 of this three-part series, a leak test method based on electrical conductivity and capacitance, also called high-voltage leak detection (HVLD), was proven to find hole leaks in small plastic bags filled with a solution of insulin aspart intended for human injection (NovoRapid®/NovoLog® by Novo Nordisk A/S, Bagsværd, Denmark). In Part 2, the ability of the HVLD method to find other types of package leaks was tested, and the impact of package material and product storage temperature on HVLD results was explored. This final Part 3 checked how well the packaged protein drug solution maintained its potency after HVLD exposure over 9 months of storage under long-term stability conditions. Results showed that HVLD caused no harm to the product.

WaferOptics® mass volume production and reliability

NASA Astrophysics Data System (ADS)

Wolterink, E.; Demeyer, K.

2010-05-01

The Anteryon WaferOptics® Technology platform contains imaging optics designs, materials, metrologies and combined with wafer level based Semicon & MEMS production methods. WaferOptics® first required complete new system engineering. This system closes the loop between application requirement specifications, Anteryon product specification, Monte Carlo Analysis, process windows, process controls and supply reject criteria. Regarding the Anteryon product Integrated Lens Stack (ILS), new design rules, test methods and control systems were assessed, implemented, validated and customer released for mass production. This includes novel reflowable materials, mastering process, replication, bonding, dicing, assembly, metrology, reliability programs and quality assurance systems. Many of Design of Experiments were performed to assess correlations between optical performance parameters and machine settings of all process steps. Lens metrologies such as FFL, BFL, and MTF were adapted for wafer level production and wafer mapping was introduced for yield management. Test methods for screening and validating suitable optical materials were designed. Critical failure modes such as delamination and popcorning were assessed and modeled with FEM. Anteryon successfully managed to integrate the different technologies starting from single prototypes to high yield mass volume production These parallel efforts resulted in a steep yield increase from 30% to over 90% in a 8 months period.

40 CFR 91.1002 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... business for product development, production method assessment, or market promotion purposes. Testing exemption means an exemption which may be granted under § 91.1104(b) for the purpose of research...

48 CFR 31.205-42 - Termination costs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the reasonable quantitative requirements of other work. (b) Costs continuing after termination... production due to testing and changing production methods; (iii) Training; and (iv) Lack of familiarity or...

Validation studies and proficiency testing.

PubMed

Ankilam, Elke; Heinze, Petra; Kay, Simon; Van den Eede, Guy; Popping, Bert

2002-01-01

Genetically modified organisms (GMOs) entered the European food market in 1996. Current legislation demands the labeling of food products if they contain <1% GMO, as assessed for each ingredient of the product. To create confidence in the testing methods and to complement enforcement requirements, there is an urgent need for internationally validated methods, which could serve as reference methods. To date, several methods have been submitted to validation trials at an international level; approaches now exist that can be used in different circumstances and for different food matrixes. Moreover, the requirement for the formal validation of methods is clearly accepted; several national and international bodies are active in organizing studies. Further validation studies, especially on the quantitative polymerase chain reaction methods, need to be performed to cover the rising demand for new extraction methods and other background matrixes, as well as for novel GMO constructs.

Pyrogen tests of infusions, blood anticoagulant solutions, plastic materials and rubber products.

PubMed

Pintér, J; Zsdánszky, C; Györffy, G

1977-01-01

The methods of the pyrogen test in rabbit as adopted by the authors are presented. The test includes positive and negative controls. The conditions of using the same rabbits on two consecutive days are discussed. Methods of sampling of sterile infusions and the preparation for pyrogen test of anticoagulant solutions containing citrate, phosphate and/or edetate ions are presented. The necessity of pyrogen control of distilled water is stressed. Attention is called on the importance of testing for pyrogenicity of the plastic materials and the rubber-wares to be applied during the production of anticoagulant solutions and infusions. A pyrogen test highly sensitive for detecting traces of detergent is applied for washed glassware. It is emphasized that sensitive pyrogen tests are indispensable not only when new derivatives are being introduced, but also during routine control, because occasional changes in the manufacturer's technology may sometimes be demonstrable in this way.

A method to isolate bacterial communities and characterize ecosystems from food products: Validation and utilization in as a reproducible chicken meat model.

PubMed

Rouger, Amélie; Remenant, Benoit; Prévost, Hervé; Zagorec, Monique

2017-04-17

Influenced by production and storage processes and by seasonal changes the diversity of meat products microbiota can be very variable. Because microbiotas influence meat quality and safety, characterizing and understanding their dynamics during processing and storage is important for proposing innovative and efficient storage conditions. Challenge tests are usually performed using meat from the same batch, inoculated at high levels with one or few strains. Such experiments do not reflect the true microbial situation, and the global ecosystem is not taken into account. Our purpose was to constitute live stocks of chicken meat microbiotas to create standard and reproducible ecosystems. We searched for the best method to collect contaminating bacterial communities from chicken cuts to store as frozen aliquots. We tested several methods to extract DNA of these stored communities for subsequent PCR amplification. We determined the best moment to collect bacteria in sufficient amounts during the product shelf life. Results showed that the rinsing method associated to the use of Mobio DNA extraction kit was the most reliable method to collect bacteria and obtain DNA for subsequent PCR amplification. Then, 23 different chicken meat microbiotas were collected using this procedure. Microbiota aliquots were stored at -80°C without important loss of viability. Their characterization by cultural methods confirmed the large variability (richness and abundance) of bacterial communities present on chicken cuts. Four of these bacterial communities were used to estimate their ability to regrow on meat matrices. Challenge tests performed on sterile matrices showed that these microbiotas were successfully inoculated and could overgrow the natural microbiota of chicken meat. They can therefore be used for performing reproducible challenge tests mimicking a true meat ecosystem and enabling the possibility to test the influence of various processing or storage conditions on complex meat matrices. Copyright © 2016 Elsevier B.V. All rights reserved.

The precision and torque production of common hip adductor squeeze tests used in elite football.

PubMed

Light, N; Thorborg, K

2016-11-01

Decreased hip adductor strength is a known risk factor for groin injury in footballers, with clinicians testing adductor strength in various positions and using different protocols. Understanding how reliable and how much torque different adductor squeeze tests produce will facilitate choosing the most appropriate method for future testing. In this study, the reliability and torque production of three common adductor squeeze tests were investigated. Test-retest reliability and cross-sectional comparison. Twenty elite level footballers (16-33 years) without previous or current groin pain were recruited. Relative and absolute test-retest reliability, and torque production of three adductor squeeze tests (long-lever in abduction, short-lever in adduction and short-lever in abduction/external rotation) were investigated. Each participant performed a series of isometric strength tests measured by hand-held dynamometry in each position, on two test days separated by two weeks. No systematic variation was seen for any of the tests when using the mean of three measures (ICC=0.84-0.97, MDC%=6.6-19.5). The smallest variation was observed when taking the mean of three repetitions in the long-lever position (ICC=0.97, MDC%=6.6). The long-lever test also yielded the highest mean torque values, which were 69% and 11% higher than the short-lever in adduction test and short-lever in abduction/external rotation test respectively (p<0.001). All three tests described in this study are reliable methods of measuring adductor squeeze strength. However, the test performed in the long-lever position seems the most promising as it displays high test-retest precision and the highest adductor torque production. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Testing isotopic labeling with [¹³C₆]glucose as a method of advanced glycation sites identification.

PubMed

Kielmas, Martyna; Kijewska, Monika; Stefanowicz, Piotr; Szewczuk, Zbigniew

2012-12-01

The Maillard reaction occurring between reducing sugars and reactive amino groups of biomolecules leads to the formation of a heterogeneous mixture of compounds: early, intermediate, and advanced glycation end products (AGEs). These compounds could be markers of certain diseases and of the premature aging process. Detection of Amadori products can be performed by various methods, including MS/MS techniques and affinity chromatography on immobilized boronic acid. However, the diversity of the structures of AGEs makes detection of these compounds more difficult. The aim of this study was to test a new method of AGE identification based on isotope (13)C labeling. The model protein (hen egg lysozyme) was modified with an equimolar mixture of [(12)C(6)]glucose and [(13)C(6)]glucose and then subjected to reduction of the disulfide bridges followed by tryptic hydrolysis. The digest obtained was analyzed by LC-MS. The glycation products were identified on the basis of characteristic isotopic patterns resulting from the use of isotopically labeled glucose. This method allowed identification of 38 early Maillard reaction products and five different structures of the end glycation products. This isotopic labeling technique combined with LC-MS is a sensitive method for identification of advanced glycation end products even if their chemical structure is unknown. Copyright © 2012 Elsevier Inc. All rights reserved.

Sample size determination for mediation analysis of longitudinal data.

PubMed

Pan, Haitao; Liu, Suyu; Miao, Danmin; Yuan, Ying

2018-03-27

Sample size planning for longitudinal data is crucial when designing mediation studies because sufficient statistical power is not only required in grant applications and peer-reviewed publications, but is essential to reliable research results. However, sample size determination is not straightforward for mediation analysis of longitudinal design. To facilitate planning the sample size for longitudinal mediation studies with a multilevel mediation model, this article provides the sample size required to achieve 80% power by simulations under various sizes of the mediation effect, within-subject correlations and numbers of repeated measures. The sample size calculation is based on three commonly used mediation tests: Sobel's method, distribution of product method and the bootstrap method. Among the three methods of testing the mediation effects, Sobel's method required the largest sample size to achieve 80% power. Bootstrapping and the distribution of the product method performed similarly and were more powerful than Sobel's method, as reflected by the relatively smaller sample sizes. For all three methods, the sample size required to achieve 80% power depended on the value of the ICC (i.e., within-subject correlation). A larger value of ICC typically required a larger sample size to achieve 80% power. Simulation results also illustrated the advantage of the longitudinal study design. The sample size tables for most encountered scenarios in practice have also been published for convenient use. Extensive simulations study showed that the distribution of the product method and bootstrapping method have superior performance to the Sobel's method, but the product method was recommended to use in practice in terms of less computation time load compared to the bootstrapping method. A R package has been developed for the product method of sample size determination in mediation longitudinal study design.

Evaluation of the new control methods for oral poliomyelitis vaccine.

PubMed

Grachev, V P; Karganova, G G; Rumyantsev, A A; Ivanova, O E; Eremeeva, T P; Drozdov, S G

2001-01-01

In the draft recommendations for production and control of OPV the WHO proposed new control methods: (i) mutant analysis with PCR and restriction enzyme cleavage (MAPREC) assay that allows evaluation of poliovirus population heterogeneity at the molecular level; (ii) neurovirulence (NV) test using transgenic mice susceptible to polioviruses and (iii) control of the seed lots for the presence of the simian virus 40 (SV40) DNA sequence. This paper is focused on our experience in the practical implementation of the new methods at the Institute of Poliomyelitis and Viral Encephalitides (IPVE). Using methods based on PCR we have demonstrated that working seed viruses used by IPVE for OPV production are free from SV40 DNA sequences. Our experience on the conduction of the OPV type 3 control using TgPVR21 mice NV test (seven vaccine lots) and the MAPREC assay (more than 150 samples of single harvests and monovalent bulks) showed that these methods may be used instead of the monkey NV test, because they could not pass the vaccine failed monkey NV test. The necessity for single harvests control is discussed.

An inventory of methods suitable to assess additive-induced characterising flavours of tobacco products.

PubMed

Talhout, Reinskje; van de Nobelen, Suzanne; Kienhuis, Anne S

2016-04-01

Products with strong non-tobacco flavours are popular among young people, and facilitate smoking initiation. Similar to the U.S. Food and Drug Administration Tobacco Control Act, the new European Tobacco Product Directive (TPD) prohibits cigarettes and roll-your-own tobacco with a characterising flavour other than tobacco. However, no methods are prescribed or operational to assess characterising flavours. This is the first study to identify, review and synthesize the existing peer-reviewed and tobacco industry literature in order to provide an inventory of methods suitable to assess characterising flavours. Authors gathered key empirical and theoretical papers examining methods suitable to assess characterising flavours. Scientific literature databases (PubMed and Scopus) and tobacco industry documents were searched, based on several keyword combinations. Inclusion criteria were relevance for smoked tobacco products, and quality of data. The findings reveal that there is a wide variation in natural tobacco flavours. Flavour differences from natural tobacco can be described by both expert and consumer sensory panels. Most methods are based on smoking tests, but odour evaluation has also been reported. Chemical analysis can be used to identify and quantify levels of specific flavour additives in tobacco products. As flavour perception is subjective, and requires human assessment, sensory analysis in consumer or expert panel studies is necessitated. We recommend developing validated tests for descriptive sensory analysis in combination with chemical-analytical measurements. Testing a broad range of brands, including those with quite subtle characterizing flavours, will provide the concentration above which an additive will impart a characterising flavour. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Products of composite operators in the exact renormalization group formalism

NASA Astrophysics Data System (ADS)

Pagani, C.; Sonoda, H.

2018-02-01

We discuss a general method of constructing the products of composite operators using the exact renormalization group formalism. Considering mainly the Wilson action at a generic fixed point of the renormalization group, we give an argument for the validity of short-distance expansions of operator products. We show how to compute the expansion coefficients by solving differential equations, and test our method with some simple examples.

40 CFR 60.244 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Fertilizer Industry: Granular Triple Superphosphate Storage Facilities § 60.244 Test methods and procedures... quantities of product are being cured or stored in the facility. (1) Total granular triple superphosphate is at least 10 percent of the building capacity, and (2) Fresh granular triple superphosphate is at...

40 CFR 60.244 - Test methods and procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Fertilizer Industry: Granular Triple Superphosphate Storage Facilities § 60.244 Test methods and procedures... quantities of product are being cured or stored in the facility. (1) Total granular triple superphosphate is at least 10 percent of the building capacity, and (2) Fresh granular triple superphosphate is at...

Machine Learning Methods for Production Cases Analysis

NASA Astrophysics Data System (ADS)

Mokrova, Nataliya V.; Mokrov, Alexander M.; Safonova, Alexandra V.; Vishnyakov, Igor V.

2018-03-01

Approach to analysis of events occurring during the production process were proposed. Described machine learning system is able to solve classification tasks related to production control and hazard identification at an early stage. Descriptors of the internal production network data were used for training and testing of applied models. k-Nearest Neighbors and Random forest methods were used to illustrate and analyze proposed solution. The quality of the developed classifiers was estimated using standard statistical metrics, such as precision, recall and accuracy.

The use of by-products from metallurgical and mineral industries as filler in cement-based materials.

PubMed

Moosberg, Helena; Lagerblad, Björn; Forssberg, Eric

2003-02-01

This investigation has been made in order to make it possible to increase the use of by-products in cement-based materials. Use of by-products requires a screening procedure that will reliably determine their impact on concrete. A test procedure was developed. The most important properties were considered to be strength development, shrinkage, expansion and workability. The methods used were calorimetry, flow table tests, F-shape measurements, measurements of compressive and flexural strength and shrinkage/expansion measurements. Scanning electron microscopy was used to verify some results. Twelve by-products were collected from Swedish metallurgical and mineral industries and classified according to the test procedure. The investigation showed that the test procedure clearly screened out the materials that can be used in the production of concrete from the unsuitable ones.

10 CFR 430.70 - Enforcement.

Code of Federal Regulations, 2010 CFR

2010-01-01

...), the Secretary may conduct testing of that covered product under this subpart by means of a test notice... be selected for testing, the method of selecting the test sample, the time at which testing shall be... shall select a batch, a batch sample, and test units from the batch sample in accordance with the...

10 CFR Appendix S to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads S Appendix S to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. S...

10 CFR Appendix S to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads S Appendix S to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. S...

10 CFR Appendix S to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads S Appendix S to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. S...

Theory and practice of conventional adventitious virus testing.

PubMed

Gregersen, Jens-Peter

2011-01-01

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) For decades conventional tests in cell cultures and in laboratory animals have served as standard methods for broad-spectrum screening for adventitious viruses. New virus detection methods based on molecular biology have broadened and improved our knowledge about potential contaminating viruses and about the suitability of the conventional test methods. This paper summarizes and discusses practical aspects of conventional test schemes, such as detectability of various viruses, questionable or false-positive results, animal numbers needed, time and cost of testing, and applicability for rapidly changing starting materials. Strategies to improve the virus safety of biological medicinal products are proposed. The strategies should be based upon a flexible application of existing and new methods along with a scientifically based risk assessment. However, testing alone does not guarantee the absence of adventitious agents and must be accompanied by virus removing or virus inactivating process steps for critical starting materials, raw materials, and for the drug product.

A Comparison of Assessment Methods and Raters in Product Creativity

ERIC Educational Resources Information Center

Lu, Chia-Chen; Luh, Ding-Bang

2012-01-01

Although previous studies have attempted to use different experiences of raters to rate product creativity by adopting the Consensus Assessment Method (CAT) approach, the validity of replacing CAT with another measurement tool has not been adequately tested. This study aimed to compare raters with different levels of experience (expert ves.…

Taguchi experimental design to determine the taste quality characteristic of candied carrot

NASA Astrophysics Data System (ADS)

Ekawati, Y.; Hapsari, A. A.

2018-03-01

Robust parameter design is used to design product that is robust to noise factors so the product’s performance fits the target and delivers a better quality. In the process of designing and developing the innovative product of candied carrot, robust parameter design is carried out using Taguchi Method. The method is used to determine an optimal quality design. The optimal quality design is based on the process and the composition of product ingredients that are in accordance with consumer needs and requirements. According to the identification of consumer needs from the previous research, quality dimensions that need to be assessed are the taste and texture of the product. The quality dimension assessed in this research is limited to the taste dimension. Organoleptic testing is used for this assessment, specifically hedonic testing that makes assessment based on consumer preferences. The data processing uses mean and signal to noise ratio calculation and optimal level setting to determine the optimal process/composition of product ingredients. The optimal value is analyzed using confirmation experiments to prove that proposed product match consumer needs and requirements. The result of this research is identification of factors that affect the product taste and the optimal quality of product according to Taguchi Method.

Anaerobic Threshold and Salivary α-amylase during Incremental Exercise.

PubMed

Akizuki, Kazunori; Yazaki, Syouichirou; Echizenya, Yuki; Ohashi, Yukari

2014-07-01

[Purpose] The purpose of this study was to clarify the validity of salivary α-amylase as a method of quickly estimating anaerobic threshold and to establish the relationship between salivary α-amylase and double-product breakpoint in order to create a way to adjust exercise intensity to a safe and effective range. [Subjects and Methods] Eleven healthy young adults performed an incremental exercise test using a cycle ergometer. During the incremental exercise test, oxygen consumption, carbon dioxide production, and ventilatory equivalent were measured using a breath-by-breath gas analyzer. Systolic blood pressure and heart rate were measured to calculate the double product, from which double-product breakpoint was determined. Salivary α-amylase was measured to calculate the salivary threshold. [Results] One-way ANOVA revealed no significant differences among workloads at the anaerobic threshold, double-product breakpoint, and salivary threshold. Significant correlations were found between anaerobic threshold and salivary threshold and between anaerobic threshold and double-product breakpoint. [Conclusion] As a method for estimating anaerobic threshold, salivary threshold was as good as or better than determination of double-product breakpoint because the correlation between anaerobic threshold and salivary threshold was higher than the correlation between anaerobic threshold and double-product breakpoint. Therefore, salivary threshold is a useful index of anaerobic threshold during an incremental workload.

Statistical characterization of carbon phenolic prepreg materials, volume 1

NASA Technical Reports Server (NTRS)

Beckley, Don A.; Stites, John, Jr.

1988-01-01

The objective was to characterize several lots of materials used for carbon/carbon and carbon/phenol product manufacture. Volume one is organized into testing categories based on raw material of product form. Each category contains a discussion of the sampling plan, comments and observations on each test method utilized, and a summary of the results obtained each category.

Characterization and Leaching Tests of the Fluidized Bed Steam Reforming (FBSR) Waste Form for LAW Immobilization

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

Neeway, James J.; Qafoku, Nikolla; Brown, Christopher F.

2013-10-01

Several supplemental technologies for treating and immobilizing Hanford low activity waste (LAW) have been evaluated. One such immobilization technology is the Fluidized Bed Steam Reforming (FBSR) granular product. The FBSR granular product is composed of insoluble sodium aluminosilicate (NAS) feldspathoid minerals. Production of the FBSR mineral product has been demonstrated both at the industrial and laboratory scale. Pacific Northwest National Laboratory (PNNL) was involved in an extensive characterization campaign. This goal of this campaign was study the durability of the FBSR mineral product and the mineral product encapsulated in a monolith to meet compressive strength requirements. This paper gives anmore » overview of results obtained using the ASTM C 1285 Product Consistency Test (PCT), the EPA Test Method 1311 Toxicity Characteristic Leaching Procedure (TCLP), and the ASTMC 1662 Single-Pass Flow-Through (SPFT) test. Along with these durability tests an overview of the characteristics of the waste form has been collected using Scanning Electron Microscopy (SEM), X-ray Diffraction (XRD), microwave digestions for chemical composition, and surface area from Brunauer, Emmett, and Teller (BET) theory.« less

Characterization and Leaching Tests of the Fluidized Bed Steam Reforming (FBSR) Waste Form for LAW Immobilization - 13400

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

Neeway, James J.; Qafoku, Nikolla P.; Peterson, Reid A.

2013-07-01

Several supplemental technologies for treating and immobilizing Hanford low activity waste (LAW) have been evaluated. One such immobilization technology is the Fluidized Bed Steam Reforming (FBSR) granular product. The FBSR granular product is composed of insoluble sodium aluminosilicate (NAS) feldspathoid minerals. Production of the FBSR mineral product has been demonstrated both at the industrial and laboratory scale. Pacific Northwest National Laboratory (PNNL) was involved in an extensive characterization campaign. The goal of this campaign was to study the durability of the FBSR mineral product and the encapsulated FBSR product in a geo-polymer monolith. This paper gives an overview of resultsmore » obtained using the ASTM C 1285 Product Consistency Test (PCT), the EPA Test Method 1311 Toxicity Characteristic Leaching Procedure (TCLP), and the ASTMC 1662 Single-Pass Flow-Through (SPFT) test. Along with these durability tests an overview of the characteristics of the waste form has been collected using Scanning Electron Microscopy (SEM), X-ray Diffraction (XRD), microwave digestions for chemical composition, and surface area from Brunauer, Emmett, and Teller (BET) theory. (authors)« less

Advantages and limitations of common testing methods for antioxidants.

PubMed

Amorati, R; Valgimigli, L

2015-05-01

Owing to the importance of antioxidants in the protection of both natural and man-made materials, a large variety of testing methods have been proposed and applied. These include methods based on inhibited autoxidation studies, which are better followed by monitoring the kinetics of oxygen consumption or of the formation of hydroperoxides, the primary oxidation products. Analytical determination of secondary oxidation products (e.g. carbonyl compounds) has also been used. The majority of testing methods, however, do not involve substrate autoxidation. They are based on the competitive bleaching of a probe (e.g. ORAC assay, β-carotene, crocin bleaching assays, and luminol assay), on reaction with a different probe (e.g. spin-trapping and TOSC assay), or they are indirect methods based on the reduction of persistent radicals (e.g. galvinoxyl, DPPH and TEAC assays), or of inorganic oxidizing species (e.g. FRAP, CUPRAC and Folin-Ciocalteu assays). Yet other methods are specific for preventive antioxidants. The relevance, advantages, and limitations of these methods are critically discussed, with respect to their chemistry and the mechanisms of antioxidant activity. A variety of cell-based assays have also been proposed, to investigate the biological activity of antioxidants. Their importance and critical aspects are discussed, along with arguments for the selection of the appropriate testing methods according to the different needs.

Genetic Stock Identification Of Production Colonies Of Russian Honey Bees

USDA-ARS?s Scientific Manuscript database

The prevalence of Nosema ceranae in managed honey bee colonies has increased dramatically in the past 10 – 20 years worldwide. A variety of genetic testing methods for species identification and prevalence are now available. However sample size and preservation method of samples prior to testing hav...

Translating research into licensed vaccines and validated and licensed diagnostic tests.

PubMed

Hill, R E; Foley, P L; Clough, N E; Ludemann, L R; Murtle, D C

2013-01-01

The USDA Center for Veterinary Biologics (CVB) has the regulatory authority to issue licenses and permits that allow the marketing of pure, safe, potent, and effective veterinary biological products. Under the standard licensing or permitting process, a manufacturer develops, characterizes, and evaluates a product prior to licensure. The CVB evaluates the submitted information, inspects the manufacturing facilities and methods of production and testing, and confirms key product test results through independent testing. This complete and comprehensive evaluation may not be possible during the emergence of a new animal disease or in response to an introduction of a significant transboundary animal disease agent. Processes are in place in the US that allow for more rapid availability of veterinary products in an emerging or emergency animal health situation. But, it can be advantageous to attain preapproval of products prior to their anticipated need. In this article, issues associated with obtaining approval for use of a biological product under emerging or emergency conditions are discussed.

Suitability of histopathology as an additional endpoint to the Isolated Chicken Eye Test for classification of non-extreme pH detergent and cleaning products.

PubMed

Cazelle, Elodie; Eskes, Chantra; Hermann, Martina; Jones, Penny; McNamee, Pauline; Prinsen, Menk; Taylor, Hannah; Wijnands, Marcel V W

2014-06-01

A.I.S.E. investigated the suitability of histopathological evaluations as an additional endpoint to the regulatory adopted ICE in vitro test method (OECD TG 438) to identify non-extreme pH detergent and cleaning products that require classification as EU CLP/UN GHS Category 1 (serious eye damage). To this aim, a total of 30 non-extreme pH products covering the range of in vivo classifications for eye irritation, and representing various product categories were tested. Epithelium vacuolation (mid and lower layers) and erosion (at least moderate) were found to be the most relevant histopathological effects induced by products classified in vivo as Category 1. Histopathology criteria specifically developed for non-extreme pH detergent and cleaning products were shown to correctly identify materials classified as Category 1 based on in vivo persistent effects, and to significantly increase the overall sensitivity of the standard ICE prediction model for Category 1 identification (to 75%) whilst maintaining a good concordance (73%). In contrast, use of EU CLP additivity approach for classification of mixtures was considerably less predictive, with a concordance of only 27%, and 100% over-predictions of non-Category 1 products. As such, use of histopathology as an addition to the ICE test method was found suitable to identify EU CLP/UN GHS Category 1 non-extreme pH detergent and cleaning products and to allow a better discrimination from Category 2 products. Copyright © 2014 Elsevier Ltd. All rights reserved.

Possible ambiguities when testing viscosity in compendial monographs - characterisation of grades of cellulose ethers.

PubMed

Doelker, E

2010-10-01

The European Pharmacopoeia (Ph. Eur.) monographs for the water-soluble cellulose ethers require viscosity determination, either in the "Tests" section or in the non-mandatory "Functionality-related characteristics" section. Although the derivatives are chemically closely related and used for similar applications, the viscosity tests strongly differ. Some monographs generically speak of the rotating viscometer method (2.2.10) and a fixed shear rate (e.g. 10 s-1), which would necessitate an absolute measuring system, while others recommend the capillary viscometer method for product grades of less than 600 mPa∙s and the rotating viscometer method and given operating conditions for grades of higher nominal viscosity. Viscometer methods also differ between the United States Pharmacopeia/National Formulary (USP/NF) and the Japanese Pharmacopoeia (JP) monographs. In addition, for some cellulose ethers the tests sometimes diverge from one pharmacopoeia to the other, although the three compendiums are in a harmonisation process. But the main issue is that the viscometer methods originally employed by the product manufacturers are often not those described in the corresponding monographs and generally vary from one manufacturer to the other. The aim of this study was therefore to investigate whether such a situation could invalidate the present pharmacopoeial requirements. 2 per cent solutions of several viscosity grades of hydroxyethylcellulose, hypromellose and methylcellulose were prepared and their (apparent) viscosity determined using both relative and absolute viscometer methods. The viscometer method used not only affects the measured viscosity but experimental values generally do not correspond to the product nominal viscosities. It emerges that, in contrast to Newtonian solutions (i.e. those of grades of up to ca. 50 mPa∙s nominal viscosity), some of the viscometer methods currently specified in the monographs are not able unambiguously to characterise the grades exhibiting non-Newtonian behaviour. It is also concluded that, unless the various manufacturers redefine their product viscosity grades using a single compendial test, two strategies could be adopted, both based on the operating conditions specified in the labeling (i.e those of the manufacturer), the test appearing either in the mandatory section if this is acceptable to the pharmacopoeia (like in some USP/NF monographs) or, for the Ph. Eur., in the "Functionality-related characteristics" section.

A Feminine Care Clinical Research Program Transforms Women's Lives.

PubMed

Tzeghai, Ghebre E; Ajayi, Funmilayo O; Miller, Kenneth W; Imbescheid, Frank; Sobel, Jack D; Farage, Miranda A

2012-12-17

Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer's quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created to measure consumer's well-being. Based on the results of this extensive clinical research and the newly developed testing methods, the changing needs of women throughout their life stages are better met.

A Feminine Care Clinical Research Program Transforms Women’s Lives

PubMed Central

Tzeghai, Ghebre E.; Ajayi, Funmilayo O.; Miller, Kenneth W.; Imbescheid, Frank; Sobel, Jack D.; Farage, Miranda A.

2015-01-01

Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer’s quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created to measure consumer’s well-being. Based on the results of this extensive clinical research and the newly developed testing methods, the changing needs of women throughout their life stages are better met. PMID:25946910

New noninvasive approach assessing in vivo sun protection factor (SPF) using diffuse reflectance spectroscopy (DRS) and in vitro transmission.

PubMed

Ruvolo Junior, Eduardo; Kollias, Nikiforos; Cole, Curtis

2014-08-01

In the past 56 years, many different in vitro methodologies have been developed and published to assess the sun protection factor (SPF) of products, but there is no method that has 1:1 correlation with in vivo measurements. Spectroscopic techniques have been used to noninvasively assess the UVA protection factor with good correlation to in vivo UVA-PF methodologies. To assess the SPF of sunscreen product by diffuse reflectance spectroscopy (DRS) technique, it is necessary to also determine the absorbance spectrum of the test material in the UVB portion of the spectrum (290-320 nm). However, because of the high absorbance characteristics of the stratum corneum and epidermis, the human skin does not remit enough UVB radiation to be used to measure the absorption spectrum of the applied product on skin. In this work, we present a new method combining the evaluation of the absolute UVA absorption spectrum, as measured by DRS with the spectral absorbance 'shape' of the UVB absorbance of the test material as determined with current in vitro thin film spectroscopy. The measurement of the in vivo UVA absorption spectrum involves the assessment of the remitted intensity of monochromatic UVA radiation (320-400 nm) before and after a sunscreen product was applied on skin using a spectrofluorimeter Fluorolog 3, FL3-22 (Yvon Horiba, Edison, NJ, USA). The probe geometry assures that light scattering products as well as colored products may be correctly assessed. This methodology has been extensively tested, validated, and reported in the literature. The in vitro absorption spectrum of the sunscreen samples and polyvinyl chloride (PVC) films 'surrogate' sunscreen standards were measured using Labsphere® UV-2000S (Labsphere, North Sutton, NH, USA). Sunscreens samples were tested using PMMA Helioplates (Helioscience, Marseille, France) as substrates. The UVB absorbance spectrum (Labsphere) is 'attached' to the UVA absorbance spectrum (diffuse reflectance) with the UVB absorbance matched to the UVA absorbance at 340 nm to complete the full spectral absorbance from which an estimate the SPF of the product can be calculated. Seventeen test materials with known in vivo SPF values were tested. Two of the tested products were PVC sunscreen thin films with 10-15 micrometers thickness and were used to investigate the absorption spectrum of these films when applied on different reflectance surfaces. Similar to the human in vivo SPF test, the developed methodology suggests limiting the use on Fitzpatrick skin phototypes I to III. The correlation of this new method with in vivo clinical SPF values was 0.98 (r2) with a slope of 1.007. This new methodology provides a new approach to determine SPF values without the extensive UV irradiation procedures (and biological responses) currently used to establish sunscreen efficacy. Further work will be conducted to establish methods for evaluation of products that are not photostable. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Qualification of a precise and easy-to-handle sweat casting imprint method for the prediction and quantification of anti-perspirant efficacy.

PubMed

Keyhani, R; Scheede, S; Thielecke, I; Wenck, H; Schmucker, R; Schreiner, V; Ennen, J; Herpens, A

2009-06-01

A time- and cost-effective sweat casting method using the forearm as test site to assess the efficacy of several anti-perspirant formulations with a low number of test subjects has been evaluated and qualified. The imprint sweat casting method is based on a 2-component silcone-imprint technique to measure the efficacy of more than eight products in parallel with the same test subject. In studies using aluminum chlorohydrate (ACH) formulations as test anti-perspirants, a clear-cut correlation could be demonstrated between sweat gland activities measured by the imprint method and gravimetric measurement of sweat gland activities. Concentration-dependent inhibition of sweat gland activity could be observed with the imprint technique up to an ACH concentration of 15%, and all formulations containing 2% ACH or above resulted in statistically significant reduction of sweat gland activity (P < 0.001) when compared with untreated control areas. Furthermore, the SDs of individual studies using the imprint technique were in a range of +/-20% of sweat gland activity, which can be regarded rather low for in vivo measurements of a complex process like sweat secretion. A group-wise comparison between the measurements of anti-perspirant activity as determined by the imprint protocol and the Food and Drug Administration (FDA) Guideline compliant gravimetric hot-room protocol revealed that the test results for anti-perspirant activity obtained with the imprint protocol are similar to those obtained with the hot-room protocol. Moreover, the data generated with the imprint protocol have a high predictive value for the outcome of a later guideline-compliant hot-room test. As the imprint casting method tends to be a little more sensitive for formulations with low anti-perspirant activity, and seems to be associated with less interassay variability than the standard gravimetric hot-room test, the imprint casting method may select products which later fail to pass the standard gravimetric hot-room test. Meanwhile the imprint sweat casting has proven to be a robust method useful to support efficacy-oriented product development. Therefore, in later stages of utilization it might even evolve into an efficient claim substantiation tool.

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.

Aspects of fabrication aluminium matrix heterophase composites by suspension method

NASA Astrophysics Data System (ADS)

Dolata, A. J.; Dyzia, M.

2012-05-01

Composites with an aluminium alloy matrix (AlMMC) exhibit several advantageous properties such as good strength, stiffness, low density, resistance and dimensional stability to elevated temperatures, good thermal expansion coefficient and particularly high resistance to friction wear. Therefore such composites are more and more used in modern engineering constructions. Composites reinforced with hard ceramic particles (Al2O3, SiC) are gradually being implemented into production in automotive or aircraft industries. Another application of AlMMC is in the electronics industry, where the dimensional stability and capacity to absorb and remove heat is used in radiators. However the main problems are still: a reduction of production costs, developing methods of composite material tests and final product quality assessment, standardisation, development of recycling and mechanical processing methods. AlMMC production technologies, based on liquid-phase methods, and the shaping of products by casting methods, belong to the cheapest production methods. Application of a suspension method for the production of composites with heterophase reinforcement may turn out to be a new material and technological solution. The article presents the material and technological aspects of the transfer procedures for the production of composite suspensions from laboratory scale to a semi-industrial scale.

9 CFR 442.5 - Handling of failed product.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Handling of failed product. 442.5 Section 442.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled...

9 CFR 442.5 - Handling of failed product.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Handling of failed product. 442.5 Section 442.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled...

9 CFR 442.5 - Handling of failed product.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Handling of failed product. 442.5 Section 442.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled...

9 CFR 442.5 - Handling of failed product.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Handling of failed product. 442.5 Section 442.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled...

9 CFR 442.5 - Handling of failed product.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Handling of failed product. 442.5 Section 442.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... upon testing in accordance with the methods prescribed in § 442.2 of this subchapter shall be handled...

Introduction of the 2007-2008 JOGMEC/NRCan/Aurora Mallik Gas Hydrate Production Research Program, NWT, Canada

NASA Astrophysics Data System (ADS)

Yamamoto, K.; Dallimore, S. R.; Numasawa, M.; Yasuda, M.; Fujii, T.; Fujii, K.; Wright, J.; Nixon, F.

2007-12-01

Japan Oil, Gas and Metals National Corporation (JOGMEC) and Natural Resource Canada (NRCan) have embarked on a new research program to study the production potential of gas hydrates. The program is being carried out at the Mallik gas hydrate field in the Mackenzie Delta, a location where two previous scientific investigations have been carried in 1998 and 2002. In the 2002 program that was undertaken by seven partners from five countries, 468m3 of gas flow was measured during 124 hours of thermal stimulation using hot warm fluid. Small-scale pressure drawdown tests were also carried out using Schlumberger's Modular Dynamics Tester (MDT) wireline tool, gas flow was observed and the inferred formation permeabilities suggested the possible effectiveness of the simple depressurization method. While the testing undertaken in 2002 can be cited as the first well constrained gas production from a gas hydrate deposit, the results fell short of that required to fully calibrate reservoir simulation models or indeed establish the technical viability of long term production from gas hydrates. The objectives of the current JOGMEC/NRCan/Aurora Mallik production research program are to undertake longer term production testing to further constrain the scientific unknowns and to demonstrate the technical feasibility of sustained gas hydrate production using the depressurization method. A key priority is to accurately measure water and gas production using state-of-art production technologies. The primary production test well was established during the 2007 field season with the re-entry and deepening of JAPEX/JNOC/GSC Mallik 2L-38 well, originally drilled in 1998. Production testing was carried out in April of 2007 under a relatively low drawdown pressure condition. Flow of methane gas was measured from a 12m perforated interval of gas-hydrate-saturated sands from 1093 to 1105m. The results establish the potential of the depressurization method and provide a basis for future prolonged testing planned in the near future. The authors acknowledge the Research Consortium for Methane Hydrate Resources in Japan (MH21), the Ministry of Economy, Trade and Industry (METI) and NRCan for the support and funding. The Mallik 2002 program was undertaken jointly by JNOC, NRCan, GeoForschungsZentrum Potsdam (GFZ), the United State Geological Survey (USGS), the United States Department of Energy (USDOE), the India Ministry of Petroleum and Natural Gas (MOPNG)-Gas Authority of India (GAIL), and the BP-Chevron Texaco Mackenzie Delta Joint Venture.

Labor Productivity Standards in Texas School Foodservice Operations

ERIC Educational Resources Information Center

Sherrin, A. Rachelle; Bednar, Carolyn; Kwon, Junehee

2009-01-01

Purpose: Purpose of this research was to investigate utilization of labor productivity standards and variables that affect productivity in Texas school foodservice operations. Methods: A questionnaire was developed, validated, and pilot tested, then mailed to 200 randomly selected Texas school foodservice directors. Descriptive statistics for…

A novel mass spectrometric method for formaldehyde in children's personal-care products and water via derivatization with acetylacetone.

PubMed

Backe, Will J

2017-06-30

New legislation in the state of Minnesota prohibits the sale of children's personal-care products (PCPs) that contain more than 500 ng/mg formaldehyde. Previous attempts to quantify formaldehyde in PCPs use nonspecific derivatization procedures that employ harsh reagents and/or nonspecific detection. Derivatization of formaldehyde by acetylacetone occurs under mild conditions and is specific for formaldehyde but it has not been investigated using high-performance liquid chromatography/tandem mass-spectrometry (HPLC/MS/MS). To determine formaldehyde, PCPs were dissolved and then interferences were minimized by graphitized-carbon solid-phase extraction. Formaldehyde was derivatized to 3,5-diacetyl-1,4-dihydrolutidine (DDL) using an acetylacetone solution. Post-derivatization, samples were diluted and analyzed by HPLC/MS/MS. Quantification was performed by isotopic dilution. Product-ion spectra were acquired for DDL and D 12 -DDL. The mass shifts between the two product-ion spectra were used to assign fragment structures. To confirm molecular formulas, high-resolution accurate-mass analysis of the DDL product ions was performed by quadrupole time-of-flight MS. Structures were proposed for all product ions of DDL above 10% relative intensity. Method accuracy ranged between 96-104% for all matrices at all concentrations tested. Method precision was less than 4% relative standard deviation. The reporting limit was 10 ng/mg in PCPs and 100 μg/L in water. Twenty children's PCPs were tested to demonstrate the method and formaldehyde was reported in five from 23-1500 ng/mg. Of those five, two samples contained formaldehyde above the Minnesota regulatory limit. The developed method allows for the accurate quantification of formaldehyde in PCPs at levels below those required by a new regulation on children's products in Minnesota. The method includes a derivatization procedure that is newly adapted to HPLC/MS/MS; therefore, structures were proposed for the product ions of the derivative (DDL). Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Challenges, uncertainties, and issues facing gas production from gas-hydrate deposits

USGS Publications Warehouse

Moridis, G.J.; Collett, T.S.; Pooladi-Darvish, M.; Hancock, S.; Santamarina, C.; Boswel, R.; Kneafsey, T.; Rutqvist, J.; Kowalsky, M.B.; Reagan, M.T.; Sloan, E.D.; Sum, A.K.; Koh, C.A.

2011-01-01

The current paper complements the Moridis et al. (2009) review of the status of the effort toward commercial gas production from hydrates. We aim to describe the concept of the gas-hydrate (GH) petroleum system; to discuss advances, requirements, and suggested practices in GH prospecting and GH deposit characterization; and to review the associated technical, economic, and environmental challenges and uncertainties, which include the following: accurate assessment of producible fractions of the GH resource; development of methods for identifying suitable production targets; sampling of hydrate-bearing sediments (HBS) and sample analysis; analysis and interpretation of geophysical surveys of GH reservoirs; well-testing methods; interpretation of well-testing results; geomechanical and reservoir/well stability concerns; well design, operation, and installation; field operations and extending production beyond sand-dominated GH reservoirs; monitoring production and geomechanical stability; laboratory investigations; fundamental knowledge of hydrate behavior; the economics of commercial gas production from hydrates; and associated environmental concerns. ?? 2011 Society of Petroleum Engineers.

10 CFR Appendix P to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Pool Heaters

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Energy Consumption of Pool Heaters P Appendix P to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. P Appendix P to...

10 CFR Appendix P to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Pool Heaters

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Uniform Test Method for Measuring the Energy Consumption of Pool Heaters P Appendix P to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. P Appendix P to...

10 CFR Appendix V to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Ceiling Fan Light Kits

Code of Federal Regulations, 2011 CFR

2011-01-01

... of Ceiling Fan Light Kits V Appendix V to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. V Appendix V to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Ceiling Fan...

10 CFR Appendix Q to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Fluorescent Lamp Ballasts

Code of Federal Regulations, 2014 CFR

2014-01-01

... of Fluorescent Lamp Ballasts Q Appendix Q to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. Q Appendix Q to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Fluorescent...

10 CFR Appendix Q to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Fluorescent Lamp Ballasts

Code of Federal Regulations, 2012 CFR

2012-01-01

... of Fluorescent Lamp Ballasts Q Appendix Q to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. Q Appendix Q to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Fluorescent...

10 CFR Appendix Q to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Fluorescent Lamp Ballasts

Code of Federal Regulations, 2013 CFR

2013-01-01

... of Fluorescent Lamp Ballasts Q Appendix Q to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. Q Appendix Q to Subpart B of Part 430—Uniform Test Method for Measuring the Energy Consumption of Fluorescent...

40 CFR Appendix A to Subpart Wwww... - Test Method for Determining Vapor Suppressant Effectiveness

Code of Federal Regulations, 2014 CFR

2014-07-01

...-alone test for emissions determination. This test is designed to evaluate the performance of film... production. This comparative test quantifies the loss of volatiles from a fiberglass reinforced laminate...-suppressed resins. 11.5Data Acceptance Criteria: 11.5.1A test set is designed as twelve individual test runs...

40 CFR Appendix A to Subpart Wwww... - Test Method for Determining Vapor Suppressant Effectiveness

Code of Federal Regulations, 2013 CFR

2013-07-01

...-alone test for emissions determination. This test is designed to evaluate the performance of film... production. This comparative test quantifies the loss of volatiles from a fiberglass reinforced laminate...-suppressed resins. 11.5Data Acceptance Criteria: 11.5.1A test set is designed as twelve individual test runs...

40 CFR Appendix A to Subpart Wwww... - Test Method for Determining Vapor Suppressant Effectiveness

Code of Federal Regulations, 2011 CFR

2011-07-01

... test for emissions determination. This test is designed to evaluate the performance of film forming... production. This comparative test quantifies the loss of volatiles from a fiberglass reinforced laminate...-suppressed resins. 11.5Data Acceptance Criteria: 11.5.1A test set is designed as twelve individual test runs...

40 CFR Appendix A to Subpart Wwww... - Test Method for Determining Vapor Suppressant Effectiveness

Code of Federal Regulations, 2010 CFR

2010-07-01

... test for emissions determination. This test is designed to evaluate the performance of film forming... production. This comparative test quantifies the loss of volatiles from a fiberglass reinforced laminate...-suppressed resins. 11.5Data Acceptance Criteria: 11.5.1A test set is designed as twelve individual test runs...

40 CFR Appendix A to Subpart Wwww... - Test Method for Determining Vapor Suppressant Effectiveness

Code of Federal Regulations, 2012 CFR

2012-07-01

...-alone test for emissions determination. This test is designed to evaluate the performance of film... production. This comparative test quantifies the loss of volatiles from a fiberglass reinforced laminate...-suppressed resins. 11.5Data Acceptance Criteria: 11.5.1A test set is designed as twelve individual test runs...

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

PubMed

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory acceptance of 3R testing approaches, including a process for collection of real-life data (safe harbour). Pathways for regulatory acceptance of 3R testing approaches are depicted and a new procedure for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches is described.

Comparison of DNA extraction methods for meat analysis.

PubMed

Yalçınkaya, Burhanettin; Yumbul, Eylem; Mozioğlu, Erkan; Akgoz, Muslum

2017-04-15

Preventing adulteration of meat and meat products with less desirable or objectionable meat species is important not only for economical, religious and health reasons, but also, it is important for fair trade practices, therefore, several methods for identification of meat and meat products have been developed. In the present study, ten different DNA extraction methods, including Tris-EDTA Method, a modified Cetyltrimethylammonium Bromide (CTAB) Method, Alkaline Method, Urea Method, Salt Method, Guanidinium Isothiocyanate (GuSCN) Method, Wizard Method, Qiagen Method, Zymogen Method and Genespin Method were examined to determine their relative effectiveness for extracting DNA from meat samples. The results show that the salt method is easy to perform, inexpensive and environmentally friendly. Additionally, it has the highest yield among all the isolation methods tested. We suggest this method as an alternative method for DNA isolation from meat and meat products. Copyright © 2016 Elsevier Ltd. All rights reserved.

Multi-material poly(lactic acid) scaffold fabricated via fused deposition modeling and direct hydroxyapatite injection as spacers in laminoplasty

NASA Astrophysics Data System (ADS)

Syuhada, Ghifari; Ramahdita, Ghiska; Rahyussalim, A. J.; Whulanza, Yudan

2018-02-01

Nowadays, additive manufacturing method has been used extensively to realize any product with specific attributes rather than the conventional subtractive manufacturing method. For instance, the additive manufacturing has enable us to construct a product layer-by-layer by successively depositing several materials in one session and one platform. This paper studied the properties of a 3D printed scaffold fabricated through Poly(Lactic-acid) (PLA) deposition modelling in combination with injectable hydroxyapatite (HA)/alginate as cell carrier. The scaffold was designed to serve as a spacer in cervical laminoplasty. Therefore, a series of test were conducted to elaborate the mechanical property, porosity and in-vitro toxicity testing. The results showed that the method is reliable to fabricate the scaffold as desired although the toxicity test needs more confirmation.

A review of modern instrumental techniques for measurements of ice cream characteristics.

PubMed

Bahram-Parvar, Maryam

2015-12-01

There is an increasing demand of the food industries and research institutes to have means of measurement allowing the characterization of foods. Ice cream, as a complex food system, consists of a frozen matrix containing air bubbles, fat globules, ice crystals, and an unfrozen serum phase. Some deficiencies in conventional methods for testing this product encourage the use of alternative techniques such as rheometry, spectroscopy, X-ray, electro-analytical techniques, ultrasound, and laser. Despite the development of novel instrumental applications in food science, use of some of them in ice cream testing is few, but has shown promising results. Developing the novel methods should increase our understanding of characteristics of ice cream and may allow online testing of the product. This review article discusses the potential of destructive and non-destructive methodologies in determining the quality and characteristics of ice cream and similar products. Copyright © 2015. Published by Elsevier Ltd.

15 CFR 10.0 - General.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., performance criteria, inspection requirements, marking requirements, testing equipment, test procedures and... purchase, installation, and use of the product being standardized. (b) Requirements for Department of... organization to such an extent that it would contain similar requirements and test methods for identical types...

"Product on Stopper" in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?

PubMed

Mehta, Shyam B; Roy, Shouvik; Yang, Han-Chang Cathy

2018-06-01

During manufacturing of a lyophilized drug product, operator errors in product handling during loading of product filled vials onto the lyophilizer can lead to a seemingly cosmetic defect which can impact certain critical quality attributes of finished product. In this study, filling of a formulated monoclonal antibody in vials was performed using a peristaltic pump filling unit, and subsequently, the product was lyophilized. After lyophilization, upon visual inspection, around 40% of vials had cosmetic defect with residual product around stopper of the vial and were categorized as "product on stopper" vials, whereas remaining 60% vials with no cosmetic defect were called "acceptable vials." Both groups of vials from 1 single batch were tested for critical quality attributes including protein concentration (ultraviolet absorbance at 280), residual moisture (Karl Fischer), sterility (membrane filtration), and container closure integrity (CCI) (blue dye ingress). Analysis of protein quality attributes such as aggregation, protein concentration, residual moisture showed no significant difference between vials with "product on stopper" and "acceptable vials." However, CCI of the "product on stopper" vials was compromised due to the presence of product around stopper of the vial. The results from this case study demonstrate the following 2 important findings: (1) that a seemingly cosmetic defect may impact product quality, compromising the integrity of the product and (2) that CCI test method can be used as an orthogonal method to sterility testing to evaluate sterility assurance of the product. The corrective action proposed to mitigate this defect is use of a larger sized vial that can potentially minimize this defect that arises because of product handling errors. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

40 CFR 60.85 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... flow rate of the effluent gas, dscm/hr (dscf/hr). P=production rate of 100 percent H2SO4, metric ton/hr... the volumetric flow rate and production rate: (i) The integrated technique of Method 3 is used to... mist and SO2 concentrations (C's) and the volumetric flow rate (Qsd) of the effluent gas. The moisture...

Testing of household products and materials for emission of toluene diisocyanate.

PubMed

Kelly, T J; Myers, J D; Holdren, M W

1999-06-01

Polyurethane products were subjected to chamber testing to determine their emission rates of 2,4- and 2,6-toluene diisocyanate (TDI). The polyurethane (PU) products included carpet padding, furniture cushions, sheet foam, varnishes, and sealants, as well as a commercially-applied water sealant product for concrete that contained up to 4 percent TDI by weight. The PU products were screened in a 9-L glass chamber, under elevated temperature and chamber loading conditions, using both a time-integrated sampling and analysis method specific for TDI and a continuous but non-specific real-time monitor for isocyanates. None of the products normally found in residences showed a positive response in the screening tests, indicating that TDI emissions and consequently toxic effects from such products are negligible. However, the commercially-applied water sealant gave a positive response in the screening test. Further testing of that product at realistic temperatures showed initial TDI emission rates of about 300,000 micrograms/m2/hr, with emissions lasting only one hour or less. At 21 and 27 degrees C, about 1 percent and 5 percent, respectively, of the TDI content of the product was released to the air. The emitted TDI was predominantly the 2,6-isomer, although the TDI originally present in the product was predominantly the 2,4-isomer.

Report Briefs: Publications of the Energy Division, Oak Ridge National Laboratory, 1999

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

Moser, C.I.

The Bureau of Labor Statistics (BLS) is responsible for collecting data to estimate price indices such as the Consumer Price Index (CPI). BLS accomplishes this task by sending field staff to places of business to price actual products. The field staff are given product checklists to help them determine whether the products found are comparable to products priced the previous month. Prices for noncomparable products are not included in the current month's price index calculations. A serious problem facing BLS is developing product checklists for dynamic product areas, new industries, and the service sector. It is difficult to keep checklistsmore » up to date and quite often simply to develop checklists for service industry products. Some people estimate that more than 50% of U.S. economic activity is not accounted for in the CPI. The objective it to provide the results of tests on a method for helping BLS staff build new product checklists quickly and efficiently. The domain chosen for studying the method was the telecommunications industry. The method developed by ORNL is based on behavioral science and knowledge-engineering principles. The method has ten steps, which include developing a sample of domain experts, asking experts to list products in the domain, culling the list of products to a manageable number, asking experts to group the remaining products, identifying product clusters using multidimensional scaling and cluster analysis, asking experts to compare pairs of products within clusters, and, finally, developing checklists with the comparison data. The method performed as expected. Several prototype checklists for products in the telecommunications domain were developed, including checklists for paging services, digital cell phones, web browsers, routers, and LAN modems. It was particularly difficult, however, to find experts to participate in the project. Attending a professional meeting and contacting experts from the conference's mailing list proved to be the best approach for this domain. The method has performed well in two domains: the telecommunications industry, as demonstrated in this project, and the PC software industry, as demonstrated in a previous project. It is recommended that the method be further tested in additional service industries, such as the nursing home industry. In addition, further attention needs to be devoted to developing procedures for the method to improve its cost and time efficiency. For example, if automated methods were used to collect information from the experts and if the experts could be assembled at one time, it could be possible to create prototype checklists in one day.« less

Culture-Independent Metagenomic Surveillance of Commercially Available Probiotics with High-Throughput Next-Generation Sequencing.

PubMed

Patro, Jennifer N; Ramachandran, Padmini; Barnaba, Tammy; Mammel, Mark K; Lewis, Jada L; Elkins, Christopher A

2016-01-01

Millions of people consume dietary supplements either following a doctor's recommendation or at their own discretion to improve their overall health and well-being. This is a rapidly growing trend, with an associated and expanding manufacturing industry to meet the demand for new health-related products. In this study, we examined the contents and microbial viability of several popular probiotic products on the United States market. Culture-independent methods are proving ideal for fast and efficient analysis of foodborne pathogens and their associated microbial communities but may also be relevant for analyzing probiotics containing mixed microbial constituents. These products were subjected to next-generation whole-genome sequencing and analyzed by a custom in-house-developed k-mer counting method to validate manufacturer label information. In addition, the batch variability of respective products was examined to determine if any changes in their formulations and/or the manufacturing process occurred. Overall, the products we tested adhered to the ingredient claims and lot-to-lot differences were minimal. However, there were a few discrepancies in the naming of closely related Lactobacillus and Bifidobacterium species, whereas one product contained an apparent Enterococcus contaminant in two of its three lots. With the microbial contents of the products identified, we used traditional PCR and colony counting methods to comparatively assess our results and verify the viability of the microbes in these products with regard to the labeling claims. Of all the supplements examined, only one was found to be inaccurate in viability. Our use of next-generation sequencing as an analytical tool clearly demonstrated its utility for quickly analyzing commercially available products containing multiple microbes to ensure consumer safety. IMPORTANCE The rapidly growing supplement industry operates without a formal premarket approval process. Consumers rely on product labels to be accurate and true. Those products containing live microbials report both identity and viability on most product labels. This study used next-generation sequencing technology as an analytical tool in conjunction with classic culture methods to examine the validity of the labels on supplement products containing live microbials found in the United States marketplace. Our results show the importance of testing these products for identity, viability, and potential contaminants, as well as introduce a new culture-independent diagnostic approach for testing these products. Podcast: A podcast concerning this article is available.

Culture-Independent Metagenomic Surveillance of Commercially Available Probiotics with High-Throughput Next-Generation Sequencing

PubMed Central

Patro, Jennifer N.; Ramachandran, Padmini; Barnaba, Tammy; Mammel, Mark K.; Lewis, Jada L.

2016-01-01

ABSTRACT Millions of people consume dietary supplements either following a doctor’s recommendation or at their own discretion to improve their overall health and well-being. This is a rapidly growing trend, with an associated and expanding manufacturing industry to meet the demand for new health-related products. In this study, we examined the contents and microbial viability of several popular probiotic products on the United States market. Culture-independent methods are proving ideal for fast and efficient analysis of foodborne pathogens and their associated microbial communities but may also be relevant for analyzing probiotics containing mixed microbial constituents. These products were subjected to next-generation whole-genome sequencing and analyzed by a custom in-house-developed k-mer counting method to validate manufacturer label information. In addition, the batch variability of respective products was examined to determine if any changes in their formulations and/or the manufacturing process occurred. Overall, the products we tested adhered to the ingredient claims and lot-to-lot differences were minimal. However, there were a few discrepancies in the naming of closely related Lactobacillus and Bifidobacterium species, whereas one product contained an apparent Enterococcus contaminant in two of its three lots. With the microbial contents of the products identified, we used traditional PCR and colony counting methods to comparatively assess our results and verify the viability of the microbes in these products with regard to the labeling claims. Of all the supplements examined, only one was found to be inaccurate in viability. Our use of next-generation sequencing as an analytical tool clearly demonstrated its utility for quickly analyzing commercially available products containing multiple microbes to ensure consumer safety. IMPORTANCE The rapidly growing supplement industry operates without a formal premarket approval process. Consumers rely on product labels to be accurate and true. Those products containing live microbials report both identity and viability on most product labels. This study used next-generation sequencing technology as an analytical tool in conjunction with classic culture methods to examine the validity of the labels on supplement products containing live microbials found in the United States marketplace. Our results show the importance of testing these products for identity, viability, and potential contaminants, as well as introduce a new culture-independent diagnostic approach for testing these products. Podcast: A podcast concerning this article is available. PMID:27303722

Analysis of formation pressure test results in the Mount Elbert methane hydrate reservoir through numerical simulation

USGS Publications Warehouse

Kurihara, M.; Sato, A.; Funatsu, K.; Ouchi, H.; Masuda, Y.; Narita, H.; Collett, T.S.

2011-01-01

Targeting the methane hydrate (MH) bearing units C and D at the Mount Elbert prospect on the Alaska North Slope, four MDT (Modular Dynamic Formation Tester) tests were conducted in February 2007. The C2 MDT test was selected for history matching simulation in the MH Simulator Code Comparison Study. Through history matching simulation, the physical and chemical properties of the unit C were adjusted, which suggested the most likely reservoir properties of this unit. Based on these properties thus tuned, the numerical models replicating "Mount Elbert C2 zone like reservoir" "PBU L-Pad like reservoir" and "PBU L-Pad down dip like reservoir" were constructed. The long term production performances of wells in these reservoirs were then forecasted assuming the MH dissociation and production by the methods of depressurization, combination of depressurization and wellbore heating, and hot water huff and puff. The predicted cumulative gas production ranges from 2.16??106m3/well to 8.22??108m3/well depending mainly on the initial temperature of the reservoir and on the production method.This paper describes the details of modeling and history matching simulation. This paper also presents the results of the examinations on the effects of reservoir properties on MH dissociation and production performances under the application of the depressurization and thermal methods. ?? 2010 Elsevier Ltd.

Development of advanced test methods for the improvement of production standards for ceramic powders used in solid oxide fuel cells

NASA Astrophysics Data System (ADS)

Ward, Brian

Solid oxide fuel cells (SOFCs) are energy conversion devices that use ceramic powders as a precursor material for their electrodes. Presently, powder manufacturers are encountering complications producing consistent precursor powders. Through various thermal, chemical and physical tests, such as DSC and XRD, a preliminary production standard will be developed.

Chest Wall Motion during Speech Production in Patients with Advanced Ankylosing Spondylitis

ERIC Educational Resources Information Center

Kalliakosta, Georgia; Mandros, Charalampos; Tzelepis, George E.

2007-01-01

Purpose: To test the hypothesis that ankylosing spondylitis (AS) alters the pattern of chest wall motion during speech production. Method: The pattern of chest wall motion during speech was measured with respiratory inductive plethysmography in 6 participants with advanced AS (5 men, 1 woman, age 45 plus or minus 8 years, Schober test 1.45 plus or…

40 CFR 63.772 - Test methods, compliance procedures, and compliance demonstrations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Oil and Natural Gas Production Facilities § 63.772 Test methods, compliance procedures, and compliance...) A mixture of methane in air at a concentration less than 10,000 parts per million by volume. (5) An... methane and ethane) or total HAP (Ei, Eo) shall be computed using the equations and procedures specified...

40 CFR 63.772 - Test methods, compliance procedures, and compliance demonstrations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Oil and Natural Gas Production Facilities § 63.772 Test methods, compliance procedures, and compliance...) A mixture of methane in air at a concentration less than 10,000 parts per million by volume. (5) An... methane and ethane) or total HAP (Ei, Eo) shall be computed using the equations and procedures specified...

77 FR 61610 - Interagency Coordinating Committee on the Validation of Alternative Methods Evaluation Report and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... Chemical Eye Hazards With Fewer Animals; Availability of Report; Notice of Transmittal to Federal Agencies... (ICCVAM) test method evaluation report (TMER) that provides recommendations for identifying chemical eye... animals in a three-animal test to identify chemicals and products that are eye hazards will maintain...

75 FR 66735 - National Fire Protection Association (NFPA): Request for Comments on NFPA's Codes and Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-29

... Ignitibility of Exterior Wall Assemblies Using a Radiant Heat Energy Source. NFPA 269 Standard Test Method P... for Heat and Visible Smoke Release Rates for Materials and Products Using an Oxygen Consumption... Plastic Insulation. NFPA 285 Standard Fire Test P Method for Evaluation of Fire Propagation...

40 CFR Table I-12 to Subpart I of... - Default Emission Factors (1-Uij) for Gas Utilization Rates (Uij) and By-Product Formation Rates...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Use With the Stack Test Method (300 mm and 450 mm Wafers) I Table I-12 to Subpart I of Part 98... (Bijk) for Semiconductor Manufacturing for Use With the Stack Test Method (300 mm and 450 mm Wafers...

40 CFR Table I-11 to Subpart I of... - Default Emission Factors (1-Uij) for Gas Utilization Rates (Uij) and By-Product Formation Rates...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Use With the Stack Test Method (150 mm and 200 mm Wafers) I Table I-11 to Subpart I of Part 98... (Bijk) for Semiconductor Manufacturing for Use With the Stack Test Method (150 mm and 200 mm Wafers...

Applications of laser ultrasound NDT methods on composite structures in aerospace industry

NASA Astrophysics Data System (ADS)

Kalms, Michael; Focke, Oliver; v. Kopylow, Christoph

2008-09-01

Composite materials are used more and more in aircraft production. Main composite types are Carbon Fiber Reinforced Plastics (CFRP), Glass Fiber Reinforced Plastics (GFRP) and metal-aluminium laminates (e. g. Glass Fiber Aluminium Reinforced GLARE©). Typical parts made of CFRP material are flaps, vertical and horizontal tail planes, center wing boxes, rear pressure bulkheads, ribs and stringers. These composite parts require adequate nondestructive testing (NDT) methods. Flaws to be detected are delaminations and debondings, porosity and foreign body inclusion. Manual ultrasonic testing with single element transducers is still the most applied method for composite parts with small and medium size. The extension of the conventional ultrasound technique for nondestructive testing with the laser ultrasound method brings new possibilities into the production processes for example the inspection of complex CFRP-components and the possibilities of online observation under remote control. In this paper we describe the principle of laser ultrasound with respect to the demands of nondestructive testing especially of small complex CFRP and C/PPS parts. We report applications of laser-based ultrasound options with generated types of guided and bulk waves on modern aircraft materials.

Development of a high temperature microbial fermentation process for butanol

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

Jeor, Jeffery D. St.; Reed, David W.; Daubaras, Dayna L.

2015-08-01

Transforming renewable biomass into cost-competitive high-performance biofuels and bioproducts is key to the U.S. future energy and chemical needs. Butanol production by microbial fermentation for chemical conversion to polyolefins, elastomers, drop-in jet or diesel fuel, and other chemicals is a promising solution. A high temperature fermentation process could decrease energy costs, capital cost, give higher butanol production, and allow for continuous fermentation. In this paper, we describe our approach to genetically transform Geobacillus caldoxylosiliticus, using a pUCG18 plasmid, for potential insertion of a butanol production pathway. Transformation methods tested were electroporation of electrocompetent cells, ternary conjugation with E. coli donormore » and helper strains, and protoplast fusion. These methods have not been successful using the current plasmid. Growth controls show cells survive the various methods tested, suggesting the possibility of transformation inhibition from a DNA restriction modification system in G. caldoxylosiliticus, as reported in the literature.« less

Identification of polar volatile organic compounds in consumer products and common microenvironments

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

Wallace, L.A.; Nelson, W.C.; Pellizzari, E.

1991-03-01

Polar volatile organic compounds were identified in the headspace of 31 fragrance products such as perfumes, colognes and soaps. About 150 different chemicals were identified in a semiquantitative fashion, using two methods to analyze the headspace: direct injection into a gas chromatograph and collection by an evacuated canister, each followed by GC-MS analysis. The canister method displayed low recoveries for most of the 25 polar chemical standards tested. However, reconstructed ion chromatograms (RICs) from the canister showed good agreement with RICs from the direct injection method except for some high boiling point compounds. Canister samples collected in 15 microenvironments expectedmore » to contain the fragrance products tested (potpourri stores, fragrance sections of department stores, etc.) showed relatively low concentrations of most of these polar chemicals compared with certain common nonpolar chemicals. The results presented will be useful for models of personal exposure and indoor air quality.« less

The water flea Daphnia magna (Crustacea, Cladocera) as a test species for screening and evaluation of chemicals with endocrine disrupting effects on crustaceans.

PubMed

Tatarazako, Norihisa; Oda, Shigeto

2007-02-01

The water flea Daphnia magna (Crustacea, Cladocera) is a cyclical parthenogen, which can reproduce both by parthenogenesis and by sexual reproduction. With its ease of handling in the laboratory, several testing methods using D. magna exist for regulatory toxicity testing. Recently, several studies revealed that one of the major hormone groups in insects and crustaceans, juvenile hormones, are involved in the shift of reproductive mode from parthenogenesis to sexual reproduction (production of male neonates). Using offspring sex ratio as a new endpoint has made it possible to identify chemicals with juvenile hormone-like effects on crustaceans. The testing method using D. magna, in which offspring sex ratio is incorporated as a new endpoint, is now being proposed to the OECD as an enhanced version of the existing OECD Test Guideline 211: Daphnia magna reproduction test. No other clear-cut endpoint for identifying juvenile-hormone disrupting effects has ever been found in crustaceans than the induction of male neonates production in cladocerans. In this regard, it is expected that testing methods using D. magna are suitable for screening and risk assessment of chemicals with juvenile-hormone disrupting effects.

Prediction of global ionospheric VTEC maps using an adaptive autoregressive model

NASA Astrophysics Data System (ADS)

Wang, Cheng; Xin, Shaoming; Liu, Xiaolu; Shi, Chuang; Fan, Lei

2018-02-01

In this contribution, an adaptive autoregressive model is proposed and developed to predict global ionospheric vertical total electron content maps (VTEC). Specifically, the spherical harmonic (SH) coefficients are predicted based on the autoregressive model, and the order of the autoregressive model is determined adaptively using the F-test method. To test our method, final CODE and IGS global ionospheric map (GIM) products, as well as altimeter TEC data during low and mid-to-high solar activity period collected by JASON, are used to evaluate the precision of our forecasting products. Results indicate that the predicted products derived from the model proposed in this paper have good consistency with the final GIMs in low solar activity, where the annual mean of the root-mean-square value is approximately 1.5 TECU. However, the performance of predicted vertical TEC in periods of mid-to-high solar activity has less accuracy than that during low solar activity periods, especially in the equatorial ionization anomaly region and the Southern Hemisphere. Additionally, in comparison with forecasting products, the final IGS GIMs have the best consistency with altimeter TEC data. Future work is needed to investigate the performance of forecasting products using the proposed method in an operational environment, rather than using the SH coefficients from the final CODE products, to understand the real-time applicability of the method.

Comparison of three DNA extraction methods for the detection and quantification of GMO in Ecuadorian manufactured food.

PubMed

Pacheco Coello, Ricardo; Pestana Justo, Jorge; Factos Mendoza, Andrés; Santos Ordoñez, Efrén

2017-12-20

In Ecuador, food products need to be labeled if exceeded 0.9% of transgenic content in whole products. For the detection of genetically modified organisms (GMOs), three DNA extraction methods were tested in 35 food products commercialized in Ecuador. Samples with positive amplification of endogenous genes were screened for the presence of the Cauliflower mosaic virus 35S-promoter (P35S) and the nopaline synthase-terminator (Tnos). TaqMan™ probes were used for determination of transgenic content of the GTS 40-3-2 and MON810 events through quantitative PCR (qPCR). Twenty-six processed food samples were positive for the P35S alone and eight samples for the Tnos and P35S. Absolute qPCR results indicated that eleven samples were positive for GTS 40-3-2 specific event and two for MON810 specific event. A total of nine samples for events GTS 40-3-2 and MON810 exceeded the umbral allowed of transgenic content in the whole food product with the specific events. Different food products may require different DNA extraction protocols for GMO detection through PCR. Among the three methods tested, the DNeasy mericon food kit DNA extraction method obtained higher proportion of amplified endogenous genes through PCR. Finally, event-specific GMOs were detected in food products in Ecuador.

The effect of sea-water and fresh-water soaking on the hedonic test of Eucheuma sp. syrup and pudding

NASA Astrophysics Data System (ADS)

Novianty, H.; Herandarudewi, S. M. C.

2018-04-01

Seaweed is a non-fishery marine commodity that has great opportunities to be developed in Indonesia. One of the seaweed with a high economic value is Eucheuma alvarezii. This seaweed can be used as an additional material in cosmetic and pharmaceutical products or directly used for syrup and pudding. Post-harvest technique conducted by the seaweed farmers will affects the quality of dried and processed products. The purpose of this study is to see the effect of post harvest technique on the quality of dried seaweed and hedonic test (favorable test) of processed product (syrup and pudding). This study was conducted using descriptive method. The study compared dried, syrup, and puddings from two differents post-harvest technique, between salt and fresh-water draining products. The results showed that fresh-water draining technique obtained better quality results organoleptic test. Supported by hedonic test, that showed more panelists were prefered the fresh-water drained products of syrup and pudding. The preference were much higher for the fresh-water drained products in all three catagories of color, taste, and smell.

Cryptosporidium oocysts and giardia cysts on salad products irrigated with contaminated water.

PubMed

Amorós, Inmaculada; Alonso, José L; Cuesta, Gonzalo

2010-06-01

A field study in Valencia, Spain, was done to determine the occurrence of Giardia and Cryptosporidium on salad products that are frequently eaten raw, such as lettuces and Chinese cabbage, and in irrigation waters. Four water samples were taken weekly 1 month before harvesting the vegetables. All water samples were analyzed using techniques included in the U.S. Environmental Protection Agency Method 1623. Standard methods for detecting protozoan parasites on salad vegetables are not available. Published techniques for the isolation of parasites from vegetables generally have low and variable recovery efficiencies. In this study, vegetables were analyzed using a recently reported method for detection of Cryptosporidium oocysts and Giardia cysts on salad products. The waters tested were positive for both Cryptosporidium and Giardia. Of 19 salad products studied, we observed Cryptosporidium in 12 samples and Giardia in 10 samples. Recoveries of the Texas Red-stained Cryptosporidium and Giardia, which were used as internal controls, were 24.5% +/- 3.5% for Cryptosporidium and 16.7% +/- 8.1% for Giardia (n = 8). This study provides data on the occurrence of Cryptosporidium and Giardia in salad products in Spain. The method was useful in the detection of Cryptosporidium oocysts and Giardia cysts on the vegetables tested, and it provides a useful analytical tool for occurrence monitoring.

Testing and characterizations of infrared sensor over the temperature range of 2 Kelvin to 300 Kelvin

NASA Technical Reports Server (NTRS)

Hansen, R. G.

1983-01-01

Various cryogenic techniques were used to evaluate state of the art electro-optic devices. As research, development, and production demands require more sensitive testing techniques, faster test results, and higher production throughput, the emphasis on supporting cryogenic systems increases. The three traditional methods currently utilized in electro-optic device testing are discussed: (1) liquid contaiment dewars; (2) liquid transfer systems; and (3) closed cycle refrigeration systems. Advantages, disadvantages, and the current state of the art of each of these cryogenic techniques is discussed.

Evaluation of Alternative Methods for Testing the Bioefficacy of Household Ambient Insecticide Products Against Aedes albopictus.

PubMed

Cassini, Rudi; Scremin, Mara; Contiero, Barbara; Drago, Andrea; Vettorato, Christian; Marcer, Federica; di Regalbono, Antonio Frangipane

2016-06-01

Ambient insecticides are receiving increasing attention in many developed countries because of their value in reducing mosquito nuisance. As required by the European Union Biocidal Products Regulation 528/2012, these devices require appropriate testing of their efficacy, which is based on estimating the knockdown and mortality rates of free-flying (free) mosquitoes in a test room. However, evaluations using free mosquitoes present many complexities. The performances of 6 alternative methods with mosquitoes held in 2 different cage designs (steel wire and gauze/plastic) with and without an operating fan for air circulation were monitored in a test room through a closed-circuit television system and were compared with the currently recommended method using free mosquitoes. Results for caged mosquitoes without a fan showed a clearly delayed knockdown effect, whereas outcomes for caged mosquitoes with a fan recorded higher mortality at 24 h, compared to free mosquitoes. Among the 6 methods, cages made of gauze and plastic operating with fan wind speed at 2.5-2.8 m/sec was the only method without a significant difference in results for free mosquitoes, and therefore appears as the best alternative to assess knockdown by ambient insecticides accurately.

Preparation of pyrolysis reference samples: evaluation of a standard method using a tube furnace.

PubMed

Sandercock, P Mark L

2012-05-01

A new, simple method for the reproducible creation of pyrolysis products from different materials that may be found at a fire scene is described. A temperature programmable steady-state tube furnace was used to generate pyrolysis products from different substrates, including softwoods, paper, vinyl sheet flooring, and carpet. The temperature profile of the tube furnace was characterized, and the suitability of the method to reproducibly create pyrolysates similar to those found in real fire debris was assessed. The use of this method to create proficiency tests to realistically test an examiner's ability to interpret complex gas chromatograph-mass spectrometric fire debris data, and to create a library of pyrolsates generated from materials commonly found at a fire scene, is demonstrated. © 2011 American Academy of Forensic Sciences.

An effective identification and quantification method for Ginkgo biloba flavonol glycosides with targeted evaluation of adulterated products.

PubMed

Ma, Yuan-Chun; Mani, Ana; Cai, Yaling; Thomson, Jaclyn; Ma, Jie; Peudru, Flavie; Chen, Sarah; Luo, Mai; Zhang, Junzeng; Chapman, Robert G; Shi, Zhen-Tuo

2016-04-15

Ginkgo biloba L. (Ginkgoaceae) leaf extract is one of the most popular herbal products on the market, as it contains flavone glycosides (≥ 24%) and terpene lactones (≥ 6%), which are proposed to have significant physiological effects. Unfortunately, the challenging financial climate has resulted in a natural health product market containing adulterated ginkgo products. 42 ginkgo samples were analyzed to establish an HPLC profile for authentic ginkgo and common ginkgo adulterants, and to develop a method capable of easily detecting adulteration in ginkgo commercial products. In this study an efficient and targeted HPLC analysis method was established that is capable of distinguishing flavonol glycosides and aglycones simultaneously for the evaluation of ginkgo powdered extracts (PEs) and finished products in a single, 13 min run. Thirteen ginkgo leaf samples, fifteen standardized powdered extracts, and fourteen commercially available ginkgo products have been analyzed using this new HPLC method. Chromatograms were compared to six standard reference materials: one flavonol glycoside (rutin), three aglycones (quercetin, kaempferol and isorhamnetin), and two isoflavones (genestin and genistein). The quantitative chromatographic data was interpreted by principal component analysis (PCA), which assisted in the detection of unexpected chromatographic features in various adulterated botanical products. Only three of the commercially available ginkgo finished products tested in this study were determined to be authentic, with flavonol glycoside rutin, and aglycones quercetin, kaempferol, and isorhamnetin found to be common adulterants in the ginkgo powdered extract and finished product samples. Despite evidence of adulteration in most of the samples, each of the samples discussed herein met most of the current pharmacopeial standards. It is therefore critical that a preliminary evaluation be utilized to detect adulteration in commercial ginkgo products, prior to the acid hydrolysis procedure utilized in the current testing methods. Copyright © 2016 Elsevier GmbH. All rights reserved.

Enterotoxigenic coagulase positive Staphylococcus in milk and milk products, lben and jben, in northern Morocco.

PubMed

Bendahou, Abdrezzak; Abid, Mohammed; Bouteldoun, Nadine; Catelejine, Dierick; Lebbadi, Mariam

2009-04-30

The aim of this research was to determine the prevalence of enterotoxin genes (sea-seo) in Coagulase Positive Staphylococcus (CPS) isolated from unpasteurized milk and milk products. These results were compared with the results obtained by using the detection kit SET-RPLA for the specific detection of staphylococcal enterotoxins (SEA-SED). Eighty-one samples of milk and milk products were analyzed for the presence of Staphylococcus strains. Forty-six coagulase positive Staphylococcus isolates were tested for the production of staphylococcal enterotoxins (SEA-SED) by using the reversed passive latex agglutination method. The strains were also tested for the presence of se genes (sea-seo) by polymerase chain reaction. One or more classical enterotoxin products (SEA-SED) were observed in 39% of the strains tested, while se genes were detected in 56.5%. SEA and sea were most commonly detected. For newly discovered se genes among CPS isolates tested in this study, except the seh gene which was revealed in four isolates (8.7 %), none of the strains harbored any of the other se genes (see, seg, sei, sej, sek, sel, sem, seo and sen). The finding of a pathogen such as staphylococci-producing SEs and containing se genes in milk and milk products in northern Morocco may indicate a problem for public health in this region. The presence of enterotoxigenic strains in food does not always necessarily mean that the toxin will be produced. For that reason, the combination of both methods (RPLA and PCR) is a guarantee for success in diagnostic analysis tests.

Development and Validation of New Discriminative Dissolution Method for Carvedilol Tablets

PubMed Central

Raju, V.; Murthy, K. V. R.

2011-01-01

The objective of the present study was to develop and validate a discriminative dissolution method for evaluation of carvedilol tablets. Different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. The best in vitro dissolution profile was obtained using Apparatus II (paddle), 50 rpm, 900 ml of pH 6.8 phosphate buffer as dissolution medium. The drug release was evaluated by high-performance liquid chromatographic method. The dissolution method was validated according to current ICH and FDA guidelines using parameters such as the specificity, accuracy, precision and stability were evaluated and obtained results were within the acceptable range. The comparison of the obtained dissolution profiles of three different products were investigated using ANOVA-based, model-dependent and model-independent methods, results showed that there is significant difference between the products. The dissolution test developed and validated was adequate for its higher discriminative capacity in differentiating the release characteristics of the products tested and could be applied for development and quality control of carvedilol tablets. PMID:22923865

Antimicrobial drug residues in milk and meat: causes, concerns, prevalence, regulations, tests, and test performance.

PubMed

Mitchell, J M; Griffiths, M W; McEwen, S A; McNab, W B; Yee, A J

1998-06-01

This paper presents a historical review of antimicrobial use in food animals, the causes of residues in meat and milk, the types of residues found, their regulation in Canada, tests used for their detection, and test performance parameters, with an emphasis on immunoassay techniques. The development of residue detection methods began shortly after the introduction of antimicrobials to food animal production in the late 1940s. From initial technical concerns expressed by the dairy industry to the present public health and international trade implications, there has been an ongoing need for reliable, sensitive, and economical methods for the detection of antimicrobial residues in food animal products such as milk and meat. Initially there were microbial growth inhibition tests, followed by more sensitive and specific methods based on receptor binding, immunochemical, and chromatographic principle. An understanding of basic test performance parameters and their implications is essential when choosing an analytical strategy for residue testing. While each test format has its own attributes, none test will meet all the required analytical needs. Therefore the use of a tiered or integrated system employing assays designated for screening and confirmation is necessary to ensure that foods containing violative residues are not introduced into the food chain.

Influence of climatic conditions on antiperspirant efficacy determined at different test areas.

PubMed

Brandt, Marianne; Bielfeldt, Stephan; Springmann, Gunja; Wilhelm, Klaus-Peter

2008-05-01

The efficacy of antiperspirants is a current topic among the developers of cosmetic products. According to the Food and Drug Administration (FDA) for the US market, efficacy testing performed in the axilla of human volunteers is mandatory. Another method is yet available, which enables comparison of more than one antiperspirant formula in a single study by performing the test on the backs of volunteers. However, how reproducible are these methods, comparing between the back and axilla? Do they differ as a result of seasonal variation? Is a correlation between the results of the two methods possible? To answer these questions, the antiperspirant efficacy of aluminium chlorohydrate (ACH) aqueous solutions was investigated in the axilla and on the backs of volunteers, in four separate clinical studies covering cold and warm seasons. Four days of product application were followed by thermal sweat induction on the fifth day, using a sauna. The amount of sweat recovered by weighing cotton pads before and after sweat induction was used to calculate sweat reduction. Testing in the axilla and on the back was performed on the same volunteers simultaneously to achieve the best comparable data. For this reason, the FDA guideline was slightly modified to thermal stimulation in a sauna instead of in a hot room. Increasing concentrations of ACH in aqueous solutions on the backs of volunteers showed a saturation for 8% ACH with a sweat reduction of approximately 50%. The antiperspirant efficacy of solutions containing 4%, 8% or 12% ACH was repeatedly found at the same levels, when tested on the backs during summer, autumn and winter time. Axilla tests, with an 8% ACH aqueous solution, showed strongly varying results for summer and winter time, represented by sweat reduction values of -2% to 25%. As an assumption, these high variations might result from reduced gel formation in cold seasons due to low humidity in the axillae during the application phase. On the back, this effect was avoided by applying occlusive foils after product application. To gain further insight, a study, during which summer conditions were artificially simulated by thermal stimulation during the application phase, again showed decreased antiperspirant efficacy in the axilla for winter conditions with sweat reduction values of 2%, compared with 25% under simulated summer conditions. These strongly varying values of sweat reduction in the axilla under summer and winter conditions make comparisons between antiperspirant products difficult and a statement about correlation between the two test sites back and axilla impossible. A standardization of the application phase, comparable to the simulated summer conditions described here, could be a solution to reduce the high variation of results in the axilla. Consequently, testing on the back is not only a more cost-effective method to investigate the antiperspirant efficacy of more than one formulation, but a reproducible method more independent of climatic influences during test implementation than the axilla test method. It could, therefore, be regarded as the method of choice for discriminating antiperspirant efficacy between several products during development of new antiperspirant formulations.

An efficient, maintenance free and approved method for spectroscopic control and monitoring of blend uniformity: The moving F-test.

PubMed

Besseling, Rut; Damen, Michiel; Tran, Thanh; Nguyen, Thanh; van den Dries, Kaspar; Oostra, Wim; Gerich, Ad

2015-10-10

Dry powder mixing is a wide spread Unit Operation in the Pharmaceutical industry. With the advent of in-line Near Infrared (NIR) Spectroscopy and Quality by Design principles, application of Process Analytical Technology to monitor Blend Uniformity (BU) is taking a more prominent role. Yet routine use of NIR for monitoring, let alone control of blending processes is not common in the industry, despite the improved process understanding and (cost) efficiency that it may offer. Method maintenance, robustness and translation to regulatory requirements have been important barriers to implement the method. This paper presents a qualitative NIR-BU method offering a convenient and compliant approach to apply BU control for routine operation and process understanding, without extensive calibration and method maintenance requirements. The method employs a moving F-test to detect the steady state of measured spectral variances and the endpoint of mixing. The fundamentals and performance characteristics of the method are first presented, followed by a description of the link to regulatory BU criteria, the method sensitivity and practical considerations. Applications in upscaling, tech transfer and commercial production are described, along with evaluation of the method performance by comparison with results from quantitative calibration models. A full application, in which end-point detection via the F-test controls the blending process of a low dose product, was successfully filed in Europe and Australia, implemented in commercial production and routinely used for about five years and more than 100 batches. Copyright © 2015 Elsevier B.V. All rights reserved.

A new standardized method for quantification of humic and fulvic acids in humic ores and commercial products.

PubMed

Lamar, Richard T; Olk, Daniel C; Mayhew, Lawrence; Bloom, Paul R

2014-01-01

Increased use of humic substances in agriculture has generated intense interest among producers, consumers, and regulators for an accurate and reliable method to quantify humic acid (HA) and fulvic acid (FA) in raw ores and products. Here we present a thoroughly validated method, the new standardized method for determination of HA and FA contents in raw humate ores and in solid and liquid products produced from them. The methods used for preparation of HA and FA were adapted according to the guidelines of the International Humic Substances Society involving alkaline extraction followed by acidification to separate HA from the fulvic fraction. This is followed by separation of FA from the fulvic fraction by adsorption on a nonionic macroporous acrylic ester resin at acid pH. It differs from previous methods in that it determines HA and FA concentrations gravimetrically on an ash-free basis. Critical steps in the method, e.g., initial test portion mass, test portion to extract volume ratio, extraction time, and acidification of alkaline extract, were optimized for maximum and consistent recovery of HA and FA. The method detection limits for HA and FA were 4.62 and 4.8 mg/L, respectively. The method quantitation limits for HA and FA were 14.7 and 15.3 mg/L, respectively.

46 CFR 57.06-3 - Method of performing production testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 57.06-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING WELDING... attached test plates, the weld metal shall be deposited in the test plate welding groove continuously with... inspector may permit the use of separate test plates, provided the same welding process, procedure, and...

46 CFR 57.06-3 - Method of performing production testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 57.06-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING WELDING... attached test plates, the weld metal shall be deposited in the test plate welding groove continuously with... inspector may permit the use of separate test plates, provided the same welding process, procedure, and...

46 CFR 57.06-3 - Method of performing production testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 57.06-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING WELDING... attached test plates, the weld metal shall be deposited in the test plate welding groove continuously with... inspector may permit the use of separate test plates, provided the same welding process, procedure, and...

46 CFR 57.06-3 - Method of performing production testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 57.06-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING WELDING... attached test plates, the weld metal shall be deposited in the test plate welding groove continuously with... inspector may permit the use of separate test plates, provided the same welding process, procedure, and...

46 CFR 57.06-3 - Method of performing production testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 57.06-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING WELDING... attached test plates, the weld metal shall be deposited in the test plate welding groove continuously with... inspector may permit the use of separate test plates, provided the same welding process, procedure, and...

77 FR 31742 - Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

.... Test Procedure for Commercial Prerinse Spray Valves 4. Design Requirements for Showerheads 5... procedures prescribed or amended under this section shall be reasonably designed to produce test results...] American Society for Testing and Materials [ASTM] Standard F2324, entitled `Standard Test Method for Pre...

77 FR 49063 - Energy Conservation Program: Test Procedures for Residential Dishwashers and Cooking Products

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

...The U.S. Department of Energy (DOE) proposes to amend its test procedures for residential dishwashers to update certain obsolete dishware, flatware and food items, make minor amendments to the definition of the normal cycle, and update the ambient temperature and preconditioning requirements as well as the industry test method referenced in DOE's test procedure. DOE also proposes to add water pressure, drain height, rack position, loading, rinse aid container, and soil preparation specifications to the dishwasher test procedure. DOE additionally proposes to amend the test procedures for both dishwashers and conventional cooking products for the measurement of energy use in fan-only mode.

Bio-diesel production directly from the microalgae biomass of Nannochloropsis by microwave and ultrasound radiation.

PubMed

Koberg, Miri; Cohen, Moshe; Ben-Amotz, Ami; Gedanken, Aharon

2011-03-01

This work offers an optimized method for the direct conversion of harvested Nannochloropsis algae into bio-diesel using two novel techniques. The first is a unique bio-technology-based environmental system utilizing flue gas from coal burning power stations for microalgae cultivation. This method reduces considerably the cost of algae production. The second technique is the direct transesterification (a one-stage method) of the Nannochloropsis biomass to bio-diesel production using microwave and ultrasound radiation with the aid of a SrO catalyst. These two techniques were tested and compared to identify the most effective bio-diesel production method. Based on our results, it is concluded that the microwave oven method appears to be the most simple and efficient method for the one-stage direct transesterification of the as-harvested Nannochloropsis algae. Copyright © 2010 Elsevier Ltd. All rights reserved.

Equation of State of Detonation Products for TNT by Aquarium Technique

NASA Astrophysics Data System (ADS)

Han, Yong

2017-06-01

During explosive detonation, the detonation pressure (P) and temperature (T) will decay quickly with the expansion of detonation products, and the damage effect is determined by the thermodynamic state of detonation products under high pressure. The traditional and important method for calibrating the parameters of thermodynamic state is cylinder test, but the results showed that when the cylinder expanded to a certain distance, the cylinder wall would break up and the detonation products would jet out, which would affect the accuracy of the calibration parameters of thermodynamic state. In this paper, the aquarium technique was used to study the detonation product thermodynamic state of TNT explosive, obtaining the shock wave track under the water and the trace of the interface between water and detonation products in the specific position with the high speed rotating mirror camera. By thermodynamic calculation program BKW and VHL, the parameters of equation of state were obtained. Using the parameters and the dynamic software LS-DYNA, the underwater explosion of TNT was simulated. Comparison with experimental results shows that the thermodynamic state parameters which is calculated by VHL is more accurate than that of BKW. It is concluded that the aquarium test is a more effective method to calibrate the thermodynamic state than cylinder test.

Best Technical Approach for the Petroleum Quality Analysis (PQA) System

DTIC Science & Technology

1994-08-01

two test methods for determination of water content in a fuel. The Karl Fischer titration method (ASTM D 1744) measures for total water, both...difficult to automate. ASTM D 664, "Standard Test Method for Acid Number of Petroleum Products by Potentiometric Titration," is simple to automate...release. distribution unlimnied 13. ABSTRACT (Maximum 2C3 words) Recent U.S. militar-y operations have identified a need for improved methods of fuel and

NREL's New Perovskite Ink Opens Window for Quality Cells | News | News |

Science.gov Websites

scalable deposition methods, which are suitable for future module production, still lag behind state-of-the -coating methods. Both methods were tested and produced indistinguishable film morphology and device

Equivalence testing using existing reference data: An example with genetically modified and conventional crops in animal feeding studies.

PubMed

van der Voet, Hilko; Goedhart, Paul W; Schmidt, Kerstin

2017-11-01

An equivalence testing method is described to assess the safety of regulated products using relevant data obtained in historical studies with assumedly safe reference products. The method is illustrated using data from a series of animal feeding studies with genetically modified and reference maize varieties. Several criteria for quantifying equivalence are discussed, and study-corrected distribution-wise equivalence is selected as being appropriate for the example case study. An equivalence test is proposed based on a high probability of declaring equivalence in a simplified situation, where there is no between-group variation, where the historical and current studies have the same residual variance, and where the current study is assumed to have a sample size as set by a regulator. The method makes use of generalized fiducial inference methods to integrate uncertainties from both the historical and the current data. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Development of adapted GMR-probes for automated detection of hidden defects in thin steel sheets

NASA Astrophysics Data System (ADS)

Pelkner, Matthias; Pohl, Rainer; Kreutzbruck, Marc; Commandeur, Colin

2016-02-01

Thin steel sheets with a thickness of 0.3 mm and less are the base materials of many everyday life products (cans, batteries, etc.). Potential inhomogeneities such as non-metallic inclusions inside the steel can lead to a rupture of the sheets when it is formed into a product such as a beverage can. Therefore, there is a need to develop automated NDT techniques to detect hidden defects and inclusions in thin sheets during production. For this purpose Tata Steel Europe and BAM, the Federal Institute for Materials Research and Testing (Germany), collaborate in order to develop an automated NDT-system. Defect detection systems have to be robust against external influences, especially when used in an industrial environment. In addition, such a facility has to achieve a high sensitivity and a high spatial resolution in terms of detecting small inclusions in the μm-regime. In a first step, we carried out a feasibility study to determine which testing method is promising for detecting hidden defects and inclusions inside ferrous thin steel sheets. Therefore, two methods were investigated in more detail - magnetic flux leakage testing (MFL) using giant magneto resistance sensor arrays (GMR) as receivers [1,2] and eddy current testing (ET). The capabilities of both methods were tested with 0.2 mm-thick steel samples containing small defects with depths ranging from 5 µm up to 60 µm. Only in case of GMR-MFL-testing, we were able to detect parts of the hidden defects with a depth of 10 µm trustworthily with a SNR better than 10 dB. Here, the lift off between sensor and surface was 250 µm. On this basis, we investigated different testing scenarios including velocity tests and different lift offs. In this contribution we present the results of the feasibility study leading to first prototypes of GMR-probes which are now installed as part of a demonstrator inside a production line.

High resolution identity testing of inactivated poliovirus vaccines.

PubMed

Mee, Edward T; Minor, Philip D; Martin, Javier

2015-07-09

Definitive identification of poliovirus strains in vaccines is essential for quality control, particularly where multiple wild-type and Sabin strains are produced in the same facility. Sequence-based identification provides the ultimate in identity testing and would offer several advantages over serological methods. We employed random RT-PCR and high throughput sequencing to recover full-length genome sequences from monovalent and trivalent poliovirus vaccine products at various stages of the manufacturing process. All expected strains were detected in previously characterised products and the method permitted identification of strains comprising as little as 0.1% of sequence reads. Highly similar Mahoney and Sabin 1 strains were readily discriminated on the basis of specific variant positions. Analysis of a product known to contain incorrect strains demonstrated that the method correctly identified the contaminants. Random RT-PCR and shotgun sequencing provided high resolution identification of vaccine components. In addition to the recovery of full-length genome sequences, the method could also be easily adapted to the characterisation of minor variant frequencies and distinction of closely related products on the basis of distinguishing consensus and low frequency polymorphisms. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Evaluation of disconnect boxes and signal heads for hurricane resistance.

DOT National Transportation Integrated Search

2013-05-01

The objectives of this project were to quantify the maximum load requirements for disconnect boxes and signal heads and to develop test methods for product testing. Test programs for both flexure and tension were developed with the goal of producing ...

Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

PubMed Central

Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

2006-01-01

Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

Validation of an HPLC method for the quantification of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form stress test for stability evaluation.

PubMed

Heinänen, M; Barbas, C

2001-03-01

A method is described for ambroxol, trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride, and benzoic acid separation by HPLC with UV detection at 247 nm in a syrup as pharmaceutical presentation. Optimal conditions were: Column Symmetry Shield RPC8, 5 microm 250 x 4.6 mm, and methanol/(H(3)PO(4) 8.5 mM/triethylamine pH=2.8) 40:60 v/v. Validation was performed using standards and the pharmaceutical preparation which contains the compounds described above. Results from both standards and samples show suitable validation parameters. The pharmaceutical grade substances were tested by factors that could influence the chemical stability. These reaction mixtures were analysed to evaluate the capability of the method to separate degradation products. Degradation products did not interfere with the determination of the substances tested by the assay.

New strategy to improve quality control of Montenegro skin test at the production level.

PubMed

Guedes, Deborah Carbonera; Minozzo, João Carlos; Pasquali, Aline Kuhn Sbruzzi; Faulds, Craig; Soccol, Carlos Ricardo; Thomaz-Soccol, Vanete

2017-01-01

The production of the Montenegro antigen for skin test poses difficulties regarding quality control. Here, we propose that certain animal models reproducing a similar immune response to humans may be used in the quality control of Montenegro antigen production. Fifteen Cavia porcellus (guinea pigs) were immunized with Leishmania amazonensis or Leishmania braziliensis , and, after 30 days, they were skin tested with standard Montenegro antigen. To validate C. porcellus as an animal model for skin tests, eighteen Mesocricetus auratus (hamsters) were infected with L. amazonensis or L. braziliensis , and, after 45 days, they were skin tested with standard Montenegro antigen. Cavia porcellus immunized with L. amazonensis or L. braziliensis , and hamsters infected with the same species presented induration reactions when skin tested with standard Montenegro antigen 48-72h after the test. The comparison between immunization methods and immune response from the two animal species validated C. porcellus as a good model for Montenegro skin test, and the model showed strong potential as an in vivo model in the quality control of the production of Montenegro antigen.

Mycoplasma testing of cell substrates and biologics: Review of alternative non-microbiological techniques.

PubMed

Volokhov, Dmitriy V; Graham, Laurie J; Brorson, Kurt A; Chizhikov, Vladimir E

2011-01-01

Mycoplasmas, particularly species of the genera Mycoplasma and Acholeplasma, are known to be occasional microbial contaminants of cell cultures that produce biologics. This presents a serious concern regarding the risk of mycoplasma contamination for research laboratories and commercial facilities developing and manufacturing cell-derived biological and biopharmaceutical products for therapeutic use. Potential undetected contamination of these products or process intermediates with mycoplasmas represents a potential safety risk for patients and a business risk for producers of biopharmaceuticals. To minimize these risks, monitoring for adventitious agents, such as viruses and mycoplasmas, is performed during the manufacture of biologics produced in cell culture substrates. The "gold standard" microbiological assay, currently recommended by the USP, EP, JP and the US FDA, for the mycoplasma testing of biologics, involves the culture of viable mycoplasmas in broth, agar plates and indicator cells. Although the procedure enables highly efficient mycoplasma detection in cell substrates and cell-derived products, the overall testing strategy is time consuming (a minimum of 28 days) and requires skilled interpretation of the results. The long time period required for these conventional assays does not permit their use for products with short shelf-lives or for timely 'go/no-go' decisions during routine in-process testing. PCR methodology has existed for decades, however PCR based and other alternative methods for mycoplasma detection have only recently been considered for application to biologics manufacture. The application of alternative nucleic acid-based, enzyme-based and/or recombinant cell-culture methods, particularly in combination with efficient sample preparation procedures, could provide advantages over conventional microbiological methods in terms of analytical throughput, simplicity, and turnaround time. However, a challenge to the application of alternative methods for detection of mycoplasmas remains whether these alternative methods can provide a limit of detection comparable or superior to those of the culture methods. An additional challenge is that nucleic acid amplification technique (NAT) methods do not allow for accurate discrimination between viable and non-viable mycoplasma contaminants, which might lead to false-positive results (e.g. from inactivated raw materials, etc.). Our review provides an overview of these alternative methods and discusses the pros and cons of their application for the testing of mycoplasmas in biologics and cell substrates. Published by Elsevier Ltd.

Modification to the AOAC Sporicidal Activity of Disinfectants Test (Method 966.04): collaborative study.

PubMed

Tomasino, Stephen F; Hamilton, Martin A

2006-01-01

In an effort to improve AOAC Method 966.04, the Sporicidal Activity of Disinfectants Test, selected modifications to the procedure were evaluated in a collaborative study. Method 966.04 is used to generate efficacy data to support the product registration of sporicides and sterilants. The method is a carrier-based test that provides a qualitative measure of product efficacy against spores of Bacillus subtilis and Clostridium sporogenes. The use of garden soil extract and the lack of standard procedures for the enumeration of spores and neutralization of the test chemicals have been considered problematic for many years. The proposed modifications were limited to the B. subtilis and hard surface carrier (porcelain penicylinder) components of the method. The study included the evaluation of a replacement for soil extract nutrient broth and an establishment of a minimum spore titer per carrier, both considered crucial for the improvement and utilization of the method. Additionally, an alternative hard surface material and a neutralization confirmation procedure were evaluated. To determine the equivalence of the proposed alternatives to the standard method, 3 medium/carrier combinations, (1) soil extract nutrient broth/porcelain carrier (current method), (2) nutrient agar amended with 5 microg/mL manganese sulfate/porcelain carrier, and (3) nutrient agar amended with 5 microg/mL manganese sulfate/stainless steel carrier were analyzed for carrier counts, HCI resistance, efficacy, quantitative efficacy, and spore wash-off. The test chemicals used in the study represent 3 chemical classes and are commercially available antimicrobial liquid products: sodium hypochlorite (bleach), glutaraldehyde, and a combination of peracetic acid and hydrogen peroxide. Four laboratories participated in the study. The results of the spore titer per carrier, HCI resistance, efficacy, and wash-off studies demonstrate that amended nutrient agar in conjunction with the porcelain is comparable to the current method, soil extract nutrient broth/porcelain. The nutrient agar method is simple, inexpensive, reproducible, and provides an ample supply of high quality spores. Due to the current use of porcelain carriers for testing C. sporogenes, it is advisable to retain the use of porcelain carriers until stainless steel can be evaluated as a replacement carrier material for Clostridium. The evaluation of stainless steel for Clostridium has been initiated by the Study Director. Study Director recommendations for First Action revisions are provided in a modified method.

Green Toxicology: a strategy for sustainable chemical and material development.

PubMed

Crawford, Sarah E; Hartung, Thomas; Hollert, Henner; Mathes, Björn; van Ravenzwaay, Bennard; Steger-Hartmann, Thomas; Studer, Christoph; Krug, Harald F

2017-01-01

Green Toxicology refers to the application of predictive toxicology in the sustainable development and production of new less harmful materials and chemicals, subsequently reducing waste and exposure. Built upon the foundation of "Green Chemistry" and "Green Engineering", "Green Toxicology" aims to shape future manufacturing processes and safe synthesis of chemicals in terms of environmental and human health impacts. Being an integral part of Green Chemistry, the principles of Green Toxicology amplify the role of health-related aspects for the benefit of consumers and the environment, in addition to being economical for manufacturing companies. Due to the costly development and preparation of new materials and chemicals for market entry, it is no longer practical to ignore the safety and environmental status of new products during product development stages. However, this is only possible if toxicologists and chemists work together early on in the development of materials and chemicals to utilize safe design strategies and innovative in vitro and in silico tools. This paper discusses some of the most relevant aspects, advances and limitations of the emergence of Green Toxicology from the perspective of different industry and research groups. The integration of new testing methods and strategies in product development, testing and regulation stages are presented with examples of the application of in silico, omics and in vitro methods. Other tools for Green Toxicology, including the reduction of animal testing, alternative test methods, and read-across approaches are also discussed.

In-vitro activity of essential oils, in particular Melaleuca alternifolia (tea tree) oil and tea tree oil products, against Candida spp.

PubMed

Hammer, K A; Carson, C F; Riley, T V

1998-11-01

The in-vitro activity of a range of essential oils, including tea tree oil, against the yeast candida was examined. Of the 24 essential oils tested by the agar dilution method against Candida albicans ATCC 10231, three did not inhibit C. albicans at the highest concentration tested, which was 2.0% (v/v) oil. Sandalwood oil had the lowest MIC, inhibiting C. albicans at 0.06%. Melaleuca alternifolia (tea tree) oil was investigated for activity against 81 C. albicans isolates and 33 non-albicans Candida isolates. By the broth microdilution method, the minimum concentration of oil inhibiting 90% of isolates for both C. albicans and non-albicans Candida species was 0.25% (v/v). The minimum concentration of oil killing 90% of isolates was 0.25% for C. albicans and 0.5% for non-albicans Candida species. Fifty-seven Candida isolates were tested for sensitivity to tea tree oil by the agar dilution method; the minimum concentration of oil inhibiting 90% of isolates was 0.5%. Tests on three intra-vaginal tea tree oil products showed these products to have MICs and minimum fungicidal concentrations comparable to those of non-formulated tea tree oil, indicating that the tea tree oil contained in these products has retained its anticandidal activity. These data indicate that some essential oils are active against Candida spp., suggesting that they may be useful in the topical treatment of superficial candida infections.

Research of test fault diagnosis method for micro-satellite PSS

NASA Astrophysics Data System (ADS)

Wu, Haichao; Wang, Jinqi; Yang, Zhi; Yan, Meizhi

2017-11-01

Along with the increase in the number of micro-satellite and the shortening of the product's lifecycle, negative effects of satellite ground test failure become more and more serious. Real-time and efficient fault diagnosis becomes more and more necessary. PSS plays an important role in the satellite ground test's safety and reliability as one of the most important subsystems that guarantees the safety of micro-satellite energy. Take test fault diagnosis method of micro-satellite PSS as research object. On the basis of system features of PSS and classic fault diagnosis methods, propose a kind of fault diagnosis method based on the layered and loose coupling way. This article can provide certain reference for fault diagnosis methods research of other subsystems of micro-satellite.

Recent Efforts to Improve the Near Real Time Forest Disturbance Monitoring Capabilities of the ForWarn System

NASA Technical Reports Server (NTRS)

Spruce, Joseph; Hargrove, William; Gasser, Gerald

2013-01-01

This presentation discusses the development of anew method for computing NDVI temporal composites from near real time eMODIS data This research is being conducted to improve forest change products used in the ForWarn system for monitoring regional forest disturbances in the United States. ForWarn provides nation-wide NDVI-based forest disturbance detection products that are refreshed every 8 days. Current eMODIS and historical MOD13 24 day NDVI data are used to compute the disturbance detection products. The eMODIS 24 day NDVI data re-aggregated from 7 day NDVI products. The 24 day eMODIS NDVIs are generally cloud free, but do not necessarily use the freshest quality data. To shorten the disturbance detection time, a method has been developed that performs adaptive length/maximum value compositing of eMODIS NDVI, along with cloud and shadow "noise" mitigation. Tests indicate that this method can reduce detection rates by 8-16 days for known recent disturbance events, depending on the cloud frequencies and disturbance type. The noise mitigation in these tests, though imperfect, helped to improve quality of the resulting NDVI and forest change products.

New challenges in assuring vaccine quality.

PubMed Central

Dellepiane, N.; Griffiths, E.; Milstien, J. B.

2000-01-01

In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

40 CFR 63.772 - Test methods, compliance procedures, and compliance demonstrations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Oil and Natural Gas Production Facilities § 63.772 Test methods, compliance procedures, and compliance...) A mixture of methane in air at a concentration less than 10,000 parts per million by volume. (5) An... rate of either TOC (minus methane and ethane) or total HAP (Ei, Eo) shall be computed using the...

40 CFR 63.772 - Test methods, compliance procedures, and compliance demonstrations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Oil and Natural Gas Production Facilities § 63.772 Test methods, compliance procedures, and compliance...) A mixture of methane in air at a concentration less than 10,000 parts per million by volume. (5) An... rate of either TOC (minus methane and ethane) or total HAP (Ei, Eo) shall be computed using the...

A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

PubMed

Low, Ariana; Kok, Si Ling; Khong, Yuet Mei; Chan, Sui Yung; Gokhale, Rajeev

2015-11-01

No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Comparison of chemiluminescence methods for analysis of hydrogen peroxide and hydroxyl radicals

NASA Astrophysics Data System (ADS)

Pehrman, R.; Amme, M.; Cachoir, C.

2006-01-01

Assessment of alpha radiolysis influence on the chemistry of geologically disposed spent fuel demands analytical methods for radiolytic product determination at trace levels. Several chemiluminescence methods for the detection of radiolytic oxidants hydrogen peroxide and hydroxyl radicals are tested. Two of hydrogen peroxide methods use luminol, catalyzed by either μ-peroxidase or hemin, one uses 10-methyl-9-(p-formylphenyl)-acridinium carboxylate trifluoromethanesulfonate and one potassium periodate. All recipes are tested as batch systems in basic conditions. For hydroxyl radical detection luminophores selected are 3-hydroxyphthalic hydrazide and rutin. Both methods are tested as batch systems. The results are compared and the applicability of the methods for near-field dissolution studies is discussed.

Bacteriocins from lactic acid bacteria and their potential in the preservation of fruit products.

PubMed

Barbosa, Ana Andréa Teixeira; Mantovani, Hilário Cuquetto; Jain, Sona

2017-11-01

Bacteriocins produced by lactic acid bacteria (LAB) are well-recognized for their potential as natural food preservatives. These antimicrobial peptides usually do not change the sensorial properties of food products and can be used in combination with traditional preservation methods to ensure microbial stability. In recent years, fruit products are increasingly being associated with food-borne pathogens and spoilage microorganisms, and bacteriocins are important candidates to preserve these products. Bacteriocins have been extensively studied to preserve foods of animal origin. However, little information is available for their use in vegetable products, especially in minimally processed ready-to-eat fruits. Although, many bacteriocins possess useful characteristics that can be used to preserve fruit products, to date, only nisin, enterocin AS-48, bovicin HC5, enterocin 416K1, pediocin and bificin C6165 have been tested for their activity against spoilage and pathogenic microorganisms in these products. Among these, only nisin and pediocin are approved to be commercially used as food additives, and their use in fruit products is still limited to certain countries. Considering the increasing demand for fresh-tasting fruit products and concern for public safety, the study of other bacteriocins with biochemical characteristics that make them candidates for the preservation of these products are of great interest. Efforts for their approval as food additives are also important. In this review, we discuss why the study of bacteriocins as an alternative method to preserve fruit products is important; we detail the biotechnological approaches for the use of bacteriocins in fruit products; and describe some bacteriocins that have been tested and have potential to be tested for the preservation of fruit products.

New method for determination of efficacy of health care personnel hand wash products.

PubMed Central

Mahl, M C

1989-01-01

A method of studying the effects of health care personnel hand wash products is described. The fingernail regions of the hands of volunteers are inoculated with a mixture of Escherichia coli and Serratia marcescens, and the areas are dried for a standard time. After routine hand washing, each fingernail region is individually scrubbed with an electric toothbrush which moves longitudinally to the handle into collection fluid contained in a petri dish. The test bacteria in the fluid are then enumerated. (Bacillus subtilis spores may be included as tracers to show degree of physical removal of the procedure.) This method has several advantages over the frequently used glove juice technique. Experimental designs with large numbers of volunteers, multiple sampling sites, and many hand wash products may be performed. Ten sampling sites (fingers) are available, versus the two gloved hands for testing products. (Efficiency is almost 100% in the recovery of spore tracers placed on the fingernails.) Many commercial health care personnel hand wash products containing antimicrobial agents substantive to the skin do not rapidly reduce numbers of inoculated bacteria in the fingernail regions to any greater extent than nonantimicrobial hand washes. Products containing isopropanol or ethanol are very effective in decreasing bacteria in areas around and under the fingernails. PMID:2685028

A Statistical Review of Alternative Zinc and Copper Extraction from Mineral Fertilizers and Industrial By-Products.

PubMed

Cenciani de Souza, Camila Prado; Aparecida de Abreu, Cleide; Coscione, Aline Renée; Alberto de Andrade, Cristiano; Teixeira, Luiz Antonio Junqueira; Consolini, Flavia

2018-01-01

Rapid, accurate, and low-cost alternative analytical methods for micronutrient quantification in fertilizers are fundamental in QC. The purpose of this study was to evaluate whether zinc (Zn) and copper (Cu) content in mineral fertilizers and industrial by-products determined by the alternative methods USEPA 3051a, 10% HCl, and 10% H2SO4 are statistically equivalent to the standard method, consisting of hot-plate digestion using concentrated HCl. The commercially marketed Zn and Cu sources in Brazil consisted of oxides, carbonate, and sulfate fertilizers and by-products consisting of galvanizing ash, galvanizing sludge, brass ash, and brass or scrap slag. The contents of sources ranged from 15 to 82% and 10 to 45%, respectively, for Zn and Cu. The Zn and Cu contents refer to the variation of the elements found in the different sources evaluated with the concentrated HCl method as shown in Table 1. A protocol based on the following criteria was used for the statistical analysis assessment of the methods: F-test modified by Graybill, t-test for the mean error, and linear correlation coefficient analysis. In terms of equivalents, 10% HCl extraction was equivalent to the standard method for Zn, and the results of the USEPA 3051a and 10% HCl methods indicated that these methods were equivalents for Cu. Therefore, these methods can be considered viable alternatives to the standard method of determination for Cu and Zn in mineral fertilizers and industrial by-products in future research for their complete validation.

New method of noncontact temperature measurement in on-line textile production

NASA Astrophysics Data System (ADS)

Cheng, Xianping; Song, Xing-Li; Deng, Xing-Zhong

1993-09-01

Based on the condition of textile production the method of infrared non-contact temperature measurement is adcpted in the heat-setting and drying heat-treatment process . This method is used to monitor the moving cloth. The temperature of the cloth is displayed rapidly and exactly. The principle of the temperature measurement is analysed theoretically in this paper. Mathematical analysis and calculation are used for introducing signal transmitting method. Adopted method of combining software with hardware the temperature is corrected and compensated with the aid of a single-chip microcomputer. The results of test indicate that the application of temperature measurement instrument provides reliable parameters in the quality control. And it is an important measure on improving the quality of products.

Idiographic duo-trio tests using a constant-reference based on preference of each consumer: Sample presentation sequence in difference test can be customized for individual consumers to reduce error.

PubMed

Kim, Min-A; Sim, Hye-Min; Lee, Hye-Seong

2016-11-01

As reformulations and processing changes are increasingly needed in the food industry to produce healthier, more sustainable, and cost effective products while maintaining superior quality, reliable measurements of consumers' sensory perception and discrimination are becoming more critical. Consumer discrimination methods using a preferred-reference duo-trio test design have been shown to be effective in improving the discrimination performance by customizing sample presentation sequences. However, this design can add complexity to the discrimination task for some consumers, resulting in more errors in sensory discrimination. The objective of the present study was to investigate the effects of different types of test instructions using the preference-reference duo-trio test design where a paired-preference test is followed by 6 repeated preferred-reference duo-trio tests, in comparison to the analytical method using the balanced-reference duo-trio. Analyses of d' estimates (product-related measure) and probabilistic sensory discriminators in momentary numbers of subjects showing statistical significance (subject-related measure) revealed that only preferred-reference duo-trio test using affective reference-framing, either by providing no information about the reference or information on a previously preferred sample, improved the sensory discrimination more than the analytical method. No decrease in discrimination performance was observed with any type of instruction, confirming that consumers could handle the test methods. These results suggest that when repeated tests are feasible, using the affective discrimination method would be operationally more efficient as well as ecologically more reliable for measuring consumers' sensory discrimination ability. Copyright © 2016 Elsevier Ltd. All rights reserved.

The application of biotechnological methods in authenticity testing.

PubMed

Popping, Bert

2002-09-11

By counterfeiting brand names in the food and drink industry as well as fraudulently labelling and selling low quality products as premium products, this sector of the industry has lost significant amounts of money and the consumer has been deceived. While it was difficult to establish certain types of fraud before the advent of modern biotechnology, DNA-based methods make an important contribution to protect high-quality brand names and protect the consumer. Several years ago, DNA technologies were considered as methods used in universities, primarily for research purpose, not so much for 'real-life' applications. However, this has changed and a number of laboratories have specialised in offering such services to the industry. This article will review DNA-based techniques commonly used for authenticity testing.

Food safety issues: a summary report of a panel session addressing pre- and post-harvest strategies to improve public health.

PubMed

Kirkhorn, Steven R

2008-01-01

The paper presents a summary of a panel presentation by animal scientists and public health veterinarians on food safety methods to improve public health of the public consuming beef and poultry. Pre-harvest methods discussed include vaccination to decrease shedding of Esherichia coli O157:H7, direct-fed microbials (DFMs), calving methods, and responsible use of antimicrobials. Post-harvest methods discussed include increased sampling and use of hazard analysis and critical control point (HACCP) methods, test-and-hold of meat products prior to release for public consumption, development of attainment categories, the use of pulsed field gel electrophoresis (PFGE) for genotyping and serotyping, and an 11-step surveillance program. The public health concern and financial consequences of contamination with E. coli O157:H7 is discussed. A "carrot and stick" approach for both producers and processors to increase vaccination and product testing is recommended.

Application of FT-IR Classification Method in Silica-Plant Extracts Composites Quality Testing

NASA Astrophysics Data System (ADS)

Bicu, A.; Drumea, V.; Mihaiescu, D. E.; Purcareanu, B.; Florea, M. A.; Trică, B.; Vasilievici, G.; Draga, S.; Buse, E.; Olariu, L.

2018-06-01

Our present work is concerned with the validation and quality testing efforts of mesoporous silica - plant extracts composites, in order to sustain the standardization process of plant-based pharmaceutical products. The synthesis of the silica support were performed by using a TEOS based synthetic route and CTAB as a template, at room temperature and normal pressure. The silica support was analyzed by advanced characterization methods (SEM, TEM, BET, DLS and FT-IR), and loaded with Calendula officinalis and Salvia officinalis standardized extracts. Further desorption studies were performed in order to prove the sustained release properties of the final materials. Intermediate and final product identification was performed by a FT-IR classification method, using the MID-range of the IR spectra, and statistical representative samples from repetitive synthetic stages. The obtained results recommend this analytical method as a fast and cost effective alternative to the classic identification methods.

Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: part 2--evaluation of a method for determining equivalence.

PubMed

Christopher, David; Adams, Wallace P; Lee, Douglas S; Morgan, Beth; Pan, Ziqing; Singh, Gur Jai Pal; Tsong, Yi; Lyapustina, Svetlana

2007-01-19

The purpose of this article is to present the thought process, methods, and interim results of a PQRI Working Group, which was charged with evaluating the chi-square ratio test as a potential method for determining in vitro equivalence of aerodynamic particle size distribution (APSD) profiles obtained from cascade impactor measurements. Because this test was designed with the intention of being used as a tool in regulatory review of drug applications, the capability of the test to detect differences in APSD profiles correctly and consistently was evaluated in a systematic way across a designed space of possible profiles. To establish a "base line," properties of the test in the simplest case of pairs of identical profiles were studied. Next, the test's performance was studied with pairs of profiles, where some difference was simulated in a systematic way on a single deposition site using realistic product profiles. The results obtained in these studies, which are presented in detail here, suggest that the chi-square ratio test in itself is not sufficient to determine equivalence of particle size distributions. This article, therefore, introduces the proposal to combine the chi-square ratio test with a test for impactor-sized mass based on Population Bioequivalence and describes methods for evaluating discrimination capabilities of the combined test. The approaches and results described in this article elucidate some of the capabilities and limitations of the original chi-square ratio test and provide rationale for development of additional tests capable of comparing APSD profiles of pharmaceutical aerosols.

Immunofluorescence detection of pea protein in meat products.

PubMed

Petrášová, Michaela; Pospiech, Matej; Tremlová, Bohuslava; Javůrková, Zdeňka

2016-08-01

In this study we developed an immunofluorescence method to detect pea protein in meat products. Pea protein has a high nutritional value but in sensitive individuals it may be responsible for causing allergic reactions. We produced model meat products with various additions of pea protein and flour; the detection limit (LOD) of the method for pea flour was 0.5% addition, and for pea protein it was 0.001% addition. The repeatabilities and reproducibilities for samples both positive and negative for pea protein were all 100%. In a blind test with model products and commercial samples, there was no statistically significant difference (p > 0.05) between the declared concentrations of pea protein and flour and the immunofluorescence method results. Sensitivity was 1.06 and specificity was 1.00. These results show that the immunofluorescence method is suitable for the detection of pea protein in meat products.

46 CFR 160.062-4 - Inspections and tests.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approved hydraulic releases are manufactured or reconditioned to observe production methods and to conduct... place of manufacture by the marine inspector. (b) Classification of tests. The sampling, inspections... shall be tested by applying buoyant loads of its designed capacity to its spring-tensioned gripe as...

Assessment of different pre-treatment methods for the removal of limonene in citrus waste and their effect on methane potential and methane production rate.

PubMed

Ruiz, Begoña; de Benito, Amparo; Rivera, José Daniel; Flotats, Xavier

2016-12-01

The objective of this study was to assess the limonene removal efficiency of three pre-treatment methods when applied to citrus waste and to evaluate their effects on the biochemical methane potential and the methane production rate using batch anaerobic tests. The methods tested were based on removal (biological pretreatment by fungi) or recovery (steam distillation and ethanol extraction) of limonene. All the treatments decreased the concentration of limonene in orange peel, with average efficiencies of 22%, 44% and 100% for the biological treatment, steam distillation and ethanol extraction, respectively. By-products from limonene biodegradation by fungi exhibited an inhibitory effect also, not making interesting the biological pretreatment. The methane potential and production rate of the treated orange peel increased significantly after applying the recovery strategies, which separated and recovered simultaneously other inhibitory components of the citrus essential oil. Apart from the high recovery efficiency of the ethanol extraction process, it presented a favourable energy balance. © The Author(s) 2016.

10 CFR Appendix M to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps M Appendix M to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. M Appendix M to Subpart B of...

10 CFR Appendix M to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps M Appendix M to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. M Appendix M to Subpart B of...

10 CFR Appendix M to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps M Appendix M to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. M Appendix M to Subpart B of...

10 CFR Appendix M to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps M Appendix M to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. M Appendix M to Subpart B of...

10 CFR Appendix M to Subpart B of... - Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps M Appendix M to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. M Appendix M to Subpart B of...

10 CFR Appendix T to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals T Appendix T to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. T Appendix T to Subpart B of Part 430—Uniform...

10 CFR Appendix T to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals T Appendix T to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. T Appendix T to Subpart B of Part 430—Uniform...

10 CFR Appendix T to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals T Appendix T to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. T Appendix T to Subpart B of Part 430—Uniform...

10 CFR Appendix T to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals T Appendix T to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. T Appendix T to Subpart B of Part 430—Uniform...

10 CFR Appendix T to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Water Consumption of Water Closets and Urinals T Appendix T to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. T Appendix T to Subpart B of Part 430—Uniform...

10 CFR Appendix S to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads S Appendix S to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. S Appendix S to Subpart B of Part 430—Uniform...

10 CFR Appendix S to Subpart B of... - Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Uniform Test Method for Measuring the Water Consumption of Faucets and Showerheads S Appendix S to Subpart B of Part 430 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS Test Procedures Pt. 430, Subpt. B, App. S Appendix S to Subpart B of Part 430—Uniform...

77 FR 2456 - Incorporation of Revised ASTM Standards That Provide Flexibility in the Use of Alternatives to...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... (General Bomb Method), IBR approved for appendix A to subpart D. (4) ASTM D287-92, Standard Test Method for... Method for Sulfur in Petroleum Products (General Bomb Method), IBR approved for Sec. 94.108. (4) ASTM...

40 CFR 60.74 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... select the sampling site, and the sampling point shall be the centroid of the stack or duct or at a point... the production rate (P) of 100 percent nitric acid for each run. Material balance over the production...

Green toxicology.

PubMed

Maertens, Alexandra; Anastas, Nicholas; Spencer, Pamela J; Stephens, Martin; Goldberg, Alan; Hartung, Thomas

2014-01-01

Historically, early identification and characterization of adverse effects of industrial chemicals was difficult because conventional toxicological test methods did not meet R&D needs for rapid, relatively inexpensive methods amenable to small amounts of test material. The pharmaceutical industry now front-loads toxicity testing, using in silico, in vitro, and less demanding animal tests at earlier stages of product development to identify and anticipate undesirable toxicological effects and optimize product development. The Green Chemistry movement embraces similar ideas for development of less toxic products, safer processes, and less waste and exposure. Further, the concept of benign design suggests ways to consider possible toxicities before the actual synthesis and to apply some structure/activity rules (SAR) and in silico methods. This requires not only scientific development but also a change in corporate culture in which synthetic chemists work with toxicologists. An emerging discipline called Green Toxicology (Anastas, 2012) provides a framework for integrating the principles of toxicology into the enterprise of designing safer chemicals, thereby minimizing potential toxicity as early in production as possible. Green Toxicology`s novel utility lies in driving innovation by moving safety considerations to the earliest stage in a chemical`s lifecycle, i.e., to molecular design. In principle, this field is no different than other subdisciplines of toxicology that endeavor to focus on a specific area - for example, clinical, environmental or forensic toxicology. We use the same principles and tools to evaluate an existing substance or to design a new one. The unique emphasis is in using 21st century toxicology tools as a preventative strategy to "design out" undesired human health and environmental effects, thereby increasing the likelihood of launching a successful, sustainable product. Starting with the formation of a steering group and a series of workshops, the Green Toxicology concept is currently spreading internationally and is being refined via an iterative process.

The Growth of Tense Productivity

ERIC Educational Resources Information Center

Rispoli, Matthew; Hadley, Pamela A.; Holt, Janet K.

2009-01-01

Purpose: This study tests empirical predictions of a maturational model for the growth of tense in children younger than 36 months using a type-based productivity measure. Method: Caregiver-child language samples were collected from 20 typically developing children every 3 months from 21 to 33 months of age. Growth in the productivity of tense…

24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

AN ENVIRONMENTAL TECHNOLOGY VERIFICATION (ETV) TESTING OF THREE IMMUNOASSAY TEST KITS FOR ANTHRAX, BOTULINUM TOXIN AND RICIN

EPA Science Inventory

Immunoassay test kits are based on immunoassay methods, where specific antibodies are used to detect and measure the contaminants of interest. Immunoassay test kits rely on the reaction of a contaminant or antigen with a selective antibody to give a product that can be measures....

A proposed method for determining peak power in the jump squat exercise.

PubMed

Li, Li; Olson, Michael W; Winchester, Jason B

2008-03-01

In recent years a great deal of research has been published using peak power (PP) in the jump squat (JS) exercise as a measure of athletic performance. However, no standardized method for the determination of PP exists at this time to accurately evaluate this variable. Our proposed method (PM) for determining PP (PPPM) in the JS uses the product of vertical ground reaction forces and velocity of the center of mass of both the subject and the external resistance of a loaded Olympic bar. Fifteen male subjects with a mean age of 27 +/- 3 years, weight of 78 +/- 17 kg, and height of 175 +/- 10 cm participated in this study. PP was measured in the JS at five different testing loads (30%, 35%, 40%, 45%, and 50% body weight) based on methods commonly discussed in the literature to compare PP results of previous methods to those obtained using the PM. Paired t-tests at different load levels were used for statistical analysis with an overall alpha = 0.05. The average PP among five testing loads, measured by the PM, was 3782 +/- 906 W. PP derived from the product of force and velocity of the bar alone was 72% lower than PPPM at 1057 +/- 243 W (P < 0.0001). The PP estimated by the product of bar velocity and vertical ground reaction forces of the bar plus the subject was 8% higher than PPPM at 4100 +/- 844 W (P = 0.0001). Our results indicate that using the methods traditionally reported in the literature may cause an overestimation of PP during athletic performance. Using the PM in future research will facilitate test validity and enable the generalization of results outside the scope of specific research projects.

Systematic Evaluation of In Vitro and In Vivo Adventitious Virus Assays for the Detection of Viral Contamination of Cell Banks and Biological Products1

PubMed Central

Gombold, James; Karakasidis, Stephen; Niksa, Paula; Podczasy, John; Neumann, Kitti; Richardson, James; Sane, Nandini; Johnson-Leva, Renita; Randolph, Valerie; Sadoff, Jerald; Minor, Phillip; Schmidt, Alexander; Duncan, Paul; Sheets, Rebecca L.

2015-01-01

Viral vaccines and the cell substrates used to manufacture them are subjected to tests for adventitious agents, including viruses, which might contaminant them. Some of the compendial methods (in vivo and in vitro in cell culture) were established in the mid-20th century. These methods have not been subjected to current assay validation, as new methods would need to be. This study was undertaken to provide insight into the breadth (selectivity) and sensitivity (limit of detection) of the routine methods, two such validation parameters. Sixteen viral stocks were prepared and characterized. These stocks were tested in serial dilutions by the routine methods to establish which viruses were detected by which methods and above what limit of detection. Sixteen out of sixteen viruses were detected in vitro, though one (bovine viral diarrhea virus) required special conditions to detect and another (rubella virus) was detected with low sensitivity. Many were detected at levels below 1 TCID50 or PFU (titers were established on the production cell line in most cases). In contrast, in vivo, only 6/11 viruses were detected, and 4 of these were detected only at amounts one or more logs above 1 TCID50 or PFU. Only influenza virus and vesicular stomatitis virus were detected at lower amounts in vivo than in vitro. Given the call to reduce, refine, or replace (3 R's) the use of animals in product safety testing and the emergence of new technologies for the detection of viruses, a re-examination of the current adventitious virus testing strategies seems warranted. Suggested pathways forward are offered. PMID:24681273

40 CFR 92.5 - Reference materials.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., or at http://www.ansi.org. (1) ANSI B109.1-1992, Diaphragm Type Gas Displacment Meters, IBR approved..., Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method), IBR...

40 CFR 92.5 - Reference materials.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., or at http://www.ansi.org. (1) ANSI B109.1-1992, Diaphragm Type Gas Displacment Meters, IBR approved..., Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method), IBR...

40 CFR 92.5 - Reference materials.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., or at http://www.ansi.org. (1) ANSI B109.1-1992, Diaphragm Type Gas Displacment Meters, IBR approved..., Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method), IBR...

Comparing Indirect Effects in Different Groups in Single-Group and Multi-Group Structural Equation Models

PubMed Central

Ryu, Ehri; Cheong, Jeewon

2017-01-01

In this article, we evaluated the performance of statistical methods in single-group and multi-group analysis approaches for testing group difference in indirect effects and for testing simple indirect effects in each group. We also investigated whether the performance of the methods in the single-group approach was affected when the assumption of equal variance was not satisfied. The assumption was critical for the performance of the two methods in the single-group analysis: the method using a product term for testing the group difference in a single path coefficient, and the Wald test for testing the group difference in the indirect effect. Bootstrap confidence intervals in the single-group approach and all methods in the multi-group approach were not affected by the violation of the assumption. We compared the performance of the methods and provided recommendations. PMID:28553248

[A Simultaneous Determination Method with Acetonitrile-n-Hexane Partitioning and Solid-Phase Extraction for Pesticide Residues in Livestock and Marine Products by GC-MS].

PubMed

Yoshizaki, Mayuko; Kobayashi, Yukari; Shimizu, Masanori; Maruyama, Kouichi

2015-01-01

A simultaneous determination method was examined for 312 pesticides (including isomers) in muscle of livestock and marine products by GC-MS. The pesticide residues extracted from samples with acetone and n-hexane were purified by acetonitrile-n-hexane partitioning, and C18 and SAX/PSA solid-phase extraction without using GPC. Matrix components such as cholesterol were effectively removed. In recovery tests performed by this method using pork, beef, chicken and shrimp, 237-257 pesticides showed recoveries within the range of 70-120% in each sample. Validity was confirmed for 214 of the target pesticides by means of a validation test using pork. In comparison with the Japanese official method using GPC, the treatment time of samples and the quantity of solvent were reduced substantially.

The Texas A&M Radioisotope Production and Radiochemistry Program

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

Akabani, Gamal

The main motivation of the project at Texas A&M University was to carry out the production of critically needed radioisotopes used in medicine for diagnostic and therapy, and to establish an academic program in radionuclide production and separation methods. After a lengthy battle with the Texas A&M University Radiation Safety Office, the Texas Department of State Health Services granted us a license for the production of radionuclides in July 2015, allowing us to work in earnest in our project objectives. Experiments began immediately after licensing, and we started the assembly and testing of our target systems. There were four analytical/theoreticalmore » projects and two experimental target systems. These were for At-211 production and for Zn- 62/Cu-62 production. The theoretical projects were related to the production of Mo-99/Tc-99m using (a) a subcritical aqueous target system and (b) production of Tc-99m from accelerator-generated Mo-99 utilizing a photon-neutron interaction with enriched Mo-100 targets. The two experimental projects were the development of targetry systems and production of At-211 and Zn-62/Cu-62 generator. The targetry system for At-211 has been tested and production of At-211 is chronic depending of availability of beam time at the cyclotron. The installation and testing of the targetry system for the production of Zn-62/Cu-62 has not been finalized. A description of the systems is described. The academic program in radionuclide production and separation methods was initiated in the fall of 2011; due to the lack of a radiochemistry laboratory, it was suspended. We expect to re-start the academic program at the Texas A&M Institute for Preclinical Studies under the Molecular Imaging Program.« less

The Texas A&M Radioisotope Production and Radiochemistry Program

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

Akabani, Gamal

The main motivation of the project at Texas A&M University was to carry out the production of critically needed radioisotopes used in medicine for diagnostics and therapy, and to establish an academic program in radionuclide production and separation methods. After a lengthy battle with the Texas A&M University Radiation Safety Office, the Texas Department of State Health Services granted us a license for the production of radionuclides in July 2015, allowing us to work in earnest in our project objectives. Experiments began immediately after licensing, and we started the assembly and testing of our target systems. There were four analytical/theoreticalmore » projects and two experimental target systems. These were for At-211 production and for Zn-62/Cu-62 production. The theoretical projects were related to the production of Mo-99/Tc-99m using a) a subcritical aqueous target system and b) production of Tc-99m from accelerator-generated Mo-99 utilizing a photon-neutron interaction with enriched Mo-100 targets. The two experimental projects were the development of targetry systems and production of At-211 and Zn-62/Cu-62 generator. The targetry system for At-211 has been tested and production of At-211 is chronic depending of availability of beam time at the cyclotron. The installation and testing of the targetry system for the production of Zn-62/Cu-62 has not been finalized. A description of the systems is described. The academic program in radionuclide production and separation methods was initiated in the fall of 2011 and, due to the lack of a radiochemistry laboratory, it was suspended. We expect to re-start the academic program at the Texas A&M Institute for Preclinical Studies under the Molecular Imaging Program.« less

Test marketing of new smokeless tobacco products in four U.S. cities

PubMed Central

Biener, Lois; Clark, Pamela I.

2010-01-01

Introduction This exploratory study was designed to assess the availability, price, and point-of-purchase marketing strategies for new smokeless tobacco products in 4 test market areas. Methods A random sample of 50 gas stations, convenience and food stores, and tobacco shops was selected in each of 4 test market areas. Pairs of observers visited each store, recorded product information, and engaged vendors in conversation about product demand. Results Snus was available in 64% of the stores, but availability and price differed by brand. Point-of-purchase marketing also varied by brand on a variety of dimensions and all brands appeared to be marketed primarily to smokers. Camel Snus was described by store attendants as having the highest demand and was also the most expensive of the observed products. In light of the number of test market cities and intensity of promotion at retail locations, Camel Snus was the most intensively marketed product. Discussion The results appear to reflect differences in marketing strategy by American snus manufacturers. These strategies may help to predict future marketing of snus and other tobacco products and may provide a baseline for later assessments of product acceptance. PMID:19917598

Ex vivo effectiveness of French over-the-counter products against head lice (Pediculus humanus capitis De Geer, 1778).

PubMed

Combescot-Lang, Catherine; Vander Stichele, Robert H; Toubate, Berthine; Veirron, Emilie; Mumcuoglu, Kosta Y

2015-05-01

Head lice infestation is still a public health problem worldwide, with an intracountry and intercountry prevalence variation of 0.7 to 59%. There is a large variety of over-the-counter anti-louse products, but their efficacy is not always well assessed. Our objective was to test the pediculicidal and ovicidal efficacy of 21 over-the-counter head louse products, available in France during the period of 2008 to 2012. We tested children living in Tours City in central France and visiting preschools, primary schools, kindergarten, camps, and child care facilities, as well as children in their family houses, and were examined for the presence of lice. The products were collected from randomly selected pharmacies by covert investigators and then tested in the laboratory on an ex vivo sample of head lice and their eggs, collected from the hair of infested children. Living lice and unharmed eggs were collected from the scalps of 3-12 years old. The laboratory conditions for ex vivo testing mimicked the manufacturers' instructions for exposure time and application method. In 21 runs, 3919 living lice and 4321 undamaged living eggs were collected from the scalp of over 400 children. The 21 products were classified in three groups: 6 products in a group of potentially 100% pediculicidal activity and potentially 100% ovicidal activity, 8 products in a group of potentially 100% pediculicidal activity but insufficient ovicidal activity (including 2 products with claims of single application treatment), and 7 products in a group of insufficient pediculicidal activity and ovicidal activity. The pharmaceutical market for head lice products in France is swamped with poorly tested and ineffective products. Rigorous efficacy testing preregistration and periodic screening and testing of effectiveness in the post-registration period should be endorsed by the health authorities.

On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.

PubMed

Yang, Harry; Novick, Steven; Burdick, Richard K

Analytical similarity is the foundation for demonstration of biosimilarity between a proposed product and a reference product. For this assessment, currently the U.S. Food and Drug Administration (FDA) recommends a tiered system in which quality attributes are categorized into three tiers commensurate with their risk and approaches of varying statistical rigor are subsequently used for the three-tier quality attributes. Key to the analyses of Tiers 1 and 2 quality attributes is the establishment of equivalence acceptance criterion and quality range. For particular licensure applications, the FDA has provided advice on statistical methods for demonstration of analytical similarity. For example, for Tier 1 assessment, an equivalence test can be used based on an equivalence margin of 1.5 σ R , where σ R is the reference product variability estimated by the sample standard deviation S R from a sample of reference lots. The quality range for demonstrating Tier 2 analytical similarity is of the form X̄ R ± K × σ R where the constant K is appropriately justified. To demonstrate Tier 2 analytical similarity, a large percentage (e.g., 90%) of test product must fall in the quality range. In this paper, through both theoretical derivations and simulations, we show that when the reference drug product lots are correlated, the sample standard deviation S R underestimates the true reference product variability σ R As a result, substituting S R for σ R in the Tier 1 equivalence acceptance criterion and the Tier 2 quality range inappropriately reduces the statistical power and the ability to declare analytical similarity. Also explored is the impact of correlation among drug product lots on Type I error rate and power. Three methods based on generalized pivotal quantities are introduced, and their performance is compared against a two-one-sided tests (TOST) approach. Finally, strategies to mitigate risk of correlation among the reference products lots are discussed. A biosimilar is a generic version of the original biological drug product. A key component of a biosimilar development is the demonstration of analytical similarity between the biosimilar and the reference product. Such demonstration relies on application of statistical methods to establish a similarity margin and appropriate test for equivalence between the two products. This paper discusses statistical issues with demonstration of analytical similarity and provides alternate approaches to potentially mitigate these problems. © PDA, Inc. 2016.

Production scheduling and rescheduling with genetic algorithms.

PubMed

Bierwirth, C; Mattfeld, D C

1999-01-01

A general model for job shop scheduling is described which applies to static, dynamic and non-deterministic production environments. Next, a Genetic Algorithm is presented which solves the job shop scheduling problem. This algorithm is tested in a dynamic environment under different workload situations. Thereby, a highly efficient decoding procedure is proposed which strongly improves the quality of schedules. Finally, this technique is tested for scheduling and rescheduling in a non-deterministic environment. It is shown by experiment that conventional methods of production control are clearly outperformed at reasonable run-time costs.

[A reliability growth assessment method and its application in the development of equipment in space cabin].

PubMed

Chen, J D; Sun, H L

1999-04-01

Objective. To assess and predict reliability of an equipment dynamically by making full use of various test informations in the development of products. Method. A new reliability growth assessment method based on army material system analysis activity (AMSAA) model was developed. The method is composed of the AMSAA model and test data conversion technology. Result. The assessment and prediction results of a space-borne equipment conform to its expectations. Conclusion. It is suggested that this method should be further researched and popularized.

Determination of Chloride in Infant Formula and Adult/Pediatric Nutritional Formula by Potentiometric Titration: Single-Laboratory Validation, First Action 2015.07.

PubMed

Bolong, Wu; Fengxia, Zhang; Xiaoning, Ma; Fengjuan, Zhou; Brunelle, Sharon L

2016-01-01

A potentiometric method for determination of chloride was validated against AOAC Standard Method Performance Requirement (SMPR(®)) 2014.015. Ten AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) matrixes, including National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 1849a, were tested in duplicate on 6 independent days. The repeatability (RSDr) ranged from 0.43 to 1.34%, and the intermediate reproducibility (RSDiR) ranged from 0.80 to 3.04%. All results for NIST SRM 1849a were within the range of the certified concentration (701 ± 17 mg/100 g). Recovery was demonstrated with two overspike levels, 50 and 100%, in the 10 SPIFAN matrixes. Samples were tested in duplicate on 3 different days, and all results were within the SMPR requirement of 95 to 105%. The LOQs of the method for powdered products and ready-to-feed or reconstituted products were 20 mg/100 g and 2.2 mg/100 mL, respectively. A wide analytical range from the LOQ to 99.5% chlorine content can be reached with an appropriate dilution factor, but in practice, the upper analytical value observed in routine matrix testing was approximately 1080 mg/100 g in skim milk powder. This is a rapid, simple, and reliable chlorine-testing method applicable to infant formula, adult nutritionals, and ingredients used in these dairy-based products, such as skim milk powder, desalted whey powder, whey protein powder, and whole milk powder.

Test-Retest Stability of the Task and Ego Orientation Questionnaire

ERIC Educational Resources Information Center

Lane, Andrew M.; Nevill, Alan M.; Bowes, Neal; Fox, Kenneth R.

2005-01-01

Establishing stability, defined as observing minimal measurement error in a test-retest assessment, is vital to validating psychometric tools. Correlational methods, such as Pearson product-moment, intraclass, and kappa are tests of association or consistency, whereas stability or reproducibility (regarded here as synonymous) assesses the…

A bioanalytical HPLC method for coumestrol quantification in skin permeation tests followed by UPLC-QTOF/HDMS stability-indicating method for identification of degradation products.

PubMed

Bianchi, Sara E; Teixeira, Helder F; Kaiser, Samuel; Ortega, George G; Schneider, Paulo Henrique; Bassani, Valquiria L

2016-05-01

Coumestrol is present in several species of the Fabaceae family widely distributed in plants. The estrogenic and antioxidant activities of this molecule show its potential as skin anti-aging agent. These characteristics reveal the interest in developing analytical methodology for permeation studies, as well as to know the stability of coumestrol identifying the major degradation products. Thus, the present study was designed, first, to develop and validate a versatile liquid chromatography (HPLC) method to quantify coumestrol in a hydrogel formulation in different porcine skin layers (stratum corneum, epidermis, and dermis) in permeation tests. In the stability-indicating test coumestrol samples were exposed to stress conditions: temperature, UVC light, oxidative, acid and alkaline media. The degradation products, as well as the constituents extracted from the hydrogel, adhesive tape or skin were not eluted in the retention time of the coumestrol. Hence, the HPLC method showed to be versatile, specific, accurate, precise and robust showing excellent performance for quantifying coumestrol in complex matrices involving skin permeation studies. Coumestrol recovery from porcine ear skin was found to be in the range of 97.07-107.28 μg/mL; the intra-day precision (repeatability) and intermediate precision (inter-day precision), respectively lower than 4.71% and 2.09%. The analysis using ultra-performance liquid chromatography coupled to a quadrupole time-of-flight high definition mass spectrometry detector (UPLC-QTOF/HDMS) suggest the MS fragmentation patterns and the chemical structure of the main degradation products. These results represent new and relevant findings for the development of coumestrol pharmaceutical and cosmetic products. Copyright © 2016 Elsevier B.V. All rights reserved.

40 CFR 63.5719 - How do I conduct a performance test?

Code of Federal Regulations, 2012 CFR

2012-07-01

... sampling sites. (2) Use Method 2, 2A, 2C, 2D, 2F or 2G of appendix A to 40 CFR part 60, as appropriate, to... organic HAP emissions. (4) You may use American Society for Testing and Materials (ASTM) D6420-99... respect to the types of parts being made and material application methods. The production conditions...

40 CFR 63.5719 - How do I conduct a performance test?

Code of Federal Regulations, 2014 CFR

2014-07-01

... sampling sites. (2) Use Method 2, 2A, 2C, 2D, 2F or 2G of appendix A to 40 CFR part 60, as appropriate, to... organic HAP emissions. (4) You may use American Society for Testing and Materials (ASTM) D6420-99... respect to the types of parts being made and material application methods. The production conditions...

40 CFR 63.5719 - How do I conduct a performance test?

Code of Federal Regulations, 2013 CFR

2013-07-01

... sampling sites. (2) Use Method 2, 2A, 2C, 2D, 2F or 2G of appendix A to 40 CFR part 60, as appropriate, to... organic HAP emissions. (4) You may use American Society for Testing and Materials (ASTM) D6420-99... respect to the types of parts being made and material application methods. The production conditions...

Mass extraction container closure integrity physical testing method development for parenteral container closure systems.

PubMed

Yoon, Seung-Yil; Sagi, Hemi; Goldhammer, Craig; Li, Lei

2012-01-01

Container closure integrity (CCI) is a critical factor to ensure that product sterility is maintained over its entire shelf life. Assuring the CCI during container closure (C/C) system qualification, routine manufacturing and stability is important. FDA guidance also encourages industry to develop a CCI physical testing method in lieu of sterility testing in a stability program. A mass extraction system has been developed to check CCI for a variety of container closure systems such as vials, syringes, and cartridges. Various types of defects (e.g., glass micropipette, laser drill, wire) were created and used to demonstrate a detection limit. Leakage, detected as mass flow in this study, changes as a function of defect length and diameter. Therefore, the morphology of defects has been examined in detail with fluid theories. This study demonstrated that a mass extraction system was able to distinguish between intact samples and samples with 2 μm defects reliably when the defect was exposed to air, water, placebo, or drug product (3 mg/mL concentration) solution. Also, it has been verified that the method was robust, and capable of determining the acceptance limit using 3σ for syringes and 6σ for vials. Sterile products must maintain their sterility over their entire shelf life. Container closure systems such as those found in syringes and vials provide a seal between rubber and glass containers. This seal must be ensured to maintain product sterility. A mass extraction system has been developed to check container closure integrity for a variety of container closure systems such as vials, syringes, and cartridges. In order to demonstrate the method's capability, various types of defects (e.g., glass micropipette, laser drill, wire) were created in syringes and vials and were tested. This study demonstrated that a mass extraction system was able to distinguish between intact samples and samples with 2 μm defects reliably when the defect was exposed to air, water, placebo, or drug product (3 mg/mL concentration) solution. Also, it was verified that the method showed consistent results, and was able to determine the acceptance limit using 3σ for syringes and 6σ for vials.

Development of a SARS Coronavirus Vaccine from Recombinant Spike Protein Plus Delta Inulin Adjuvant.

PubMed

McPherson, Clifton; Chubet, Richard; Holtz, Kathy; Honda-Okubo, Yoshikazu; Barnard, Dale; Cox, Manon; Petrovsky, Nikolai

2016-01-01

Given periodic outbreaks of fatal human infections caused by coronaviruses, development of an optimal coronavirus vaccine platform capable of rapid production is an ongoing priority. This chapter describes the use of an insect cell expression system for rapid production of a recombinant vaccine against severe acute respiratory syndrome coronavirus (SARS). Detailed methods are presented for expression, purification, and release testing of SARS recombinant spike protein antigen, followed by adjuvant formulation and animal testing. The methods herein described for rapid development of a highly protective SARS vaccine are equally suited to rapid development of vaccines against other fatal human coronavirus infections, e.g., the MERS coronavirus.

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)

RNActive® Technology: Generation and Testing of Stable and Immunogenic mRNA Vaccines.

PubMed

Rauch, Susanne; Lutz, Johannes; Kowalczyk, Aleksandra; Schlake, Thomas; Heidenreich, Regina

2017-01-01

Developing effective mRNA vaccines poses certain challenges concerning mRNA stability and ability to induce sufficient immune stimulation and requires a specific panel of techniques for production and testing. Here, we describe the production of stabilized mRNA with enhanced immunogenicity, generated using conventional nucleotides only, by introducing changes to the mRNA sequence and by complexation with the nucleotide-binding peptide protamine (RNActive® technology). Methods described here include the synthesis, purification, and protamine complexation of mRNA vaccines as well as a comprehensive panel of in vitro and in vivo methods for evaluation of vaccine quality and immunogenicity.

[The principle of registration, evaluation and testing of disinfecting preparations].

PubMed

Röhm-Rodowald, Ewa; Jakimiak, Bozenna; Podgórska, Marta

2008-01-01

Disinfectants are used to produce a state in which the number of living micro-organisms has been reduced to a level which is appropriate to the practical situation. For any products which are included in the Biocidal Directive 98/8/EC, for which specific activity is claimed, test data has to be approved by the regulatory authority and a product license obtained before the product can be offered for sale. Disinfectants can be recorded as biocidal products or medical devices. Presently, it is possible to measure the activity of a product on defined micro-organisms in specified experimental conditions. Efficacy is the result of the use of a product according to a defined application. To allow different requirements in different areas of application, separate tests and pass criteria have been or will be prepared for each of following three areas of application: medical, veterinary and group comprising food, industrial, domestic and institutional areas. The laboratory methods to be used for testing the activity of chemical disinfectants meets the European standards. The tests are categorised on a modular basis as follows: phase 1 tests, phase 2 step 1 tests, phase 2 step 2 tests and phase 3 tests. In order to claim that a product has disinfectant properties, suitable for use in the medical area, the product shall be tested according to European standards: phase 2 step 1 tests, phase 2 step 2 tests. Phase 1 tests are not required to support claims for chemical disinfectants used in human medicine. Only phase 1 tests are required to support claims for active substances for which no particular area of application is specified. Medical devices are subjects to the European Directive 93/42/EEC which requires that a product must carry a CE mark. Disinfectants which are intended specifically by its manufacturer to be used on medical devices are themselves medical devices and so these products, as well as conforming to the instrument disinfection European standards as specified in EN 14885, are also required to carry a CE mark.

Semi-Automated Pulse-Echo Ultrasonic System for Inspecting Tires

DOT National Transportation Integrated Search

1977-07-01

A nondestructive tire-testing system has been developed using the pulse-echo ultrasonic technique, which offers substantial advantages over all other physical nondestructive-testing methods and shows promise of reducing the cost of production-tire in...

Comparative Application of PLS and PCR Methods to Simultaneous Quantitative Estimation and Simultaneous Dissolution Test of Zidovudine - Lamivudine Tablets.

PubMed

Üstündağ, Özgür; Dinç, Erdal; Özdemir, Nurten; Tilkan, M Günseli

2015-01-01

In the development strategies of new drug products and generic drug products, the simultaneous in-vitro dissolution behavior of oral dosage formulations is the most important indication for the quantitative estimation of efficiency and biopharmaceutical characteristics of drug substances. This is to force the related field's scientists to improve very powerful analytical methods to get more reliable, precise and accurate results in the quantitative analysis and dissolution testing of drug formulations. In this context, two new chemometric tools, partial least squares (PLS) and principal component regression (PCR) were improved for the simultaneous quantitative estimation and dissolution testing of zidovudine (ZID) and lamivudine (LAM) in a tablet dosage form. The results obtained in this study strongly encourage us to use them for the quality control, the routine analysis and the dissolution test of the marketing tablets containing ZID and LAM drugs.

Acrolein Yields in Mainstream Smoke From Commercial Cigarette and Little Cigar Tobacco Products.

PubMed

Cecil, Todd L; Brewer, Tim M; Young, Mimy; Holman, Matthew R

2017-07-01

Many carbonyls are produced from the combustion of tobacco products and many of these carbonyls are harmful or potentially harmful constituents of mainstream cigarette smoke. One carbonyl of particular interest is acrolein, which is formed from the incomplete combustion of organic matter and the most significant contributor to non-cancer respiratory effects from cigarette smoke. Sheet-wrapped cigars, also known as "little cigars," are a type of tobacco products that have not been extensively investigated in literature. This study uses standard cigarette testing protocols to determine the acrolein yields from sheet-wrapped cigars. Sheet-wrapped cigar and cigarette products were tested by derivatizing the mainstream smoke with 2,4-dinitrophenylhydrazine (DNPH) solution and then quantifying the derivatives using conventional analytical systems. The results demonstrate that sheet-wrapped cigars can be tested for acrolein yields in mainstream smoke using the same methods used for the evaluation of cigarettes. The variability in the sheet-wrapped cigars and cigarettes under the International Organization for Standardization smoking regimen is statistically similar at the 95% confidence interval; however, increased variability is observed for sheet-wrapped cigar products under the Health Canada Intense (CI) smoking regimen. The amount of acrolein released by smoking sheet-wrapped cigars can be measured using standard smoking regimen currently used for cigarettes. The sheet-wrapped cigars were determined to yield similar quantity of acrolein from commercial cigarette products using two standard smoking regimens. This article reports on the measured quantity of acrolein from 15 commercial sheet-wrapped cigars using a validated standard smoking test method that derivatizes acrolein in the mainstream smoke with DNPH solution, and uses Liquid Chromatography/Ultra-Violet Detection (LC/UV) for separation and detection. These acrolein yields were similar to the levels found in the smoke from 35 commercial cigarette products measured in the same manner. Although sheet-wrapped cigar data were slightly more variable than those found for the cigarette data, this article reports that the production of acrolein is similar to cigarettes. The results demonstrate that sheet-wrapped cigars can be tested for acrolein yields in mainstream smoke using the same methods used for the evaluation of cigarettes. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Four applications of permutation methods to testing a single-mediator model.

PubMed

Taylor, Aaron B; MacKinnon, David P

2012-09-01

Four applications of permutation tests to the single-mediator model are described and evaluated in this study. Permutation tests work by rearranging data in many possible ways in order to estimate the sampling distribution for the test statistic. The four applications to mediation evaluated here are the permutation test of ab, the permutation joint significance test, and the noniterative and iterative permutation confidence intervals for ab. A Monte Carlo simulation study was used to compare these four tests with the four best available tests for mediation found in previous research: the joint significance test, the distribution of the product test, and the percentile and bias-corrected bootstrap tests. We compared the different methods on Type I error, power, and confidence interval coverage. The noniterative permutation confidence interval for ab was the best performer among the new methods. It successfully controlled Type I error, had power nearly as good as the most powerful existing methods, and had better coverage than any existing method. The iterative permutation confidence interval for ab had lower power than do some existing methods, but it performed better than any other method in terms of coverage. The permutation confidence interval methods are recommended when estimating a confidence interval is a primary concern. SPSS and SAS macros that estimate these confidence intervals are provided.

Hydrogen Infrastructure Testing and Research Facility | Hydrogen and Fuel

Science.gov Websites

stations, enabling NREL to validate current industry standards and methods for hydrogen fueling as well as the HITRF to: Develop, quantify performance of, and improve renewable hydrogen production methods

40 CFR 60.296 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., g/kg. cs=concentration of particulate matter, g/dsm. Qsd=volumetric flow rate, dscm/hr. A=zero... (borosilicate) glass, wool fiberglass, and flat glass. P=glass production rate, kg/hr. (2) Method 5 shall be...

Radiation prevulcanized natural rubber latex: Cytotoxicity and safety evaluation on animal

NASA Astrophysics Data System (ADS)

Keong, C. C.; Zin, W. M. Wan; Ibrahim, P.; Ibrahim, S.

2010-05-01

Radiation prevulcanized natural rubber latex (RVNRL) was claimed to be more user friendly than natural rubber latex prevulcanized by sulphur curing system. The absence of Type IV allergy inducing chemicals in RVNRL make it a suitable material for manufacturing of many kinds of latex products, especially those come into direct contact with users. This paper reveals and discusses the findings of cytotoxicity test and safety evaluation on animal for RVNRL. The test was done on RVNRL films prepared by coagulant dipping method and RVNRL dipped products produced by latex dipped product manufacturers. Cytotocixity test was carried out on mammalian cell culture American Type Culture Collection CCL 81, Vero. Results indicated that no cytotoxic effect from RVNRL films and products was found on the cell culture. Two animal studies, namely dermal sensitization study and primary skin irritation study, were done on gloves made from RVNRL. Albino white guinea pigs were used as test subjects in dermal sensitization study and results showed no sensitization induced by the application of test material in the guinea pigs. Primary skin irritation study was done on New Zealand white rabbits and results showed that the product tested was not corrosive and was not a primary irritant

Providing a Science Base for the Evaluation of Tobacco Products

PubMed Central

Berman, Micah L.; Connolly, Greg; Cummings, K. Michael; Djordjevic, Mirjana V.; Hatsukami, Dorothy K.; Henningfield, Jack E.; Myers, Matthew; O'Connor, Richard J.; Parascandola, Mark; Rees, Vaughan; Rice, Jerry M.

2015-01-01

Objective Evidence-based tobacco regulation requires a comprehensive scientific framework to guide the evaluation of new tobacco products and health-related claims made by product manufacturers. Methods The Tobacco Product Assessment Consortium (TobPRAC) employed an iterative process involving consortia investigators, consultants, a workshop of independent scientists and public health experts, and written reviews in order to develop a conceptual framework for evaluating tobacco products. Results The consortium developed a four-phased framework for the scientific evaluation of tobacco products. The four phases addressed by the framework are: (1) pre-market evaluation, (2) pre-claims evaluation, (3) post-market activities, and (4) monitoring and re-evaluation. For each phase, the framework proposes the use of validated testing procedures that will evaluate potential harms at both the individual and population level. Conclusions While the validation of methods for evaluating tobacco products is an ongoing and necessary process, the proposed framework need not wait for fully validated methods to be used in guiding tobacco product regulation today. PMID:26665160

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

PubMed

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

2016-01-01

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

An expanded nuclear phylogenomic PCR toolkit for Sapindales1

PubMed Central

Collins, Elizabeth S.; Gostel, Morgan R.; Weeks, Andrea

2016-01-01

Premise of the study: We tested PCR amplification of 91 low-copy nuclear gene loci in taxa from Sapindales using primers developed for Bursera simaruba (Burseraceae). Methods and Results: Cross-amplification of these markers among 10 taxa tested was related to their phylogenetic distance from B. simaruba. On average, each Sapindalean taxon yielded product for 53 gene regions (range: 16–90). Arabidopsis thaliana (Brassicales), by contrast, yielded product for two. Single representatives of Anacardiaceae and Rutacaeae yielded 34 and 26 products, respectively. Twenty-six primer pairs worked for all Burseraceae species tested if highly divergent Aucoumea klaineana is excluded, and eight of these amplified product in every Sapindalean taxon. Conclusions: Our study demonstrates that customized primers for Bursera can amplify product in a range of Sapindalean taxa. This collection of primer pairs, therefore, is a valuable addition to the toolkit for nuclear phylogenomic analyses of Sapindales and warrants further investigation. PMID:28101434

Safety evaluations under the proposed US Safe Cosmetics and Personal Care Products Act of 2013: animal use and cost estimates.

PubMed

Knight, Jean; Rovida, Costanca

2014-01-01

The proposed Safe Cosmetics and Personal Care Products Act of 2013 calls for a new evaluation program for cosmetic ingredients in the US, with the new assessments initially dependent on expanded animal testing. This paper considers possible testing scenarios under the proposed Act and estimates the number of test animals and cost under each scenario. It focuses on the impact for the first 10 years of testing, the period of greatest impact on animals and costs. The analysis suggests the first 10 years of testing under the Act could evaluate, at most, about 50% of ingredients used in cosmetics. Testing during this period would cost about $ 1.7-$ 9 billion and 1-11.5 million animals. By test year 10, alternative, high-throughput test methods under development are expected to be available, replacing animal testing and allowing rapid evaluation of all ingredients. Given the high cost in dollars and animal lives of the first 10 years for only about half of ingredients, a better choice may be to accelerate development of high-throughput methods. This would allow evaluation of 100% of cosmetic ingredients before year 10 at lower cost and without animal testing.

Rapid spot test for the determination of esculin hydrolysis.

PubMed

Edberg, S C; Gam, K; Bottenbley, C J; Singer, J M

1976-08-01

Esculin hydrolysis is a useful test in the differentiation of both gram-positive and gram-negative bacteria covering a wide spectrum of aerobes, facultative anaerobes, and anaerobes. Commonly utilized methods require a minimum of 18 h of incubation in broth or agar medium and utilize the production of a brown-black compound, due to the combination of ferric ions with the hydrolysis product esculetin, as indicator. A procedure is presented that requires 15 to 30 min for completion and utilizes fluorescence loss as the indicator of hydrolysis. Esculin fluoresces at 366 nm, whereas the hydrolysis product esculetin does not. Over 1,400 strains of gram-positive and gram-negative bacteria were tested. There was 98.4% of correlation between the spot test and esculin broth and 97% correlation with the bile-esculin agar.

Solution of nonlinear time-dependent PDEs through componentwise approximation of matrix functions

NASA Astrophysics Data System (ADS)

Cibotarica, Alexandru; Lambers, James V.; Palchak, Elisabeth M.

2016-09-01

Exponential propagation iterative (EPI) methods provide an efficient approach to the solution of large stiff systems of ODEs, compared to standard integrators. However, the bulk of the computational effort in these methods is due to products of matrix functions and vectors, which can become very costly at high resolution due to an increase in the number of Krylov projection steps needed to maintain accuracy. In this paper, it is proposed to modify EPI methods by using Krylov subspace spectral (KSS) methods, instead of standard Krylov projection methods, to compute products of matrix functions and vectors. Numerical experiments demonstrate that this modification causes the number of Krylov projection steps to become bounded independently of the grid size, thus dramatically improving efficiency and scalability. As a result, for each test problem featured, as the total number of grid points increases, the growth in computation time is just below linear, while other methods achieved this only on selected test problems or not at all.

Method of Harmonic Balance in Full-Scale-Model Tests of Electrical Devices

NASA Astrophysics Data System (ADS)

Gorbatenko, N. I.; Lankin, A. M.; Lankin, M. V.

2017-01-01

Methods for determining the weber-ampere characteristics of electrical devices, one of which is based on solution of direct problem of harmonic balance and the other on solution of inverse problem of harmonic balance by the method of full-scale-model tests, are suggested. The mathematical model of the device is constructed using the describing function and simplex optimization methods. The presented results of experimental applications of the method show its efficiency. The advantage of the method is the possibility of application for nondestructive inspection of electrical devices in the processes of their production and operation.

Prediction of cancer cell sensitivity to natural products based on genomic and chemical properties.

PubMed

Yue, Zhenyu; Zhang, Wenna; Lu, Yongming; Yang, Qiaoyue; Ding, Qiuying; Xia, Junfeng; Chen, Yan

2015-01-01

Natural products play a significant role in cancer chemotherapy. They are likely to provide many lead structures, which can be used as templates for the construction of novel drugs with enhanced antitumor activity. Traditional research approaches studied structure-activity relationship of natural products and obtained key structural properties, such as chemical bond or group, with the purpose of ascertaining their effect on a single cell line or a single tissue type. Here, for the first time, we develop a machine learning method to comprehensively predict natural products responses against a panel of cancer cell lines based on both the gene expression and the chemical properties of natural products. The results on two datasets, training set and independent test set, show that this proposed method yields significantly better prediction accuracy. In addition, we also demonstrate the predictive power of our proposed method by modeling the cancer cell sensitivity to two natural products, Curcumin and Resveratrol, which indicate that our method can effectively predict the response of cancer cell lines to these two natural products. Taken together, the method will facilitate the identification of natural products as cancer therapies and the development of precision medicine by linking the features of patient genomes to natural product sensitivity.

Safety and efficacy of personal care products containing colloidal oatmeal

PubMed Central

Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

2012-01-01

Background Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. Methods In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. Results We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Conclusion Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period. PMID:23204849

Statistical analysis of the electric energy production from photovoltaic conversion using mobile and fixed constructions

NASA Astrophysics Data System (ADS)

Bugała, Artur; Bednarek, Karol; Kasprzyk, Leszek; Tomczewski, Andrzej

2017-10-01

The paper presents the most representative - from the three-year measurement time period - characteristics of daily and monthly electricity production from a photovoltaic conversion using modules installed in a fixed and 2-axis tracking construction. Results are presented for selected summer, autumn, spring and winter days. Analyzed measuring stand is located on the roof of the Faculty of Electrical Engineering Poznan University of Technology building. The basic parameters of the statistical analysis like mean value, standard deviation, skewness, kurtosis, median, range, or coefficient of variation were used. It was found that the asymmetry factor can be useful in the analysis of the daily electricity production from a photovoltaic conversion. In order to determine the repeatability of monthly electricity production, occurring between the summer, and summer and winter months, a non-parametric Mann-Whitney U test was used as a statistical solution. In order to analyze the repeatability of daily peak hours, describing the largest value of the hourly electricity production, a non-parametric Kruskal-Wallis test was applied as an extension of the Mann-Whitney U test. Based on the analysis of the electric energy distribution from a prepared monitoring system it was found that traditional forecasting methods of the electricity production from a photovoltaic conversion, like multiple regression models, should not be the preferred methods of the analysis.

Animal use in the chemical and product manufacturing sectors - can the downtrend continue?

PubMed

Curren, Rodger

2009-12-01

During the 1990s and early 2000s, a number of manufacturing companies in the cosmetic, personal care and household product industries were able to substantially reduce their use of animals for testing (or to not use animals in the first place). These reductions were almost always the result of significant financial contributions to either direct, in-house alternatives research, or to support personnel whose duties were to understand and apply the current state-of-the-art for in vitro testing. They occurred almost exclusively in non-regulatory areas, and primarily involved acute topical toxicities. Over the last few years, the reduction in animal use has been much less dramatic, because some companies are still reluctant to change from the traditional animal studies, because systemic, repeat-dose toxicity is more difficult to model in vitro, and because many products still require animal testing for regulatory approval. Encouragingly, we are now observing an increased acceptance of non-animal methods by regulatory agencies. This is due to mounting scientific evidence from larger databases, agreement by companies to share data and testing strategies with regulatory agencies, and a focus on smaller domains of applicability. These changes, along with new emphasis and financial support for addressing systemic toxicities, promise to provide additional possibilities for industry to replace animals with in vitro methods, alone or in combination with in silico methods. However, the largest advance will not occur until more companies commit to using the non-animal test strategies that are currently available. 2009 FRAME.

Using pattern enumeration to accelerate process development and ramp yield

NASA Astrophysics Data System (ADS)

Zhuang, Linda; Pang, Jenny; Xu, Jessy; Tsai, Mengfeng; Wang, Amy; Zhang, Yifan; Sweis, Jason; Lai, Ya-Chieh; Ding, Hua

2016-03-01

During a new technology node process setup phase, foundries do not initially have enough product chip designs to conduct exhaustive process development. Different operational teams use manually designed simple test keys to set up their process flows and recipes. When the very first version of the design rule manual (DRM) is ready, foundries enter the process development phase where new experiment design data is manually created based on these design rules. However, these IP/test keys contain very uniform or simple design structures. This kind of design normally does not contain critical design structures or process unfriendly design patterns that pass design rule checks but are found to be less manufacturable. It is desired to have a method to generate exhaustive test patterns allowed by design rules at development stage to verify the gap of design rule and process. This paper presents a novel method of how to generate test key patterns which contain known problematic patterns as well as any constructs which designers could possibly draw based on current design rules. The enumerated test key patterns will contain the most critical design structures which are allowed by any particular design rule. A layout profiling method is used to do design chip analysis in order to find potential weak points on new incoming products so fab can take preemptive action to avoid yield loss. It can be achieved by comparing different products and leveraging the knowledge learned from previous manufactured chips to find possible yield detractors.

[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.

The need for performance criteria in evaluating the durability of wood products

Treesearch

Stan Lebow; Bessie Woodward; Patricia Lebow; Carol Clausen

2010-01-01

Data generated from wood-product durability evaluations can be difficult to interpret. Standard methods used to evaluate the potential long-term durability of wood products often provide little guidance on interpretation of test results. Decisions on acceptable performance for standardization and code compliance are based on the judgment of reviewers or committees....

Seed production estimation for mountain big sagebrush (Artemisia tridentata ssp. vaseyana)

Treesearch

Melissa L. Landeen; Loreen Allphin; Stanley G. Kitchen; Steven L. Petersen

2017-01-01

Seed production is an essential component of postdisturbance recovery for mountain big sagebrush (Artemisia tridentata Nutt. ssp vaseyana [Rydb] Beetle; MBS). We tested a method for rapid estimation of MBS seed production using measurements of inflorescence morphology. We measured total stem length, stem length from first branchlet to stem tip, stem diameter, fresh...

75 FR 7568 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... methods and testing devices. In order to better identify and evaluate the risks of product- related incidents, the Commission staff seeks to solicit consumer opinions and perceptions related to consumer... experiences, opinions and/or perceptions on the use or pattern of use of a specific product or type of product...

Characterization of Low-Molecular-Weight Heparins by Strong Anion-Exchange Chromatography.

PubMed

Sadowski, Radosław; Gadzała-Kopciuch, Renata; Kowalkowski, Tomasz; Widomski, Paweł; Jujeczka, Ludwik; Buszewski, Bogusław

2017-11-01

Currently, detailed structural characterization of low-molecular-weight heparin (LMWH) products is an analytical subject of great interest. In this work, we carried out a comprehensive structural analysis of LMWHs and applied a modified pharmacopeial method, as well as methods developed by other researchers, to the analysis of novel biosimilar LMWH products; and, for the first time, compared the qualitative and quantitative composition of commercially available drugs (enoxaparin, nadroparin, and dalteparin). For this purpose, we used strong anion-exchange (SAX) chromatography with spectrophotometric detection because this method is more helpful, easier, and faster than other separation techniques for the detailed disaccharide analysis of new LMWH drugs. In addition, we subjected the obtained results to statistical analysis (factor analysis, t-test, and Newman-Keuls post hoc test).

On-Line Measurement of Heat of Combustion of Gaseous Hydrocarbon Fuel Mixtures

NASA Technical Reports Server (NTRS)

Sprinkle, Danny R.; Chaturvedi, Sushil K.; Kheireddine, Ali

1996-01-01

A method for the on-line measurement of the heat of combustion of gaseous hydrocarbon fuel mixtures has been developed and tested. The method involves combustion of a test gas with a measured quantity of air to achieve a preset concentration of oxygen in the combustion products. This method involves using a controller which maintains the fuel (gas) volumetric flow rate at a level consistent with the desired oxygen concentration in the combustion products. The heat of combustion is determined form a known correlation with the fuel flow rate. An on-line computer accesses the fuel flow data and displays the heat of combustion measurement at desired time intervals. This technique appears to be especially applicable for measuring heats of combustion of hydrocarbon mixtures of unknown composition such as natural gas.

Adaptation of the Conditions of US EPA Method 538 for the ...

EPA Pesticide Factsheets

Report The objective of this study was to evaluate U.S. EPA’s Method 538 for the assessment of drinking water exposure to the nerve agent degradation product, EA2192, the most toxic degradation product of nerve agent VX. As a result of the similarities in sample preparation and analysis that Method 538 uses for nonvolatile chemicals, this method is applicable to the nonvolatile Chemical Warfare Agent (CWA) degradation product, EA2192, in drinking water. The method may be applicable to other nonvolatile CWAs and their respective degradation products as well, but the method will need extensive testing to verify compatibility. Gaps associated with the need for analysis methods capable of analyzing such analytes were addressed by adapting the EPA 538 method for this CWA degradation product. Many laboratories have the experience and capability to run the already rigorous method for nonvolatile compounds in drinking water. Increasing the number of laboratories capable of carrying out these methods serves to significantly increase the surge laboratory capacity to address sample throughput during a large exposure event. The approach desired for this study was to start with a proven high performance liquid chromatography tandem mass spectrometry (HPLC/MS/MS) method for nonvolatile chemicals in drinking water and assess the inclusion of a similar nonvolatile chemical, EA2192.

Anthropometric Procedures for Protective Equipment Sizing and Design

PubMed Central

Hsiao, Hongwei

2015-01-01

Objectives This article presented four anthropometric theories (univariate, bivariate/probability distribution, multivariate, and shape-based methods) for protective equipment design decisions. Background While the significance of anthropometric information for product design is well recognized, designers continue to face challenges in selecting efficient anthropometric data processing methods and translating the acquired information into effective product designs. Methods For this study, 100 farm tractor operators, 3,718 respirator users, 951 firefighters, and 816 civilian workers participated in four studies on the design of tractor roll-over protective structures (ROPS), respirator test panels, fire truck cabs, and fall-arrest harnesses, respectively. Their anthropometry and participant-equipment interfaces were evaluated. Results Study 1 showed a need to extend the 90-cm vertical clearance for tractor ROPS in the current industrial standards to 98.3 to 101.3 cm. Study 2 indicated that current respirator test panel would have excluded 10% of the male firefighter population; a systematic adjustment to the boundaries of test panel cells was suggested. Study 3 provided 24 principal component analysis-based firefighter body models to facilitate fire truck cab design. Study 4 developed an improved gender-based fall-arrest harness sizing scheme to supplant the current unisex system. Conclusions This article presented four anthropometric approaches and a six-step design paradigm for ROPS, respirator test panel, fire truck cab, and fall-arrest harness applications, which demonstrated anthropometric theories and practices for defining protective equipment fit and sizing schemes. Applications The study provided a basis for equipment designers, standards writers, and industry manufacturers to advance anthropometric applications for product design and improve product efficacy. PMID:23516791

40 CFR 90.902 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... sale by itself or in a vehicle employed from year to year in the ordinary course of business for product development, production method assessment, and market promotion purposes. Testing exemption means an exemption granted under § 90.1004(b) for the purpose of research, investigations, studies...

Field analysis for explosives: TNT and RDX

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

Elcoate, W.; Mapes, J.

The EPA has listed as hazardous many of the compounds used in the production of ammunitions and other explosive ordnance. The contamination of soil with TNT (2,4,6-trinitrotoluene), the major component of many munitions formulations and to a lesser degree RDX (hexhydro-1,3,5-trinitro-1,3,5-trizine) is a significant problem at many ammunition manufacturing facilities, depots, and ordnance disposal sites. Field test kits for explosives TNT and RDX (hexhydro-1,3,5-trinitro-1,3,5-triazine) were developed based on the methods of T.F. Jenkins and M.E. Walsh and T.F Jenkins. EnSys Environmental Products, Inc. with technical support from T.F. Jenkins took the original TNT procedure, modified it for easier field use,more » performed validation studies to ensure that it met or exceeded the method specifications for both the T.F. Jenkins and SW-846 methods, and developed an easy to use test format for the field testing of TNT. The RDX procedure has gone through the development cycle and is presently in the field validation phase. This paper describes the test protocol and performance characteristics of the TNT test procedure.« less

Comparative evaluation of concrete bridge deck sealers.

DOT National Transportation Integrated Search

2015-08-01

The main objective of this research was to compare the performance of five bridge deck sealer products using a : synthesis of two testing methods: NCHRP Report 244 Series II tests and standards developed by the Alberta : Ministry of Transportation (B...

An Inexpensive System for Producing Examinations with Minimal Typing and Proofreading.

ERIC Educational Resources Information Center

Mershon, Donald H.

1982-01-01

Describes a method for increasing efficiency of examination production which uses file cards to store and organize test items. The process of reproducing tests directly from master copies made with file cards is discussed. (AM)

A novel hybrid tobacco product that delivers a tobacco flavour note with vapour aerosol (Part 2): In vitro biological assessment and comparison with different tobacco-heating products.

PubMed

Breheny, Damien; Adamson, Jason; Azzopardi, David; Baxter, Andrew; Bishop, Emma; Carr, Tony; Crooks, Ian; Hewitt, Katherine; Jaunky, Tomasz; Larard, Sophie; Lowe, Frazer; Oke, Oluwatobiloba; Taylor, Mark; Santopietro, Simone; Thorne, David; Zainuddin, Benjamin; Gaça, Marianna; Liu, Chuan; Murphy, James; Proctor, Christopher

2017-08-01

This study assessed the toxicological and biological responses of aerosols from a novel hybrid tobacco product. Toxicological responses from the hybrid tobacco product were compared to those from a commercially available Tobacco Heating Product (c-THP), a prototype THP (p-THP) and a 3R4F reference cigarette, using in vitro test methods which were outlined as part of a framework to substantiate the risk reduction potential of novel tobacco and nicotine products. Exposure matrices used included total particulate matter (TPM), whole aerosol (WA), and aqueous aerosol extracts (AqE) obtained after machine-puffing the test products under the Health Canada Intense smoking regime. Levels of carbonyls and nicotine in these matrices were measured to understand the aerosol dosimetry of the products. The hybrid tobacco product tested negative across the in vitro assays including mutagenicity, genotoxicity, cytotoxicity, tumour promotion, oxidative stress and endothelial dysfunction. All the THPs tested demonstrated significantly reduced responses in these in vitro assays when compared to 3R4F. The findings suggest these products have the potential for reduced health risks. Further pre-clinical and clinical assessments are required to substantiate the risk reduction of these novel products at individual and population levels. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Antioxidant Capability of Ultra-high Temperature Milk and Ultra-high Temperature Soy Milk and their Fermented Products Determined by Four Distinct Spectrophotometric Methods

PubMed Central

Baghbadorani, Sahar Torki; Ehsani, Mohammad Reza; Mirlohi, Maryam; Ezzatpanah, Hamid; Azadbakht, Leila; Babashahi, Mina

2017-01-01

Background: Due to the recent emerging information on the antioxidant properties of soy products, substitution of soy milk for milk in the diet has been proposed by some nutritionists. We aimed to compare four distinct antioxidant measuring methods in the evaluation of antioxidant properties of industrial ultra-high temperature (UHT) milk, UHT soy milk, and their fermented products by Lactobacillus plantarum A7. Materials and Methods: Ascorbate auto-oxidation inhibition assay, 2,2-diphenyl-1-picryl-hydrazyl-hydrate (DPPH) free radical scavenging method, hydrogen peroxide neutralization assay and reducing activity test were compared for the homogeneity and accuracy of the results. Results: The results obtained by the four tested methods did not completely match with each other. The results of the DPPH assay and the reducing activity were more coordinated than the other methods. By the use of these methods, the antioxidant capability of UHT soy milk was measured more than UHT milk (33.51 ± 6.00% and 945 ± 56 μM cysteine compared to 8.70 ± 3.20% and 795 ± 82 μM cysteine). The negative effect of fermentation on the antioxidant potential of UHT soy milk was revealed as ascorbate auto-oxidation inhibition assay, DPPH method and reducing activity tests ended to approximately 52%, 58%, and 80% reduction in antioxidant potential of UHT soy milk, respectively. Conclusions: The antioxidative properties of UHT soy milk could not be solely due to its phenolic components. Peptides and amino acids derived from thermal processing in soy milk probably have a main role in its antioxidant activity, which should be studied in the future. PMID:28603703

40 CFR 63.561 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... HAP by weight or less. An impurity does not serve a useful purpose in the production or use of the... (ppmv) or greater as methane that is determined using the test methods in Method 21, appendix A of part...

Pharmaceutics, Drug Delivery and Pharmaceutical Technology: A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.

PubMed

Low, Ariana; Kok, Si Ling; Khong, Yuetmei; Chan, Sui Yung; Gokhale, Rajeev

2015-11-01

No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3893-3903, 2015. Copyright © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Preliminary study of tin slag concrete mixture

NASA Astrophysics Data System (ADS)

Hashim, Mohd Jamil; Mansor, Ishak; Pauzi Ismail, Mohamad; Sani, Suhairy; Azmi, Azhar; Sayuti, Shaharudin; Zaidi Ibrahim, Mohd; Adli Anuar, Abul; Rahim, Abdul Adha Abdul

2018-01-01

The study focuses on practices to facilitate tin smelting industry to reduce radioactive waste product (Tin Slag) by diluting its radioactivity to a safe level and turning it to a safer infrastructural building product. In the process the concrete mix which include Portland cement, sand, tin slag, water and plasticizer are used to produce interlocking brick pavements, piles and other infrastructural products. The mixing method follows DOE (UK) standard method of mixing targeted at in selected compressive strength suitable for its function and durability. A batching machine is used in the mixing and six test cubes are produced for the test. The testing equipment used are a compressional machine, ultrasonic measurement and a Geiger Muller counter to evaluate of the concrete mix to find the lowest emission of radiation surface dose without compromising the strength of concrete mix. The result obtained indicated the radioactivity of tin slag in the mixing process has reduced to background level that is 0.5μSv/h while the strength and workability of the concrete has not been severely affected. In conclusion, the concrete mix with tin slag has shown the potential it can be turned into a safe beneficial infrastructural product with good strength.

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

Maines, Warren Russell; Kittell, David E.; Hobbs, Michael L.

In this work, we combined the miniature cylinder expansion test (Mini-Cylex), with the Disk Acceleration Test (DAX) using Type K copper, Picatinny Liquid Explosive, and photonic Doppler velocimetry. We estimated the CJ state using plate reverberation methods at the test cap. We extracted velocities at 2, 7, and 10 volume expansions to fit Jones-Wilkins-Lee Equation of State and estimated Gurney velocity at the tube wall. The test also provides an additional method to estimate reaction products Hugoniot through knowledge of the copper test cap. Our experiments and simulations are within expected uncertainty. Lastly, the test and the analysis effectively reducemore » costs while keeping or increasing fidelity.« less

The effect of sea-water and fresh-water soaking on the quality of Eucheuma sp. syrup and pudding

NASA Astrophysics Data System (ADS)

Novianty, H.; Herandarudewi, S. M. C.

2018-04-01

Eucheuma alvarezii is one of marine commodity with great opportunities to be developed in Indonesia. This seaweed can be used as an additional material in cosmetic and pharmaceutical products or for syrup and pudding. Post-harvest technique conducted by the seaweed farmers will affects the quality of dried and processed products. The purpose of this study was to observe the effect of post harvest technique on the quality of dried seaweed and hedonic test (favorable test) of processed product (syrup and pudding). This study was conducted using descriptive method. The study compared dried, syrup, and puddings from two differents post-harvest technique, between salt and fresh-water draining products. The results showed that fresh-water draining technique obtained better quality results organoleptic test. The results showed that panelist prefered the fresh-water drained products of syrup and pudding. The hedonic scores were much higher for the fresh-water drained products in all three catagories of color, taste, and smell.

Assessment of ocular discomfort caused by 5 shampoos using the Slug Mucosal Irritation test.

PubMed

Petit, Jean-Yanique; Doré, Vanessa; Marignac, Geneviève; Perrot, Sébastien

2017-04-01

Assessment of ocular discomfort caused by veterinary care products is less legitimately regulated than that caused by human care products. The Slug Mucosal Irritation (SMI) assay was adapted to evaluate canine hygiene shampoos to predict ocular discomfort. Experiments were performed using four commercial canine shampoos, a baby care product, and two controls (ArtTear® and BAC1%). Groups of 3 slugs were tested with 5% dilution of the 7 test substances. The negative control (ArtTear®) was the best tolerated. The baby care product Mixa bébé as well as Douxo Entretien Démêlant and Phlox Shampooing Entretien were classified to cause mild ocular discomfort. Together with the positive control (BAC 1%), Shampooing Physiologique Virbac and Physiovet Shampooing were considered to cause severe ocular discomfort. Different intensities of ocular discomfort were measured for veterinary care products. The SMI model was considered as a reproducible and adaptable evaluation method for screening veterinary care products causing ocular discomfort. Copyright © 2017 Elsevier Ltd. All rights reserved.

Conference on abuse liability and appeal of tobacco products: conclusions and recommendations.

PubMed

Henningfield, Jack E; Hatsukami, Dorothy K; Zeller, Mitch; Peters, Ellen

2011-07-01

The rate of initiation and progression to dependence and premature mortality are higher for tobacco products than for any other dependence producing substance. This is not explained simply by the addictiveness ("abuse liability") or by enticing product designs ("product appeal") alone, but rather by both of these factors in combination with marketing and social influences that also influence "product appeal". A working meeting of leading experts in abuse liability (AL) and product appeal was convened to examine how these disciplines could be more effectively applied to the evaluation of tobacco products for the purposes of regulation that would include setting standards for designs and contents intended to reduce the risk of initiation and dependence. It was concluded that abuse liability assessment (ALA) is a validated approach to testing pharmaceutical products but has not been extensively applied to tobacco products: such application has demonstrated feasibility, but special challenges include the diverse range of products, product complexity, and the absence of satisfactory placebo products. Consumer testing for product appeal is widely used by consumer product marketers as well as by researchers in their efforts to understand consumer product preferences and use but has not been extensively applied to tobacco products except by the tobacco industry. Recommendations for testing, methods development, and research were developed. A major recommendation was that tobacco products should be tested for AL and product appeal, and the results integrated and evaluated so as to more accurately predict risk of initiation, dependence, and persistence of use. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Conference on Abuse Liability and Appeal of Tobacco Products: Conclusions and Recommendations*

PubMed Central

Hatsukami, Dorothy K.; Zeller, Mitch; Peters, Ellen

2011-01-01

The rate of initiation and progression to dependence and premature mortality are higher for tobacco products than for any other dependence producing substance. This is not explained simply by the addictiveness (“abuse liability”) or by enticing product designs (“product appeal”) alone, but rather by both of these factors in combination with marketing and social influences that also influence “product appeal”. A working meeting of leading experts in abuse liability (AL) and product appeal was convened to examine how these disciplines could be more effectively applied to the evaluation of tobacco products for the purposes of regulation that would include setting standards for designs and contents intended to reduce the risk of initiation and dependence. It was concluded that abuse liability assessment (ALA) is a validated approach to testing pharmaceutical products but has not been extensively applied to tobacco products: such application has demonstrated feasibility, but special challenges include the diverse range of products, product complexity, and the absence of satisfactory placebo products. Consumer testing for product appeal is widely used by consumer products marketers as well as by researchers in their efforts to understand consumer product preferences and use but has not been extensively applied to tobacco products except by the tobacco industry. Recommendations for testing, methods development, and research were developed. A major recommendation was that tobacco products should be tested for AL and product appeal, and the results integrated and evaluated so as to more accurately predict risk of initiation, dependence, and persistence of use. PMID:21376479

Development and application of a validated stability-indicating HPLC method for simultaneous determination of granisetron hydrochloride, benzyl alcohol and their main degradation products in parenteral dosage forms.

PubMed

Hewala, Ismail; El-Fatatre, Hamed; Emam, Ehab; Mubrouk, Mokhtar

2010-06-30

A simple, rapid and sensitive reversed phase high performance liquid chromatographic method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, benzyl alcohol, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron) and benzaldehyde (the main degradation product of benzyl alcohol) in granisetron injections. The separation was achieved on Hypersil BDS C8 (250 mm x 4.6 mm i.d., 5 microm particle diameter) column using a mobile phase consisted of acetonitrile:0.05 M KH(2)PO(4):triethylamine (22:100:0.15) adjusted to pH 4.8. The column was maintained at 25 degrees C and 20 microL of solutions was injected. Photodiode array detector was used to test the peak purity and the chromatograms were extracted at 210 nm. Naphazoline hydrochloride was used as internal standard. The method was validated with respect to specificity, linearity, accuracy, precision, limit of quantitation and limit of detection. The validation acceptance criteria were met in all cases. Identification of the pure peaks was carried out using library match programmer and wavelengths of derivative optima of the spectrograms of the peaks. The method was successfully applied to the determination of the investigated drugs and their degradation products in different batches of granisetron injections. The method was proved to be sensitive for the determination down to 0.03 and 0.01% of granisetron degradation product and benzaldehyde, respectively, which are far below the compendia limits for testing these degradation products in their corresponding intact drugs. Copyright 2010 Elsevier B.V. All rights reserved.

Evaluation of Pyrrolidonyl Arylamidase Activity in Staphylococcus delphini.

PubMed

Compton, Samantha T; Kania, Stephen A; Robertson, Amy E; Lawhon, Sara D; Jenkins, Stephen G; Westblade, Lars F; Bemis, David A

2017-03-01

Clinical reference textbooks lack data for pyrrolidonyl arylamidase (PYR) activity in Staphylococcus delphini This study evaluated PYR activities of 21 S. delphini strains by reference broth, rapid disc, and rapid slide methods. Species and subgroup identifications were confirmed by nucleic acid-based methods and included nine group A and 12 group B strains. Testing by rapid PYR methods with products from four manufacturers was performed at two testing locations, and, with the exception of one strain tested at one location using reagents from one manufacturer, each S. delphini strain tested positive for PYR activity. Therefore, PYR may be a useful single-test adjunct for distinguishing Staphylococcus aureus from S. delphini and other members of the Staphylococcus intermedius group. Copyright © 2017 American Society for Microbiology.

Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species

PubMed Central

Osathanunkul, Maslin; Madesis, Panagiotis; de Boer, Hugo

2015-01-01

Medicinal plants are used as a popular alternative to synthetic drugs, both in developed and developing countries. The economic importance of the herbal and natural supplement industry is increasing every year. As the herbal industry grows, consumer safety is one issue that cannot be overlooked. Herbal products in Thai local markets are commonly sold without packaging or labels. Plant powders are stored in large bags or boxes, and therefore buying local herbal products poses a high risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Here DNA barcoding was used in combination with High Resolution Melting analysis (Bar-HRM) to authenticate three medicinal Acanthaceae species (Acanthus ebracteatus, Andrographis paniculata and Rhinacanthus nasutus) commonly used in Thailand. The rbcL barcode was selected for use in primers design for HRM analysis to produce standard melting profiles of the selected species. Melting data from the HRM assay using the designed rbcL primers showed that the three chosen species could be distinguished from each other. HRM curves of all fifteen test samples indicated that three of tested products did not contain the indicated species. Two closely related species (A. paniculata and R. nasutus), which have a high level of morphological similarity, were interchanged with one another in three tested products. Incorrect information on packaging and labels of the tested herbal products was the cause of the results shown here. Morphological similarity among the species of interest also hindered the collection process. The Bar-HRM method developed here proved useful in aiding in the identification and authentication of herbal species in processed samples. In the future, species authentication through Bar-HRM could be used to promote consumer trust, as well as raising the quality of herbal products. PMID:26011474

Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species.

PubMed

Osathanunkul, Maslin; Madesis, Panagiotis; de Boer, Hugo

2015-01-01

Medicinal plants are used as a popular alternative to synthetic drugs, both in developed and developing countries. The economic importance of the herbal and natural supplement industry is increasing every year. As the herbal industry grows, consumer safety is one issue that cannot be overlooked. Herbal products in Thai local markets are commonly sold without packaging or labels. Plant powders are stored in large bags or boxes, and therefore buying local herbal products poses a high risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Here DNA barcoding was used in combination with High Resolution Melting analysis (Bar-HRM) to authenticate three medicinal Acanthaceae species (Acanthus ebracteatus, Andrographis paniculata and Rhinacanthus nasutus) commonly used in Thailand. The rbcL barcode was selected for use in primers design for HRM analysis to produce standard melting profiles of the selected species. Melting data from the HRM assay using the designed rbcL primers showed that the three chosen species could be distinguished from each other. HRM curves of all fifteen test samples indicated that three of tested products did not contain the indicated species. Two closely related species (A. paniculata and R. nasutus), which have a high level of morphological similarity, were interchanged with one another in three tested products. Incorrect information on packaging and labels of the tested herbal products was the cause of the results shown here. Morphological similarity among the species of interest also hindered the collection process. The Bar-HRM method developed here proved useful in aiding in the identification and authentication of herbal species in processed samples. In the future, species authentication through Bar-HRM could be used to promote consumer trust, as well as raising the quality of herbal products.

40 CFR 89.902 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... piece of equipment employed from year to year in the ordinary course of business for product development, production method assessment, and market promotion purposes. Testing exemption means an exemption which may be granted under § 89.1004(b) for the purpose of research investigations, studies, demonstrations or...

40 CFR 63.7324 - What procedures must I use to demonstrate initial compliance with the opacity limits?

Code of Federal Regulations, 2010 CFR

2010-07-01

... of 15 percent for a by-product coke oven battery on a normal coking cycle or 20 percent for a by-product coke oven battery on batterywide extended coking, follow the test methods and procedures in...

Development of a bar code-based exposure assessment method to evaluate occupational exposure to disinfectants and cleaning products: a pilot study.

PubMed

Quinot, Catherine; Amsellem-Dubourget, Sylvie; Temam, Sofia; Sevin, Etienne; Barreto, Christine; Tackin, Arzu; Félicité, Jérémy; Lyon-Caen, Sarah; Siroux, Valérie; Girard, Raphaële; Descatha, Alexis; Le Moual, Nicole; Dumas, Orianne

2018-05-14

Healthcare workers are highly exposed to various types of disinfectants and cleaning products. Assessment of exposure to these products remains a challenge. We aimed to investigate the feasibility of a method, based on a smartphone application and bar codes, to improve occupational exposure assessment among hospital/cleaning workers in epidemiological studies. A database of disinfectants and cleaning products used in French hospitals, including their names, bar codes and composition, was developed using several sources: ProdHyBase (a database of disinfectants managed by hospital hygiene experts), and specific regulatory agencies and industrial websites. A smartphone application has been created to scan bar codes of products and fill a short questionnaire. The application was tested in a French hospital. The ease of use and the ability to record information through this new approach were estimated. The method was tested in a French hospital (7 units, 14 participants). Through the application, 126 records (one record referred to one product entered by one participant/unit) were registered, majority of which were liquids (55.5%) or sprays (23.8%); 20.6% were used to clean surfaces and 15.9% to clean toilets. Workers used mostly products with alcohol and quaternary ammonium compounds (>90% with weekly use), followed by hypochlorite bleach and hydrogen peroxide (28.6%). For most records, information was available on the name (93.7%) and bar code (77.0%). Information on product compounds was available for all products and recorded in the database. This innovative and easy-to-use method could help to improve the assessment of occupational exposure to disinfectants/cleaning products in epidemiological studies. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Testing of optical components to assure performance in a high-average-power environment

NASA Astrophysics Data System (ADS)

Chow, Robert; Taylor, John R.; Eickelberg, William K.; Primdahl, Keith A.

1997-11-01

Evaluation and testing of the optical components used in the atomic vapor laser isotope separation plant is critical for qualification of suppliers, developments of new optical multilayer designs and manufacturing processes, and assurance of performance in the production cycle. The range of specifications requires development of specialized test equipment and methods which are not routine or readily available in industry. Specifications are given on material characteristics such as index homogeneity, subsurface damage left after polishing, microscopic surface defects and contamination, coating absorption, and high average power laser damage. The approach to testing these performance characteristics and assuring the quality throughout the production cycle is described.

Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: f2 Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products.

PubMed

Yoshida, Hiroyuki; Shibata, Hiroko; Izutsu, Ken-Ichi; Goda, Yukihiro

2017-01-01

The current Japanese Ministry of Health Labour and Welfare (MHLW)'s Guideline for Bioequivalence Studies of Generic Products uses averaged dissolution rates for the assessment of dissolution similarity between test and reference formulations. This study clarifies how the application of model-independent multivariate confidence region procedure (Method B), described in the European Medical Agency and U.S. Food and Drug Administration guidelines, affects similarity outcomes obtained empirically from dissolution profiles with large variations in individual dissolution rates. Sixty-one datasets of dissolution profiles for immediate release, oral generic, and corresponding innovator products that showed large variation in individual dissolution rates in generic products were assessed on their similarity by using the f 2 statistics defined in the MHLW guidelines (MHLW f 2 method) and two different Method B procedures, including a bootstrap method applied with f 2 statistics (BS method) and a multivariate analysis method using the Mahalanobis distance (MV method). The MHLW f 2 and BS methods provided similar dissolution similarities between reference and generic products. Although a small difference in the similarity assessment may be due to the decrease in the lower confidence interval for expected f 2 values derived from the large variation in individual dissolution rates, the MV method provided results different from those obtained through MHLW f 2 and BS methods. Analysis of actual dissolution data for products with large individual variations would provide valuable information towards an enhanced understanding of these methods and their possible incorporation in the MHLW guidelines.

Fire safety evaluation of aircraft lavatory and cargo compartments

NASA Technical Reports Server (NTRS)

Kourtides, D. A.; Parker, J. A.; Hilado, C. J.; Anderson, R. A.; Tustin, E.; Arnold, D. E.; Gaume, J. G.; Binding, A. T.; Mikeska, J. L.

1975-01-01

Large-scale aircraft lavatory and cargo compartment fire tests are described. Tests were conducted to evaluate the effectiveness of these compartments to contain fire and smoke. Two tests were conducted and are detailed. Test 1 involved a production Boeing 747 lavatory of the latest design installed in an enclosure outside the aircraft, to collect gases and expose animals to these gases. Results indicate that the interior of the lavatory was completely burned, evolving smoke and combustion products in the enclosure. Test 2 involved a simulated Douglas DC-10 cargo compartment retro-fitted with standard fiberglass liner. The fire caused excessive damage to the liner and burned through the ceiling in two areas. Test objectives, methods, materials, and results are presented and discussed.

Test and evaluation procedures for Sandia's Teraflops Operating System (TOS) on Janus.

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

Barnette, Daniel Wayne

This report describes the test and evaluation methods by which the Teraflops Operating System, or TOS, that resides on Sandia's massively-parallel computer Janus is verified for production release. Also discussed are methods used to build TOS before testing and evaluating, miscellaneous utility scripts, a sample test plan, and a proposed post-test method for quickly examining the large number of test results. The purpose of the report is threefold: (1) to provide a guide to T&E procedures, (2) to aid and guide others who will run T&E procedures on the new ASCI Red Storm machine, and (3) to document some ofmore » the history of evaluation and testing of TOS. This report is not intended to serve as an exhaustive manual for testers to conduct T&E procedures.« less

Applying high-resolution melting (HRM) technology to identify five commonly used Artemisia species.

PubMed

Song, Ming; Li, Jingjian; Xiong, Chao; Liu, Hexia; Liang, Junsong

2016-10-04

Many members of the genus Artemisia are important for medicinal purposes with multiple pharmacological properties. Often, these herbal plants sold on the markets are in processed forms so it is difficult to authenticate. Routine testing and identification of these herbal materials should be performed to ensure that the raw materials used in pharmaceutical products are suitable for their intended use. In this study, five commonly used Artemisia species included Artemisia argyi, Artemisia annua, Artemisia lavandulaefolia, Artemisia indica, and Artemisia atrovirens were analyzed using high resolution melting (HRM) analysis based on the internal transcribed spacer 2 (ITS2) sequences. The melting profiles of the ITS2 amplicons of the five closely related herbal species are clearly separated so that they can be differentiated by HRM method. The method was further applied to authenticate commercial products in powdered. HRM curves of all the commercial samples tested are similar to the botanical species as labeled. These congeneric medicinal products were also clearly separated using the neighbor-joining (NJ) tree. Therefore, HRM method could provide an efficient and reliable authentication system to distinguish these commonly used Artemisia herbal products on the markets and offer a technical reference for medicines quality control in the drug supply chain.

Extension of biomass estimates to pre-assessment periods using density dependent surplus production approach.

PubMed

Horbowy, Jan; Tomczak, Maciej T

2017-01-01

Biomass reconstructions to pre-assessment periods for commercially important and exploitable fish species are important tools for understanding long-term processes and fluctuation on stock and ecosystem level. For some stocks only fisheries statistics and fishery dependent data are available, for periods before surveys were conducted. The methods for the backward extension of the analytical assessment of biomass for years for which only total catch volumes are available were developed and tested in this paper. Two of the approaches developed apply the concept of the surplus production rate (SPR), which is shown to be stock density dependent if stock dynamics is governed by classical stock-production models. The other approach used a modified form of the Schaefer production model that allows for backward biomass estimation. The performance of the methods was tested on the Arctic cod and North Sea herring stocks, for which analytical biomass estimates extend back to the late 1940s. Next, the methods were applied to extend biomass estimates of the North-east Atlantic mackerel from the 1970s (analytical biomass estimates available) to the 1950s, for which only total catch volumes were available. For comparison with other methods which employs a constant SPR estimated as an average of the observed values, was also applied. The analyses showed that the performance of the methods is stock and data specific; the methods that work well for one stock may fail for the others. The constant SPR method is not recommended in those cases when the SPR is relatively high and the catch volumes in the reconstructed period are low.

Extension of biomass estimates to pre-assessment periods using density dependent surplus production approach

PubMed Central

Horbowy, Jan

2017-01-01

Biomass reconstructions to pre-assessment periods for commercially important and exploitable fish species are important tools for understanding long-term processes and fluctuation on stock and ecosystem level. For some stocks only fisheries statistics and fishery dependent data are available, for periods before surveys were conducted. The methods for the backward extension of the analytical assessment of biomass for years for which only total catch volumes are available were developed and tested in this paper. Two of the approaches developed apply the concept of the surplus production rate (SPR), which is shown to be stock density dependent if stock dynamics is governed by classical stock-production models. The other approach used a modified form of the Schaefer production model that allows for backward biomass estimation. The performance of the methods was tested on the Arctic cod and North Sea herring stocks, for which analytical biomass estimates extend back to the late 1940s. Next, the methods were applied to extend biomass estimates of the North-east Atlantic mackerel from the 1970s (analytical biomass estimates available) to the 1950s, for which only total catch volumes were available. For comparison with other methods which employs a constant SPR estimated as an average of the observed values, was also applied. The analyses showed that the performance of the methods is stock and data specific; the methods that work well for one stock may fail for the others. The constant SPR method is not recommended in those cases when the SPR is relatively high and the catch volumes in the reconstructed period are low. PMID:29131850

Evaluation of thin-layer chromatography methods for quality control of commercial products containing Aesculus hippocastanum, Turnera diffusa, Matricaria recutita, Passiflora incarnata, and Tilia occidentalis.

PubMed

Ramírez-Durón, Rosalba; Ceniceros-Almaguer, Lucía; Salazar-Aranda, Ricardo; Salazar-Cavazos, Ma de la Luz; Waksman de Torres, Noemi

2007-01-01

In Mexico, plant-derived products with health claims are sold as herbal dietary supplements, and there are no rules for their legal quality control. Aesculus hippocastanum, Turnera diffusa, Matricaria recutita, Passiflora incarnata, and Tilia occidentalis are some of the major commercial products obtained from plants used in this region. In this paper, we describe the effectiveness of thin-layer chromatography methods to provide for the quality control of several commercial products containing these plants. Standardized extracts were used. Of the 49 commercial products analyzed, only 32.65% matched the chromatographic characteristic of standardized extracts. A significant number of commercial products did not match their label, indicating a problem resulting from the lack of regulation for these products. The proposed methods are simple, sensitive, and specific and can be used for routine quality control of raw herbals and formulations of the tested plants. The results obtained show the need to develop simple and reliable analytical methods that can be performed in any laboratory for the purpose of quality control of dietary supplements or commercial herbal products sold in Mexico.

Diagnostics of Polymer Composite Materials and Analysis of Their Production Technology by Using the Method of Acoustic Emission

NASA Astrophysics Data System (ADS)

Bashkov, O. V.; Protsenko, A. E.; Bryanskii, A. A.; Romashko, R. V.

2017-09-01

The strength properties of glass-fiber-reinforced plastics produced by vacuum and vacuum autoclave molding techniques are studied. Based on acoustic emission data, a method of diagnostic and prediction of the bearing capacity of polymer composite materials by using data from three-point bending tests is developed. The method is based on evaluating changes in the exponent of a power function relating the total acoustic emission to the test stress.

Design, ancillary testing, analysis and fabrication data for the advanced composite stabilizer for Boeing 737 aircraft. Volume 1: Technical summary

NASA Technical Reports Server (NTRS)

Aniversario, R. B.; Harvey, S. T.; Mccarty, J. E.; Parsons, J. T.; Peterson, D. C.; Pritchett, L. D.; Wilson, D. R.; Wogulis, E. R.

1983-01-01

The horizontal stabilizer of the 737 transport was redesigned. Five shipsets were fabricated using composite materials. Weight reduction greater than the 20% goal was achieved. Parts and assemblies were readily produced on production-type tooling. Quality assurance methods were demonstrated. Repair methods were developed and demonstrated. Strength and stiffness analytical methods were substantiated by comparison with test results. Cost data was accumulated in a semiproduction environment. FAA certification was obtained.

A Guide to Computer Adaptive Testing Systems

ERIC Educational Resources Information Center

Davey, Tim

2011-01-01

Some brand names are used generically to describe an entire class of products that perform the same function. "Kleenex," "Xerox," "Thermos," and "Band-Aid" are good examples. The term "computerized adaptive testing" (CAT) is similar in that it is often applied uniformly across a diverse family of testing methods. Although the various members of…

Kinetic release of hydrogen peroxide from different whitening products.

PubMed

da Silva Marques, Duarte Nuno; Silveira, Joao Miguel; Marques, Joana Rita; Amaral, Joao Almeida; Guilherme, Nuno Marques; da Mata, António Duarte

2012-01-01

The objective of this in vitro study was to evaluate the kinetics of hydrogen peroxide (HP) release from five different bleaching products: VivaStyle® 10% fitted tray gel, VivaStyle® 30% in-office bleaching gel, VivaStyle® Paint-On Plus paint-on bleaching varnish, Opalescence PF® 10% carbamide peroxide gel and Trèswhite Supreme™ 10% HP gel. Each product was firstly titrated for its HP content by a described method. HP release kinetics was assessed by a modified spectrophotometric technique. One sample t test was performed to test for differences between the manufacturers' claimed HP concentrations and the titrated HP content in the whitening products. Analysis of variance plus Tamhane's post hoc tests and Pearson correlation analysis were used as appropriate. Values of P < 0.05 were taken as significant. Titrated HP revealed an increased content when compared to the manufacturer's specifications for all the products tested (P < 0.05), although only products from one manufacturer produced significantly higher results. All products presented a significant (P < 0.05) and sustained release of HP. However, the product with paint-on cellulose-based matrix resulted in significantly (P < 0.05) faster kinetics when compared to other products tested. These results are consistent with manufacturers' reduced recommended application times. The results of this study suggest that modifying the matrix composition may be a viable alternative to HP concentration increase, since this may result in faster release kinetics without exposure to high HP concentrations.

Combined Mini-Cylex & Disk Acceleration Tests in Type K Copper

DOE PAGES

Maines, Warren Russell; Kittell, David E.; Hobbs, Michael L.

2018-04-16

In this work, we combined the miniature cylinder expansion test (Mini-Cylex), with the Disk Acceleration Test (DAX) using Type K copper, Picatinny Liquid Explosive, and photonic Doppler velocimetry. We estimated the CJ state using plate reverberation methods at the test cap. We extracted velocities at 2, 7, and 10 volume expansions to fit Jones-Wilkins-Lee Equation of State and estimated Gurney velocity at the tube wall. The test also provides an additional method to estimate reaction products Hugoniot through knowledge of the copper test cap. Our experiments and simulations are within expected uncertainty. Lastly, the test and the analysis effectively reducemore » costs while keeping or increasing fidelity.« less

Combined Mini-Cylex & Disk Acceleration Tests in Type K Copper

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

Maines, Warren Russell; Kittell, David E.; Hobbs, Michael L.

In this work, we combined the miniature cylinder expansion test (Mini-Cylex), with the Disk Acceleration Test (DAX) using Type K copper, Picatinny Liquid Explosive, and photonic Doppler velocimetry. We estimated the CJ state using plate reverberation methods at the test cap. We extracted velocities at 2, 7, and 10 volume expansions to fit Jones-Wilkins-Lee Equation of State and estimated Gurney velocity at the tube wall. The test also provides an additional method to estimate reaction products Hugoniot through knowledge of the copper test cap. Our experiments and simulations are within expected uncertainty. Lastly, the test and the analysis effectively reducemore » costs while keeping or increasing fidelity.« less

The New Product Watch: Successes and Challenges of Crowdsourcing as a Method of Surveillance.

PubMed

Nyman, Amy L; Biener, Lois

2016-01-01

New smokeless tobacco (eg, snus and dissolvable tobacco products) and nontobacco nicotine products (eg, e-cigarettes) have emerged in recent years amid widespread speculation about locations of test marketing, toxic constituents, and consumer targeting. The New Product Watch was a pilot online monitoring system aimed at filling these information gaps by using a form of crowdsourcing: recruiting volunteers to visit local retailers and report their findings. With very little funding, the New Product Watch gathered county-specific data on new product availability in 19 states as well as trend data on product marketing and demand, and completed 2 rounds of product purchases and subsequent toxic constituent analyses. Data were collected over a 2-year period, between 2009 and 2011. Despite the successes, we found that this small-scale, volunteer effort was not a sustainable method for ensuring continuous, systematic surveillance of new product availability, marketing, and toxicity.

Comparative study of flexural strength test methods on CAD/CAM Y-TZP dental ceramics

PubMed Central

Xu, Yongxiang; Han, Jianmin; Lin, Hong; An, Linan

2015-01-01

Clinically, fractures are the main cause of computer-aided design and computer-aided manufacturing (CAD/CAM) 3 mol%-yttria-stabilized tetragonal zirconia polycrystal (Y-TZP) all-ceramic dental restorations failure because of repetitive occlusal loading. The goal of this work is to study the effect of test methods and specimen’s size on the flexural strength of five ceramic products. Both bi-axial flexure test (BI) and uni-axial flexure tests (UNI), including three-point flexure test (3PF) and four-point flexure test (4PF), are used in this study. For all five products, the flexural strength is as follows: BI > 3PF > 4PF. Furthermore, specimens with smaller size (3PF-s) have higher values than the bigger ones (3PF). The difference between BI and UNI resulted from the edge flaws in ceramic specimens. The relationship between different UNI (including 3PF-s, 3PF and 4PF) can be explained according to Weibull statistical fracture theory. BI is recommended to evaluate the flexural strength of CAD/CAM Y-TZP dental ceramics. PMID:26816646

Automated Production of Movies on a Cluster of Computers

NASA Technical Reports Server (NTRS)

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

2008-01-01

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

Evaluation of SAGE Electrochromic Devices: Cooperative Research and Development Final Report, CRADA Number CRD-15-579

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

Tenent, Robert C.

2017-12-06

NREL will conduct durability testing of Sage Electrochromics dynamic windows products using American Society for Testing and Materials (ASTM) standard methods and drive parameters as defined by Sage. Window units will be tested and standard analysis performed. Data will be summarized and reported back to Sage at the end of the testing period.

Contamination Detection and Mitigation Strategies for Unsymmetric Dimethylhydrazine/Nitrogen Tetroxide Non-Combustion Product Residues

NASA Technical Reports Server (NTRS)

Greene, Benjamin; Buchanan, Vanessa D.; Baker, David L.

2006-01-01

Dimethylamine and nitrite, which are non-combustion reaction products of unsymmetrical dimethylhydrazine (UDMH) and nitrogen tetroxide (NTO) propellants, can contaminate spacesuits during extra-vehicular activity (EVA) operations. They can react with water in the International Space Station (ISS) airlock to form N-nitrosodimethylamine (NDMA), a carcinogen. Detection methods for assessing nitrite and dimethylamine contamination were investigated. The methods are based on color-forming reactions in which intensity of color is proportional to concentration. A concept color detection kit using a commercially available presumptive field test for methamphetamine coupled with nitrite test strips was developed and used to detect dimethylamine and nitrite. Contamination mitigation strategies were also developed.

Comparison of Sample and Detection Quantification Methods for Salmonella Enterica from Produce

NASA Technical Reports Server (NTRS)

Hummerick, M. P.; Khodadad, C.; Richards, J. T.; Dixit, A.; Spencer, L. M.; Larson, B.; Parrish, C., II; Birmele, M.; Wheeler, Raymond

2014-01-01

The purpose of this study was to identify and optimize fast and reliable sampling and detection methods for the identification of pathogens that may be present on produce grown in small vegetable production units on the International Space Station (ISS), thus a field setting. Microbiological testing is necessary before astronauts are allowed to consume produce grown on ISS where currently there are two vegetable production units deployed, Lada and Veggie.

40 CFR 60.74 - Test methods and procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... production rate, metric ton/hr (ton/hr) or 100 percent nitric acid. K=conversion factor, 1000 g/kg (1.0 lb/lb...=emission rate of NOX as NO2, kg/metric ton (lb/ton) of 100 percent nitric acid. Cs = concentration of NOX... over the production system shall be used to confirm the production rate. (c) The owner or operator may...

The Impact of Project Work and the Writing Process Method on Writing Production

ERIC Educational Resources Information Center

Díaz Ramírez, Marcela

2014-01-01

This article presents the outcomes of an investigation whose main goal was to implement the methodology of project work and a process approach in order to improve writing production in an English class of Colombian university students since their diagnostic tests showed that their written production had the lowest score. Based on data collected,…

Current State of Agile User-Centered Design: A Survey

NASA Astrophysics Data System (ADS)

Hussain, Zahid; Slany, Wolfgang; Holzinger, Andreas

Agile software development methods are quite popular nowadays and are being adopted at an increasing rate in the industry every year. However, these methods are still lacking usability awareness in their development lifecycle, and the integration of usability/User-Centered Design (UCD) into agile methods is not adequately addressed. This paper presents the preliminary results of a recently conducted online survey regarding the current state of the integration of agile methods and usability/UCD. A world wide response of 92 practitioners was received. The results show that the majority of practitioners perceive that the integration of agile methods with usability/UCD has added value to their adopted processes and to their teams; has resulted in the improvement of usability and quality of the product developed; and has increased the satisfaction of the end-users of the product developed. The top most used HCI techniques are low-fidelity prototyping, conceptual designs, observational studies of users, usability expert evaluations, field studies, personas, rapid iterative testing, and laboratory usability testing.

Statistical Method to Overcome Overfitting Issue in Rational Function Models

NASA Astrophysics Data System (ADS)

Alizadeh Moghaddam, S. H.; Mokhtarzade, M.; Alizadeh Naeini, A.; Alizadeh Moghaddam, S. A.

2017-09-01

Rational function models (RFMs) are known as one of the most appealing models which are extensively applied in geometric correction of satellite images and map production. Overfitting is a common issue, in the case of terrain dependent RFMs, that degrades the accuracy of RFMs-derived geospatial products. This issue, resulting from the high number of RFMs' parameters, leads to ill-posedness of the RFMs. To tackle this problem, in this study, a fast and robust statistical approach is proposed and compared to Tikhonov regularization (TR) method, as a frequently-used solution to RFMs' overfitting. In the proposed method, a statistical test, namely, significance test is applied to search for the RFMs' parameters that are resistant against overfitting issue. The performance of the proposed method was evaluated for two real data sets of Cartosat-1 satellite images. The obtained results demonstrate the efficiency of the proposed method in term of the achievable level of accuracy. This technique, indeed, shows an improvement of 50-80% over the TR.

Determination of quaternary ammonium compounds by potentiometric titration with an ionic surfactant electrode: single-laboratory validation.

PubMed

Price, Randi; Wan, Ping

2010-01-01

A potentiometric titration for determining the quaternary ammonium compounds (QAC) commonly found in antimicrobial products was validated by a single laboratory. Traditionally, QACs were determined by using a biphasic (chloroform and water) manual titration procedure. Because of safety considerations regarding chloroform, as well as the subjectivity of color indicator-based manual titration determinations, an automatic potentiometric titration procedure was tested with quaternary nitrogen product formulations. By using the Metrohm Titrando system coupled with an ionic surfactant electrode and an Ag/AgCl reference electrode, titrations were performed with various QAC-containing formulation products/matrixes; a standard sodium lauryl sulfate solution was used as the titrant. Results for the products tested are sufficiently reproducible and accurate for the purpose of regulatory product enforcement. The robustness of the method was measured by varying pH levels, as well as by comparing buffered versus unbuffered titration systems. A quantitation range of 1-1000 ppm quaternary nitrogen was established. Eight commercially available antimicrobial products covering a variety of matrixes were assayed; the results obtained were comparable to those obtained by the manual titration method. Recoveries of 94 to 104% were obtained for spiked samples.

Rapid spot test for the determination of esculin hydrolysis.

PubMed Central

Edberg, S C; Gam, K; Bottenbley, C J; Singer, J M

1976-01-01

Esculin hydrolysis is a useful test in the differentiation of both gram-positive and gram-negative bacteria covering a wide spectrum of aerobes, facultative anaerobes, and anaerobes. Commonly utilized methods require a minimum of 18 h of incubation in broth or agar medium and utilize the production of a brown-black compound, due to the combination of ferric ions with the hydrolysis product esculetin, as indicator. A procedure is presented that requires 15 to 30 min for completion and utilizes fluorescence loss as the indicator of hydrolysis. Esculin fluoresces at 366 nm, whereas the hydrolysis product esculetin does not. Over 1,400 strains of gram-positive and gram-negative bacteria were tested. There was 98.4% of correlation between the spot test and esculin broth and 97% correlation with the bile-esculin agar. Images PMID:787006

A Brief Study on Toxic Combustion Products of the Polymers Used in High-Pressure Oxygen Systems

NASA Technical Reports Server (NTRS)

Hshieh, Fu-Yu; Beeson, Harold D.

2005-01-01

One likely cause of polymer ignition in a high-pressure oxygen system is the adiabatic-compression heating of polymers caused by pneumatic impact. Oxidative pyrolysis or combustion of polymers in a high-pressure oxygen system could generate toxic gases. This paper investigates the feasibility of using the NASA pneumatic-impact system to conduct adiabatic-compression combustion tests and determines the toxic combustion products produced from the burning of five selected polymers. Five polymers commonly used in high-pressure oxygen systems, Zytel(Registered TradeMark) 42 (Nylon 6/6), Buna N (nitrile rubber), Witon(Registered TradeMark) A (copolymer of vinylidene fluoride and hexafluoropropylene), Neoflon(Registered TradeMark) (polychlorotrifluoroethylene), and Teflon(Registered TradeMark) (polytetrafluoroethylene), were tested in the NASA pneumatic-impact test system at 17.2-MPa oxygen pressure. The polymers were ignited and burned; combustion products were collected in a stainless-steel sample bottle and analyzed using various methods. The results show that the NASA pneumatic-impact system is an appropriate test system to conduct adiabatic-compression combustion tests and to collect combustion products for further chemical analysis. The composition of the combustion product gas generated from burning the five selected polymers are presented and discussed.

Determination of coumarin, vanillin, and ethyl vanillin in vanilla extract products: liquid chromatography mass spectrometry method development and validation studies.

PubMed

de Jager, Lowri S; Perfetti, Gracia A; Diachenko, Gregory W

2007-03-23

A LC-MS method was developed for the determination of coumarin, vanillin, and ethyl vanillin in vanilla products. Samples were analyzed using LC-electrospray ionization (ESI)-MS in the positive ionization mode. Limits of detection for the method ranged from 0.051 to 0.073 microg mL(-1). Using the optimized method, 24 vanilla products were analyzed. All samples tested negative for coumarin. Concentrations ranged from 0.38 to 8.59 mg mL(-1) (x =3.73) for vanillin and 0.33 to 2.27 mg mL(-1) (x =1.03) for ethyl vanillin. The measured concentrations are compared to values calculated using UV monitoring and to results reported in a similar survey in 1988. Analytical results, method precision, and accuracy data are presented.

Review of the cultivation program within the National Alliance for Advanced Biofuels and Bioproducts

DOE PAGES

Lammers, Peter J.; Huesemann, Michael; Boeing, Wiebke; ...

2016-12-12

The cultivation efforts within the National Alliance for Advanced Biofuels and Bioproducts (NAABB) were developed to provide four major goals for the consortium, which included biomass production for downstream experimentation, development of new assessment tools for cultivation, development of new cultivation reactor technologies, and development of methods for robust cultivation. The NAABB consortium testbeds produced over 1500 kg of biomass for downstream processing. The biomass production included a number of model production strains, but also took into production some of the more promising strains found through the prospecting efforts of the consortium. Cultivation efforts at large scale are intensive andmore » costly, therefore the consortium developed tools and models to assess the productivity of strains under various environmental conditions, at lab scale, and validated these against scaled outdoor production systems. Two new pond-based bioreactor designs were tested for their ability to minimize energy consumption while maintaining, and even exceeding, the productivity of algae cultivation compared to traditional systems. Also, molecular markers were developed for quality control and to facilitate detection of bacterial communities associated with cultivated algal species, including the Chlorella spp. pathogen, Vampirovibrio chlorellavorus, which was identified in at least two test site locations in Arizona and New Mexico. Finally, the consortium worked on understanding methods to utilize compromised municipal wastewater streams for cultivation. In conclusion, this review provides an overview of the cultivation methods and tools developed by the NAABB consortium to produce algae biomass, in robust low energy systems, for biofuel production.« less

Small sample estimation of the reliability function for technical products

NASA Astrophysics Data System (ADS)

Lyamets, L. L.; Yakimenko, I. V.; Kanishchev, O. A.; Bliznyuk, O. A.

2017-12-01

It is demonstrated that, in the absence of big statistic samples obtained as a result of testing complex technical products for failure, statistic estimation of the reliability function of initial elements can be made by the moments method. A formal description of the moments method is given and its advantages in the analysis of small censored samples are discussed. A modified algorithm is proposed for the implementation of the moments method with the use of only the moments at which the failures of initial elements occur.

A fast algorithm for determining bounds and accurate approximate p-values of the rank product statistic for replicate experiments.

PubMed

Heskes, Tom; Eisinga, Rob; Breitling, Rainer

2014-11-21

The rank product method is a powerful statistical technique for identifying differentially expressed molecules in replicated experiments. A critical issue in molecule selection is accurate calculation of the p-value of the rank product statistic to adequately address multiple testing. Both exact calculation and permutation and gamma approximations have been proposed to determine molecule-level significance. These current approaches have serious drawbacks as they are either computationally burdensome or provide inaccurate estimates in the tail of the p-value distribution. We derive strict lower and upper bounds to the exact p-value along with an accurate approximation that can be used to assess the significance of the rank product statistic in a computationally fast manner. The bounds and the proposed approximation are shown to provide far better accuracy over existing approximate methods in determining tail probabilities, with the slightly conservative upper bound protecting against false positives. We illustrate the proposed method in the context of a recently published analysis on transcriptomic profiling performed in blood. We provide a method to determine upper bounds and accurate approximate p-values of the rank product statistic. The proposed algorithm provides an order of magnitude increase in throughput as compared with current approaches and offers the opportunity to explore new application domains with even larger multiple testing issue. The R code is published in one of the Additional files and is available at http://www.ru.nl/publish/pages/726696/rankprodbounds.zip .