Sample records for lot release testing

  1. A Comparative Study on the Lot Release Systems for Vaccines as of 2016.

    PubMed

    Fujita, Kentaro; Naito, Seishiro; Ochiai, Masaki; Konda, Toshifumi; Kato, Atsushi

    2017-09-25

    Many countries have already established their own vaccine lot release system that is designed for each country's situation: while the World Health Organization promotes for the convergence of these regulatory systems so that vaccines of assured quality are provided globally. We conducted a questionnaire-based investigation of the lot release systems for vaccines in 7 countries and 2 regions. We found that a review of the summary protocol by the National Regulatory Authorities was commonly applied for the independent lot release of vaccines, however, we also noted some diversity between countries, especially in regard to the testing policy. Some countries and regions, including Japan, regularly tested every lot of vaccines, whereas the frequency of these tests was reduced in other countries and regions as determined based on the risk assessment of these products. Test items selected for the lot release varied among the countries or regions investigated, although there was a tendency to prioritize the potency tests. An understanding of the lot release policy may contribute to improving and harmonizing the lot release system globally in the future.

  2. 21 CFR 610.1 - Tests prior to release required for each lot.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Tests prior to release required for each lot. 610.1 Section 610.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Release Requirements § 610.1 Tests prior to...

  3. The Anthrax Vaccine Debate: A Medical Review for Commanders

    DTIC Science & Technology

    2001-04-01

    tested , certified, and released the new lots for distribution.65 BioPort has a total of 32 lots of Anthrax Vaccine, Adsorbed in storage for ...cit., 1744. 159. New anthrax vaccines have been developed and are ready for clinical testing . But so far, lack of funding has prevented the ...anthrax vaccine. The FDA has not yet certified the new facilities and has not released new lots for sale. DoD has not used any of these

  4. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 3: Pig islet product manufacturing and release testing.

    PubMed

    Korbutt, Gregory S

    2009-01-01

    This chapter provides recommendations on pig islet product manufacturing and release testing to scientific and corporate programs interested in future clinical studies using xenogeneic porcine pancreatic islet cell products for the treatment of type 1 diabetes.To facilitate control of manufacturing as well as reproducibility and consistency of product lots, the manufacturing process, and the manufacturing facility must be in compliance with current Good Manufacturing Practices regulations. Data must be provided to demonstrate that islet products can be consistently prepared that would meet basic lot release requirements. To facilitate product safety: (i) materials used in the manufacturing process, including the pig pancreas, must be free of adventitious agents; (ii) islets must be manufactured using aseptic processing; and (iii) final product must undergo tests for sterility, mycoplasma (if cultured) and endotoxin. Safety specifications for pig islet product release include a negative Gram stain and an endotoxin content of <5.0 EU/kg recipient body weight. Product post-release assessments must include sterility cultures on the final product. Because results for sterility are available only retrospectively, a plan of action must be in place for patient notification and treatment in case the sterility culture results are positive for contamination. Product characterization information must address important aspects of lot release testing such as identity/purity (cell composition), quantity [islet equivalents (IE), cell number] and potency (insulin secretory capacity, oxygen consumption rate corrected for DNA or transplant bioassay in immunoincompetent diabetic mice). This information is also critical to demonstrate manufacturing control and product consistency across multiple islet preparations (lots). Providing islet products containing an islet mass sufficient to restore euglycemia in trial participants (>or=10 000 IE/kg) requires pooling of islets from multiple donor pancreata (two to four from adult donors and seven to 10 from neonatal donors). Demonstration of product consistency across products from individual pancreata would warrant release testing to be performed on a sample of the pooled product. As product development and clinical trials advance, the increasingly more detailed specifications of potency assays on adult porcine islet products are expected to be predictive of post-transplant glycemic control. The immaturity of fetal and neonatal porcine islet tissue precludes the use of in vitro insulin secretion as a potency test as part of lot release testing; another measure of potency appropriate to fetal and neonatal cells will need to be developed for product release testing and evaluation of aliquots of these products in mouse transplant bioassays should be performed to provide meaningful post-release information.

  5. Investigation of factors affecting in vitro doxorubicin release from PEGylated liposomal doxorubicin for the development of in vitro release testing conditions.

    PubMed

    Shibata, Hiroko; Izutsu, Ken-Ichi; Yomota, Chikako; Okuda, Haruhiro; Goda, Yukihiro

    2015-01-01

    Establishing appropriate drug release testing methods of liposomal products for assuring quality and performance requires the determination of factors affecting in vitro drug release. In this study, we investigated the effects of test conditions (human plasma lot, pH/salt concentration in the test media, dilution factor, temperature, ultrasound irradiation, etc.), and liposomal preparation conditions (pH/concentration of ammonium sulfate solution), on doxorubicin (DXR) release from PEGylated liposomal DXR. Higher temperature and lower pH significantly increased DXR release. The evaluation of DXR solubility indicated that the high DXR release induced by low pH may be attributed to the high solubility of DXR at low pH. Ultrasound irradiation induced rapid DXR release in an amplitude-dependent manner. The salt concentration in the test solution, human plasma lot, and dilution factor had a limited impact on DXR-release. Variations in the ammonium sulfate concentration used in solutions for the formation/hydration of liposomes significantly affected DXR release behavior, whereas differences in pH did not. In addition, heating condition in phosphate-buffered saline at lower pH (<6.5) exhibited higher discriminative ability for the release profiles from various liposomes with different concentrations of ammonium sulfate than did ultrasound irradiation. These results are expected to be helpful in the process of establishing appropriate drug release testing methods for PEGylated liposomal DXR.

  6. Validation of pharmaceutical potency determinations by quantitative nuclear magnetic resonance spectrometry.

    PubMed

    Webster, Gregory K; Marsden, Ian; Pommerening, Cynthia A; Tyrakowski, Christina M

    2010-05-01

    With the changing development paradigms in the pharmaceutical industry, laboratories are challenged to release materials for clinical studies with rapid turnaround times. To minimize cost demands, many businesses are looking to develop ways of using early Good Manufacturing Practice (GMP) materials of active pharmaceutical ingredients (API) for Good Laboratory Practice (GLP) toxicology studies. To make this happen, the analytical laboratory releases the material by one of three scenarios: (1) holding the GLP release until full GMP testing is ready, (2) issuing a separate lot number for a portion of the GMP material and releasing the material for GLP use, or (3) releasing the lot of material for GLP using alternate (equivalent) method(s) not specified for GMP release testing. Many companies are finding the third scenario to be advantageous in terms of cost and efficiency through the use of quantitative nuclear magnetic resonance (q-NMR). The use of q-NMR has proved to be a single-point replacement for routine early development testing that previously combined elements of identity testing, chromatographic assay, moisture analysis, residual solvent analysis, and elemental analysis. This study highlights that q-NMR can be validated to meet current regulatory analytical method guidelines for routine pharmaceutical analysis.

  7. 21 CFR 660.46 - Samples; protocols; official release.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... with 125I or unlyophilized HBsAg-coated red blood cells means a sample from each lot of diagnostic test...) One sample until written notification of official release is no longer required under paragraph (c)(2... notification of official release is no longer required under paragraph (c)(2) of this section. The sample...

  8. 21 CFR 660.46 - Samples; protocols; official release.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... with 125I or unlyophilized HBsAg-coated red blood cells means a sample from each lot of diagnostic test...) One sample until written notification of official release is no longer required under paragraph (c)(2... notification of official release is no longer required under paragraph (c)(2) of this section. The sample...

  9. 21 CFR 660.46 - Samples; protocols; official release.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... with 125I or unlyophilized HBsAg-coated red blood cells means a sample from each lot of diagnostic test...) One sample until written notification of official release is no longer required under paragraph (c)(2... notification of official release is no longer required under paragraph (c)(2) of this section. The sample...

  10. Assessment of pharmaceutical quality of furosemide tablets from multinational markets.

    PubMed

    Qureshi, S A; McGilveray, I J

    1998-11-01

    This report describes results of a collaborative study in which samples of the 40-mg strength of furosemide tablets were evaluated following a common protocol based on British (BP), European (Ph. Eur.), and US Pharmacopoeial (USP) specifications. Several tests, including identification, uniformity of mass, and dissolution, were performed. In total, excluding Lasix lots, results for 162 lots obtained from 115 manufacturers or suppliers were submitted. Also, 23 laboratories identified and submitted data for 34 lots of Lasix products available in their countries. There were no reported abnormalities in the physical test requirements of the products analyzed. The summaries (n, mean, and 95% CI) of the assay results for the "standard sample" (a common sample), Lasix lots from participating countries, and for all other furosemide products, respectively, are as follows: 30, 99.8%, 96-104; 33, 100.0%, 94-106; and 162, 99.6, 94-105. About half (approximately 62%) of the reported uniformity of mass results based on tablet weights were in the range 150-175 mg/tablet. However, there appears to be notable variability in tablet weights that would result in significant differences in the ratios (0.14 to 0.40) of active ingredient to excipient. The reported disintegration times ranged from 0 (instantaneous) to 18 min, with most less than 1 min. The drug dissolution testing was conducted with phosphate buffer at pH 5.8 (USP recommended). Another test was conducted with acetate buffer at pH 4.6 (noncompendial). There appears to be remarkable similarity in overall percentage of drug release from the three types of products (standard sample, Lasix lots, and other products). Although apparently there is a very wide spread in dissolution characteristics of the products tested, the analyses of variance did not detect differences among the products tested and, to this extent, would not indicate differences in bioavailability characteristics for most of these products. It is observed that about 20-38% of the variability in dissolution testing is not product related (i.e., it is from the dissolution testing itself), while the remaining 62-80% variability is product related (manufacturing, formulation, etc). The results of this multinational collaborative study showed that most of the furosemide products available in different countries met the required pharmaceutical quality standards, including drug-release characteristics. Based on an extensive statistical analysis, the main concern from the study was that the high variability in drug dissolution testing would require wide tolerance standards (e.g., pharmacopoeial standards). This may result in lack of needed discriminating ability of the test in revealing the impacts of formulation and manufacturing changes on in vitro, and perhaps in vivo, drug-release characteristics.

  11. Human leukocytic pyrogen test for detection of pyrogenic material in growth hormone produced by recombinant Escherichia coli.

    PubMed Central

    Dinarello, C A; O'Connor, J V; LoPreste, G; Swift, R L

    1984-01-01

    Human growth hormone is biosynthetically produced in recombinant strains of Escherichia coli as methionyl human growth hormone (met-hGH). When purified from the bacterial culture, met-hGH is biologically active in established assays for growth hormone. Therefore, a phase I trial of met-hGH was carried out in healthy human adults; during the first trial, however, signs, symptoms, and clinical laboratory tests characteristic of an acute-phase response to pyrogenic agents was observed. Prior testing of the met-hGH preparation used in the phase I trial did not reveal evidence of toxicity, and the U.S. Pharmacopeial Convention rabbit pyrogen test, as well as the Limulus amoebocyte lysate (LAL) test, had not detected significant levels of exogenous pyrogens or endotoxin. In addition, standard inhibition studies with added endotoxin showed no inhibition by the LAL test. When this preparation of met-hGH was incubated with human blood mononuclear cells, leukocytic pyrogen (LP) was released into the supernatant medium, suggesting that the preparation contained pyrogenic material. Various lots of met-hGH based on different purification and formulating methods were tested by the human LP assay for contaminating pyrogens. The results of these tests aided in the identification of procedures for met-hGH preparations which did not induce LP in vitro. Thus, subsequent lots of met-hGH which had passed the LP test were used in repeat clinical studies, and no inflammatory or pyrogenic reactions were observed. When the LP test was used, experiments revealed that the original lot of met-hGH was contaminated with endotoxin which had not been detected in the LAL or rabbit pyrogen tests. Lyophilization in glycine-phosphate buffer had resulted in a 10- to 20-fold reduction of endotoxin reactivity in the LAL test and the U.S. Pharmacopeial Convention rabbit pyrogen test. These data provide a probable explanation for the negative result from the LAL and rabbit pyrogen test in the initial lot of met-hGH which induced acute-phase reactions. In addition, these studies demonstrate that the release of LP from human cells is a reliable indicator of the presence of materials that are pyrogenic for humans. PMID:6386853

  12. In-vitro characterization of 5-aminosalicylic acid release from MMX mesalamine tablets and determination of tablet coating thickness.

    PubMed

    Tenjarla, Srini; Abinusawa, Adeyinka

    2011-01-01

    Substantial variability in gastrointestinal pH is observed in patients with ulcerative colitis (UC). We characterized the effect of pH on 5-aminosalicylic acid (5-ASA) release from MMX mesalamine tablets (Shire Pharmaceuticals Inc., Wayne, PA, USA), examined thickness/uniformity of tablet film coatings, and explored the influence of simulating altered gastrointestinal motility. Nondestructive, three-dimensional, terahertz pulse imaging (TPI) was used to characterize the film coating of three lots of MMX mesalamine tablets (n=36). Thereafter, 5-ASA release from these tablets was evaluated using United States Pharmacopeia (USP) apparatus II at pH 6.8 and 7.2. Onset of tablet film-coat breach and mean dissolution time were determined for each lot. 5-ASA release was also assessed at three different paddle rotation speeds (50, 75, and 100 rpm) at pH 7.2. The mean ± SD film-coating thickness of the three lots of MMX mesalamine tablets were 109.2 ± 16.8, 113.1 ± 19.5, and 113.8 ± 19.8 μM, respectively. At pH 6.8 (100 rpm), the onset of film-coat breach was 10-30 minutes, whereas at pH 7.2 this was observed within 10 minutes. 5-ASA release was uniform at both pH conditions, with minimal lot-to-lot variability. Complete drug release was achieved within 6 hours under both pH conditions. 5-ASA release increased in proportion with paddle speed, but remained prolonged at all speeds. 5-ASA release from MMX mesalamine is unaffected by normal variations in simulated intracolonic pH. The dissolution profile of 5-ASA from MMX mesalamine tablets may be attributed to consistent outer film coatings and the hydrogel-forming matrix that controls the drug release after dissolution of the film coating.

  13. 21 CFR 610.2 - Requests for samples and protocols; official release.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Biologics Evaluation and Research, a manufacturer shall not distribute a lot of a product until the lot is... Evaluation and Research, a manufacturer shall not distribute a lot of a biological product until the lot is... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Requests for samples and protocols; official...

  14. 21 CFR 610.2 - Requests for samples and protocols; official release.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Biologics Evaluation and Research, a manufacturer shall not distribute a lot of a product until the lot is... Evaluation and Research, a manufacturer shall not distribute a lot of a biological product until the lot is... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Requests for samples and protocols; official...

  15. Chinese plasma-derived products supply under the lot release management system in 2007-2011.

    PubMed

    Zhang, Xuejun; Ye, Shengliang; Du, Xi; Yuan, Jing; Zhao, Chaoming; Li, Changqing

    2013-11-01

    In 2007, the Chinese State Food and Drug Administration (SFDA) implemented a management system for lot release of all plasma-derived products. Since then, there have been only a few systematic studies of the blood supply, which is a concern when considering the small amount of plasma collected per capita (approximately 3 L/1000 people). As a result, there may be a threat to the safety of the available blood supply. In this study, we examined the characteristics of the supply of Chinese plasma-derived products. We investigated the reports of lot-released biological products derived from all 8 national or regional regulatory authorities in China from 2007 to 2011. The market supply characteristics of Chinese plasma-derived products were analyzed by reviewing the changes in supply varieties, the batches of lot-released plasma-derived products and the actual supply. As a result, the national regulatory authorities can more accurately develop a specific understanding of the production and quality management information provided by Chinese plasma product manufacturers. The implementation of the lot release system further ensures the clinical validity of the plasma-derived products in China and improves the safety of using plasma-derived products. This work provides an assessment of the future Chinese market supply of plasma-derived products and can function as a theoretical basis for the establishment of hemovigilance. Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  16. Development and application of a biorelevant dissolution method using USP apparatus 4 in early phase formulation development.

    PubMed

    Fang, Jiang B; Robertson, Vivian K; Rawat, Archana; Flick, Tawnya; Tang, Zhe J; Cauchon, Nina S; McElvain, James S

    2010-10-04

    Dissolution testing is frequently used to determine the rate and extent at which a drug is released from a dosage form, and it plays many important roles throughout drug product development. However, the traditional dissolution approach often emphasizes its application in quality control testing and usually strives to obtain 100% drug release. As a result, dissolution methods are not necessarily biorelevant and meaningful application of traditional dissolution methods in the early phases of drug product development can be very limited. This article will describe the development of a biorelevant in vitro dissolution method using USP apparatus 4, biorelevant media, and real-time online UV analysis. Several case studies in the areas of formulation selection, lot-to-lot variability, and food effect will be presented to demonstrate the application of this method in early phase formulation development. This biorelevant dissolution method using USP apparatus 4 provides a valuable tool to predict certain aspects of the in vivo drug release. It can be used to facilitate the formulation development/selection for pharmacokinetic (PK) and clinical studies. It may also potentially be used to minimize the number of PK studies, and to aid in the design of more efficient PK and clinical studies.

  17. Development of an in vitro alternative assay method for vaginal irritation.

    PubMed

    Ayehunie, Seyoum; Cannon, Chris; Larosa, Karen; Pudney, Jeffrey; Anderson, Deborah J; Klausner, Mitchell

    2011-01-11

    The vaginal mucosa is commonly exposed to chemicals and therapeutic agents that may result in irritation and/or inflammation. In addition to acute effects, vaginal irritation and inflammation can make women more susceptible to infections such as HIV-1 and herpes simplex virus 2 (HSV-2). Hence, the vaginal irritation potential of feminine care formulations and vaginally administered therapeutic agents is a significant public health concern. Traditionally, testing of such materials has been performed using the rabbit vaginal irritation (RVI) assay. In the current study, we investigated whether the organotypic, highly differentiated EpiVaginal™ tissue could be used as a non-animal alternative to the RVI test. The EpiVaginal tissue was exposed to a single application of ingredients commonly found in feminine hygiene products and the effects on tissue viability (MTT assay), barrier disruption (measured by transepithelial electrical resistance, TEER and sodium fluorescein (NaFl) leakage), and inflammatory cytokine release (interleukin (IL)-1α, IL-1β, IL-6, and IL-8) patterns were examined. When compared to untreated controls, two irritating ingredients, nonoxynol 9 and benzalkonium chloride, reduced tissue viability to <40% and TEER to <60% while increasing NaFl leakage by 11-24% and IL-1α and IL-1β release by >100%. Four other non-irritating materials had minimal effects on these parameters. Assay reproducibility was confirmed by testing the chemicals using three different tissue production lots and by using tissues reconstructed from cells obtained from three different donors. Coefficients of variation between tissue lots reconstructed with cells obtained from the same donor or lots reconstructed with cells obtained from different donors were less than 10% and 12%, respectively. In conclusion, decreases in tissue viability and barrier function and increases in IL-1α and IL-1β release appear to be useful endpoints for preclinical screening of topically applied chemicals and formulations for their vaginal irritation potential. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  18. A Test-Bed of Secure Mobile Cloud Computing for Military Applications

    DTIC Science & Technology

    2016-09-13

    searching databases. This kind of applications is a typical example of mobile cloud computing (MCC). MCC has lots of applications in the military...Release; Distribution Unlimited UU UU UU UU 13-09-2016 1-Aug-2014 31-Jul-2016 Final Report: A Test-bed of Secure Mobile Cloud Computing for Military...Army Research Office P.O. Box 12211 Research Triangle Park, NC 27709-2211 Test-bed, Mobile Cloud Computing , Security, Military Applications REPORT

  19. Use of an unmanned aerial vehicle-mounted video camera to assess feeding behavior of Raramuri Criollo cows

    USDA-ARS?s Scientific Manuscript database

    We determined the feasibility of using unmanned aerial vehicle (UAV) video monitoring to predict intake of discrete food items of rangeland-raised Raramuri Criollo non-nursing beef cows. Thirty-five cows were released into a 405-m2 rectangular dry lot, either in pairs (pilot tests) or individually (...

  20. 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

  1. 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.

  2. Registration of FC1018, FC1019, FC1020, and FC1022, Sugarbeet Multigerm Pollinator Germplasms with Disease Resistance

    USDA-ARS?s Scientific Manuscript database

    ‘FC1018’, ‘FC1019’, ‘FC1020’, and ‘FC1022’ (PI 658059, PI 658060, PI 658061, PI 658062, respectively) sugarbeet germplasm (Beta vulgaris L.) were released in 2009 from 05-FC1018, 05-FC1019, 07-/08-FC1020 and 05-FC101022 seed lots, respectively, and tested under those designations. They were develo...

  3. Development of a microwave assisted extraction method for the analysis of 2,4,6-trichloroanisole in cork stoppers by SIDA-SBSE-GC-MS.

    PubMed

    Vestner, Jochen; Fritsch, Stefanie; Rauhut, Doris

    2010-02-15

    The aim of this research work was focused on the replacement of the time-consuming soaking of cork stoppers which is mainly used as screening method for cork lots in connection with sensory analysis and/or analytical methods to detect releasable 2,4,6-trichloroanisole (TCA) of natural cork stoppers. Releasable TCA from whole cork stoppers was analysed with the application of a microwave assisted extraction method (MAE) in combination with stir bar sorptive extraction (SBSE). The soaking of corks (SOAK) was used as a reference method to optimise MAE parameters. Cork lots of different quality and TCA contamination levels were used to adapt MAE. Pre-tests indicated that an MAE at 40 degrees C for 120 min with 90 min of cooling time are suitable conditions to avoid an over-extraction of TCA of low and medium tainted cork stoppers in comparison to SOAK. These MAE parameters allow the measuring of almost the same amounts of releasable TCA as with the application of the soaking procedure in the relevant range (<25 ng L(-1) releasable TCA from one cork) to evaluate the TCA level of cork stoppers. Stable isotope dilution assay (SIDA) was applied to optimise quantification of the released TCA with deuterium-labelled TCA (TCA-d(5)) using a time-saving GC-MS technique in single ion monitoring (SIM) mode. The developed MAE method allows the measuring of releasable TCA from the whole cork stopper under improved conditions and in connection with a low use of solvent and a higher sample throughput. Copyright 2009 Elsevier B.V. All rights reserved.

  4. Estimating degradation in real time and accelerated stability tests with random lot-to-lot variation: a simulation study.

    PubMed

    Magari, Robert T

    2002-03-01

    The effect of different lot-to-lot variability levels on the prediction of stability are studied based on two statistical models for estimating degradation in real time and accelerated stability tests. Lot-to-lot variability is considered as random in both models, and is attributed to two sources-variability at time zero, and variability of degradation rate. Real-time stability tests are modeled as a function of time while accelerated stability tests as a function of time and temperatures. Several data sets were simulated, and a maximum likelihood approach was used for estimation. The 95% confidence intervals for the degradation rate depend on the amount of lot-to-lot variability. When lot-to-lot degradation rate variability is relatively large (CV > or = 8%) the estimated confidence intervals do not represent the trend for individual lots. In such cases it is recommended to analyze each lot individually. Copyright 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91: 893-899, 2002

  5. Registration of 'FC1028', 'FC1037, 'FC1038' and, 'FC1036' multigerm sugarbeet germplasm with multiple disease resistances

    USDA-ARS?s Scientific Manuscript database

    ‘FC1028’, ‘FC1036’, ‘FC1037’, and ‘FC1038’ (PI 665053, PI 665054, PI 665055, PI 665056) sugarbeet germplasms (Beta vulgaris L.) were released from 20111027, 09-FC1036, 20111025, and 04-FC1038 seed lots, respectively, and tested under the designations 04-FC1028; 05-, 06-, 07-, 08-, 09-FC1036; 04-FC10...

  6. Validation of a quantitative cerebrospinal fluid alpha-synuclein assay in a European-wide interlaboratory study.

    PubMed

    Kruse, Niels; Persson, Staffan; Alcolea, Daniel; Bahl, Justyna M C; Baldeiras, Ines; Capello, Elisabetta; Chiasserini, Davide; Bocchio Chiavetto, Luisella; Emersic, Andreja; Engelborghs, Sebastiaan; Eren, Erden; Fladby, Tormod; Frisoni, Giovanni; García-Ayllón, María-Salud; Genc, Sermin; Gkatzima, Olymbia; Heegaard, Niels H H; Janeiro, André M; Kováčech, Branislav; Kuiperij, H Bea; Leitão, Maria J; Lleó, Alberto; Martins, Madalena; Matos, Mafalda; Mollergard, Hanne M; Nobili, Flavio; Öhrfelt, Annika; Parnetti, Lucilla; de Oliveira, Catarina Resende; Rot, Uros; Sáez-Valero, Javier; Struyfs, Hanne; Tanassi, Julia T; Taylor, Peggy; Tsolaki, Magda; Vanmechelen, Eugeen; Verbeek, Marcel M; Zilka, Norbert; Blennow, Kaj; Zetterberg, Henrik; Mollenhauer, Brit

    2015-09-01

    Decreased levels of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) in Parkinson's disease and related synucleinopathies have been reported, however, not consistently in all cross-sectional studies. To test the performance of one recently released human-specific enzyme-linked immunosorbent assay (ELISA) for the quantification of aSyn in CSF, we carried out a round robin trial with 18 participating laboratories trained in CSF ELISA analyses within the BIOMARKAPD project in the EU Joint Program - Neurodegenerative Disease Research. CSF samples (homogeneous aliquots from pools) and ELISA kits (one lot) were provided centrally and data reported back to one laboratory for data analysis. Our study showed that although factors such as preanalytical sample handling and lot-to-lot variability were minimized by our study design, we identified high variation in absolute values of CSF aSyn even when the same samples and same lots of assays were applied. We further demonstrate that although absolute concentrations differ between laboratories the quantitative results are comparable. With further standardization this assay may become an attractive tool for comparing aSyn measurements in diverse settings. Recommendations for further validation experiments and improvement of the interlaboratory results obtained are given. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Lewis Online Travel System: Preparer's/Traveler's Manual, Release 1.0

    NASA Technical Reports Server (NTRS)

    Seese, Michael

    1992-01-01

    The Lewis Online Travel System (LOTS) is a menu-driven interactive application that automates nearly all of the functions associated with government travel. The purpose of this manual is to provide LOTS users with concise instructions for using the computerized application. As such, it will not go into the details of travel regulations.

  8. 46 CFR 160.077-23 - Production tests and inspections.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... fixed anchor, or (C) a tensile test machine that is capable of holding a given tension. The assembly... testing of each incoming lot of inflation chamber material before using that lot in production; (iii) Have... inspector must perform or supervise testing and inspection of at least one PFD lot in each five lots...

  9. Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197

    PubMed Central

    Baumstark, Annette; Pleus, Stefan; Schmid, Christina; Link, Manuela; Haug, Cornelia; Freckmann, Guido

    2012-01-01

    Background Accurate and reliable blood glucose (BG) measurements require that different test strip lots of the same BG monitoring system provide comparable measurement results. Only a small number of studies addressing this question have been published. Methods In this study, four test strip lots for each of five different BG systems [Accu-Chek® Aviva (system A), FreeStyle Lite® (system B), GlucoCheck XL (system C), Pura™/mylife™ Pura (system D), and OneTouch® Verio™ Pro (system E)] were evaluated with procedures according to DIN EN ISO 15197:2003. The BG system measurement results were compared with the manufacturer’s measurement procedure (glucose oxidase or hexokinase method). Relative bias according to Bland and Altman and system accuracy according to ISO 15197 were analyzed. A BG system consists of the BG meter itself and the test strips. Results The maximum lot-to-lot difference between any two of the four evaluated test strip lots per BG system was 1.0% for system E, 2.1% for system A, 3.1% for system C, 6.9% for system B, and 13.0% for system D. Only two systems (systems A and B) fulfill the criteria of DIN EN ISO 15197:2003 with each test strip lot. Conclusions Considerable lot-to-lot variability between test strip lots of the same BG system was found. These variations add to other sources of inaccuracy with the specific BG system. Manufacturers should regularly and effectively check the accuracy of their BG meters and test strips even between different test strip lots to minimize risk of false treatment decisions. PMID:23063033

  10. Fingerprint test data report: FM 5834 test lots No. 1, 3, 4, and 5. [resin matrix composites

    NASA Technical Reports Server (NTRS)

    1986-01-01

    Quality control testing is presented for various lots of resin matrix composites. The tests conducted were filler test, resin test, fabric test, and prepreg test for lots 1, 3, 4, and 5. The results of the tests are presented in chart forms.

  11. 76 FR 41504 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... annual average of lots released in FY 2010 (6,752), number of recalls made (1,881), and total number of... fill lot numbers for the total number of dosage units of each strength or potency distributed (e.g., 50... manufacture and distribution of a product including any recalls. These recordkeeping requirements serve...

  12. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  13. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  14. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  15. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

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

    PubMed

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

    2016-11-01

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

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

    PubMed Central

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

    2016-01-01

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

  18. Brood stock segregation of spring chinook salmon Oncorhynchus tshawytscha by use of the enzyme-linked immunosorbent assay (ELISA) and the fluorescent antibody technique (FAT) affects the prevalence and levels of Renibacterium salmoninarum infection in progeny

    USGS Publications Warehouse

    Pascho, Ronald J.; Elliott, Diane G.; Streufert, Jonathan M.

    1991-01-01

    A study of the effect of maternal Renibacterium salmoninarum infection levels on the prevalence and levels of bacterial kidney disease (BKD) in progeny fish was conducted at a production salmon hatchery. A total of 302 mating pairs of spring chinook salmon Oncorhynchus tshawytscha was screened in August 1988 for R. salmoninarum by an enzyme-linked immunosorbent assay (ELISA). On the basis of ELISA testing of kidney tissues from all fish and the testing of ovarian fluid samples from a subsample of the females by a direct membrane filtration fluorescent antibody technique (MF-FAT), selected egg lots were segregated into 2 groups of 30 egg lots or about 135 000 eggs each. One group contained egg lots from male and female parents that had low R. salmoninarum infection levels or tested negative for R. salmoninarum (low-BKD group), and the other group contained egg lots from female parents with relatively high R. salmoninarum infection levels and male parents with various infection levels (high-BKD group). The progeny groups were maintained in separate rearing units supplied with untreated river water, and were monitored for R. salmoninarum by the ELISA until they were released from the hatchery in April 1990. Total mortality of the juvenile fish was higher (p = 0.0001) in the high-BKD group (20%) than in the low-BKD group (10 %). Mortality in the high-BKD group was highest after the fish were moved from nursery tanks to raceways, and clinical BKD became evident in this group. During the 11 mo of raceway rearing, mortality in the high-BKD group was 17 % compared with 5 % for the low-BKD group. An ELISA analysis of smolts just before release showed an R. salmoninarum infection rate of 85 % in the high-BKD group and 62 % in the low-BKD group. Of the positive fish, 98 % in the low-BKD group and 55 % in the high-BKD group had low infection levels, whereas 36 % in the high-BKD group and only 1 % in the low-BKD group had high infection levels. The results of this research suggest that segregation of brood stock by the ELISA and the MF-FAT can be used to reduce the prevalence and levels of BKD in hatchery-reared spring chinook salmon, even in locations with open water supplies.

  19. Lack of evidence for the presence of emerging HoBi-like viruses in North American fetal bovine serum lots.

    PubMed

    Bauermann, Fernando V; Flores, Eduardo F; Falkenberg, Shollie M; Weiblen, Rudi; Ridpath, Julia F

    2014-01-01

    The detection of an emerging pestivirus species, "HoBi-like virus," in fetal bovine serum (FBS) labeled as U.S. origin, but packaged in Europe, raised concerns that HoBi-like virus may have entered the United States. In the current study, 90 lots of FBS originating in North America (NA) were screened for pestivirus antigen and antibodies. Lots in group 1 (G1, 72 samples) and group 2 (G2, 9 samples) originated in NA and were packaged in the United States. Group 3 (G3) was composed of 9 lots collected in NA and processed in Europe. Lots in G1 were claimed negative for Bovine viral diarrhea virus (BVDV), while lots in G2 and G3 were claimed positive by the commercial processor. All lots in G1 and G2 tested negative by reverse transcription polymerase chain reaction (RT-PCR) using HoBi-like-specific primers. Two G1 lots tested positive by BVDV RT-PCR. One of these was also positive by virus isolation. All G2 lots were positive by BVDV RT-PCR. In addition, four G2 lots were VI positive while 1 lot was antigen-capture enzyme-linked immunosorbent assay (ELISA) positive. Two G3 lots were positive by HoBi-like-specific RT-PCR tests. All lots were negative for HoBi_D32/00 neutralizing antibodies. Seven lots (4 G1; 1 G2; 2 G3) had antibodies against BVDV by virus neutralization and/or antigen-capture ELISA. While there is no evidence of HoBi-like viruses in NA based on tested samples, further studies are required to validate HoBi-like virus-free status and develop means to prevent the spread of HoBi-like virus into NA.

  20. The Gulch

    NASA Image and Video Library

    2016-10-27

    This archival image was released as part of a gallery comparing JPL's past and present, commemorating the 80th anniversary of NASA's Jet Propulsion Laboratory on Oct. 31, 2016. At the northeast end of the Jet Propulsion Laboratory, there was a row of rocket test pits and storage buildings that housed explosives. This was near the Arroyo Seco, a dry canyon wash at the base of the San Gabriel Mountains. The picture was taken in August 1944. Today, this area is a small parking lot behind the Fabrication Shop (Building 103). http://photojournal.jpl.nasa.gov/catalog/PIA21119

  1. 49 CFR 178.33-8 - Tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Tests. 178.33-8 Section 178.33-8 Transportation... Containers, and Linings § 178.33-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  2. 49 CFR 178.33-8 - Tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 false Tests. 178.33-8 Section 178.33-8 Transportation... Containers, and Linings § 178.33-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  3. 49 CFR 178.33-8 - Tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Tests. 178.33-8 Section 178.33-8 Transportation... Containers, and Linings § 178.33-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  4. 49 CFR 178.33-8 - Tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 3 2014-10-01 2014-10-01 false Tests. 178.33-8 Section 178.33-8 Transportation... Containers, and Linings § 178.33-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  5. Spray-dried nanofibrillar cellulose microparticles for sustained drug release.

    PubMed

    Kolakovic, Ruzica; Laaksonen, Timo; Peltonen, Leena; Laukkanen, Antti; Hirvonen, Jouni

    2012-07-01

    Nanofibrillar cellulose (also referred to as cellulose nanofibers, nanocellulose, microfibrillated or nanofibrillated cellulose) has gained a lot of attention in recent years in different research areas including biomedical applications. In this study we have evaluated the applicability of nanofibrillar cellulose (NFC) as a material for the formation of matrix systems for sustained drug delivery. For that purpose, drug loaded NFC microparticles were produced by a spray drying method. The microparticles were characterized in terms of size and morphology, total drug loading, and physical state of the encapsulated drug. Drug release from the microparticles was assessed by dissolution tests, and suitable mathematical models were used to explain the drug releasing kinetics. The particles had spherical shapes with diameters of around 5 μm; the encapsulated drug was mainly in amorphous form. The controlled drug release was achieved. The drug releasing curves were fitted to a mathematical model describing the drug releasing kinetics from a spherical matrix. Different drugs had different release kinetics, which was a consequence of several factors, including different solubilities of the drugs in the chosen medium and different affinities of the drugs to the NFC. It can be concluded that NFC microparticles can sustain drug release by forming a tight fiber network and thus limit drug diffusion from the system. Copyright © 2012 Elsevier B.V. All rights reserved.

  6. Investigating Premature Ignition of Thruster Pressure Cartridges by Mechanical Impact of Internal Components

    NASA Technical Reports Server (NTRS)

    Woods, Stephen S.; Saulsberry, Regor

    2010-01-01

    Pyrotechnic thruster pressure cartridges (TPCs) are used for aeroshell separation on a new NASA crew launch vehicle. The premature ignition concern was hypothesized based on the potential range of motion of the subassemblies, projected worst case accelerations, and the internal geometry that could subject propellant grains to mechanical impact sufficiently high for ignition. This possibility was investigated by fabricating a high-fidelity model of the suspected contact geometry, placing a representative amount of propellant in it, and impacting the propellant with a range of forces equivalent to and greater than the maximum possible during launch. Testing demonstrated that the likelihood of ignition is less than 1 in 1,000,000. The test apparatus, methodology, and results are described in this paper. Nondestructive evaluation ( NDE) during TPC acceptance testing indicated that internal assemblies moved during shock and vibration testing due to an internal bond anomaly. This caused concerns that the launch environment might produce the same movement and release propellant grains that might be prematurely ignited through impact or through electrostatic discharge (ESD) as grains vibrated against internal surfaces. Since a new lot could not be fabricated in time, a determination had to be made as to whether the lot was acceptable to fly. This paper discusses the analysis and impact testing used to address the potential impact issue and a separate paper addresses the ESD issue.

  7. Development of an Accelerated Hydrogen Embrittlement Test for Manganese Phosphated Steels

    DTIC Science & Technology

    2011-05-01

    from the same vendor (RSL Testing Systems) and lot (HT/ HTP ) were used. See Appendix B for the certifications for lots HT/ HTP . Note: lot HTP is...Based on the vendor certification of the notched tensile specimens from RSL lot HT/ HTP , the NTS was 373 ksi and the average load at failure was...Systems Lot HT/ HTP ). Note that use of a higher reference NTS and load to failure is a conservative approach since the specimens will experience

  8. 49 CFR 178.33a-8 - Tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Tests. 178.33a-8 Section 178.33a-8 Transportation... Containers, and Linings § 178.33a-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  9. 49 CFR 178.33a-8 - Tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 3 2014-10-01 2014-10-01 false Tests. 178.33a-8 Section 178.33a-8 Transportation... Containers, and Linings § 178.33a-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  10. 49 CFR 178.33a-8 - Tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 false Tests. 178.33a-8 Section 178.33a-8 Transportation... Containers, and Linings § 178.33a-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  11. 49 CFR 178.33a-8 - Tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Tests. 178.33a-8 Section 178.33a-8 Transportation... Containers, and Linings § 178.33a-8 Tests. (a) One out of each lot of 25,000 containers or less, successively..., successively produced per day, shall constitute a lot and if the test container shall fail, the lot shall be...

  12. LM193 Dual Differential Comparator Total Ionizing Dose Test Report

    NASA Technical Reports Server (NTRS)

    Topper, Alyson; Forney, James; Campola, Michael

    2017-01-01

    The purpose of this test was to characterize the flight lot of Texas Instruments' LM193 (flight part number is 5962-9452601Q2A) for total dose response. This test served as the radiation lot acceptance test (RLAT) for the lot date code (LDC) tested. Low dose rate (LDR) irradiations were performed in this test so that the device susceptibility to enhanced low dose rate sensitivity (ELDRS) was determined.

  13. Effects of Controlled Release Fertilizer on the Post-Production Performance of Impatiens Wallerana

    USDA-ARS?s Scientific Manuscript database

    Controlled release fertilizers (CRF) in production systems have been known to reduce environmental contamination. However, there is a lot to be explored as per its use in bedding plant production. Bedding plant growers have not adapted CRF use because there is little information about its use and ...

  14. 21 CFR 660.46 - Samples; protocols; official release.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Samples; protocols; official release. 660.46 Section 660.46 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES..., a sample of product not iodinated with 125I means a sample from each filling of each lot packaged as...

  15. Rules for Optical Testing

    NASA Technical Reports Server (NTRS)

    Stahl, H. Philip

    2014-01-01

    Based on 30 years of optical testing experience, a lot of mistakes, a lot of learning and a lot of experience, I have defined seven guiding principles for optical testing - regardless of how small or how large the optical testing or metrology task: Fully Understand the Task, Develop an Error Budget, Continuous Metrology Coverage, Know where you are, Test like you fly, Independent Cross-Checks, Understand All Anomalies. These rules have been applied with great success to the inprocess optical testing and final specification compliance testing of the JWST mirrors.

  16. Association of vaccine handling conditions with effectiveness of live attenuated influenza vaccine against H1N1pdm09 viruses in the United States.

    PubMed

    Caspard, Herve; Coelingh, Kathleen L; Mallory, Raburn M; Ambrose, Christopher S

    2016-09-30

    This analysis examined potential causes of the lack of vaccine effectiveness (VE) of live attenuated influenza vaccine (LAIV) against A/H1N1pdm09 viruses in the United States (US) during the 2013-2014 season. Laboratory studies have demonstrated reduced thermal stability of A/California/07/2009, the A/H1N1pdm09 strain utilized in LAIV from 2009 through 2013-2014. Post hoc analyses of a 2013-2014 test-negative case-control (TNCC) effectiveness study investigated associations between vaccine shipping conditions and LAIV lot effectiveness. Investigational sites provided the LAIV lot numbers administered to each LAIV recipient enrolled in the study, and the vaccine distributor used by the site for commercially purchased vaccine. Additionally, a review was conducted of 2009-2014 pediatric observational TNCC effectiveness studies of LAIV, summarizing effectiveness by type/subtype, season, and geographic location. From the 2013 to 2014 TNCC study, the proportion of LAIV recipients who tested positive for H1N1pdm09 was significantly higher among children who received a lot released between August 1 and September 15, 2013, compared with a lot shipped either earlier or later (21% versus 4%; P<0.01). A linear relationship was observed between the proportion of subjects testing positive for H1N1pdm09 and outdoor temperatures during truck unloading at distributors' central locations. The review of LAIV VE studies showed that in the 2010-2011 and 2013-2014 influenza seasons, no significant effectiveness of LAIV against H1N1pdm09 was demonstrated for the trivalent or quadrivalent formulations of LAIV in the US, respectively, in contrast to significant effectiveness against A/H3N2 and B strains during 2010-2014. This study showed that the lack of VE observed with LAIV in the US against H1N1pdm09 viruses was associated with exposure of some LAIV lots to temperatures above recommended storage conditions during US distribution, and is likely explained by the increased susceptibility of the A/California/7/2009 (H1N1pdm09) LAIV strain to thermal degradation. NCT01997450. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  17. Effects of greening and community reuse of vacant lots on crime

    PubMed Central

    Kondo, Michelle; Hohl, Bernadette; Han, SeungHoon; Branas, Charles

    2016-01-01

    The Youngstown Neighborhood Development Corporation initiated a ‘Lots of Green’ programme to reuse vacant land in 2010. We performed a difference-in-differences analysis of the effects of this programme on crime in and around newly treated lots, in comparison to crimes in and around randomly selected and matched, untreated vacant lot controls. The effects of two types of vacant lot treatments on crime were tested: a cleaning and greening ‘stabilisation’ treatment and a ‘community reuse’ treatment mostly involving community gardens. The combined effects of both types of vacant lot treatments were also tested. After adjustment for various sociodemographic factors, linear and Poisson regression models demonstrated statistically significant reductions in all crime classes for at least one lot treatment type. Regression models adjusted for spatial autocorrelation found the most consistent significant reductions in burglaries around stabilisation lots, and in assaults around community reuse lots. Spill-over crime reduction effects were found in contiguous areas around newly treated lots. Significant increases in motor vehicle thefts around both types of lots were also found after they had been greened. Community-initiated vacant lot greening may have a greater impact on reducing more serious, violent crimes. PMID:28529389

  18. Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013.

    PubMed

    Hehmke, Bernd; Berg, Sabine; Salzsieder, Eckhard

    2017-05-01

    Continuous standardized verification of the accuracy of blood glucose meter systems for self-monitoring after their introduction into the market is an important clinically tool to assure reliable performance of subsequently released lots of strips. Moreover, such published verification studies permit comparison of different blood glucose monitoring systems and, thus, are increasingly involved in the process of evidence-based purchase decision making.

  19. 78 FR 48926 - Notice of Request To Release Airport Property

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-12

    ... that approximately 4.80 acres of property, Lot 3, be released for sale to CT Development, LLC. for use... future aviation needs at the airport. The FAA may approve the request, in whole or in part, no sooner... sale of the subject property will result in the land at the Ottumwa Regional Airport (OTM) being...

  20. 78 FR 48217 - Notice of Request To Release Airport Property

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... approximately 2.21 acres of property, Lot 6, be released for sale to Al-Jon for use as a light manufacturing.... The FAA may approve the request, in whole or in part, no sooner than thirty days after the publication... acquired airport property to be used for non-aviation purposes. The sale of the subject property will...

  1. First release of the Dietary Supplement Ingredient Database: Nutrient estimates and methodology for 18 vitamins and minerals in adult multivitamin/minerals (MVMs)

    USDA-ARS?s Scientific Manuscript database

    The Dietary Supplement Ingredient Database (DSID) is a federal initiative to provide analytical validation of ingredients in dietary supplements. The first release on vitamins and minerals in adult MVMs is now available. Multiple lots of >100 representative adult MVMs were chemically analyzed for ...

  2. 78 FR 49790 - Notice of Request To Release Airport Property

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-15

    ... of any comments submitted to the FAA must be mailed or delivered to: Tom Francis, Airport Manager, C... to rule and invites public comment on the release of land, Lot 2, at the Ottumwa Regional Airport, Ottumwa, Iowa, under the provisions of 49 U.S.C. 47107(h)(2). DATES: Comments must be received on or...

  3. 46 CFR 160.053-4 - Inspections and tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  4. 46 CFR 160.053-4 - Inspections and tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  5. 46 CFR 160.053-4 - Inspections and tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  6. 46 CFR 160.026-6 - Sampling, inspection, and tests of production lots.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Bacteriological limits and salt content MIL-W-15117 and U.S. Public Health “Drinking Water Standards.” (e) Lot..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Water, Emergency Drinking (In... lots. (a) General. Containers of emergency drinking water must be tested in accordance with the...

  7. 46 CFR 160.026-6 - Sampling, inspection, and tests of production lots.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Bacteriological limits and salt content MIL-W-15117 and U.S. Public Health “Drinking Water Standards.” (e) Lot..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Water, Emergency Drinking (In... lots. (a) General. Containers of emergency drinking water must be tested in accordance with the...

  8. 46 CFR 160.026-6 - Sampling, inspection, and tests of production lots.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Bacteriological limits and salt content MIL-W-15117 and U.S. Public Health “Drinking Water Standards.” (e) Lot..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Water, Emergency Drinking (In... lots. (a) General. Containers of emergency drinking water must be tested in accordance with the...

  9. 46 CFR 160.026-6 - Sampling, inspection, and tests of production lots.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Bacteriological limits and salt content MIL-W-15117 and U.S. Public Health “Drinking Water Standards.” (e) Lot..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Water, Emergency Drinking (In... lots. (a) General. Containers of emergency drinking water must be tested in accordance with the...

  10. 46 CFR 160.026-6 - Sampling, inspection, and tests of production lots.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Bacteriological limits and salt content MIL-W-15117 and U.S. Public Health “Drinking Water Standards.” (e) Lot..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Water, Emergency Drinking (In... lots. (a) General. Containers of emergency drinking water must be tested in accordance with the...

  11. 78 FR 48926 - Notice of Request To Release Airport Property

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-12

    ... requested from the FAA that approximately 0.68 acres of property, Lot 14, be released for sale to Al-Jon for... impact future aviation needs at the airport. The FAA may approve the request, in whole or in part, no... purposes. The sale of the subject property will result in the land at the Ottumwa Regional Airport (OTM...

  12. Joint Air-to-Surface Standoff Missile (JASSM)

    DTIC Science & Technology

    2015-12-01

    6.1.3) All Ops All Ops Joint Critical Ops All Ops All Ops Missile Reliability (KSA) (CPD para 6.2.8) 4th Lot .91 4th Lot .91 IOT &E .80 4th Lot .85 IOT &E...the ORD 303-95-III dated January 20, 2004 Change Explanations None Acronyms and Abbreviations IOT &E - Initial Operational Test and Evaluation KSA... Actuator Control Card, Lots 12 and 4 Systems Engineering Program Support/Program Tooling and Test Equipment, and JASSM-ER Standard Data Protocol (DS

  13. Evaluation of Commercially Available Cyanide Test Kits against Various Matrices

    DTIC Science & Technology

    2016-08-01

    further evaluation in a second phase of testing. Cyantesmo paper was tested against 15 matrices, including baking soda, boric acid, brewer’s yeast...matrices were baking soda, boric acid, brewer’s yeast, chalk dust, chitin, coffee powder (instant coffee), cornstarch, drywall dust, flour, kaolin...TN);  DG powdered sugar;  DG talcum powder (Lot 14312THW);  DG Clover Valley baking soda (Lot PMHB51);  Boric acid (Lot 766965; Fisher

  14. Safety testing of acellular pertussis vaccines: Use of animals and 3Rs alternatives

    PubMed Central

    Hoonakker, Marieke; Arciniega, Juan; Hendriksen, Coenraad

    2017-01-01

    ABSTRACT The current test of acellular Bordetella pertussis (aP) vaccines for residual pertussis toxin (PTx) is the Histamine Sensitization test (HIST), based on the empirical finding that PTx sensitizes mice to histamine. Although HIST has ensured the safety of aP vaccines for years, it is criticized for the limited understanding of how it works, its technical difficulty, and for animal welfare reasons. To estimate the number of mice used worldwide for HIST, we surveyed major aP manufacturers and organizations performing, requiring, or recommending the test. The survey revealed marked regional differences in regulatory guidelines, including the number of animals used for a single test. Based on information provided by the parties surveyed, we estimated the worldwide number of mice used for testing to be 65,000 per year: ∼48,000 by manufacturers and ∼17,000 by national control laboratories, although the latter number is more affected by uncertainty, due to confidentiality policies. These animals covered the release of approximately 850 final lots and 250 in-process lots of aP vaccines yearly. Although there are several approaches for HIST refinement and reduction, we discuss why the efforts needed for validation and implementation of these interim alternatives may not be worthwhile, when there are several in vitro alternatives in various stages of development, some already fairly advanced. Upon implementation, one or more of these replacement alternatives can substantially reduce the number of animals currently used for the HIST, although careful evaluation of each alternative's mechanism and its suitable validation will be necessary in the path to implementation. PMID:28857652

  15. Safety testing of acellular pertussis vaccines: Use of animals and 3Rs alternatives.

    PubMed

    Hoonakker, Marieke; Arciniega, Juan; Hendriksen, Coenraad

    2017-11-02

    The current test of acellular Bordetella pertussis (aP) vaccines for residual pertussis toxin (PTx) is the Histamine Sensitization test (HIST), based on the empirical finding that PTx sensitizes mice to histamine. Although HIST has ensured the safety of aP vaccines for years, it is criticized for the limited understanding of how it works, its technical difficulty, and for animal welfare reasons. To estimate the number of mice used worldwide for HIST, we surveyed major aP manufacturers and organizations performing, requiring, or recommending the test. The survey revealed marked regional differences in regulatory guidelines, including the number of animals used for a single test. Based on information provided by the parties surveyed, we estimated the worldwide number of mice used for testing to be 65,000 per year: ∼48,000 by manufacturers and ∼17,000 by national control laboratories, although the latter number is more affected by uncertainty, due to confidentiality policies. These animals covered the release of approximately 850 final lots and 250 in-process lots of aP vaccines yearly. Although there are several approaches for HIST refinement and reduction, we discuss why the efforts needed for validation and implementation of these interim alternatives may not be worthwhile, when there are several in vitro alternatives in various stages of development, some already fairly advanced. Upon implementation, one or more of these replacement alternatives can substantially reduce the number of animals currently used for the HIST, although careful evaluation of each alternative's mechanism and its suitable validation will be necessary in the path to implementation.

  16. 21 CFR 7.3 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... firm's removal or correction of a product that has not been marketed or that has not left the direct... and no portion of the lot has been released for sale or use. (l) Recall strategy means a planned...

  17. 21 CFR 7.3 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... firm's removal or correction of a product that has not been marketed or that has not left the direct... and no portion of the lot has been released for sale or use. (l) Recall strategy means a planned...

  18. COTS Ceramic Chip Capacitors: An Evaluation of the Parts and Assurance Methodologies

    NASA Technical Reports Server (NTRS)

    Brusse, Jay A.; Sampson, Michael J.

    2004-01-01

    Commercial-Off-The-Shelf (COTS) multilayer ceramic chip capacitors (MLCCs) are continually evolving to reduce physical size and increase volumetric efficiency. Designers of high reliability aerospace and military systems are attracted to these attributes of COTS MLCCs and would like to take advantage of them while maintaining the high standards for long-term reliable operation they are accustomed io when selecting military qualified established reliability (MIL-ER) MLCCs. However, MIL-ER MLCCs are not available in the full range of small chip sizes with high capacitance as found in today's COTS MLCCs. The objectives for this evaluation were to assess the long-term performance of small case size COTS MLCCs and to identify effective, lower-cost product assurance methodologies. Fifteen (15) lots of COTS X7R dielectric MLCCs from four (4) different manufacturers and two (2) MIL-ER BX dielectric MLCCs from two (2) of the same manufacturers were evaluated. Both 0805 and 0402 chip sizes were included. Several voltage ratings were tested ranging from a high of 50 volts to a low of 6.3 volts. The evaluation consisted of a comprehensive screening and qualification test program based upon MIL-PRF-55681 (i.e., voltage conditioning, thermal shock, moisture resistance, 2000-hour life test, etc.). In addition, several lot characterization tests were performed including Destructive Physical Analysis (DPA), Highly Accelerated Life Test (HALT) and Dielectric Voltage Breakdown Strength. The data analysis included a comparison of the 2000-hour life test results (used as a metric for long-term performance) relative to the screening and characterization test results. Results of this analysis indicate that the long-term life performance of COTS MLCCs is variable -- some lots perform well, some lots perform poorly. DPA and HALT were found to be promising lot characterization tests to identify substandard COTS MLCC lots prior to conducting more expensive screening and qualification tests. The results indicate that lot- specific screening and qualification are still recommended for high reliability applications. One significant and concerning observation is that MIL- type voltage conditioning (100 hours at twice rated voltage, 125 C) was not an effective screen in removing infant mortality parts for the particular lots of COTS MLCCs evaluated.

  19. 46 CFR 160.176-15 - Production tests and inspections.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... known weight and winch, (B) a scale, winch, and fixed anchor, or (C) a tensile test machine that is... laboratory inspector tests and inspects the lot; (ii) Perform required testing of each incoming lot of... produced the components used in the lifejacket. (d) Samples. (1) Samples used in testing and inspections...

  20. Etiology of Early Lifestage Diseases, Project 84-44, 1985 Final Report.

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

    Sauter, R.W.

    1986-10-01

    Each year hatcheries experience loss of eggs, fry and fingerlings due to a group of poorly defined diseases called White Spot and Coagulated Yolk. Samples of maternal blood and ovarian fluid (coelomic fluid), as well as unfertilized eggs, were collected at spawning and subsequently tested for the presence of bacteria. Our tests reveal that there is a wide range in mortality rates experienced by the progeny of different brood salmon. Microbiologic tests revealed that these eggs contained a variety of both Gram positive and Gram negative bacteria within their yolk and that the fluids from the females who produced thesemore » lots were contaminated with a variety of bacteria. In contrast the eggs and maternal fluids from the six egg lots which experienced the lowest mortalities did not contain high numbers of Gram positive bacteria and contributed only 5% of the total mortalities observed within the 30 egg lots tested. From the 60 egg lots tested over two brood years we have isolated 18 different bacterial genera containing 32 different species from within the yolk surface sterilized, unfertilized eggs. Our tests suggest that Aeromonas hydrophila, Pseudomonas (3 species) Staphylococcus aureus, Vibrio sp., Corynebacterium hoffmanii, Listeria sp. and Bacillus sp. when detected within the yolk of eggs sampled from egg lots prior to fertilization will be associated with higher than normal mortality rates when the remainder of the egg lots containing these bacteria are incubated and reared. 36 refs., 16 figs.« less

  1. HF-Release of Sacrificial Layers in CMOS-integrated MOEMS structures

    NASA Astrophysics Data System (ADS)

    Döring, S.; Friedrichs, M.; Pufe, W.; Schulze, M.

    2016-10-01

    In this paper we will present details of the release process of SiO2 sacrificial layers we use within a multi-level MOEMS process developed by IPMS. Using such sacrificial layers gain a lot of benefits necessary for the production of high-end MOEMS devices like high surface quality and great surface planarity. However the HF-release of the sacrificial layer can be connected with specific issues. We present, which mechanisms are involved in the release process and how knowing them, can be the key for an optimized performance of the device. More-over we will present how to protect the CMOS backplane of our devices from unwanted HF attack during the release.

  2. Statistical validation of reagent lot change in the clinical chemistry laboratory can confer insights on good clinical laboratory practice.

    PubMed

    Cho, Min-Chul; Kim, So Young; Jeong, Tae-Dong; Lee, Woochang; Chun, Sail; Min, Won-Ki

    2014-11-01

    Verification of new lot reagent's suitability is necessary to ensure that results for patients' samples are consistent before and after reagent lot changes. A typical procedure is to measure results of some patients' samples along with quality control (QC) materials. In this study, the results of patients' samples and QC materials in reagent lot changes were analysed. In addition, the opinion regarding QC target range adjustment along with reagent lot changes was proposed. Patients' sample and QC material results of 360 reagent lot change events involving 61 analytes and eight instrument platforms were analysed. The between-lot differences for the patients' samples (ΔP) and the QC materials (ΔQC) were tested by Mann-Whitney U tests. The size of the between-lot differences in the QC data was calculated as multiples of standard deviation (SD). The ΔP and ΔQC values only differed significantly in 7.8% of the reagent lot change events. This frequency was not affected by the assay principle or the QC material source. One SD was proposed for the cutoff for maintaining pre-existing target range after reagent lot change. While non-commutable QC material results were infrequent in the present study, our data confirmed that QC materials have limited usefulness when assessing new reagent lots. Also a 1 SD standard for establishing a new QC target range after reagent lot change event was proposed. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  3. 49 CFR 178.33b-8 - Production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Production tests. 178.33b-8 Section 178.33b-8... Containers, and Linings § 178.33b-8 Production tests. (a) Burst Testing. (1) One out of each lot of 5,000...,000 containers or less, successively produced per day, shall constitute a lot and if the test...

  4. 49 CFR 178.33-8 - Tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Tests. 178.33-8 Section 178.33-8 Transportation... Inside Containers, and Linings § 178.33-8 Tests. (a) One out of each lot of 25,000 containers or less... less, successively produced per day, shall constitute a lot and if the test container shall fail, the...

  5. 46 CFR 164.023-13 - Production tests and inspections.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Constant Rate of Traverse tensile testing machine, capable of initial clamp separation of ten inches and a... production testing on a lot must meet the following criteria for the lot to be shipped as Coast Guard... the acceptance testing values but not less than the performance minimums. (2) Length/weight values...

  6. 7 CFR 51.3417 - Optional test for specific gravity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Optional test for specific gravity. 51.3417 Section 51... § 51.3417 Optional test for specific gravity. Tests to determine specific gravity shall be made in... lot with respect to size and quality. The specific gravity for any lot of potatoes shall be the...

  7. 7 CFR 51.3417 - Optional test for specific gravity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Optional test for specific gravity. 51.3417 Section 51... § 51.3417 Optional test for specific gravity. Tests to determine specific gravity shall be made in... lot with respect to size and quality. The specific gravity for any lot of potatoes shall be the...

  8. Item response theory analysis of the life orientation test-revised: age and gender differential item functioning analyses.

    PubMed

    Steca, Patrizia; Monzani, Dario; Greco, Andrea; Chiesi, Francesca; Primi, Caterina

    2015-06-01

    This study is aimed at testing the measurement properties of the Life Orientation Test-Revised (LOT-R) for the assessment of dispositional optimism by employing item response theory (IRT) analyses. The LOT-R was administered to a large sample of 2,862 Italian adults. First, confirmatory factor analyses demonstrated the theoretical conceptualization of the construct measured by the LOT-R as a single bipolar dimension. Subsequently, IRT analyses for polytomous, ordered response category data were applied to investigate the items' properties. The equivalence of the items across gender and age was assessed by analyzing differential item functioning. Discrimination and severity parameters indicated that all items were able to distinguish people with different levels of optimism and adequately covered the spectrum of the latent trait. Additionally, the LOT-R appears to be gender invariant and, with minor exceptions, age invariant. Results provided evidence that the LOT-R is a reliable and valid measure of dispositional optimism. © The Author(s) 2014.

  9. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method.

    PubMed

    Link, Manuela; Schmid, Christina; Pleus, Stefan; Baumstark, Annette; Rittmeyer, Delia; Haug, Cornelia; Freckmann, Guido

    2015-04-14

    The standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek Aviva, ContourXT, GlucoCheck XL, GlucoMen LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used. The evaluation was performed in a standardized manner following test procedures described in ISO 15197:2003 (section 7.3). System accuracy was assessed by applying ISO 15197:2003 and in addition ISO 15197:2013 criteria (section 6.3.3). For each system, comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus glucose analyzer) and a hexokinase (cobas c111) method. All 4 systems fulfilled the accuracy requirements of ISO 15197:2003 with the tested lots. More stringent accuracy criteria of ISO 15197:2013 were fulfilled by 3 systems (Accu-Chek Aviva, ContourXT, GlucoMen LX PLUS) when compared to the manufacturer's comparison method and by 2 systems (Accu-Chek Aviva, ContourXT) when compared to the alternative comparison method. All systems showed lot-to-lot variability to a certain degree; 2 systems (Accu-Chek Aviva, ContourXT), however, showed only minimal differences in relative bias between the 3 evaluated lots. In this study, all 4 systems complied with the evaluated test strip lots with accuracy criteria of ISO 15197:2003. Applying ISO 15197:2013 accuracy limits, differences in the accuracy of the tested systems were observed, also demonstrating that the applied comparison method/system and the lot-to-lot variability can have a decisive influence on accuracy data obtained for a SMBG system. © 2015 Diabetes Technology Society.

  10. A Translation and Validation Study of the Life Orientation Test Revised in the Greek Speaking Population of Nurses among Three Hospitals in Athens and Ioannina

    ERIC Educational Resources Information Center

    Lyrakos, George N.; Damigos, Dimitrios; Mavreas, Venetsanos; Georgia, Kostopanagiotou; Dimoliatis, Ioannis D. K.

    2010-01-01

    The life orientation test-revised (LOT-R) (Scheier et al. in "Journal of Personality and Social Psychology" 67:1063-1078, 1994) is a brief measure for assessing dispositional optimism. The aim of this study was to develop a Greek language version of the LOT-R and to assess the instrument's psychometric properties. The LOT-R was…

  11. Deflection test evaluation of different lots of the same nickel-titanium wire commercial brand

    PubMed Central

    Neves, Murilo Gaby; Lima, Fabrício Viana Pereira; Gurgel, Júlio de Araújo; Pinzan-Vercelino, Célia Regina Maio; Rezende, Fernanda Soares; Brandão, Gustavo Antônio Martins

    2016-01-01

    Introduction: The aim of this in vitro study was to compare the elastic properties of the load-deflection ratio of orthodontic wires of different lot numbers and the same commercial brand. Methods: A total of 40 nickel-titanium (NiTi) wire segments (Morelli OrtodontiaTM - Sorocaba, SP, Brazil), 0.016-in in diameter were used. Groups were sorted according to lot numbers (lots 1, 2, 3 and 4). 28-mm length segments from the straight portion (ends) of archwires were used. Deflection tests were performed in an EMIC universal testing machine with 5-N load cell at 1 mm/minute speed. Force at deactivation was recorded at 0.5, 1, 2 and 3 mm deflection. Analysis of variance (ANOVA) was used to compare differences between group means. Results: When comparing the force of groups at the same deflection (3, 2 and 1 mm), during deactivation, no statistical differences were found. Conclusion: There are no changes in the elastic properties of different lots of the same commercial brand; thus, the use of different lots of the orthodontic wires used in this research does not compromise the final outcomes of the load-deflection ratio. PMID:27007760

  12. Deflection test evaluation of different lots of the same nickel-titanium wire commercial brand.

    PubMed

    Neves, Murilo Gaby; Lima, Fabrício Viana Pereira; Gurgel, Júlio de Araújo; Pinzan-Vercelino, Célia Regina Maio; Rezende, Fernanda Soares; Brandão, Gustavo Antônio Martins

    2016-01-01

    The aim of this in vitro study was to compare the elastic properties of the load-deflection ratio of orthodontic wires of different lot numbers and the same commercial brand. A total of 40 nickel-titanium (NiTi) wire segments (Morelli Ortodontia™--Sorocaba, SP, Brazil), 0.016-in in diameter were used. Groups were sorted according to lot numbers (lots 1, 2, 3 and 4). 28-mm length segments from the straight portion (ends) of archwires were used. Deflection tests were performed in an EMIC universal testing machine with 5-N load cell at 1 mm/minute speed. Force at deactivation was recorded at 0.5, 1, 2 and 3 mm deflection. Analysis of variance (ANOVA) was used to compare differences between group means. When comparing the force of groups at the same deflection (3, 2 and 1 mm), during deactivation, no statistical differences were found. There are no changes in the elastic properties of different lots of the same commercial brand; thus, the use of different lots of the orthodontic wires used in this research does not compromise the final outcomes of the load-deflection ratio.

  13. 46 CFR 161.012-13 - Production tests and inspections.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ten lights from each lot of lights produced. Each lot must not exceed 1,000 lights. At least nine of the ten lights, when tested in accordance with the test described in § 161.012-11(c), must meet the... random sample of ten lights must be taken and tested. If less than nine of these lights meet the test...

  14. The Importance of Reagent Lot Registration in External Quality Assurance/Proficiency Testing Schemes.

    PubMed

    Stavelin, Anne; Riksheim, Berit Oddny; Christensen, Nina Gade; Sandberg, Sverre

    2016-05-01

    Providers of external quality assurance (EQA)/proficiency testing schemes have traditionally focused on evaluation of measurement procedures and participant performance and little attention has been given to reagent lot variation. The aim of the present study was to show the importance of reagent lot registration and evaluation in EQA schemes. Results from the Noklus (Norwegian Quality Improvement of Primary Care Laboratories) urine albumin/creatinine ratio (ACR) and prothrombin time international normalized ratio (INR) point-of-care EQA schemes from 2009-2015 were used as examples in this study. The between-participant CV for Afinion ACR increased from 6%-7% to 11% in 3 consecutive surveys. This increase was caused by differences between albumin reagent lots that were also observed when fresh urine samples were used. For the INR scheme, the CoaguChek INR results increased with the production date of the reagent lots, with reagent lot medians increasing from 2.0 to 2.5 INR and from 2.7 to 3.3 INR (from the oldest to the newest reagent lot) for 2 control levels, respectively. These differences in lot medians were not observed when native patient samples were used. Presenting results from different reagent lots in EQA feedback reports can give helpful information to the participants that may explain their deviant EQA results. Information regarding whether the reagent lot differences found in the schemes can affect patient samples is important and should be communicated to the participants as well as to the manufacturers. EQA providers should consider registering and evaluating results from reagent lots. © 2016 American Association for Clinical Chemistry.

  15. 49 CFR 178.33a-8 - Tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Tests. 178.33a-8 Section 178.33a-8 Transportation... Inside Containers, and Linings § 178.33a-8 Tests. (a) One out of each lot of 25,000 containers or less... less, successively produced per day, shall constitute a lot and if the test container shall fail, the...

  16. Susceptibility to Cracking of Different Lots of CDR35 Capacitors

    NASA Technical Reports Server (NTRS)

    Teverovsky, Alexander

    2017-01-01

    On-orbit flight anomalies that occurred after several months of operation were attributed to excessive leakage currents in CDR35 style 0.47 microF 50 V capacitors operating at 10 V. In this work, a lot of capacitors similar to the lot that caused the anomaly have been evaluated in parallel with another lot of similar parts to assess their susceptibility to cracking under manual soldering conditions and get insight into a possible mechanism of failure. Leakage currents in capacitors were monitored at different voltages and environmental conditions before and after terminal solder dip testing that was used to simulate thermal shock during manual soldering. Results of cross-sectioning, acoustic microscopy, and measurements of electrical and mechanical characteristics of the parts have been analyzed, and possible mechanisms of failures considered. It is shown that the susceptibility to cracking and failures caused by manual soldering is lot-related. Recommendations for testing that would help to select lots that are more robust against manual soldering stresses and mitigate the risk of failures suggested.

  17. The Urban Watershed Research Facility, Edison, New Jersey

    EPA Science Inventory

    In an undeveloped and undisturbed environment, rainfall is naturally filtered and absorbed by soil and plants, protecting aquatic systems by slowly releasing the water to ground water and streams. In an urban setting with development and lots of impervious surfaces, natural prote...

  18. 46 CFR 160.047-5 - Inspections and tests. 1

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods.... (b) Lot size and sampling. (1) A lot consists of 500 buoyant vests or fewer. (2) A new lot begins...

  19. 46 CFR 160.047-5 - Inspections and tests. 1

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods.... (b) Lot size and sampling. (1) A lot consists of 500 buoyant vests or fewer. (2) A new lot begins...

  20. 46 CFR 160.047-5 - Inspections and tests. 1

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Vest, Kapok or Fibrous Glass, Adult... labeled buoyant vests shall— (1) Maintain quality control of the materials used, the manufacturing methods.... (b) Lot size and sampling. (1) A lot consists of 500 buoyant vests or fewer. (2) A new lot begins...

  1. ECX and PEX rheology. Progress report, October--December 1975

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

    West, G.T.

    1975-01-01

    The objectives of this project are: (1) to evaluate the capillary rheometer as a device to qualitatively measure the extrusion properties of extrusion cast and paste explosives; (2) to study and determine means to distinguish and characterize the rheological properties of different lots of ECX and PEX; and (3) to apply results from (1) and (2) to production loading operations involving ECX and PEX. The second objective (to study and determine means to distinguish and characterize rheological properties) of this project has been accomplished. Testing procedures were finalized, and general knowledge of the rheometer itself was gained. Three batches ofmore » 85/15 (wt. percent) RDX/Sylgard were tested in the Instron Capillary Rheometer. Each lot was statistically distinguishable from the other two lots. One lot exhibited a significantly lower apparent viscosity than the other two lots, which were statistically different from each other, but which were in fairly close agreement.« less

  2. Observed distribution of radiocaesium contamination in shiitake lots and variability of test results.

    PubMed

    Tsuchiyama, Tomoyuki; Miyazaki, Hitoshi; Terada, Hisaya; Nakajima, Masahiro

    2015-01-01

    Shiitake mushrooms (Lentinula edodes) cultivated on bed-log are known to accumulate radiocaesium. Since the Fukushima-Diichi nuclear power plant accident (2011), the violation rate has been higher for log-cultivated shiitake than that for agricultural products or other foodstuffs. When testing shiitake mushrooms for radionuclide contamination, the validation of the sampling plan can be severely compromised by the heterogeneous contamination within shiitake lots. Currently, few data are available on the statistical properties of the radiocaesium contamination of log-cultivated shiitake. In this paper, shiitake lots contaminated by radiocaesium were identified and the distribution of the radiocaesium concentration within the lots investigated. The risk of misclassifying shiitake lots was predicted from the operating characteristic curve generated from Monte Carlo simulations and the performance of various sampling plans was evaluated. This study provides useful information for deciding on an acceptable level of misclassification risk.

  3. 9 CFR 113.64 - General requirements for live bacterial vaccines.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... completed product from each serial and subserial, and samples of each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in... samples of each lot of Master Seed Bacteria shall be tested for safety in young adult mice in accordance...

  4. 9 CFR 113.64 - General requirements for live bacterial vaccines.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... completed product from each serial and subserial, and samples of each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in... samples of each lot of Master Seed Bacteria shall be tested for safety in young adult mice in accordance...

  5. 75 FR 8081 - Patrick J. Lais: Debarment Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ..., among other things, subpotent burn spray, aspirin that had failed dissolution testing, and antacid... as ``Uncoated Aspirin.'' This drug failed its final dissolution testing. Neither Mr. Lais nor the... coated the failed aspirin and renumbered the lot. Part of this lot then was packaged as ``Coated Aspirin...

  6. Development of Special Biological Products

    DTIC Science & Technology

    1981-01-01

    Rocky Mountain Spotted Fever (RMSF) 20. Continued B. Tissue Culture / ?Two production lots of FRhL-2 dnd three of MRC-5 were stabilized...104) was potency tested. J. Q Fever Vaccine Storage Stability Potency Testing Q fever vaccine (NDBR 105) was put on potency test. K. Rocky Mountain Spotted Fever (RMSF...Fever Vaccine Storage Stability Potency Testing Two lots of Q fever vaccine (NDBR 105) were put on potency test. K. Rocky Mountain Spotted Fever

  7. Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

    PubMed Central

    Shryock, T R; White, D W; Werner, C S; Staples, J M

    1995-01-01

    Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

  8. Variability of Acoustic Transmissions in a Shallow Water Area,

    DTIC Science & Technology

    1981-05-01

    as changes in the probability density and distribution functions, and the 17 PEILChJ4WO AA Aw i-m--t SACLANTCEN SR-46 test is sensitive to these...transducer on the bottom, i.e. no delay variations, and another with a lot of movements. The left parts of the figure show projections of spreading...change a lot from one ping group (matrix) to the next (see Figs. 9c and TOc). Comparing the runs tests (Figs. 9a and lOa) we see that there is a lot

  9. 46 CFR 160.048-5 - Inspections and tests. 1

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Inspections and tests. 1 160.048-5 Section 160.048-5... Inspections and tests. 1 1 The manufacturer of a personal flotation device must meet 33 CFR 181.701 through 33... laboratory. (b) Lot size and sampling. (1) A lot shall consist of not more than 1,000 buoyant cushions. A new...

  10. 46 CFR 160.048-5 - Inspections and tests. 1

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Inspections and tests. 1 160.048-5 Section 160.048-5... Inspections and tests. 1 1 The manufacturer of a personal flotation device must meet 33 CFR 181.701 through 33... laboratory. (b) Lot size and sampling. (1) A lot shall consist of not more than 1,000 buoyant cushions. A new...

  11. 46 CFR 160.076-29 - Production oversight.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) Samples selected for the indicated tests may not be used for more than one test. (iii) If a sample fails... 12 months. (iii) One sample of each means of marking on each type of fabric or finish used in PFD... if any sample fails one or more tests. (3) In lots of more than 200 PFDs, the lot must be rejected if...

  12. 76 FR 32867 - Hazardous Materials: Requirements for Storage of Explosives During Transportation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... from release into the environment. This final rule does not prohibit or promote the development of safe... Association Standard (NFPA) 498--Standard for Safe Havens and Interchange Lots for Vehicles Transporting Explosives (2010 Edition) for the construction and maintenance of safe havens used for unattended storage of...

  13. Total Ionizing Dose Test of Microsemi's Silicon Switching Transistors JANTXV2N2222AUB and 2N2907AUB

    NASA Technical Reports Server (NTRS)

    Campola, M.; Freeman, B.; Yau, K.

    2017-01-01

    Microsemi's silicon switching transistors, JANTXV2N2222AUB and 2N2907AUB, were tested for total ionizing dose (TID) response beginning on July 11, 2016. This test served as the radiation lot acceptance test (RLAT) for the lot date code (LDC) tested. Low dose rate (LDR) irradiations were performed in this test so that the device susceptibility to enhanced low dose rate sensitivity (ELDRS) could be determined.

  14. Total Ionizing Dose Test Report BFR92A NPN 5 GHz Wide Band Transistor from NXP

    NASA Technical Reports Server (NTRS)

    Phan, Anthony M.; Oldham, Timothy R.

    2011-01-01

    The purpose of this test was to characterize the Philips/NXP BFR92A NPN 5 gigahertz wide band silicon transistor for total dose response. This test shall serves as the radiation lot acceptance test (RLAT) for the lot date code (LDC) 1027. The BFR92A is packaged in a 3-pin plastic SOT23 package. Low dose rate (LDR/ELDRS) irradiations was performed.

  15. Fire Tests on E-vehicle Battery Cells and Packs.

    PubMed

    Sturk, David; Hoffmann, Lars; Ahlberg Tidblad, Annika

    2015-01-01

    The purpose of this study was to investigate the effects of abuse conditions, including realistic crash scenarios, on Li ion battery systems in E-vehicles in order to develop safe practices and priorities when responding to accidents involving E-vehicles. External fire tests using a single burning item equipment were performed on commercial Li ion battery cells and battery packs for electric vehicle (E-vehicle) application. The 2 most common battery cell technologies were tested: Lithium iron phosphate (LFP) and mixed transition metal oxide (lithium nickel manganese cobalt oxide, NMC) cathodes against graphite anodes, respectively. The cell types investigated were "pouch" cells, with similar physical dimensions, but the NMC cells have double the electric capacity of the LFP cells due to the higher energy density of the NMC chemistry, 7 and 14 Ah, respectively. Heat release rate (HRR) data and concentrations of toxic gases were acquired by oxygen consumption calorimetry and Fourier transform infrared spectroscopy (FTIR), respectively. The test results indicate that the state of charge (SOC) affects the HRR as well as the amount of toxic hydrogen fluoride (HF) gas formed during combustion. A larger number of cells increases the amount of HF formed per cell. There are significant differences in response to the fire exposure between the NMC and LFP cells in this study. The LFP cells generate a lot more HF per cell, but the overall reactivity of the NMC cells is higher. However, the total energy released by both batteries during combustion was independent of SOC, which indicates that the electric energy content of the test object contributes to the activation energy of the thermal and heat release process, whereas the chemical energy stored in the materials is the main source of thermal energy in the batteries. The results imply that it is difficult to draw conclusions about higher order system behavior with respect to HF emissions based on data from tests on single cells or small assemblies of cells. This applies to energy release rates as well. The present data show that mass and shielding effects between cells in multicell assemblies affect the propagation of a thermal event.

  16. Field evaluation of a prototype paper-based point-of-care fingerstick transaminase test.

    PubMed

    Pollock, Nira R; McGray, Sarah; Colby, Donn J; Noubary, Farzad; Nguyen, Huyen; Nguyen, The Anh; Khormaee, Sariah; Jain, Sidhartha; Hawkins, Kenneth; Kumar, Shailendra; Rolland, Jason P; Beattie, Patrick D; Chau, Nguyen V; Quang, Vo M; Barfield, Cori; Tietje, Kathy; Steele, Matt; Weigl, Bernhard H

    2013-01-01

    Monitoring for drug-induced liver injury (DILI) via serial transaminase measurements in patients on potentially hepatotoxic medications (e.g., for HIV and tuberculosis) is routine in resource-rich nations, but often unavailable in resource-limited settings. Towards enabling universal access to affordable point-of-care (POC) screening for DILI, we have performed the first field evaluation of a paper-based, microfluidic fingerstick test for rapid, semi-quantitative, visual measurement of blood alanine aminotransferase (ALT). Our objectives were to assess operational feasibility, inter-operator variability, lot variability, device failure rate, and accuracy, to inform device modification for further field testing. The paper-based ALT test was performed at POC on fingerstick samples from 600 outpatients receiving HIV treatment in Vietnam. Results, read independently by two clinic nurses, were compared with gold-standard automated (Roche Cobas) results from venipuncture samples obtained in parallel. Two device lots were used sequentially. We demonstrated high inter-operator agreement, with 96.3% (95% C.I., 94.3-97.7%) agreement in placing visual results into clinically-defined "bins" (<3x, 3-5x, and >5x upper limit of normal), >90% agreement in validity determination, and intraclass correlation coefficient of 0.89 (95% C.I., 0.87-0.91). Lot variability was observed in % invalids due to hemolysis (21.1% for Lot 1, 1.6% for Lot 2) and correlated with lots of incorporated plasma separation membranes. Invalid rates <1% were observed for all other device controls. Overall bin placement accuracy for the two readers was 84% (84.3%/83.6%). Our findings of extremely high inter-operator agreement for visual reading-obtained in a target clinical environment, as performed by local practitioners-indicate that the device operation and reading process is feasible and reproducible. Bin placement accuracy and lot-to-lot variability data identified specific targets for device optimization and material quality control. This is the first field study performed with a patterned paper-based microfluidic device and opens the door to development of similar assays for other important analytes.

  17. Shelf life extension for the lot AAE nozzle severance LSCs

    NASA Technical Reports Server (NTRS)

    Cook, M.

    1990-01-01

    Shelf life extension tests for the remaining lot AAE linear shaped charges for redesigned solid rocket motor nozzle aft exit cone severance were completed in the small motor conditioning and firing bay, T-11. Five linear shaped charge test articles were thermally conditioned and detonated, demonstrating proper end-to-end charge propagation. Penetration depth requirements were exceeded. Results indicate that there was no degradation in performance due to aging or the linear shaped charge curving process. It is recommended that the shelf life of the lot AAE nozzle severance linear shaped charges be extended through January 1992.

  18. Sources of uncertainty in the quantification of genetically modified oilseed rape contamination in seed lots.

    PubMed

    Begg, Graham S; Cullen, Danny W; Iannetta, Pietro P M; Squire, Geoff R

    2007-02-01

    Testing of seed and grain lots is essential in the enforcement of GM labelling legislation and needs reliable procedures for which associated errors have been identified and minimised. In this paper we consider the testing of oilseed rape seed lots obtained from the harvest of a non-GM crop known to be contaminated by volunteer plants from a GM herbicide tolerant variety. The objective was to identify and quantify the error associated with the testing of these lots from the initial sampling to completion of the real-time PCR assay with which the level of GM contamination was quantified. The results showed that, under the controlled conditions of a single laboratory, the error associated with the real-time PCR assay to be negligible in comparison with sampling error, which was exacerbated by heterogeneity in the distribution of GM seeds, most notably at a small scale, i.e. 25 cm3. Sampling error was reduced by one to two thirds on the application of appropriate homogenisation procedures.

  19. Broiler Campylobacter Contamination and Human Campylobacteriosis in Iceland ▿ †

    PubMed Central

    Callicott, Kenneth A.; Harðardóttir, Hjördís; Georgsson, Franklín; Reiersen, Jarle; Friðriksdóttir, Vala; Gunnarsson, Eggert; Michel, Pascal; Bisaillon, Jean-Robert; Kristinsson, Karl G.; Briem, Haraldur; Hiett, Kelli L.; Needleman, David S.; Stern, Norman J.

    2008-01-01

    To examine whether there is a relationship between the degree of Campylobacter contamination observed in product lots of retail Icelandic broiler chicken carcasses and the incidence of human disease, 1,617 isolates from 327 individual product lots were genetically matched (using the flaA short variable region [SVR[) to 289 isolates from cases of human campylobacteriosis whose onset was within approximately 2 weeks from the date of processing. When there was genetic identity between broiler isolates and human isolates within the appropriate time frame, a retail product lot was classified as implicated in human disease. According to the results of this analysis, there were multiple clusters of human disease linked to the same process lot or lots. Implicated and nonimplicated retail product lots were compared for four lot descriptors: lot size, prevalence, mean contamination, and maximum contamination (as characterized by direct rinse plating). For retail product distributed fresh, Mann-Whitney U tests showed that implicated product lots had significantly (P = 0.0055) higher mean contamination than nonimplicated lots. The corresponding median values were 3.56 log CFU/carcass for implicated lots and 2.72 log CFU/carcass for nonimplicated lots. For frozen retail product, implicated lots were significantly (P = 0.0281) larger than nonimplicated lots. When the time frame was removed, retail product lots containing Campylobacter flaA SVR genotypes also seen in human disease had significantly higher mean and maximum contamination numbers than lots containing no genotypes seen in human disease for both fresh and frozen product. Our results suggest that cases of broiler-borne campylobacteriosis may occur in clusters and that the differences in mean contamination levels may provide a basis for regulatory action that is more specific than a presence-absence standard. PMID:18791017

  20. Assumptions of acceptance sampling and the implications for lot contamination: Escherichia coli O157 in lots of Australian manufacturing beef.

    PubMed

    Kiermeier, Andreas; Mellor, Glen; Barlow, Robert; Jenson, Ian

    2011-04-01

    The aims of this work were to determine the distribution and concentration of Escherichia coli O157 in lots of beef destined for grinding (manufacturing beef) that failed to meet Australian requirements for export, to use these data to better understand the performance of sampling plans based on the binomial distribution, and to consider alternative approaches for evaluating sampling plans. For each of five lots from which E. coli O157 had been detected, 900 samples from the external carcass surface were tested. E. coli O157 was not detected in three lots, whereas in two lots E. coli O157 was detected in 2 and 74 samples. For lots in which E. coli O157 was not detected in the present study, the E. coli O157 level was estimated to be <12 cells per 27.2-kg carton. For the most contaminated carton, the total number of E. coli O157 cells was estimated to be 813. In the two lots in which E. coli O157 was detected, the pathogen was detected in 1 of 12 and 2 of 12 cartons. The use of acceptance sampling plans based on a binomial distribution can provide a falsely optimistic view of the value of sampling as a control measure when applied to assessment of E. coli O157 contamination in manufacturing beef. Alternative approaches to understanding sampling plans, which do not assume homogeneous contamination throughout the lot, appear more realistic. These results indicate that despite the application of stringent sampling plans, sampling and testing approaches are inefficient for controlling microbiological quality.

  1. 78 FR 76675 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-18

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71057; File No. SR-CHX-2013-21] Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Permit the Reporting of Odd Lot Transactions for Inclusion on the Consolidated Tape and Clarify...

  2. Evaluation of lot-to-lot repeatability and effect of assay media choice in the recombinant Factor C assay.

    PubMed

    McKenzie, Jennifer Helen; Alwis, K Udeni; Sordillo, Joanne E; Kalluri, Kesava Srinivas; Milton, Donald Kirby

    2011-06-01

    Measurement of environmental endotoxin exposures is complicated by variability encountered using current biological assay methods arising in part from lot-to-lot variability of the Limulus-amebocyte lysate (LAL) reagents. Therefore, we investigated the lot-to-lot repeatability of commercially available recombinant Factor C (rFC) kits as an alternative to LAL. Specifically, we compared endotoxin estimates obtained from rFC assay of twenty indoor dust samples, using four different extraction and assay media, to endotoxin estimates previously obtained by Limulus amebocyte lysate (LAL) assay and amounts of 3-hydroxy fatty acids (3-OHFA) in lipopolysaccharide (LPS) using gas-chromatography mass spectroscopy (GC-MS). We found that lot-to-lot variability of the rFC assay kits does not significantly alter endotoxin estimates in house dust samples when performed using three of the four assay media tested and that choice of assay media significantly altered endotoxin estimates obtained by rFC assay of house dust samples. Our findings demonstrate lot-to-lot reproducibility of rFC assay of environmental samples and suggest that use of rFC assay performed with Tris buffer or water as the extraction and assay medium for measurement of endotoxin in dust samples may be a suitable choice for developing a standardized methodology.

  3. The establishment of a bank of stored clinical bone marrow stromal cell products

    PubMed Central

    2012-01-01

    Background Bone marrow stromal cells (BMSCs) are being used to treat a variety of conditions. For many applications a supply of cryopreserved products that can be used for acute therapy is needed. The establishment of a bank of BMSC products from healthy third party donors is described. Methods The recruitment of healthy subjects willing to donate marrow for BMSC production and the Good Manufacturing Practices (GMP) used for assessing potential donors, collecting marrow, culturing BMSCs and BMSC cryopreservation are described. Results Seventeen subjects were enrolled in our marrow collection protocol for BMSC production. Six of the 17 subjects were found to be ineligible during the donor screening process and one became ill and their donation was cancelled. Approximately 12 ml of marrow was aspirated from one posterior iliac crest of 10 donors; one donor donated twice. The BMSCs were initially cultured in T-75 flasks and then expanded for three passages in multilayer cell factories. The final BMSC product was packaged into units of 100 × 106 viable cells, cryopreserved and stored in a vapor phase liquid nitrogen tank under continuous monitoring. BMSC products meeting all lot release criteria were obtained from 8 of the 11 marrow collections. The rate of growth of the primary cultures was similar for all products except those generated from the two oldest donors. One lot did not meet the criteria for final release; its CD34 antigen expression was greater than the cut off set at 5%. The mean number of BMSC units obtained from each donor was 17 and ranged from 3 to 40. Conclusions The production of large numbers of BMSCs from bone marrow aspirates of healthy donors is feasible, but is limited by the high number of donors that did not meet eligibility criteria and products that did not meet lot release criteria. PMID:22309358

  4. Certification of NIST Room Temperature Low-Energy and High-Energy Charpy Verification Specimens

    PubMed Central

    Lucon, Enrico; McCowan, Chris N.; Santoyo, Ray L.

    2015-01-01

    The possibility for NIST to certify Charpy reference specimens for testing at room temperature (21 °C ± 1 °C) instead of −40 °C was investigated by performing 130 room-temperature tests from five low-energy and four high-energy lots of steel on the three master Charpy machines located in Boulder, CO. The statistical analyses performed show that in most cases the variability of results (i.e., the experimental scatter) is reduced when testing at room temperature. For eight out of the nine lots considered, the observed variability was lower at 21 °C than at −40 °C. The results of this study will allow NIST to satisfy requests for room-temperature Charpy verification specimens that have been received from customers for several years: testing at 21 °C removes from the verification process the operator’s skill in transferring the specimen in a timely fashion from the cooling bath to the impact position, and puts the focus back on the machine performance. For NIST, it also reduces the time and cost for certifying new verification lots. For one of the low-energy lots tested with a C-shaped hammer, we experienced two specimens jamming, which yielded unusually high values of absorbed energy. For both specimens, the signs of jamming were clearly visible. For all the low-energy lots investigated, jamming is slightly more likely to occur at 21 °C than at −40 °C, since at room temperature low-energy samples tend to remain in the test area after impact rather than exiting in the opposite direction of the pendulum swing. In the evaluation of a verification set, any jammed specimen should be removed from the analyses. PMID:26958453

  5. Certification of NIST Room Temperature Low-Energy and High-Energy Charpy Verification Specimens.

    PubMed

    Lucon, Enrico; McCowan, Chris N; Santoyo, Ray L

    2015-01-01

    The possibility for NIST to certify Charpy reference specimens for testing at room temperature (21 °C ± 1 °C) instead of -40 °C was investigated by performing 130 room-temperature tests from five low-energy and four high-energy lots of steel on the three master Charpy machines located in Boulder, CO. The statistical analyses performed show that in most cases the variability of results (i.e., the experimental scatter) is reduced when testing at room temperature. For eight out of the nine lots considered, the observed variability was lower at 21 °C than at -40 °C. The results of this study will allow NIST to satisfy requests for room-temperature Charpy verification specimens that have been received from customers for several years: testing at 21 °C removes from the verification process the operator's skill in transferring the specimen in a timely fashion from the cooling bath to the impact position, and puts the focus back on the machine performance. For NIST, it also reduces the time and cost for certifying new verification lots. For one of the low-energy lots tested with a C-shaped hammer, we experienced two specimens jamming, which yielded unusually high values of absorbed energy. For both specimens, the signs of jamming were clearly visible. For all the low-energy lots investigated, jamming is slightly more likely to occur at 21 °C than at -40 °C, since at room temperature low-energy samples tend to remain in the test area after impact rather than exiting in the opposite direction of the pendulum swing. In the evaluation of a verification set, any jammed specimen should be removed from the analyses.

  6. Validation of the Chinese Version of the Life Orientation Test with a Robust Weighted Least Squares Approach

    ERIC Educational Resources Information Center

    Li, Cheng-Hsien

    2012-01-01

    Of the several measures of optimism presently available in the literature, the Life Orientation Test (LOT; Scheier & Carver, 1985) has been the most widely used in empirical research. This article explores, confirms, and cross-validates the factor structure of the Chinese version of the LOT with ordinal data by using robust weighted least…

  7. Instructions for Plastic Encapsulated Microcircuit(PEM) Selection, Screening and Qualification.

    NASA Technical Reports Server (NTRS)

    King, Terry; Teverovsky, Alexander; Leidecker, Henning

    2002-01-01

    The use of Plastic Encapsulated Microcircuits (PEMs) is permitted on NASA Goddard Space Flight Center (GSFC) spaceflight applications, provided each use is thoroughly evaluated for thermal, mechanical, and radiation implications of the specific application and found to meet mission requirements. PEMs shall be selected for their functional advantage and availability, not for cost saving; the steps necessary to ensure reliability usually negate any initial apparent cost advantage. A PEM shall not be substituted for a form, fit and functional equivalent, high reliability, hermetic device in spaceflight applications. Due to the rapid change in wafer-level designs typical of commercial parts and the unknown traceability between packaging lots and wafer lots, lot specific testing is required for PEMs, unless specifically excepted by the Mission Assurance Requirements (MAR) for the project. Lot specific qualification, screening, radiation hardness assurance analysis and/or testing, shall be consistent with the required reliability level as defined in the MAR. Developers proposing to use PEMs shall address the following items in their Performance Assurance Implementation Plan: source selection (manufacturers and distributors), storage conditions for all stages of use, packing, shipping and handling, electrostatic discharge (ESD), screening and qualification testing, derating, radiation hardness assurance, test house selection and control, data collection and retention.

  8. ACS from development to operations

    NASA Astrophysics Data System (ADS)

    Caproni, Alessandro; Colomer, Pau; Jeram, Bogdan; Sommer, Heiko; Chiozzi, Gianluca; Mañas, Miguel M.

    2016-08-01

    The ALMA Common Software (ACS), provides the infrastructure of the distributed software system of ALMA and other projects. ACS, built on top of CORBA and Data Distribution Service (DDS) middleware, is based on a Component- Container paradigm and hides the complexity of the middleware allowing the developer to focus on domain specific issues. The transition of the ALMA observatory from construction to operations brings with it that ACS effort focuses primarily on scalability, stability and robustness rather than on new features. The transition came together with a shorter release cycle and a more extensive testing. For scalability, the most problematic area has been the CORBA notification service, used to implement the publisher subscriber pattern because of the asynchronous nature of the paradigm: a lot of effort has been spent to improve its stability and recovery from run time errors. The original bulk data mechanism, implemented using the CORBA Audio/Video Streaming Service, showed its limitations and has been replaced with a more performant and scalable DDS implementation. Operational needs showed soon the difference between releases cycles for Online software (i.e. used during observations) and Offline software, which requires much more frequent releases. This paper attempts to describe the impact the transition from construction to operations had on ACS, the solution adopted so far and a look into future evolution.

  9. 3D printing of high drug loaded dosage forms using thermoplastic polyurethanes.

    PubMed

    Verstraete, G; Samaro, A; Grymonpré, W; Vanhoorne, V; Van Snick, B; Boone, M N; Hellemans, T; Van Hoorebeke, L; Remon, J P; Vervaet, C

    2018-01-30

    It was the aim of this study to develop high drug loaded (>30%, w/w), thermoplastic polyurethane (TPU)-based dosage forms via fused deposition modelling (FDM). Model drugs with different particle size and aqueous solubility were pre-processed in combination with diverse TPU grades via hot melt extrusion (HME) into filaments with a diameter of 1.75 ± 0.05 mm. Subsequently, TPU-based filaments which featured acceptable quality attributes (i.e. consistent filament diameter, smooth surface morphology and good mechanical properties) were printed into tablets. The sustained release potential of the 3D printed dosage forms was tested in vitro. Moreover, the impact of printing parameters on the in vitro drug release was investigated. TPU-based filaments could be loaded with 60% (w/w) fine drug powder without observing severe shark skinning or inconsistent filament diameter. During 3D printing experiments, HME filaments based on hard TPU grades were successfully converted into personalized dosage forms containing a high concentration of crystalline drug (up to 60%, w/w). In vitro release kinetics were mainly affected by the matrix composition and tablet infill degree. Therefore, this study clearly demonstrated that TPU-based FDM feedstock material offers a lot of formulation freedom for the development of personalized dosage forms. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Artificial neural networks in evaluation and optimization of modified release solid dosage forms.

    PubMed

    Ibrić, Svetlana; Djuriš, Jelena; Parojčić, Jelena; Djurić, Zorica

    2012-10-18

    Implementation of the Quality by Design (QbD) approach in pharmaceutical development has compelled researchers in the pharmaceutical industry to employ Design of Experiments (DoE) as a statistical tool, in product development. Among all DoE techniques, response surface methodology (RSM) is the one most frequently used. Progress of computer science has had an impact on pharmaceutical development as well. Simultaneous with the implementation of statistical methods, machine learning tools took an important place in drug formulation. Twenty years ago, the first papers describing application of artificial neural networks in optimization of modified release products appeared. Since then, a lot of work has been done towards implementation of new techniques, especially Artificial Neural Networks (ANN) in modeling of production, drug release and drug stability of modified release solid dosage forms. The aim of this paper is to review artificial neural networks in evaluation and optimization of modified release solid dosage forms.

  11. Artificial Neural Networks in Evaluation and Optimization of Modified Release Solid Dosage Forms

    PubMed Central

    Ibrić, Svetlana; Djuriš, Jelena; Parojčić, Jelena; Djurić, Zorica

    2012-01-01

    Implementation of the Quality by Design (QbD) approach in pharmaceutical development has compelled researchers in the pharmaceutical industry to employ Design of Experiments (DoE) as a statistical tool, in product development. Among all DoE techniques, response surface methodology (RSM) is the one most frequently used. Progress of computer science has had an impact on pharmaceutical development as well. Simultaneous with the implementation of statistical methods, machine learning tools took an important place in drug formulation. Twenty years ago, the first papers describing application of artificial neural networks in optimization of modified release products appeared. Since then, a lot of work has been done towards implementation of new techniques, especially Artificial Neural Networks (ANN) in modeling of production, drug release and drug stability of modified release solid dosage forms. The aim of this paper is to review artificial neural networks in evaluation and optimization of modified release solid dosage forms. PMID:24300369

  12. The contribution of lot-to-lot variation to the measurement uncertainty of an LC-MS-based multi-mycotoxin assay.

    PubMed

    Stadler, David; Sulyok, Michael; Schuhmacher, Rainer; Berthiller, Franz; Krska, Rudolf

    2018-05-01

    Multi-mycotoxin determination by LC-MS is commonly based on external solvent-based or matrix-matched calibration and, if necessary, the correction for the method bias. In everyday practice, the method bias (expressed as apparent recovery RA), which may be caused by losses during the recovery process and/or signal/suppression enhancement, is evaluated by replicate analysis of a single spiked lot of a matrix. However, RA may vary for different lots of the same matrix, i.e., lot-to-lot variation, which can result in a higher relative expanded measurement uncertainty (U r ). We applied a straightforward procedure for the calculation of U r from the within-laboratory reproducibility, which is also called intermediate precision, and the uncertainty of RA (u r,RA ). To estimate the contribution of the lot-to-lot variation to U r , the measurement results of one replicate of seven different lots of figs and maize and seven replicates of a single lot of these matrices, respectively, were used to calculate U r . The lot-to-lot variation was contributing to u r,RA and thus to U r for the majority of the 66 evaluated analytes in both figs and maize. The major contributions of the lot-to-lot variation to u r,RA were differences in analyte recovery in figs and relative matrix effects in maize. U r was estimated from long-term participation in proficiency test schemes with 58%. Provided proper validation, a fit-for-purpose U r of 50% was proposed for measurement results obtained by an LC-MS-based multi-mycotoxin assay, independent of the concentration of the analytes.

  13. 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.

  14. Investigation of failure to separate an Inconel 718 frangible nut

    NASA Technical Reports Server (NTRS)

    Hoffman, William C., III; Hohmann, Carl

    1994-01-01

    The 2.5-inch frangible nut is used in two places to attach the Space Shuttle Orbiter to the External Tank. It must be capable of sustaining structural loads and must also separate into two pieces upon command. Structural load capability is verified by proof loading each flight nut, while ability to separate is verified on a sample of a production lot. Production lots of frangible nuts beginning in 1987 experienced an inability to reliably separate using one of two redundant explosive boosters. The problems were identified in lot acceptance tests, and the cause of failure has been attributed to differences in the response of the Inconel 718. Subsequent tests performed on the frangible nuts resulted in design modifications to the nuts along with redesign of the explosive booster to reliably separate the frangible nut. The problem history along with the design modifications to both the explosive booster and frangible nut are discussed in this paper. Implications of this failure experience impact any pyrotechnic separation system involving fracture of materials with respect to design margin control and lot acceptance testing.

  15. Space Transportation System (STS)-133/External Tank (ET)-137 Intertank (IT) Stringer Cracking Issue and Repair Assessment: Proximate Cause Determination and Material Characterization Study

    NASA Technical Reports Server (NTRS)

    Piascik, Robert S.

    2011-01-01

    Several cracks were detected in stringers located beneath the foam on the External Tank (ET) following the launch scrub of Space Transportation System (STS)-133 on November 5, 2010. The stringer material was aluminum-lithium (AL-Li) 2090-T83 fabricated from sheets that were nominally 0.064 inches thick. The mechanical properties of the stringer material were known to vary between different material lots, with the stringers from ET-137 (predominately lots 620853 and 620854) having the highest yield and ultimate stresses. Subsequent testing determined that these same lots also had the lowest fracture toughness properties. The NASA Engineering and Safety Center (NESC) supported the Space Shuttle Program (SSP)-led investigation. The objective of this investigation was to develop a database of test results to provide validation for structural analysis models, independently confirm test results obtained from other investigators, and determine the proximate cause of the anomalous low fracture toughness observed in stringer lots 620853 and 620854. This document contains the outcome of the investigation.

  16. Heroes and Myths: On Davis Guggenheim's "Superman"

    ERIC Educational Resources Information Center

    Olorunda, Tolu

    2011-01-01

    David Guggenheim's latest documentary, "Waiting for 'Superman'," stops only an inch away from insisting upon the total razing of the public school system. Guggenheim stated that, with the release of this film, he was "trying to attack... this mental block that a lot of Americans have--which is that the problems with our schools are too complex,…

  17. 76 FR 37874 - Notice of Intent To Rule on Request To Release Airport Property at Lehigh Valley International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... Acres as open space dedication to meet the conditions of an existing zone change (Resolution 07-08), and...--to Hanover Township for Current & Advance Open Space Dedication Purposes A certain lot, piece or... existing zone change (Resolution 07-08), and the open space dedication requirements of the Subdivision and...

  18. GeoGebra for Mathematical Statistics

    ERIC Educational Resources Information Center

    Hewson, Paul

    2009-01-01

    The GeoGebra software is attracting a lot of interest in the mathematical community, consequently there is a wide range of experience and resources to help use this application. This article briefly outlines how GeoGebra will be of great value in statistical education. The release of GeoGebra is an excellent example of the power of free software…

  19. 78 FR 15804 - Waiver of Aeronautical Land-Use Assurance: Rolla National Airport (VIH), Rolla, MO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ...The Federal Aviation Administration (FAA) is considering a proposal from the City of Rolla (sponsor), Rolla, MO, to release a 10 acre parcel (Lot 1) of land from the federal obligation dedicating it to aeronautical use and to authorize this parcel to be used for revenue-producing, non-aeronautical purposes.

  20. Can't Make 'em Do It: Sleeping, Eating, Toileting

    ERIC Educational Resources Information Center

    Duffy, Roslyn

    2008-01-01

    Sleeping, eating, and toileting battles frustrate most adults--mainly because they cannot make children do it. Falling asleep (or not) is within a child's control. The same is true for chewing and swallowing, or withholding and releasing urine and feces. Sleeping, Eating, and Toileting (S.E.T.) create lots of frustration. An exhausted adult wants…

  1. FY 2011 Federal Budget Process Begins with Bold Proposal

    ERIC Educational Resources Information Center

    Karolak, Eric

    2010-01-01

    The federal government's annual budget process was kick-started this year with a bold proposal that has implications for anyone who provides child care. But keeping child care front and center in Washington will take a lot of effort in 2010. On February 1, the Administration released the Budget Proposal for Federal Fiscal Year 2011. It calls for…

  2. Comparative analyses of industrial-scale human platelet lysate preparations.

    PubMed

    Pierce, Jan; Benedetti, Eric; Preslar, Amber; Jacobson, Pam; Jin, Ping; Stroncek, David F; Reems, Jo-Anna

    2017-12-01

    Efforts are underway to eliminate fetal bovine serum from mammalian cell cultures for clinical use. An emerging, viable replacement option for fetal bovine serum is human platelet lysate (PL) as either a plasma-based or serum-based product. Nine industrial-scale, serum-based PL manufacturing runs (i.e., lots) were performed, consisting of an average ± standard deviation volume of 24.6 ± 2.2 liters of pooled, platelet-rich plasma units that were obtained from apheresis donors. Manufactured lots were compared by evaluating various biochemical and functional test results. Comprehensive cytokine profiles of PL lots and product stability tests were performed. Global gene expression profiles of mesenchymal stromal cells (MSCs) cultured with plasma-based or serum-based PL were compared to MSCs cultured with fetal bovine serum. Electrolyte and protein levels were relatively consistent among all serum-based PL lots, with only slight variations in glucose and calcium levels. All nine lots were as good as or better than fetal bovine serum in expanding MSCs. Serum-based PL stored at -80°C remained stable over 2 years. Quantitative cytokine arrays showed similarities as well as dissimilarities in the proteins present in serum-based PL. Greater differences in MSC gene expression profiles were attributable to the starting cell source rather than with the use of either PL or fetal bovine serum as a culture supplement. Using a large-scale, standardized method, lot-to-lot variations were noted for industrial-scale preparations of serum-based PL products. However, all lots performed as well as or better than fetal bovine serum in supporting MSC growth. Together, these data indicate that off-the-shelf PL is a feasible substitute for fetal bovine serum in MSC cultures. © 2017 AABB.

  3. Design of a sampling plan to detect ochratoxin A in green coffee.

    PubMed

    Vargas, E A; Whitaker, T B; Dos Santos, E A; Slate, A B; Lima, F B; Franca, R C A

    2006-01-01

    The establishment of maximum limits for ochratoxin A (OTA) in coffee by importing countries requires that coffee-producing countries develop scientifically based sampling plans to assess OTA contents in lots of green coffee before coffee enters the market thus reducing consumer exposure to OTA, minimizing the number of lots rejected, and reducing financial loss for producing countries. A study was carried out to design an official sampling plan to determine OTA in green coffee produced in Brazil. Twenty-five lots of green coffee (type 7 - approximately 160 defects) were sampled according to an experimental protocol where 16 test samples were taken from each lot (total of 16 kg) resulting in a total of 800 OTA analyses. The total, sampling, sample preparation, and analytical variances were 10.75 (CV = 65.6%), 7.80 (CV = 55.8%), 2.84 (CV = 33.7%), and 0.11 (CV = 6.6%), respectively, assuming a regulatory limit of 5 microg kg(-1) OTA and using a 1 kg sample, Romer RAS mill, 25 g sub-samples, and high performance liquid chromatography. The observed OTA distribution among the 16 OTA sample results was compared to several theoretical distributions. The 2 parameter-log normal distribution was selected to model OTA test results for green coffee as it gave the best fit across all 25 lot distributions. Specific computer software was developed using the variance and distribution information to predict the probability of accepting or rejecting coffee lots at specific OTA concentrations. The acceptation probability was used to compute an operating characteristic (OC) curve specific to a sampling plan design. The OC curve was used to predict the rejection of good lots (sellers' or exporters' risk) and the acceptance of bad lots (buyers' or importers' risk).

  4. Testing the Forensic Interestingness of Image Files Based on Size and Type

    DTIC Science & Technology

    2017-09-01

    there were still a lot of uninteresting files that were marked as interesting. Also, the results do not show a correlation between the...interesting, but there were still a lot of uninteresting files that were marked as interesting. Also, the results do not show a correlation between...7  IV.  DESCRIPTION OF METHODOLOGY ...........................................................11  A.  TEST SETUP

  5. Manufacture and evaluation of Li/BCX DD cells

    NASA Technical Reports Server (NTRS)

    Meyer, S.; Takeuchi, E.

    1990-01-01

    This project is divided into four main tasks: cell manufacture, acceptance, and lot certification of cells, performance testing of cells, and abuse testing of cells. Lithium/bromine chloride in thionyl chloride (Li/BCX) 149 DD cells (PN 3B2085-XA) were built according to the provisions of Electrochem Industries Quality Plan 17096. Acceptance and lot certification testing was performed according to NASA JSC Document EP5-83-025, Revision B. Acceptance testing included open circuit and load voltage check, visual examination, size and weight measurements, and high temperature exposure. Lot certification tests were performed for capacity performance and for performance under conditions of thermal and electrical abuse. These tests included 149 C exposure, capacity discharge, fuse check, high temperature exposure, high rate discharge, short circuit, vibration, and overdischarge testing. A quantity of 200 cells was delivered to Johnson Space Center for life test evaluation. A parametric evaluation of the capacity discharge of Li/BCX DD cells was performed over a variety of temperatures and discharge rates. This testing served to map the performance capability of the cell. Tests were also performed over a variety of electrical and thermal abuse conditions. Abuse tests included short circuit, charging, overdischarge, high temperature exposure, shock, and vibration.

  6. Manufacturability: from design to SPC limits through "corner-lot" characterization

    NASA Astrophysics Data System (ADS)

    Hogan, Timothy J.; Baker, James C.; Wesneski, Lisa; Black, Robert S.; Rothenbury, Dave

    2004-12-01

    Texas Instruments" Digital Micro-mirror Device, is used in a wide variety of optical display applications ranging from fixed and portable projectors to high-definition television (HDTV) to digital cinema projection systems. A new DMD pixel architecture, called "FTP", was designed and qualified by Texas Instruments DLPTMTM Group in 2003 to meet increased performance objectives for brightness and contrast ratio. Coordination between design, test and fabrication groups was required to balance pixel performance requirements and manufacturing capability. "Corner Lot" designed experiments (DOE) were used to verify "fabrication space" available for the pixel design. The corner lot technique allows confirmation of manufacturability projections early in the design/qualification cycle. Through careful design and analysis of the corner-lot DOE, a balance of critical dimension (cd) "budgets" is possible so that specification and process control limits can be established that meet both customer and factory requirements. The application of corner-lot DOE is illustrated in a case history of the DMD "FTP" pixel. The process for balancing test parameter requirements with multiple critical dimension budgets is shown. MEMS/MOEMS device design and fabrication can use similar techniques to achieve agressive design-to-qualification goals.

  7. Manufacturability: from design to SPC limits through "corner-lot" characterization

    NASA Astrophysics Data System (ADS)

    Hogan, Timothy J.; Baker, James C.; Wesneski, Lisa; Black, Robert S.; Rothenbury, Dave

    2005-01-01

    Texas Instruments" Digital Micro-mirror Device, is used in a wide variety of optical display applications ranging from fixed and portable projectors to high-definition television (HDTV) to digital cinema projection systems. A new DMD pixel architecture, called "FTP", was designed and qualified by Texas Instruments DLPTMTM Group in 2003 to meet increased performance objectives for brightness and contrast ratio. Coordination between design, test and fabrication groups was required to balance pixel performance requirements and manufacturing capability. "Corner Lot" designed experiments (DOE) were used to verify "fabrication space" available for the pixel design. The corner lot technique allows confirmation of manufacturability projections early in the design/qualification cycle. Through careful design and analysis of the corner-lot DOE, a balance of critical dimension (cd) "budgets" is possible so that specification and process control limits can be established that meet both customer and factory requirements. The application of corner-lot DOE is illustrated in a case history of the DMD "FTP" pixel. The process for balancing test parameter requirements with multiple critical dimension budgets is shown. MEMS/MOEMS device design and fabrication can use similar techniques to achieve agressive design-to-qualification goals.

  8. 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.

  9. 7 CFR Exhibit C to Subpart G of... - Subordination by the Government for Use With Rural Housing Site Loans

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Housing Site Loans Whereas, The United States of America acting through the Farmers Home Administration or... shall retain a first lien or security interest in the above-described property in an amount of $___. Such first lien will be released only when satisfactory evidence is provided indicating that the lot...

  10. Greening vacant lots to reduce violent crime: a randomised controlled trial

    PubMed Central

    Garvin, Eugenia C; Cannuscio, Carolyn C; Branas, Charles C

    2014-01-01

    Background Vacant lots are often overgrown with unwanted vegetation and filled with trash, making them attractive places to hide illegal guns, conduct illegal activities such as drug sales and prostitution, and engage in violent crime. There is some evidence that greening vacant lots is associated with reductions in violent crime. Methods We performed a randomised controlled trial of vacant lot greening to test the impact of this intervention on police reported crime and residents’ perceptions of safety and disorder. Greening consisted of cleaning the lots, planting grass and trees, and building a wooden fence around the perimeter. We randomly allocated two vacant lot clusters to the greening intervention or to the control status (no intervention). Administrative data were used to determine crime rates, and local resident interviews at baseline (n=29) and at follow-up (n=21) were used to assess perceptions of safety and disorder. Results Unadjusted difference-in-differences estimates showed a non-significant decrease in the number of total crimes and gun assaults around greened vacant lots compared with control. People around the intervention vacant lots reported feeling significantly safer after greening compared with those living around control vacant lots (p<0.01). Conclusions In this study, greening was associated with reductions in certain gun crimes and improvements in residents’ perceptions of safety. A larger randomised controlled trial is needed to further investigate the link between vacant lot greening and violence reduction. PMID:22871378

  11. Update of FDOT state park & ride lot program planning manual chapters 3, 4, and 6

    DOT National Transportation Integrated Search

    2001-04-01

    Portions of the Florida Department of Transportation (FDOT) State Park & Ride Lot Program Planning Manual, first published in 1989 and revised in 1996, were updated. The scope included examination, testing, and updating, as necessary, the planning fo...

  12. Evaluation of CBS 600 carburized steel as a gear material

    NASA Technical Reports Server (NTRS)

    Townsend, D. P.; Parker, R. J.; Zaretsky, E. V.

    1979-01-01

    Gear endurance tests were conducted with one lot of consumable-electrode vacuum-melted (CVM) AISI 9310 gears and one lot of air-melt CBS 600 gears. The gears were 8 pitch with a pitch diameter of 8.89 centimeters (3.5 in.). Bench-type rolling-element fatigue tests were also conducted with one lot of CVM AISI 9310, three lots of CVM CBS 600, and one of air-melt CBS 600 material. The rolling-element bars were 0.952 centimeter (0.375 in.) in diameter. The CBS 600 material exhibited pitting fatigue lives in both rolling-element specimens and gears at least equivalent to that of CVM AISI 9310. Tooth fracture failure occurred with the CBS 600 gears after overrunning a fatigue spall, but it did not occur with the CVM AISI 9310 gears. Tooth fracture in the CBS 600 was attributed to excessive carbon content in the case, excessive case depth, and a higher than normal core hardness.

  13. Summary electrophoretic data base on human embryonic kidney cell strain 8514

    NASA Technical Reports Server (NTRS)

    Plank, L. D.; Kunze, M. E.; Arquiza, M. V.; Morrison, D. R.; Todd, P. W.

    1985-01-01

    To properly plan the electrophoresis equipment verification test (EEVT) and continuous flow electrophoresis system (CFES) experiments with human embryonic kidney cells, first a candidate cell lot had to be chosen on the basis of electrophoretic heterogeneity, growth potential, cytogenetics, and urokinase production. Cell lot 8514 from MA Bioproducts, Inc. was chosen for this purpose, and several essential analytical electrophoresis experiments were performed to test its final suitability for these experiments.

  14. Structural analysis of a frangible nut used on the NASA Space Shuttle

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

    Metzinger, K.E.

    A structural analysis methodology has been developed for the NASA 2.5-inch frangible nut used on the Space Shuttle. Two of these nuts are used to secure the External Tank to the aft end of the Orbiter. Both nuts must completely fracture before the Orbiter can safely separate from the External Tank. Ideally, only one of the two explosive boosters contained in each nut must detonate to completely break a nut. However, after an uncontrolled change in the Inconel 718 material processing, recent tests indicate that in certain circumstances both boosters may be required. This report details the material characterization andmore » subsequent structural analyses of nuts manufactured from two lots of Inconel 718. The nuts from the HSX lot were observed to consistently separate with only one booster, while the nuts from the HBT lot never completely fracture with a single booster. The material characterization requires only tensile test data and the determination of a tearing parameter based on a computer simulation of a tensile test. Subsequent structural analyses using the PRONTO2D finite element code correctly predict the differing response of nuts fabricated from these two lots. This agreement is important because it demonstrates that this technique can be used to screen lots of Inconel 718 before manufacturing frangible nuts from them. To put this new capability to practice, Sandia personnel have transferred this technology to the Pyrotechnics Group at NASA-JSC.« less

  15. Micron MT29F128G08AJAAA 128GB Asynchronous Flash Memory Total Ionizing Dose Characterization Test Report

    NASA Technical Reports Server (NTRS)

    Campola, Michael; Wyrwas, Edward

    2017-01-01

    The purpose of this test was to characterize the Micron MT29F128G08AJAAAs parameter degradation for total dose response and to evaluate and compare lot date codes for sensitivity. In the test, the device was exposed to both low dose and high dose rate (HDR) irradiations using gamma radiation. Device parameters such as leakage currents, quantity of upset bits and overall chip and die health were investigated to determine which lot is more robust.

  16. Investigating Premature Ignition of Thruster Pressure Cartridges by Vibration-Induced Electrostatic Discharge

    NASA Technical Reports Server (NTRS)

    Woods, Stephen S.; Saulsberry, Regor

    2010-01-01

    Pyrotechnic thruster pressure cartridges (TPCs) are used for aeroshell separation on a new NASA crew launch vehicle. Nondestructive evaluation (NDE) during TPC acceptance testing indicated that internal assemblies moved during shock and vibration testing due to an internal bond anomaly. This caused concerns that the launch environment might produce the same movement and release propellant grains that might be prematurely ignited through impact or through electrostatic discharge (ESD) as grains vibrated against internal surfaces. Since a new lot could not be fabricated in time, a determination had to be made as to whether the lot was acceptable to fly. This paper discusses the ESD evaluation and a separate paper addresses the impact problem. A challenge to straight forward assessment existed due to the unavailability of triboelectric data characterizing the static charging characteristics of the propellants within the TPC. The approach examined the physical limitations for charge buildup within the TPC system geometry and evaluated it for discharge under simulated vibrations used to qualify components for launch. A facsimile TPC was fabricated using SS 301 for the case and surrogate worst case materials for the propellants based on triboelectric data. System discharge behavior was evaluated by applying high voltage to the point of discharge in air and by placing worst case charge accumulations within the facsimile TPC and forcing discharge. The facsimile TPC contained simulated propellant grains and lycopodium, a well characterized indicator for static discharge in dust explosions, and was subjected to accelerations equivalent to the maximum accelerations possible during launch. The magnitude of charge generated within the facsimile TPC system was demonstrated to lie in a range of 100 to 10,000 times smaller than the spark energies measured to ignite propellant grains in industry standard discharge tests. The test apparatus, methodology, and results are described in this paper.

  17. Concentrations of polycyclic aromatic hydrocarbons (PAHs) and major and trace elements in simulated rainfall runoff from parking lots, Austin, Texas, 2003

    USGS Publications Warehouse

    Mahler, Barbara J.; Van Metre, Peter C.; Wilson, Jennifer T.

    2004-01-01

    Samples of creek bed sediment collected near seal-coated parking lots in Austin, Texas, by the City of Austin during 2001–02 had unusually elevated concentrations of polycyclic aromatic hydrocarbons (PAHs). To investigate the possibility that PAHs from seal-coated parking lots might be transported to urban creeks, the U.S. Geological Survey, in cooperation with the City of Austin, sampled runoff and scrapings from four test plots and 13 urban parking lots. The surfaces sampled comprise coal-tar-emulsion-sealed, asphalt-emulsion-sealed, unsealed asphalt, and unsealed concrete. Particulates and filtered water in runoff and surface scrapings were analyzed for PAHs. In addition, particulates in runoff were analyzed for major and trace elements. Samples of all three media from coal-tar-sealed parking lots had concentrations of PAHs higher than those from any other types of surface. The mean total PAH concentration in particulates in runoff from parking lots in use were 3,500,000, 620,000, and 54,000 micrograms per kilogram from coal-tar-sealed, asphalt-sealed, and unsealed (asphalt and concrete combined) lots, respectively. The probable effect concentration sediment quality guideline is 22,800 micrograms per kilogram. The mean total PAH (sum of detected PAHs) concentration in filtered water from parking lots in use was 8.6 micrograms per liter for coal-tar-sealed lots; the one sample analyzed from an asphalt-sealed lot had a concentration of 5.1 micrograms per liter and the one sample analyzed from an unsealed asphalt lot was 0.24 microgram per liter. The mean total PAH concentration in scrapings was 23,000,000, 820,000, and 14,000 micrograms per kilogram from coal-tar-sealed, asphalt-sealed, and unsealed asphalt lots, respectively. Concentrations of lead and zinc in particulates in runoff frequently exceeded the probable effect concentrations, but trace element concentrations showed no consistent variation with parking lot surface type.

  18. A New Bone Substitute Developed from 3D-Prints of Polylactide (PLA) Loaded with Collagen I: An In Vitro Study.

    PubMed

    Ritz, Ulrike; Gerke, Rebekka; Götz, Hermann; Stein, Stefan; Rommens, Pol Maria

    2017-11-29

    Although a lot of research has been performed, large segmental bone defects caused by trauma, infection, bone tumors or revision surgeries still represent big challenges for trauma surgeons. New and innovative bone substitutes are needed. Three-dimensional (3D) printing is a novel procedure to create 3D porous scaffolds that can be used for bone tissue engineering. In the present study, solid discs as well as porous cage-like 3D prints made of polylactide (PLA) are coated or filled with collagen, respectively, and tested for biocompatibility and endotoxin contamination. Microscopic analyses as well as proliferation assays were performed using various cell types on PLA discs. Stromal-derived factor (SDF-1) release from cages filled with collagen was analyzed and the effect on endothelial cells tested. This study confirms the biocompatibility of PLA and demonstrates an endotoxin contamination clearly below the FDA (Food and Drug Administration) limit. Cells of various cell types (osteoblasts, osteoblast-like cells, fibroblasts and endothelial cells) grow, spread and proliferate on PLA-printed discs. PLA cages loaded with SDF-1 collagen display a steady SDF-1 release, support cell growth of endothelial cells and induce neo-vessel formation. These results demonstrate the potential for PLA scaffolds printed with an inexpensive desktop printer in medical applications, for example, in bone tissue engineering.

  19. A New Bone Substitute Developed from 3D-Prints of Polylactide (PLA) Loaded with Collagen I: An In Vitro Study

    PubMed Central

    Gerke, Rebekka; Götz, Hermann; Rommens, Pol Maria

    2017-01-01

    Although a lot of research has been performed, large segmental bone defects caused by trauma, infection, bone tumors or revision surgeries still represent big challenges for trauma surgeons. New and innovative bone substitutes are needed. Three-dimensional (3D) printing is a novel procedure to create 3D porous scaffolds that can be used for bone tissue engineering. In the present study, solid discs as well as porous cage-like 3D prints made of polylactide (PLA) are coated or filled with collagen, respectively, and tested for biocompatibility and endotoxin contamination. Microscopic analyses as well as proliferation assays were performed using various cell types on PLA discs. Stromal-derived factor (SDF-1) release from cages filled with collagen was analyzed and the effect on endothelial cells tested. This study confirms the biocompatibility of PLA and demonstrates an endotoxin contamination clearly below the FDA (Food and Drug Administration) limit. Cells of various cell types (osteoblasts, osteoblast-like cells, fibroblasts and endothelial cells) grow, spread and proliferate on PLA-printed discs. PLA cages loaded with SDF-1 collagen display a steady SDF-1 release, support cell growth of endothelial cells and induce neo-vessel formation. These results demonstrate the potential for PLA scaffolds printed with an inexpensive desktop printer in medical applications, for example, in bone tissue engineering. PMID:29186036

  20. The advantage of hollow mesoporous carbon as a near-infrared absorbing drug carrier in chemo-photothermal therapy compared with IR-820.

    PubMed

    Zhao, Qinfu; Wang, Xiudan; Yan, Yue; Wang, Da; Zhang, Ying; Jiang, Tongying; Wang, Siling

    2017-03-01

    In this study, we synthesized a kind of hollow mesoporous carbon (HMC) as near-infrared (NIR) nanomaterial and made a comparison between HMC and IR-820 commercially available in terms of heat generation properties and thermal stability exposed under NIR laser irradiation. The NIR-induced photothermal tests indicated that HMC had excellent heat generating capacity and remained stable after exposed to NIR laser irradiation for several times. On the contrary, the IR-820 was thermal unstable and degraded completely after exposed to NIR laser irradiation for only one time. The anticancer drug DOX was chosen as a model drug to evaluate the loading capacity and release properties of carboxylated HMC (HMC-COOH). The drug loading efficiency of HMC-COOH could reach to 39.7%. In vitro release results indicated that the release rate of DOX was markedly increased under NIR laser irradiation both in pH5.0 and pH7.4 PBS. Cell viability experiments indicated that HMC-COOH/DOX has a synergistic therapeutic effect by combination of chemotherapy and photothermal therapy. This present research demonstrated that HMC could be employed as NIR-adsorbing agents as well as drug carriers to load lots of drug, realizing the synergistic treatment of chemotherapy and photothermal therapy. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. 21 CFR 660.21 - Processing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.21 Processing. (a... representative samples of each group of products manufactured in the same fashion. (2) Only that material that... specifications to verify that each sublot is identical to other sublots of the lot. (4) Each lot of Blood...

  2. Technology: Computer Applications for Young Users--BumperCar and KidPix

    ERIC Educational Resources Information Center

    Van Horn, Royal

    2004-01-01

    There is a lot of software available for young children, but there are not many applications designed especially for them. This situation may be about to change with the release of BumperCar and a new version of KidPix, both of which recently earned awards from MacWorld magazine. In this article, the author describes this new software and how it…

  3. Alternative Test Methods for Electronic Parts

    NASA Technical Reports Server (NTRS)

    Plante, Jeannette

    2004-01-01

    It is common practice within NASA to test electronic parts at the manufacturing lot level to demonstrate, statistically, that parts from the lot tested will not fail in service using generic application conditions. The test methods and the generic application conditions used have been developed over the years through cooperation between NASA, DoD, and industry in order to establish a common set of standard practices. These common practices, found in MIL-STD-883, MIL-STD-750, military part specifications, EEE-INST-002, and other guidelines are preferred because they are considered to be effective and repeatable and their results are usually straightforward to interpret. These practices can sometimes be unavailable to some NASA projects due to special application conditions that must be addressed, such as schedule constraints, cost constraints, logistical constraints, or advances in the technology that make the historical standards an inappropriate choice for establishing part performance and reliability. Alternate methods have begun to emerge and to be used by NASA programs to test parts individually or as part of a system, especially when standard lot tests cannot be applied. Four alternate screening methods will be discussed in this paper: Highly accelerated life test (HALT), forward voltage drop tests for evaluating wire-bond integrity, burn-in options during or after highly accelerated stress test (HAST), and board-level qualification.

  4. Evaluation of primary immunization coverage of infants under universal immunization programme in an urban area of bangalore city using cluster sampling and lot quality assurance sampling techniques.

    PubMed

    K, Punith; K, Lalitha; G, Suman; Bs, Pradeep; Kumar K, Jayanth

    2008-07-01

    Is LQAS technique better than cluster sampling technique in terms of resources to evaluate the immunization coverage in an urban area? To assess and compare the lot quality assurance sampling against cluster sampling in the evaluation of primary immunization coverage. Population-based cross-sectional study. Areas under Mathikere Urban Health Center. Children aged 12 months to 23 months. 220 in cluster sampling, 76 in lot quality assurance sampling. Percentages and Proportions, Chi square Test. (1) Using cluster sampling, the percentage of completely immunized, partially immunized and unimmunized children were 84.09%, 14.09% and 1.82%, respectively. With lot quality assurance sampling, it was 92.11%, 6.58% and 1.31%, respectively. (2) Immunization coverage levels as evaluated by cluster sampling technique were not statistically different from the coverage value as obtained by lot quality assurance sampling techniques. Considering the time and resources required, it was found that lot quality assurance sampling is a better technique in evaluating the primary immunization coverage in urban area.

  5. G-protein based ELISA as a potency test for rabies vaccines.

    PubMed

    Chabaud-Riou, Martine; Moreno, Nadège; Guinchard, Fabien; Nicolai, Marie Claire; Niogret-Siohan, Elisabeth; Sève, Nicolas; Manin, Catherine; Guinet-Morlot, Françoise; Riou, Patrice

    2017-03-01

    The NIH test is currently used to assess the potency of rabies vaccine, a key criterion for vaccine release. This test is based on mice immunization followed by intracerebral viral challenge. As part of global efforts to reduce animal experimentation and in the framework of the development of Sanofi Pasteur next generation, highly-purified vaccine, produced without any material of human or animal origin, we developed an ELISA as an alternative to the NIH test. This ELISA is based on monoclonal antibodies recognizing specifically the native form of the viral G-protein, the major antigen that induces neutralizing antibody response to rabies virus. We show here that our ELISA is able to distinguish between potent and different types of sub-potent vaccine lots. Satisfactory agreement was observed between the ELISA and the NIH test in the determination of the vaccine titer and their capacity to discern conform from non-conform batches. Our ELISA meets the criteria for a stability-indicating assay and has been successfully used to develop the new generation of rabies vaccine candidates. After an EPAA international pre-collaborative study, this ELISA was selected as the assay of choice for the EDQM collaborative study aimed at replacing the rabies vaccine NIH in vivo potency test. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. Corn fiber: structure, composition, and response to enzymes for fermentable sugars and coproducts.

    PubMed

    Akin, Danny E; Rigsby, Luanne L

    2008-01-01

    Corn (Zea mays L.) fiber, which is the seed coat and residual endosperm left after grain processing, is a low-value residue that contains carbohydrates and aromatic compounds that could provide value-added coproducts. Treatment of corn fiber with NaOH and assessment by gas chromatography indicated a prevalence of ferulic acid, with about 90% ester-linked in the cell walls. p-coumaric acid was much lower at about 10% of the amount of ferulic acid. Histochemical reactions employing acid phloroglucinol and diazotized sulfanilic acid indicated the presence of phenolic acids in cell walls of the pericarp and aleurone layer. Various protocols were tested using milled corn fiber and pretreatment with commercial ferulic acid esterases before cellulase treatment, and dry weight loss and sugars and phenolic acids released into the filtrate were evaluated. Ferulic acid esterases effectively degraded corn fiber and released substantial amounts of ferulic acid and sugars (e.g., glucose and xylose) in the incubation medium. Light microscopy showed that ferulic acid esterase substantially disrupted the aleurone layer but caused little visible damage to the lignified pericarp cell walls. Amounts of compounds released varied with protocols, and one study with various milling methods showed that esterase pretreatment followed by cellulase released about 2.8 to 4.4 and 1.5 to 2.9 times more ferulic acid and glucose, respectively, than cellulase alone. The highest levels for one lot of corn fiber with esterase pretreatment followed by cellulase were 3.9 and 218 mg/g of ferulic acid and glucose, respectively.

  7. Effect of Sampling Plans on the Risk of Escherichia coli O157 Illness.

    PubMed

    Kiermeier, Andreas; Sumner, John; Jenson, Ian

    2015-07-01

    Australia exports about 150,000 to 200,000 tons of manufacturing beef to the United States annually. Each lot is tested for Escherichia coli O157 using the N-60 sampling protocol, where 60 small pieces of surface meat from each lot of production are tested. A risk assessment of E. coli O157 illness from the consumption of hamburgers made from Australian manufacturing meat formed the basis to evaluate the effect of sample size and amount on the number of illnesses predicted. The sampling plans evaluated included no sampling (resulting in an estimated 55.2 illnesses per annum), the current N-60 plan (50.2 illnesses), N-90 (49.6 illnesses), N-120 (48.4 illnesses), and a more stringent N-60 sampling plan taking five 25-g samples from each of 12 cartons (47.4 illnesses per annum). While sampling may detect some highly contaminated lots, it does not guarantee that all such lots are removed from commerce. It is concluded that increasing the sample size or sample amount from the current N-60 plan would have a very small public health effect.

  8. Brief report: Assessing dispositional optimism in adolescence--factor structure and concurrent validity of the Life Orientation Test--Revised.

    PubMed

    Monzani, Dario; Steca, Patrizia; Greco, Andrea

    2014-02-01

    Dispositional optimism is an individual difference promoting psychosocial adjustment and well-being during adolescence. Dispositional optimism was originally defined as a one-dimensional construct; however, empirical evidence suggests two correlated factors in the Life Orientation Test - Revised (LOT-R). The main aim of the study was to evaluate the dimensionality of the LOT-R. This study is the first attempt to identify the best factor structure, comparing congeneric, two correlated-factor, and two orthogonal-factor models in a sample of adolescents. Concurrent validity was also assessed. The results demonstrated the superior fit of the two orthogonal-factor model thus reconciling the one-dimensional definition of dispositional optimism with the bi-dimensionality of the LOT-R. Moreover, the results of correlational analyses proved the concurrent validity of this self-report measure: optimism is moderately related to indices of psychosocial adjustment and well-being. Thus, the LOT-R is a useful, valid, and reliable self-report measure to properly assess optimism in adolescence. Copyright © 2013 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  9. Optimizing blood collection, transport and storage conditions for cell free DNA increases access to prenatal testing.

    PubMed

    Wong, David; Moturi, Sharmili; Angkachatchai, Vach; Mueller, Reinhold; DeSantis, Grace; van den Boom, Dirk; Ehrich, Mathias

    2013-08-01

    Fetal mutations and fetal chromosomal abnormalities can be detected by molecular analysis of circulating cell free fetal DNA (ccffDNA) from maternal plasma. This comprehensive study was aimed to investigate and verify blood collection and blood shipping conditions that enable Noninvasive Prenatal Testing. Specifically, the impact of shipping and storage on the stability and concentration of circulating cell-free DNA (ccfDNA) in Streck® Cell-Free DNA™ Blood Collection Tubes (Streck BCTs, Streck, Omaha NE). These BCTs were designed to minimize cellular degradation, and thus effectively prevent dilution of fetal ccf DNA by maternal genomic DNA, was evaluated. Peripheral venous maternal blood was collected into Streck BCTs to investigate four aspects of handling and processing conditions: (1) time from blood draw to plasma processing; (2) storage temperature; (3) mechanical stress; and (4) lot-to-lot tube variations. Maternal blood stored in Streck BCTs for up to 7 days at ambient temperature provides stable concentrations of ccffDNA. The amount of fetal DNA did not change over a broad range of storage temperatures (4°C, 23°C, 37°C, 40°C), but the amount of total (largely maternal) DNA increased in samples stored at 23°C and above, indicating maternal cell degradation and genomic DNA release at elevated temperatures. Shipping maternal blood in Streck BCTs, did not affect sample quality. Maternal plasma DNA stabilized for 0 to 7 days in Streck BCTs can be used for non-invasive prenatal molecular applications, when temperatures are maintained within the broad parameters assessed in this study. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Microbiological Survey of Packaged Ready-to-Eat Red Meats at Retail in New Zealand.

    PubMed

    Rivas, Lucia; Horn, Beverley; Cook, Roger; Castle, Marion

    2017-10-04

    A microbiological survey was undertaken on packaged ready-to-eat red meats available at retail in New Zealand. A total of 1,485 samples (297 lots of five samples each) were collected according to a sampling plan based on market share and regulatory regimes (Animal Products Act 1999 and Food Act 1981) and were tested against the microbiological limits specified in Food Standards Code (FSC) 1.6.1 applicable at the time of sampling. Each lot was tested as a composite for the presence or absence of Salmonella spp., coagulase-producing staphylococci, Listeria monocytogenes, and other Listeria spp. at the end of the manufacturer's stated shelf life. Individual samples within a positive lot were subsequently enumerated for L. monocytogenes. None of the samples contained Salmonella spp. or had coagulase-producing staphylococci counts above the acceptable level specified in FSC 1.6.1 (>100 CFU/g). Data showed that 93.6% (278 of 297 lots) of ready-to-eat red meat complied with the FSC 1.6.1 criteria applicable at the time of the survey. The failure of 19 lots (6.4%) was due to the presence of L. monocytogenes from product obtained from 8 of 33 producers tested. Thirteen samples of 95 positive samples were found to contain between 50 and 500 CFU/g L. monocytogenes, but all of these samples were manufactured by the same operator. Pulsed-field gel electrophoresis typing of all of the L. monocytogenes isolates obtained from the survey identified 12 different pulsotypes. Different pulsotypes were often identified in samples from the same operator sampled on separate occasions. A total of 46 lots (15.5%) contained Listeria spp. (including L. monocytogenes). The detection of Listeria in samples may highlight the existence of problems in operator processing and/or packaging processes and suggests that improvements in good hygienic practice and implementation of more effective risk mitigation strategies are needed.

  11. Coal-Tar-Based Parking Lot Sealcoat: An Unrecognized Source of PAH to Settled House Dust

    PubMed Central

    2010-01-01

    Despite much speculation, the principal factors controlling concentrations of polycyclic aromatic hydrocarbons (PAH) in settled house dust (SHD) have not yet been identified. In response to recent reports that dust from pavement with coal-tar-based sealcoat contains extremely high concentrations of PAH, we measured PAH in SHD from 23 apartments and in dust from their associated parking lots, one-half of which had coal-tar-based sealcoat (CT). The median concentration of total PAH (T-PAH) in dust from CT parking lots (4760 μg/g, n = 11) was 530 times higher than that from parking lots with other pavement surface types (asphalt-based sealcoat, unsealed asphalt, concrete [median 9.0 μg/g, n = 12]). T-PAH in SHD from apartments with CT parking lots (median 129 μg/g) was 25 times higher than that in SHD from apartments with parking lots with other pavement surface types (median 5.1 μg/g). Presence or absence of CT on a parking lot explained 48% of the variance in log-transformed T-PAH in SHD. Urban land-use intensity near the residence also had a significant but weaker relation to T-PAH. No other variables tested, including carpeting, frequency of vacuuming, and indoor burning, were significant. PMID:20063893

  12. Coal-tar-based parking lot sealcoat: An unrecognized source of PAH to settled house dust

    USGS Publications Warehouse

    Mahler, B.J.; Van Metre, P.C.; Wilson, J.T.; Musgrove, M.; Burbank, T.L.; Ennis, T.E.; Bashara, T.J.

    2010-01-01

    Despite much speculation, the principal factors controlling concentrations of polycyclic aromatic hydrocarbons (PAH) in settled house dust (SHD) have not yet been identified. In response to recent reports that dust from pavement with coaltar-based sealcoat contains extremely high concentrations of PAH, we measured PAH in SHD from 23 apartments and in dust from their associated parking lots, one-half of which had coal-tar-based sealcoat (CT). The median concentration of total PAH (T-PAH) in dust from CT parking lots (4760 ??g/g, n = 11) was 530 times higher than that from parking lots with other pavement surface types (asphalt-based sealcoat, unsealed asphalt, concrete [median 9.0 ??g/g, n = 12]). T-PAH in SHD from apartments with CT parking lots (median 129 ??g/g) was 25 times higher than that in SHD from apartments with parking lots with other pavement surface types (median 5.1 ??g/g). Presence or absence of CT on a parking lot explained 48% of the variance in log-transformed T-PAH in SHD. Urban land-use intensity near the residence also had a significant but weaker relation to T-PAH. No other variables tested, including carpeting, frequency of vacuuming, and indoor burning, were significant. ?? 2010 American Chemical Society.

  13. Supplemental Environmental Baseline Survey for Proposed Land Use Permit Modification for Expansion of the Dynamic Explosive Test Site (DETS) 9940 Main Complex Parking Lot

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

    Peek, Dennis W.

    The “subject property” is comprised of a parcel of land within the Kirtland Military Reservation, Bernalillo County, New Mexico, as shown on the map in Appendix B of this document. The land requirement for the parking lot addition to the 9940 Main Complex is approximately 2.7 acres. The scope of this Supplemental Environmental Baseline Survey (SEBS) is for the parking lot addition land transfer only. For details on the original 9940 Main Complex see Environmental Baseline Survey, Land Use Permit Request for the 9940 Complex PERM/0-KI-00-0001, August 21, 2003, and for details on the 9940 Complex Expansion see Environmental Baselinemore » Survey, Proposed Land Use Permit Expansion for 9940 DETS Complex, June 24, 2009. The 2.7-acre parcel of land for the new parking lot, which is the subject of this EBS (also referred to as the “subject property”), is adjacent to the southwest boundary of the original 12.3- acre 9940 Main Complex. No testing is known to have taken place on the subject property site. The only activity known to have taken place was the burial of overhead utility lines in 2014. Adjacent to the subject property, the 9940 Main Complex was originally a 12.3-acre site used by the Department of Energy (DOE) under a land use permit from the United States Air Force (USAF). Historical use of the site, dating from 1964, included arming, fusing, and firing of explosives and testing of explosives systems components. In the late 1970s and early 1980s experiments at the 9940 Main Complex shifted toward reactor safety issues. From 1983 to 1988, fuel coolant interaction (FCI) experiments were conducted, as were experiments with conventional high explosives (HE). Today, the land is used for training of the Nuclear Emergency Response community and for research on energetic materials. In 2009, the original complex was expanded to include four additional 20-acre areas: 9940 Training South, 9940 Training East, T-Range 6, and Training West Landing Zone. The proposed use of the subject property is for the purpose of adding a parking lot to serve the increase in customer vehicles that is occurring as the 9940 Main Complex is more heavily utilized, and as the 2009 Expansion areas come online as operational training facilities. The subject property would be used only for parking, not for testing or training activities. The parking lot would have a gravel surface. Current and future work at the 9940 Main Complex involves arming, fuzing, and firing of explosives and the testing of explosive systems components in both terrestrial and aquatic settings. It also involves specialized training activities for a variety of first responder customers, both DOE and non-DOE agencies. The approach was to perform a document search, supplemented by a visual site inspection, to identify potential environmental contamination associated with the property. Factors evaluated included hazardous substances; petroleum products and derivatives; environmental restoration sites; areas of concern; storage tanks; oil/water separators; grease traps; wash racks; waste tanks; pesticides; military munitions/ordnance; medical or bio-hazardous waste; radioactive waste; solid/municipal waste; indoor air quality; groundwater; wastewater treatment, collection, and disposal/discharge; drinking water quality; utilities; asbestos; polychlorinated biphenyls (PCBs); radon; lead-based paint; cultural resources; floodplains; and natural/biological resources. Each of these factors is evaluated separately in Section 5, Findings for Subject Property. The property categorization for this subject property would be considered Category 1- “An area or real property where no storage, release, or disposal of hazardous substances or petroleum products or their derivatives has occurred into the environment or structures or disposed on the subject property (including no migration of these substances from adjacent properties).” There appears to be sufficient information to categorize the subject property and it appears that no further effort needs to be made to obtain additional information. There are no findings of an adverse nature on the subject property itself or from adjacent properties. It is recommended that the proposed transfer of the subject property from the USAF to DOE proceed.« less

  14. Mechanical Properties of Aerojet, Thiokol, and JA2 High-Energy Gun Propellants at 1.5 m/s Deformation Rate

    DTIC Science & Technology

    2002-01-01

    a2 6 n -32 4C La /C A> i c 4S Figure 5. Remains of specimens tested at 210, 630, and -32 0C. 5 I AUg 2001 "-1t AERQJET/"THIDKOL LOTS 0111W PM 4-40.00...10.00 +78.00 STRESS (Mra) -THIOKOL LOT LA -10T3--01 +5.C THIOKOL LOT JA-IEZ35--Z-02 JAZ LOT HCL03JO14-001 -28.00 AE J>:T? +0.00 4.00 0.0 .0 *20.0 O30 +40M0...WARREN MI 48397-5000 MATERIAL SCIENCE TEAM AMSSB RSS 14 BENET LABORATORIES J HERBERT AMSTA AR CCB M SENNETT R FISCELLA KANSAS ST M SOJA NATICK MA 01760

  15. Fine Tuning the CJ Detonation Speed of a High Explosive products Equation of State

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

    Menikoff, Ralph

    For high explosive (HE) simulations, inaccuracies of a per cent or two in the detonation wave speed can result from not suficiently resolving the reaction zone width or from small inaccuracies in calibrating the products equation of state (EOS) or from variation of HE lots. More accurate detonation speeds can be obtained by ne tuning the equation of state to compensate. Here we show that two simple EOS transformations can be used to adjust the CJ detonation speed by a couple of per cent with minimal effect on the CJ release isentrope. The two transformations are (1) a shift inmore » the energy origin and (2) a linear scaling of the speci c volume. The effectiveness of the transformations is demonstrated with simulations of the cylinder test for PBX 9502 starting with a products EOS for which the CJ detonation speed is 1 per cent too low.« less

  16. Mass spectrometric-based stable isotopic 2-aminobenzoic acid glycan mapping for rapid glycan screening of biotherapeutics.

    PubMed

    Prien, Justin M; Prater, Bradley D; Qin, Qiang; Cockrill, Steven L

    2010-02-15

    Fast, sensitive, robust methods for "high-level" glycan screening are necessary during various stages of a biotherapeutic product's lifecycle, including clone selection, process changes, and quality control for lot release testing. Traditional glycan screening involves chromatographic or electrophoretic separation-based methods, and, although reproducible, these methods can be time-consuming. Even ultrahigh-performance chromatographic and microfluidic integrated LC/MS systems, which work on the tens of minute time scale, become lengthy when hundreds of samples are to be analyzed. Comparatively, a direct infusion mass spectrometry (MS)-based glycan screening method acquires data on a millisecond time scale, exhibits exquisite sensitivity and reproducibility, and is amenable to automated peak annotation. In addition, characterization of glycan species via sequential mass spectrometry can be performed simultaneously. Here, we demonstrate a quantitative high-throughput MS-based mapping approach using stable isotope 2-aminobenzoic acid (2-AA) for rapid "high-level" glycan screening.

  17. Curcumin-cyclodextrin encapsulated chitosan nanoconjugates with enhanced solubility and cell cytotoxicity.

    PubMed

    Popat, Amirali; Karmakar, Surajit; Jambhrunkar, Siddharth; Xu, Chun; Yu, Chengzhong

    2014-05-01

    Curcumin (CUR), a naturally derived anti-cancer cocktail is arguably the most widely studied neutraceutical. Despite a lot of promises, it is yet to reach the market as an active anti-cancer formulation. In the present study, we have prepared highly soluble (3 mg/ml) CUR-γ-hydroxypropyl cyclodextrin (CUR-CD) hollow spheres. CUR-CD hollow spheres were prepared by a novel and scalable spray drying method. CUR-CD was then encapsulated into positively charged biodegradable chitosan (CUR-CD-CS) nanoparticles. The CUR-CD-CS nanoparticles were characterised by TEM, SEM, DLS, drug loading and in vitro release. We tested the efficacy of these CUR-CD-CS nanoparticles in SCC25 cell lines using MTT assay and investigated its cellular uptake mechanism. We also studied Oligo DNA loading in CUR-CD-CS nanoparticles and its delivery via confocal imaging and FACS analysis. Our results demonstrated that CUR-CD-CS nanoparticles showed superior in vitro release performance and higher cytotoxicity in SCC25 cell line amongst all tested formulations. The cytotoxicity results were corroborated by cell cycle analysis and apoptosis test, showing nearly 100% apoptotic cell death in the case of CUR-CD-CS nanoparticles. Compared to CS nanoparticles, CS-CD nanoformulation showed higher cellular delivery of Cy3-Oligo DNA which was tested quantitatively using flowcytometry analysis, indicating that CD not only enhanced CUR solubility but also boosted the cellular uptake. Our study shows that rationally designed bio-degradable natural biomaterials have great potential as next generation nano-carriers for hydrophobic drug delivery such as CUR with potential of dual drug-gene delivery. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. Phytotoxicity as an indicator of stability of broiler production residues.

    PubMed

    Mendes, P M; Becker, R; Corrêa, L B; Bianchi, I; Dai Prá, M A; Lucia, T; Corrêa, E K

    2016-02-01

    Beddings used for successive broiler lots act as substrate to absorb water and feed from the excreta and may be subsequently used as agricultural fertilizers. This study evaluated the physicochemical characteristics and the phytotoxicity of beddings used to raise five consecutive broiler lots in five aviaries. Samples were collected for beddings not used yet and for beddings used at each of the five broiler lots. Lettuce and cucumber seeds were considered as phytotoxicity bioindicators. As beddings were used for greater number of lots, N, Ca, K, Mg and P contents generally increased, but the C content decreased, the pH alkalinized and humidity was reduced (P < 0.05). The germination index for lettuce and cucumber seeds was reduced with increased bedding (P < 0.05). Beddings used for at least five broiler lots presented decreased C:N ratio and would not recommended for agricultural use due to its toxicity for both tested seeds. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. AD620SQ/883B Total Ionizing Dose Radiation Lot Acceptance Report for RESTORE-LEO

    NASA Technical Reports Server (NTRS)

    Burton, Noah; Campola, Michael

    2017-01-01

    A Radiation Lot Acceptance Test was performed on the AD620SQ/883B, Lot 1708D, in accordance with MIL-STD-883, Method 1019, Condition D. Using a Co-60 source 4 biased parts and 4 unbiased parts were irradiated at 10 mrad/s (0.036 krad/hr) in intervals of approximately 1 krad from 3-10 krads, and ones of 5 krads from 10-25 krads, where it was annealed while unbiased at 25 degrees Celsius, for 2 days, and then, subsequently, annealed while biased at 25 degrees celsius, for another 7 days.

  20. Evaluation of Primary Immunization Coverage of Infants Under Universal Immunization Programme in an Urban Area of Bangalore City Using Cluster Sampling and Lot Quality Assurance Sampling Techniques

    PubMed Central

    K, Punith; K, Lalitha; G, Suman; BS, Pradeep; Kumar K, Jayanth

    2008-01-01

    Research Question: Is LQAS technique better than cluster sampling technique in terms of resources to evaluate the immunization coverage in an urban area? Objective: To assess and compare the lot quality assurance sampling against cluster sampling in the evaluation of primary immunization coverage. Study Design: Population-based cross-sectional study. Study Setting: Areas under Mathikere Urban Health Center. Study Subjects: Children aged 12 months to 23 months. Sample Size: 220 in cluster sampling, 76 in lot quality assurance sampling. Statistical Analysis: Percentages and Proportions, Chi square Test. Results: (1) Using cluster sampling, the percentage of completely immunized, partially immunized and unimmunized children were 84.09%, 14.09% and 1.82%, respectively. With lot quality assurance sampling, it was 92.11%, 6.58% and 1.31%, respectively. (2) Immunization coverage levels as evaluated by cluster sampling technique were not statistically different from the coverage value as obtained by lot quality assurance sampling techniques. Considering the time and resources required, it was found that lot quality assurance sampling is a better technique in evaluating the primary immunization coverage in urban area. PMID:19876474

  1. Investigation of whether the acute hemolysis associated with Rho(D) immune globulin intravenous (human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model

    PubMed Central

    Gaines, Ann Reed; Lee-Stroka, Hallie; Byrne, Karen; Scott, Dorothy E.; Uhl, Lynne; Lazarus, Ellen; Stroncek, David F.

    2012-01-01

    BACKGROUND Immune thrombocytopenic purpura and secondary thrombocytopenia patients treated with Rho(D) immune globulin intravenous (human; anti-D IGIV) have experienced acute hemolysis, which is inconsistent with the typical presentation of extravascular hemolysis—the presumed mechanism of action of anti-D IGIV. Although the mechanism of anti-D-IGIV–associated acute hemolysis has not been established, the onset, signs/symptoms, and complications appear consistent with the intravascular hemolysis of acute hemolytic transfusion reactions (AHTRs). In transfusion medicine, the red blood cell (RBC) antigen-antibody incompatibility(-ies) that precipitate AHTRs can be detected in vitro with compatibility testing. Under the premise that anti-D-IGIV–associated acute hemolysis results from RBC antigen-antibody–mediated complement activation, this study evaluated whether the incompatibility(-ies) could be detected in vitro with a hemolysin assay, which would support the AHTR model as the hemolytic mechanism. STUDY DESIGN AND METHODS Seven anti-D IGIV lots were tested to determine the RBC antibody identities in those lots, including four lots that had been implicated in acute hemolytic episodes. Hemolysin assays were performed that tested each of 73 RBC specimens against each lot, including the RBCs of one patient who had experienced acute hemolysis after anti-D IGIV administration. RESULTS Only two anti-D IGIV lots contained RBC antibodies beyond those expected. No hemolysis endpoint was observed in any of the hemolysin assays. CONCLUSION Although the findings did not support the AHTR model, the results are reported to contribute knowledge about the mechanism of anti-D-IGIV–associated acute hemolysis and to prompt continued investigation into cause(s), prediction, and prevention of this potentially serious adverse event. PMID:19220820

  2. The Psychometric Properties of English and Spanish Versions of the Life Orientation Test-Revised in Hispanic Americans.

    PubMed

    Pan, Tonya M; Mills, Sarah D; Fox, Rina S; Baik, Sharon H; Harry, Kadie M; Roesch, Scott C; Sadler, Georgia Robins; Malcarne, Vanessa L

    2017-12-01

    The Life Orientation Test-Revised (LOT-R) is a widely used measure of optimism and pessimism, with three positively worded and three negatively worded content items. This study examined the structural validity and invariance, internal consistency reliability, and convergent and divergent validity of the English and Spanish versions of the LOT-R among Hispanic Americans. A community sample of Hispanic Americans ( N = 422) completed self-report measures, including the LOT-R, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7, in their preferred language of English or Spanish. Based on the literature, four structural models were tested: one-factor , oblique two-factor , orthogonal two-factor method effects with positive specific factor , and orthogonal two-factor method effects with negative specific factor . Baseline support for both of the English and Spanish versions was not achieved for any model; in all models, the negatively worded items in Spanish had non-significant factor loadings. Therefore, the positively worded three-item optimism subscale of the LOT-R was examined separately and fit the data, with factor loadings equivalent across language-preference groups. Coefficient alphas for the optimism subscale were consistent across both language-preference groups (αs = .61 [English] and .66 [Spanish]). In contrast, the six-item total score and three-item pessimism subscale demonstrated extremely low or inconsistent alphas. Convergent and divergent validity were established for the optimism subscale in both languages. In sum, the optimism subscale of the LOT-R demonstrated minimally acceptable to good psychometric properties across English and Spanish language-preference groups. However, neither the total score nor the pessimism subscale showed adequate psychometric properties for Spanish-speaking Hispanic Americans, likely due to translation and cultural adaptation issues, and thus are not supported for use with this population.

  3. Fundamental Aspects of Pressuremeter Testing.

    DTIC Science & Technology

    1987-04-30

    consolidomreter is giveln ill Fig. 3.1. To reduce the consolidation time, drainage is provided at the top and botton , of the specimen. A detailed mechanical...OCf I. f,1 rr cal stait so, m~ode ~1, ThC ( ;1!1. ( Ia fl-- lot a! 9 an(.- tf. n’’.j" .. ( amn CIa, (ko-tem and 1Biriii. 1140% are it.o tt3’ (d i...plane strain tests, the intermediate principal stress is [ lot known unless the sides of the specinien corresponding to the plane of zero deform-a

  4. The Joint Logistics-Over-the-Shore (LOTS) Test and Evaluation Report. Volume I. Conduct of the Test.

    DTIC Science & Technology

    1979-01-05

    and deployed with available Military Sealift Command (MSC) shipping. The Army LOTS equipment inventory includes DeLong barges/piers which exceed all...main components of the facility, all items in the Army inventory , can be seen in Figure 2.17. They are: 0 The B DeLong barge, * The 300-ton capacity P&H...only) (1) 8-9 Preliminary Operatio s. The administrative move from Ft. Eustis to the Norfolk Naval Suppiy Center for ship loading and the subsequent

  5. Evaluation of a Test Article in the L5178Y TK+/-Mouse Lymphoma Mutagenesis Assay with Colony Size Evaluation in the Presence and Absence of Induced Rat Liver S-9 with a Confirmatory Study. Test Article: 3-Nitro-1,2,4-Triazol-5-one (NTO)

    DTIC Science & Technology

    2008-11-17

    B. Mutat. Res. J J 3;173, 1983 INDUC1NG AGENT(.): Aroclor ! 254 Monsanto Lot No, rul5 • 5QOmglkg BIOCHEMISTRY: -PROTEIN 35.8mglml Assayed... Monsanto Lot No, KL615 - SQQmgikg BIOCHEMISTRY: -PROTEIN 40.1 mglml Assayed according to the method of Lowry et al,.)BC 193:265, 1951 using bovine

  6. Fingerprint test data report: FM 5064J (Kaiser) lots No. 1 (K) - No. 4 (K). [resin matrix composites

    NASA Technical Reports Server (NTRS)

    1986-01-01

    Quality control tests are presented for resin matrix and carbon-carbon composites. Tests performed are filler test, resin test, prepregs test, and fabric test. The test results are presented in chart form.

  7. Reproducibility of toxicity test data as a function of mouse strain, animal lot, and operator. [for bisphenol A polycarbonate

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Furst, A.

    1978-01-01

    The toxicity screening test method developed at the University of San Francisco was evaluated for reproducibility. The variables addressed were strain of mouse, lot of animals, and operator. There was a significant difference in response between Swiss Webster mice and ICR mice, with the latter exhibiting greater resistance. These two strains of mice are not interchangeable in this procedure. Variation between individual animals was significant and unavoidable. In view of this variation, between-lot and between-operator variations appear to have no practical significance. The significant variation between individual animals stresses the need for average values based on at least four animals, and preferably values based on at least two experiments and eight animals. Efforts to compare materials should be based on the evaluation of relatively simple responses using substantial numbers of animals, rather than on elaborate evaluation of single animals

  8. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... other dust generating operations which have been terminated for over eight months. (3) The test methods... than or equal to a nominal 10 micrometers as measured by reference or equivalent methods that meet the...

  9. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... other dust generating operations which have been terminated for over eight months. (3) The test methods... than or equal to a nominal 10 micrometers as measured by reference or equivalent methods that meet the...

  10. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... other dust generating operations which have been terminated for over eight months. (3) The test methods... than or equal to a nominal 10 micrometers as measured by reference or equivalent methods that meet the...

  11. Fieldwork Lesson based on" the International Geography Olympiad" (iGeo)

    NASA Astrophysics Data System (ADS)

    Otani, Seiichi

    2017-04-01

    Japanese social studies consist of three fields. That's geography, history and civics. About geographical studies in Japan, it has a lot of contents of human geography and has little contents of natural geography. I think that Japanese social studies teachers should teach more natural geography contents for ESD. 　 There is a fieldwork lesson in geographical studies in Japan. This is the educational activity by which body and head were used. But in fact, fieldwork lessons are not performed in many Japanese junior high schools. I was a leader of iGeo2012 (in Germany). iGeo is held by three tests; Multimedia tests, Writing tests and Fieldwork tests. The test is included of a lot of contents of natural geography. And there are two skills that students acquire through the fieldwork test in iGeo. One is a map making skill, the other is decision making skill. Japanese students need more knowledge of natural geography. And those are not enough skills for Japanese students. So I did a fieldwork lesson based on iGeo's fieldwork test. The fieldwork lesson was performed around the school. It was also performed under the point of natural geography. After the lessons, students could improve map making skill. Because a lot of maps made by students in this lesson got prize of map contest in Japan. Some maps were included the view of natural geography.

  12. Development of a 100 nmol mol(-1) propane-in-air SRM for automobile-exhaust testing for new low-emission requirements.

    PubMed

    Rhoderick, George C

    2007-04-01

    New US federal low-level automobile emission requirements, for example zero-level-emission vehicle (ZLEV), for hydrocarbons and other species, have resulted in the need by manufacturers for new certified reference materials. The new emission requirement for hydrocarbons requires the use, by automobile manufacturing testing facilities, of a 100 nmol mol(-1) propane in air gas standard. Emission-measurement instruments are required, by federal law, to be calibrated with National Institute of Standards and Technology (NIST) traceable reference materials. Because a NIST standard reference material (SRM) containing 100 nmol mol(-1) propane was not available, the US Environmental Protection Agency (EPA) and the Automobile Industry/Government Emissions Research Consortium (AIGER) requested that NIST develop such an SRM. A cylinder lot of 30 gas mixtures containing 100 nmol mol(-1) propane in air was prepared in 6-L aluminium gas cylinders by a specialty gas company and delivered to the Gas Metrology Group at NIST. Another mixture, contained in a 30-L aluminium cylinder and included in the lot, was used as a lot standard (LS). Using gas chromatography with flame-ionization detection all 30 samples were compared to the LS to obtain the average of six peak-area ratios to the LS for each sample with standard deviations of <0.31%. The average sample-to-LS ratio determinations resulted in a range of 0.9828 to 0.9888, a spread of 0.0060, which corresponds to a relative standard deviation of 0.15% of the average for all 30 samples. NIST developed its first set of five propane in air primary gravimetric standards covering a concentration range 91 to 103 nmol mol(-1) with relative uncertainties of 0.15%. This new suite of propane gravimetric standards was used to analyze and assign a concentration value to the SRM LS. On the basis of these data each SRM sample was individually certified, furnishing the desired relative expanded uncertainty of +/-0.5%. Because automobile companies use total hydrocarbons to make their measurements, it was also vital to assign a methane concentration to the SRM samples. Some of the SRM samples were analyzed and found to contain 1.2 nmol mol(-1) methane. Twenty-five of the samples were certified and released as SRM 2765.

  13. [The establishment and application of internal quality control system for real-time quantitative PCR detection of BCR-ABL (P210) transcript levels].

    PubMed

    Zhong, C Q; He, N; Hua, M Q; Wei, X D; Ma, D X; Ji, C Y

    2016-09-14

    Objective: To set internal quality control system of BCR-ABL (P210) transcript levels for real-time quantitative PCR (RQ-PCR). Methods: Using K562 cells and HL-60 cells, we prepared high- and low-level BCR-ABL internal quality control substance. The BCR-ABL (P210) transcript levels of internal quality control substance have been determined for 184 times together with clinical samples from August 2013 to October 2015. The slope rate, intercept and correlation coefficient of standard curve were calculated according to different reagent lots (lots number 20130303, 20131212, 20140411 and 20150327 are called R1、R2、R3 and R4 for short respectively), and the detection results of quality control substance were calculated according to different reagent lots and quality control substance lots (lots number 20130725, 20140611 are called Q1、Q2 for short respectively). Then the results were analyzed by Levey-Jennings quality control chart combined with Westgard multi-rules theory. Results: ①We analyzed the slope rate and intercept of standard curve. Fifty-three times of the R1 reagent detection, 80 times of the R3 reagent detection and 14 times of the R4 reagent detection were all under control. For 37 times detection of R2 reagent, the slope rate was out of control for 6 times. It was lower than x - s for the 2-8 tests and upper the average for the 12-37 tests. The intercept was out of control for 9 times, upper the x + s for the 1-8 tests and lower the average for the 12-37 tests. ② According to the detection results of quality control substance, for Q1 quality control substance, 49 tests by R1 reagent were under control, and 1 out of 23 tests by R2 reagent was out of control. For Q2 quality control substance, 14 tests by R2 reagent detection, 72 tests by R3 reagent detection and 14 tests by R4 reagent were all under control. Conclusion: The preparation of high- and low-level quality control substance using K562 and HL-60 cells was convenient and the detection results were reliable and stable. The application of quality control substance combined with slope rate and intercept in the internal quality control may contribute to quality assurance for quantitative detection of BCR-ABL (P210) transcript levels.

  14. Broad-band BOS (BBYB) development and calibration in Taiwan

    NASA Astrophysics Data System (ADS)

    Lin, C. R.; Wang, C. C.; Kuo, B. Y.; Chen, P.; Jang, J. P.; Chang, H.; Laio, Y. C.; Chang, K. H.; Lin, F. S.

    2016-12-01

    Since 2009, combine with Academia Sinica, National Applied Research Laboratories and National Sun Yat-sen University formed ocean bottom seismograph (OBS) development team to develop sub-broadband OBS (called Yardbird OBS). Through a series deploy experiment at seafloor offshore Taiwan that got a lot of data can be used to study plate tectonics, seismic activity, source characteristics. Nowadays they have pretty good results already. Due to bandwidth limitations of the Yardbird OBS that inadequate to use for analyze global-scale earthquake. Therefor developing broadband ocean bottom seismograph is an important goal for the development team. Currently the broadband OBS (called BBYB) design and construction have completed the initial experiment phase. Due to underwater instruments always got high risk. Something accidentally making equipment sank in the sea cannot be recovery. Even recovery of equipment may also be causing poor performance because there is no data record. It cannot be to accomplish the experiment mission. In order to improve the OBS performance, avoid OBS dis-recovery or data collection is incomplete, must be sure all OBS's each component (such as seismic data recording device, balanced body, sonar dashboard, instruments and internal wiring ...) with well-done quality before assembly. Each component could go through very rigorous testing, strict and pick out the good components in the assembly process. Be sure all of produce the OBS under the water after a long deployment could successful recovery and got valuable data. In this presentation we will show a serial testing procedure and results for quality each BBYB component. Such as: Data logger: digitizer sensitivity, sampling rate, clock timing. Acoustic controller: function of Enable, Disable, Range, Release 1, Release 2, Option 1(Release disable). Air pressure gauge for glass ball: accuracy. A check lists of connector wiring check for assembling instrument. Design deploy and recovery procedure for operation on deck. We hope through repeated testing to ensure perfect performance of BBYB and apply the testing concept to another equipment for improve instruments performance. Keywords: ocean bottom seismograph (OBS); Data logger; Acoustic controller; Air pressure gauge.

  15. Role of gastrin-releasing peptides in breast cancer metastasis.

    PubMed

    Ni, Chunsheng; Zhao, Xiulan; Sun, Tao; Liu, Yanrong; Gu, Qiang; Sun, Baocun

    2012-12-01

    The gastrin-releasing peptide, which is an unfolded protein response regulator and functions as a Ca(2+)-binding molecular chaperone in the endoplasmic reticulum, is a regulatory human peptide that elicits gastrin release and regulates gastric acid secretion and enteric motor function. It has been shown to exhibit mitogenic activity in small cell lung cancer and plays a role in a lot of other human cancers including tumors in colon, stomach, pancreas, breast, and prostate. This study investigated the gastrin-releasing peptide expression in breast cancer to demonstrate the role of this biomarker in breast cancer metastasis. Gastrin-releasing peptide was analyzed in breast cancer tissue microarray specimens, including 200 primary breast cancer specimens and the corresponding lymph nodes from the same patients, through immunohistochemistry. The effect of gastrin-releasing peptide on the invasion ability of MCF-7 cells was evaluated using transwell assays. Gastrin-releasing peptide was highly expressed in breast cancer patients with lymph node metastasis. Besides, among the patients with lymph node metastasis, the ones with higher expression of gastrin-releasing peptide had shorter survival time. Overexpression of gastrin-releasing peptide significantly enhanced cell invasiveness. Conversely, a knockdown of gastrin-releasing peptide through the short hairpin RNA approach remarkably reduced MCF-7 cell invasion. Gastrin-releasing peptide expression may be associated with lymph node metastasis and may be used as an indicator of undesirable prognosis in patients with breast cancer. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. Assessment of the within- and between-lot variability of Whatman™ FTA(®) DMPK and 903(®) DBS papers and their suitability for the quantitative bioanalysis of small molecules.

    PubMed

    Luckwell, Jacquelynn; Denniff, Philip; Capper, Stephen; Michael, Paul; Spooner, Neil; Mallender, Philip; Johnson, Barry; Clegg, Sarah; Green, Mark; Ahmad, Sheelan; Woodford, Lynsey

    2013-11-01

    To ensure that PK data generated from DBS samples are of the highest quality, it is important that the paper substrate is uniform and does not unduly contribute to variability. This study investigated any within and between lot variations for four cellulose paper types: Whatman™ FTA(®) DMPK-A, -B and -C, and 903(®) (GE Healthcare, Buckinghamshire, UK). The substrates were tested to demonstrate manufacturing reproducibility (thickness, weight, chemical coating concentration) and its effect on the size of the DBS produced, and the quantitative data derived from the bioanalysis of human DBS samples containing six compounds of varying physicochemical properties. Within and between lot variations in paper thickness, mass and chemical coating concentration were within acceptable manufacturing limits. No variation in the spot size or bioanalytical data was observed. Bioanalytical results obtained for DBS samples containing a number of analytes spanning a range of chemical space are not affected by the lot used or by the location within a lot.

  17. Development of Vaccines to Prevent Wound Infections Due to Anerobic Bacteria

    DTIC Science & Technology

    1981-09-01

    lot variability of the monosaccharide constituents 4 IV. Safety and toxicity testing of Lot 1 of polysaccharide antigens from B. fragilis strains 9343...the polysaccharide into monosac- charides followed by conversion of these to alditol acetates demonstrates several interesting monosaccharides present...rats with the capsular polysaccharide of B. fragilis iniuces protection to subsequent challenge with this organism. We have prpviously shown that in

  18. Diatom-Based Material Production Demonstration

    DTIC Science & Technology

    2016-03-14

    Standard Form 298 (Rev 8/98) Prescribed by ANSI Std. Z39.18 Final Report W911NF-15-2-0012 66671-CH-DRP.5 808-212-4509 a. REPORT 14. ABSTRACT 16...diatomaceous earth. Diatomaceous earth consists of fossilized diatom cell walls, which have non uniform size with a lot of debris and a large...PROGRAM ELEMENT NUMBER 5b. GRANT NUMBER 5a. CONTRACT NUMBER Form Approved OMB NO. 0704-0188 3. DATES COVERED (From - To) - Approved for Public Release

  19. Sub-Saharan Africa Report.

    DTIC Science & Technology

    1985-11-29

    demerits of the governments withdrawal of petroleum subsidy, statistics just released show that consumption of all petroleum products has shown...political freedom to the masses while an injust economic system remains, they argue. Thus far the theory . One of my mam concerns is that we may be...reading about Aüssie and don’t have any’ illusions about the place. There are things ^e won’t like — there is apparently a lot of racism there too

  20. Test for Chemical Induction of Chromosome Aberrations in Cultured Chinese Hamster Ovary (CHO) Cells with and without Metabolic Activation, Test Article: 3-Nitro-1,2,4-Triazol-5-one (NTO)

    DTIC Science & Technology

    2008-10-30

    it consisted of phenobarbital -5,6-Benzoflavone (phenobarbitallB-naphthoflavone) -induced rat liver homogenate (S-9 fraction) and the cofactor pool...5. Storage Condition: 6. Expiration Date: Moltox 2059 32.1 mglmL (Lot No.: 2059) Phenobarbital -5,6-Benzoflavone <-70°C September 7,2008 (Lot...mL PREPARATION DATE: September 7. 2006 EXPIRATION DATE: September 7. 2008 BUllFER: O.lS4MKCl INDUCING AGENT(s): Phenobarbital • 5,6·Benzoflavone

  1. Evaluation of DuPont Qualicon Bax System PCR assay for yeast and mold.

    PubMed

    Wallace, F Morgan; Burns, Frank; Fleck, Lois; Andaloro, Bridget; Farnum, Andrew; Tice, George; Ruebl, Joanne

    2010-01-01

    Evaluations were conducted to test the performance of the BAX System PCR assay which was certified as Performance Tested Method 010902 for screening yeast and mold in yogurt, corn starch, and milk-based powdered infant formula. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent to the U.S. Food and Drug Administration's Bacteriological Analytical Manual culture method, but with a significantly shorter time to obtain results. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined affected the performance of the assay.

  2. Geometry and material choices govern hard-rock drilling performance of PDC drag cutters.

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

    Wise, Jack LeRoy

    2005-06-01

    Sandia National Laboratories has partnered with industry on a multifaceted, baseline experimental study that supports the development of improved drag cutters for advanced drill bits. Different nonstandard cutter lots were produced and subjected to laboratory tests that evaluated the influence of selected design and processing parameters on cutter loads, wear, and durability pertinent to the penetration of hard rock with mechanical properties representative of formations encountered in geothermal or deep oil/gas drilling environments. The focus was on cutters incorporating ultrahard PDC (polycrystalline diamond compact) overlays (i.e., diamond tables) on tungsten-carbide substrates. Parameter variations included changes in cutter geometry, material composition,more » and processing conditions. Geometric variables were the diamond-table thickness, the cutting-edge profile, and the PDC/substrate interface configuration. Material and processing variables for the diamond table were, respectively, the diamond particle size and the sintering pressure applied during cutter fabrication. Complementary drop-impact, granite-log abrasion, linear cutting-force, and rotary-drilling tests examined the response of cutters from each lot. Substantial changes in behavior were observed from lot to lot, allowing the identification of features contributing major (factor of 10+) improvements in cutting performance for hard-rock applications. Recent field demonstrations highlight the advantages of employing enhanced cutter technology during challenging drilling operations.« less

  3. Critical evaluation of connectivity-based point of care testing systems of glucose in a hospital environment.

    PubMed

    Floré, Katelijne M J; Fiers, Tom; Delanghe, Joris R

    2008-01-01

    In recent years a number of point of care testing (POCT) glucometers were introduced on the market. We investigated the analytical variability (lot-to-lot variation, calibration error, inter-instrument and inter-operator variability) of glucose POCT systems in a university hospital environment and compared these results with the analytical needs required for tight glucose monitoring. The reference hexokinase method was compared to different POCT systems based on glucose oxidase (blood gas instruments) or glucose dehydrogenase (handheld glucometers). Based upon daily internal quality control data, total errors were calculated for the various glucose methods and the analytical variability of the glucometers was estimated. The total error of the glucometers exceeded by far the desirable analytical specifications (based on a biological variability model). Lot-to-lot variation, inter-instrument variation and inter-operator variability contributed approximately equally to total variance. As in a hospital environment, distribution of hematocrit values is broad, converting blood glucose into plasma values using a fixed factor further increases variance. The percentage of outliers exceeded the ISO 15197 criteria in a broad glucose concentration range. Total analytical variation of handheld glucometers is larger than expected. Clinicians should be aware that the variability of glucose measurements obtained by blood gas instruments is lower than results obtained with handheld glucometers on capillary blood.

  4. 16 CFR 1633.11 - Records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... conditioning area before starting test, prototype or production identification number, and test data including.... For confirmation tests, the identification number must be that of the prototype tested. (2) Video and... prototype identification number or production lot identification number of the mattress set, date and time...

  5. Timing crisis information release via television.

    PubMed

    Wei, Jiuchang; Zhao, Dingtao; Yang, Feng; Du, Shaofu; Marinova, Dora

    2010-10-01

    When and how often to release information on television are important issues in crisis and emergency risk communication. There is a lot of crisis information, including warnings and news, to which people should have access, but most of it is not significantly urgent to interrupt the broadcasting of television programmes. Hence, the right timing for the release of crisis information should be selected based on the importance of the crisis and any associated communication requirements. Using recursive methods, this paper builds an audience coverage model of crisis information release. Based on 2007 Household Using TV (HUT) data for Hefei City, China, the optimal combination of broadcasting sequence (with frequencies between one and eight times) is obtained using the implicit enumeration method. The developed model is applicable to effective transmission of crisis information, with the aim of reducing interference with the normal television transmission process and decreasing the psychological effect on audiences. The same model can be employed for other purposes, such as news coverage and weather and road information. © 2010 The Author(s). Journal compilation © Overseas Development Institute, 2010.

  6. Getting a Urine Test (For Kids)

    MedlinePlus Videos and Cool Tools

    ... learn a lot from urine tests. Obviously, this test doesn't hurt. And if you know what to expect, it doesn't have to be embarrassing ... Visit the Nemours Web site. Note: All information on KidsHealth® is for ...

  7. Dynamic Stall Computations Using a Zonal Navier-Stokes Model

    DTIC Science & Technology

    1988-06-01

    NAVAL POSTGRADUATE SCHOOL lotMonterey ,California CD Lj STATF ,-S THESIS DYNAMIC STALL CALCULATIONS USING A ZONAL.-,_ % 0 NVETESISDE by Jack H...Conroyd, Jr. June 1988 Thesis Co-advisors: M.F. Platzer Lawrence W. Carr Approved for public release; distribution is unlimitedDOTIC , ~~~~~~~~ELECT...OINT %, Master s Thesis OM To June 212 6 SLP;’LEENTARY NOTATION ri The views expressed in this thesis are those of the author and do not reflect the

  8. Elevated temperature creep properties of NiAl cryomilled with and without Y2O3

    NASA Technical Reports Server (NTRS)

    Whittenberger, J. Daniel; Luton, Michael J.

    1995-01-01

    The creep properties of lots of NiAl cryomilled with and without Y2O3 have been determined in compression and tension. Although identical cryomilling procedures were used, differences in composition were found between the lot ground with 0.5 vol% yttria and the lot ground without Y2O3. Compression testing between 1000 and 1300 K yielded similar creep strengths for both materials, while tensile creep rupture testing indicated that the yttria-containing alloy was slightly stronger than the Y2O3-free version. Both compression and tensile testing showed two deformation regimes; whereas the stress state did not affect the high stress exponent (n approximately equals 10) mechanism, the low stress exponent regime n was approximately 6 in tension and approximately 2 in compression. The strengths in tension were somewhat less than those measured in compression, but the estimated activation energies (Q) of approximately 600 kJ/mol for tensile testing were closer to the previously measured values (approximately 700 kJ/mol) for NiAl-AlN and very different from the Q's of 400 and 200 kJ/mol for compression tests in the high and low stress exponent regimes, respectively. A Larson-Miller comparison indicated that cryomilling can produce an alloy with long-term, high-temperature strength at least equal to conventional superalloys.

  9. International Seed Testing Association List of stabilized plant names, edition 6

    USDA-ARS?s Scientific Manuscript database

    Seed-testing laboratories determine the quality of seed lots in national and international seed commerce. Those services most commonly requested include purity analysis, noxious-weed seed detection, and viability tests. Rigorous procedures for performing various tests on specific crops have been est...

  10. Improvement program for polycarbonate capacitors. [hermetically sealed, and ac wound

    NASA Technical Reports Server (NTRS)

    Bailey, R. R.; Waterman, K. D.

    1973-01-01

    Hermetically sealed, wound, AC, polycarbonate capacitors incorporating design improvements recommended in a previous study were designed and built. A 5000 hour, 400 Hz ac life test was conducted using 384 of these capacitors to verify the adequacy of the design improvements. The improvements incorporated in the capacitors designed for this program eliminated the major cause of failure found in the preceding work, termination failure. A failure cause not present in the previous test became significant in this test with capacitors built from one lot of polycarbonate film. The samples from this lot accounted for 25 percent of the total test complement. Analyses of failed samples showed that the film had an excessive solvent content. This solvent problem was found in 37 of the total 46 failures which occurred in this test. The other nine were random failures resulting from causes such as seal leaks, foreign particles, and possibly wrinkles.

  11. DuPont qualicon BAX system real-time PCR assay for Escherichia coli O157:H7.

    PubMed

    Burns, Frank; Fleck, Lois; Andaloro, Bridget; Davis, Eugene; Rohrbeck, Jeff; Tice, George; Wallace, Morgan

    2011-01-01

    Evaluations were conducted to test the performance of the BAX System Real-Time PCR assay, which was certified as Performance Tested Method 031002 for screening E. coli O157:H7 in ground beef, beef trim, spinach, and lettuce. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent or superior to the FDA-BAM and the USDA-FSIS culture methods, but with a significantly shorter time to result. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined affect the performance of the assay. An accelerated shelf life study determined an initial 36 month shelf life for the test kit.

  12. Multi-Site N-glycan mapping study 1: Capillary electrophoresis – laser induced fluorescence

    PubMed Central

    Szekrényes, Ákos; Park, SungAe Suhr; Santos, Marcia; Lew, Clarence; Jones, Aled; Haxo, Ted; Kimzey, Michael; Pourkaveh, Shiva; Szabó, Zoltán; Sosic, Zoran; Feng, Peng; Váradi, Csaba; de l'Escaille, François; Falmagne, Jean-Bernard; Sejwal, Preeti; Niedringhaus, Thomas; Michels, David; Freckleton, Gordon; Hamm, Melissa; Manuilov, Anastasiya; Schwartz, Melissa; Luo, Jiann-Kae; van Dyck, Jonathan; Leung, Pui-King; Olajos, Marcell; Gu, Yingmei; Gao, Kai; Wang, Wenbo; Wegstein, Jo; Tep, Samnang; Guttman, András

    2016-01-01

    An international team that included 20 independent laboratories from biopharmaceutical companies, universities, analytical contract laboratories and national authorities in the United States, Europe and Asia was formed to evaluate the reproducibility of sample preparation and analysis of N-glycans using capillary electrophoresis of 8-aminopyrene-1,3,6-trisulfonic acid (APTS)-labeled glycans with laser induced fluorescence (CE-LIF) detection (16 sites) and ultra high-performance liquid chromatography (UHPLC, 12 sites; results to be reported in a subsequent publication). All participants used the same lot of chemicals, samples, reagents, and columns/capillaries to run their assays. Migration time, peak area and peak area percent values were determined for all peaks with >0.1% peak area. Our results demonstrated low variability and high reproducibility, both, within any given site as well across all sites, which indicates that a standard N-glycan analysis platform appropriate for general use (clone selection, process development, lot release, etc.) within the industry can be established. PMID:26466659

  13. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells

    PubMed Central

    Bieback, Karen; Kinzebach, Sven; Karagianni, Marianna

    2010-01-01

    It sounds simple to obtain sufficient numbers of cells derived from fetal or adult human tissues, isolate and/or expand the stem cells, and then transplant an appropriate number of these cells into the patient at the correct location. However, translating basic research into routine therapies is a complex multistep process which necessitates product regulation. The challenge relates to managing the expected therapeutic benefits with the potential risks and to balance the fast move to clinical trials with time-consuming cautious risk assessment. This paper will focus on the definition of mesenchymal stromal cells (MSCs), and challenges and achievements in the manufacturing process enabling their use in clinical studies. It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements. As cellular integrity and purity, formulation and lot release testing of the final product, validation of all procedures, and quality assurance are of utmost necessity, these topics will be addressed. PMID:21318154

  14. Hubble Space Telescope nickel-hydrogen battery testing: An update

    NASA Technical Reports Server (NTRS)

    Whitt, Thomas H.; Brewer, Jeffrey C.

    1995-01-01

    The Marshall Space Flight Center (MSFC) began testing the HST Ni-H2 Six Battery Test and the 'Flight Spare Battery' Tests approximately one year before the launch of the HST. These tests are operated and reported on by the MSFC, but are managed and funded by Goddard Space Flight Center in direct support of the HST program. The HST Ni-H2 batteries are built from Eagle Picher RNH-90-3 cells. The HST EPS (electrical power system) is a direct energy transfer power system. The HST Ni-H2 Six Battery Test is a breadboard of the HST EPS. The batteries in the test are composed of test module cells and packaged into three battery modules identical to the flight modules. This test is the HST EPS testbed. The 'Flight Spare Battery' Test is a simulation of one of the six battery channels on the HST. The cells in the test are from the flight spare lot of cells, which are the same lot of cells that three of the six HST flight batteries are made from. This test is the battery life test for the HST program.

  15. 21 CFR 211.194 - Laboratory records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... specific component, drug product container, closure, in-process material, or drug product, and lot tested... product container, closure, in-process material, or drug product tested. (7) The initials or signature of... of any testing and standardization of laboratory reference standards, reagents, and standard...

  16. Effect of five lubricants on life of AISI 9310 spur gears

    NASA Technical Reports Server (NTRS)

    Townsend, D. P.; Zaretsky, E. V.

    1985-01-01

    Spur-gear surface fatigue tests were conducted with five lubricants using a single lot of consumable-electrode vacuum melted (CVM) AISI 9310 spur gears. The lot of gears was divided into five groups, each of which was tested with a different lubricant. The test lubricants are classified as either a synthetic hydrocarbon, mineral oil, or ester-based lubricant. All five lubricants have imilar viscosity and pressure-viscosity coefficients. A pentaerythritol base stock without sufficient antiwear additives produced a surface fatigue life pproximately 22 percent that of the same base stock with chlorine and phosphorus type additives. The presence of sulfur type antiwear additives in the lubricant did not appear to affect the surface fatigue life of the gears tested. No statistical difference in the 10-percent surface fatigue life was produced with four of the five lubricants.

  17. In vitro inhibition of hyaluronidase by sodium copper chlorophyllin complex and chlorophyllin analogs

    PubMed Central

    McCook, John P; Dorogi, Peter L; Vasily, David B; Cefalo, Dustin R

    2015-01-01

    Background Inhibitors of hyaluronidase are potent agents that maintain hyaluronic acid homeostasis and may serve as anti-aging, anti-inflammatory, and anti-microbial agents. Sodium copper chlorophyllin complex is being used therapeutically as a component in anti-aging cosmeceuticals, and has been shown to have anti-hyaluronidase activity. In this study we evaluated various commercial lots of sodium copper chlorophyllin complex to identify the primary small molecule constituents, and to test various sodium copper chlorophyllin complexes and their small molecule analog compounds for hyaluronidase inhibitory activity in vitro. Ascorbate analogs were tested in combination with copper chlorophyllin complexes for potential additive or synergistic activity. Materials and methods For hyaluronidase activity assays, dilutions of test materials were evaluated for hydrolytic activity of hyaluronidase by precipitation of non-digested hyaluronate by measuring related turbidity at 595 nm. High-performance liquid chromatography and mass spectroscopy was used to analyze and identify the primary small molecule constituents in various old and new commercial lots of sodium copper chlorophyllin complex. Results The most active small molecule component of sodium copper chlorophyllin complex was disodium copper isochlorin e4, followed by oxidized disodium copper isochlorin e4. Sodium copper chlorophyllin complex and copper isochlorin e4 disodium salt had hyaluronidase inhibitory activity down to 10 µg/mL. The oxidized form of copper isochlorin e4 disodium salt had substantial hyaluronidase inhibitory activity at 100 µg/mL but not at 10 µg/mL. Ascorbate derivatives did not enhance the hyaluronidase inhibitory activity of sodium copper chlorophyllin. Copper isochlorin e4 analogs were always the dominant components of the small molecule content of the commercial lots tested; oxidized copper isochlorin e4 was found in increased concentrations in older compared to newer lots tested. Conclusion These results support the concept of using the hyaluronidase inhibitory activity of sodium copper chlorophyllin complex to increase the hyaluronic acid level of the dermal extracellular matrix for the improvement of the appearance of aging facial skin. PMID:26300653

  18. In vitro inhibition of hyaluronidase by sodium copper chlorophyllin complex and chlorophyllin analogs.

    PubMed

    McCook, John P; Dorogi, Peter L; Vasily, David B; Cefalo, Dustin R

    2015-01-01

    Inhibitors of hyaluronidase are potent agents that maintain hyaluronic acid homeostasis and may serve as anti-aging, anti-inflammatory, and anti-microbial agents. Sodium copper chlorophyllin complex is being used therapeutically as a component in anti-aging cosmeceuticals, and has been shown to have anti-hyaluronidase activity. In this study we evaluated various commercial lots of sodium copper chlorophyllin complex to identify the primary small molecule constituents, and to test various sodium copper chlorophyllin complexes and their small molecule analog compounds for hyaluronidase inhibitory activity in vitro. Ascorbate analogs were tested in combination with copper chlorophyllin complexes for potential additive or synergistic activity. For hyaluronidase activity assays, dilutions of test materials were evaluated for hydrolytic activity of hyaluronidase by precipitation of non-digested hyaluronate by measuring related turbidity at 595 nm. High-performance liquid chromatography and mass spectroscopy was used to analyze and identify the primary small molecule constituents in various old and new commercial lots of sodium copper chlorophyllin complex. The most active small molecule component of sodium copper chlorophyllin complex was disodium copper isochlorin e4, followed by oxidized disodium copper isochlorin e4. Sodium copper chlorophyllin complex and copper isochlorin e4 disodium salt had hyaluronidase inhibitory activity down to 10 µg/mL. The oxidized form of copper isochlorin e4 disodium salt had substantial hyaluronidase inhibitory activity at 100 µg/mL but not at 10 µg/mL. Ascorbate derivatives did not enhance the hyaluronidase inhibitory activity of sodium copper chlorophyllin. Copper isochlorin e4 analogs were always the dominant components of the small molecule content of the commercial lots tested; oxidized copper isochlorin e4 was found in increased concentrations in older compared to newer lots tested. These results support the concept of using the hyaluronidase inhibitory activity of sodium copper chlorophyllin complex to increase the hyaluronic acid level of the dermal extracellular matrix for the improvement of the appearance of aging facial skin.

  19. 9 CFR 113.327 - Bronchitis Vaccine.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. (c) Each lot of...

  20. [Abnormal growth of spine in patients with adolescent idiopathic thoracic scoliosis].

    PubMed

    Bao, Hongda; Liu, Zhen; Qiu, Yong; Zhu, Feng; Zhu, Zezhang; Zhang, Wen

    2014-05-01

    To investigate if the growth patterns of the spine and pelvis are consistent in adolescent idiopathic scoliosis (AIS) patients with single thoracic curves. Forty-eight thoracic adolescent idiopathic scoliosis (T-AIS) female patients and 48 healthy age-matched adolescents were recruited consecutively between December 2011 and October 2012. Radiographic parameters including height of spine (HOS), length of spine (LOS), height of thoracic spine (HOT), length of thoracic spine (LOT), height of pelvis (HOP), width of pelvis (WOP) and width of thorax (WOT) were measured on the long-cassette posteroanterior standing radiographs. In addition, ratios including HOS/HOP, LOS/HOP, HOT/HOP, LOT/HOP, LOS/LOT, WOT/WOP were also calculated. Independent t-test was performed to compare the radiographic parameters and ratios between the two groups. Compared to the age-matched healthy adolescents, T-AIS patients had a significantly higher LOS and LOT (t = -2.364 and -1.495, P = 0.020 and 0.043) and smaller HOS and HOT (t = 2.060 and 3.359, P = 0.042 and 0.001). Yet, all of HOP, WOP and WOT showed no significant difference between T-AIS patients and healthy adolescents. Similarly, LOS/HOP and LOT/HOP were significantly higher in T-AIS patients as may be expected with an average LOS/HOP of 2.26 ± 0.14 in normal controls.In addition, LOS/LOT in normal controls had a trend of increase with age which was different from the stable LOS/LOT in T-AIS patients, indicating an increased growth of thoracic vertebra compared to lumbar vertebra. Compared to the age-matched healthy adolescents, T-AIS patients have an abnormal growth characteristics with longer spine. The growth of pelvis and thorax show no significant differences between T-AIS patients and healthy adolescents.

  1. Potency assays for therapeutic live whole cell cancer vaccines.

    PubMed

    Petricciani, John; Egan, William; Vicari, Giuseppe; Furesz, John; Schild, Geoffrey

    2007-04-01

    Therapeutic cancer vaccines are under development with the goal of enhancing the body's immune response to cancer cells sufficient to arrest cancer cell growth. Among the various approaches being used are those based on whole tumor cells. Developing a suitable measure of the potency of such vaccines presents a significant challenge because neither cellular associated markers nor in vivo biological responses that are correlated with efficacy have been identified; nevertheless, manufacturers and regulatory agencies will need to develop methods to evaluate these products. At this moment, the challenge for manufacturers who are developing whole cell vaccines is to demonstrate batch-to-batch consistency for the vaccine used in clinical studies and to show that comparable vaccine batches have the same capacity to achieve an acceptable level of biological activity that may be related to efficacy. This is particularly challenging in that animal models to test that activity do not exist and direct serological or immunological correlates of clinical protection are not available because protection has not yet been established in clinical trials. In the absence of well-defined biological markers and tests for manufacturing consistency, manufacturers and regulators will need to rely heavily on a highly reproducible manufacturing process--the consistency of the process therefore becomes critical. In developing regulatory approaches to whole cell cancer vaccines, the experience from the field of infectious disease vaccines should be examined for general guidance. A framework that draws heavily on the field of infectious disease vaccines is presented and suggests that at this point in the development of this new class of products, it is reasonable to develop data on quantitative antigen expression as a measure of potency with the expectation that when clinical efficacy has been established it will confirm the appropriateness of this approach. But because this will not be known until the end of a pivotal trial, a bioassay should be considered and run in parallel. Several examples of bioassays are presented along with their advantages and disadvantages. The final selection of a potency assay for use in lot release of a commercializable therapeutic whole cell vaccine ultimately will depend on the totality of the data available at the time of approval by regulatory agencies. Based on information currently available, it is likely that quantitative antigen expression or a bioassay could be used to measure potency. If both are determined to be acceptable, the use of quantitative antigen expression could be considered for routine lot release, while the bioassay could be reserved for use as one of the elements in establishing comparability when manufacturing changes are being considered after approval.

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

    Hayashi, T.; Nakamura, H.; Kawamura, Y.

    JAEA (Japan Atomic Energy Agency) manages 2 tritium handling laboratories: Tritium Processing Laboratory (TPL) in Tokai and DEMO-RD building in Rokkasho. TPL has been accumulating a gram level tritium safety handling experiences without any accidental tritium release to the environment for more than 25 years. Recently, our activities have focused on 3 categories, as follows. First, the development of a detritiation system for ITER. This task is the demonstration test of a wet Scrubber Column (SC) as a pilot scale (a few hundreds m{sup 3}/h of processing capacity). Secondly, DEMO-RD tasks are focused on investigating the general issues required formore » DEMO-RD design, such as structural materials like RAFM (Reduced Activity Ferritic/Martensitic steels) and SiC/SiC, functional materials like tritium breeder and neutron multiplier, and tritium. For the last 4 years, we have spent a lot of time and means to the construction of the DEMO-RD facility and to its licensing, so we have just started the actual research program with tritium and other radioisotopes. This tritium task includes tritium accountancy, tritium basic safety research such as tritium interactions with various materials, which will be used for DEMO-RD and durability. The third category is the recovery work from the Great East Japan earthquake (2011 earthquake). It is worth noting that despite the high magnitude of the earthquake, TPL was able to confine tritium properly without any accidental tritium release.« less

  3. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product.

    PubMed

    Zaman, K; Naser, Abu Mohd; Power, Maureen; Yaich, Mansour; Zhang, Lei; Ginsburg, Amy Sarah; Luby, Stephen P; Rahman, Mahmudur; Hills, Susan; Bhardwaj, Mukesh; Flores, Jorge

    2014-10-21

    We conducted a four-arm, double-blind, randomized controlled trial among 818 Bangladeshi infants between 10 and 12 months of age to establish equivalence among three lots of live attenuated SA 14-14-2 JE vaccine manufactured by the China National Biotec Group's Chengdu Institute of Biological Products (CDIBP) in a new Good Manufacturing Practice (GMP) facility and to evaluate non-inferiority of the product with a lot of the same vaccine manufactured in CDIBP's original facility. The study took place in two sites in Bangladesh, rural Matlab and Mirpur in urban Dhaka. We collected pre-vaccination (Day 0) and post-vaccination Day 28 (-4 to +14 days) blood samples to assess neutralizing anti-JE virus antibody titers in serum by plaque reduction neutralization tests (PRNT). Seroprotection following vaccination was defined as a PRNT titer ≥1:10 at Day 28 in participants non-immune at baseline. Follow-up for reactogenicity and safety was conducted through home visits at Day 7 and monitoring for serious adverse events through Day 28. Seroprotection rates ranged from 80.2% to 86.3% for all four lots of vaccine. Equivalence of the seroprotection rates between pairs of vaccine lots produced in the new GMP facility was satisfied at the pre-specified 10% margin of the 95% confidence interval (CI) for two of the three pairwise comparisons, but not for the third (-4.3% observed difference with 95% CI of -11.9 to 3.3%). Nevertheless, the aggregate seroprotection rate for all three vaccine lots manufactured in the GMP facility was calculated and found to be within the non-inferiority margin (within 10%) to the vaccine lot produced in the original facility. All four lots of vaccine were safe and well tolerated. These study results should facilitate the use of SA 14-14-2 JE vaccine as a routine component of immunization programs in Asian countries. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials.

    PubMed

    Vesikari, Timo; Esposito, Susanna; Prymula, Roman; Ypma, Ellen; Kohl, Igor; Toneatto, Daniela; Dull, Peter; Kimura, Alan

    2013-03-09

    Meningococcal serogroup B disease disproportionately affects infants. We assessed lot-to-lot consistency, safety and immunogenicity, and the effect of concomitant vaccination on responses to routine vaccines of an investigational multicomponent vaccine (4CMenB) in this population. We did primary and booster phase 3 studies between March 31, 2008, and Aug 16, 2010, in 70 sites in Europe. We used two series of sponsor-supplied, computer-generated randomisation envelopes to allocate healthy 2 month-old infants to receive routine vaccinations (diphtheria-tetanus-acellular pertussis, inactivated poliovirus, hepatitis B plus Haemophilus influenzae type b, and seven-valent pneumococcal vaccine) at 2, 4, and 6 months of age alone, or concomitantly with 4CMenB or serogroup C conjugate vaccine (MenC) in: 1) an open-label, lot-to-lot immunogenicity and safety substudy of three 4CMenB lots compared with routine vaccines alone (1:1:1:1, block size eight); or 2) an observer-blind, lot-to-lot safety substudy of three 4CMenB lots compared with MenC (1:1:1:3, block size six). At 12 months, 4CMenB-primed children from either substudy were randomised (1:1, block size two) to receive 4CMenB booster, with or without measles-mumps-rubella-varicella (MMRV) vaccine. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroup B test strains, and on randomly selected subsets of serum samples for routine vaccines; laboratory personnel were masked to assignment. The first coprimary outcome was lot-to-lot consistency (hSBA geometric mean ratio of all lots between 0·5 and 2·0), and the second was an immune response (hSBA titre ≥5) for each of the three strains. The primary outcome for the booster study was immune response to booster dose. Immunogenicity data for 4CMenB were for the modified intention-to-treat population, including all infants from the open-label substudy who provided serum samples. The safety population included all participants who contributed safety data after at least one dose of study vaccine. These trials are registered with ClinicalTrials.gov, numbers NCT00657709 and NCT00847145. We enrolled 2627 infants in the open-label phase, 1003 in the observer-blind phase, and 1555 in the booster study. Lot-to-lot consistency was shown for the three 4CMenB lots, with the lowest 95% lower confidence limit being 0·74 and the highest upper limit being 1·33. Of 1181–1184 infants tested 1 month after three 4CMenB doses (all lots pooled), 100% (95% CI 99–100) had hSBA titres of 5 or more against strains selective for factor H binding protein and neisserial adhesin A, and 84% (82–86) for New Zealand outer-membrane vesicle. In a subset (n=100), 84% (75–91) of infants had hSBA titres of 5 or more against neisseria heparin binding antigen. At 12 months of age, waning titres were boosted by a fourth dose, such that 95–100% of children had hSBA titres of 5 or more for all antigens, with or without concomitant MMRV. Immune responses to routine vaccines were much the same with or without concomitant 4CMenB, but concomitant vaccination was associated with increased reactogenicity. 77% (1912 of 2478) of infants had fever of 38·5°C or higher after any 4CMenB dose, compared with 45% (295 of 659) after routine vaccines alone and 47% (228 of 490) with MenC, but only two febrile seizures were deemed probably related to 4CMenB. 4CMenB is immunogenic in infants and children aged 12 months with no clinically relevant interference with routine vaccines, but increases reactogenicity when administered concomitantly with routine vaccines. This breakthrough vaccine offers an innovative solution to the major remaining cause of bacterial meningitis in infant and toddlers. Novartis Vaccines and Diagnostics.

  5. Zn(2+) release behavior and surface characteristics of Zn/LDPE nanocomposites and ZnO/LDPE nanocomposites in simulated uterine solution.

    PubMed

    Yang, Zhihong; Xie, Changsheng; Xia, Xianping; Cai, Shuizhou

    2008-11-01

    To decrease the side effects of the existing copper-bearing intrauterine devices, the zinc/low-density polyethylene (Zn/LDPE) nanocomposite and zinc-oxide/low-density polyethylene (ZnO/LDPE) nanocomposite have been developed in our research for intrauterine devices (IUDs). In this study, the influences of preparation methods of nanocomposites and particle sizes of zinc and zinc oxide on Zn(2+) release from composites incubated in simulated uterine solution were investigated. All release profiles are biphasic: an initial rapid release phase is followed by a near zero-order release period. Zn(2+) release rates of nanocomposites prepared by compressing moulding are higher than those of the nanocomposites prepared by hot-melt extrusing. Compared with Zn(2+) release from the microcomposites, the release profiles of the nanocomposites exhibit a sharp decrease in Zn(2+) release rate in the first 18 days, an early onset of the zero-order release period and a high release rate of Zn(2+) at the later stage. The microstructure of the Zn/LDPE sample and the ZnO/LDPE sample after being incubated for 200 days was characterized by SEM, XRD and EDX techniques. The results show that the dissolution depth of ZnO/LDPE nanocomposite is about 60 mum. Lots of pores were formed on the surface of the Zn/LDPE sample and ZnO/LDPE sample, indicating that these pores can provide channels for the dissolution of nanoparticles in the matrix. The undesirable deposits that are composed of ZnO are only detected on the surface of Zn/LDPE nanocomposite, which may increase the risk of side effects associated with IUDs. It can be expected that ZnO/LDPE nanocomposite is more suitable for IUDs than Zn/LDPE nanocomposite.

  6. Preparation of Chemical Compounds for the U.S. Army Drug Development Program

    DTIC Science & Technology

    1990-09-14

    Aldrich, Lot No. ML0824ML Johns Manville , no Lot No. J.T. Baker, Lot No. A42837 Fisher Scientific Lot No. 885835-60 Ashland, Lot No. 0701768E...Aldrich, Lot No. 03905ET Moore-Tec, No Lot No. Lot Nos. KAPM and KDPA Aaper, Lot Nos. R9529, 89D19-R, 89K06 Kodak, Lot No. 807198C Johns Manville , Lot...89-K06-R and 90-A124-R Fisher, Lot Nos. 881166-60, 895184-36 and 894961-36 Kodak, Lot NO. 807198C Johns Manville Lot Nos. G5P34633 and 3P-291

  7. How can water quality be improved when the urban waste water directive has been fulfilled? A case study of the Lot river (France).

    PubMed

    Garnier, Josette; Ramarson, Antsiva; Thieu, Vincent; Némery, Julien; Théry, Sylvain; Billen, Gilles; Coynel, Alexandra

    2018-04-01

    The Lot river, a major tributary of the downstream Garonne river, the largest river on the Northern side of the Pyrenees Mountains, was intensively studied in the 1970s. A pioneering program called "Lot Rivière Claire" provided a diagnosis of water quality at the scale of the whole watershed and proposed an ambitious program to manage nutrient pollution and eutrophication largely caused by urban wastewater releases. Later on, the implementation of European directives from 1991 to 2000 resulted in the nearly complete treatment of point sources of pollution in spite of a doubling of the basin's population. At the outlet of the Lot river, ammonium and phosphate contamination which respectively peaked to 1 mg N-NH 4 L -1 and 0.3 mg P-PO 4 L -1 in the 1980s returned to much lower levels in recent years (0.06 mg N-NH 4 L -1 and 0.02 mg P-PO 4 L -1 ), a reduction by a factor 15. However, during this time, nitrate contamination has regularly increased since the 1980s, from 0.5 to 1.2 mg N-NO 3 L -1 in average, owing to the intensification of agriculture and livestock farming. Application of the Riverstrahler model allowed us to simulate the water quality of the Lot drainage network for the 2002-2014 period. We showed that, with respect to algal requirements, phosphorus and silica are well balanced, but nitrogen remains largely in excess over phosphorus and silica. This imbalance can be problematic for the ecological status of the water bodies. Using the model, for simulating various scenarios of watershed management, we showed that improvement of urban wastewater treatment would not result in any significant change in the river's water quality. Even though arable land occupies a rather limited fraction of the watershed area, only the adoption of better farming practices or more radical changes in the agro-food system could reverse the trend of increasing nitrate contamination.

  8. Development of acceptance criteria for batches of silane primer for external tank thermal protection system bonding applications

    NASA Technical Reports Server (NTRS)

    Mikes, F.

    1984-01-01

    Silane primers for use as thermal protection on external tanks were subjected to various analytic techniques to determine the most effective testing method for silane lot evaluation. The analytic methods included high performance liquid chromatography, gas chromatography, thermogravimetry (TGA), and fourier transform infrared spectroscopy (FTIR). It is suggested that FTIR be used as the method for silane lot evaluation. Chromatograms, TGA profiles, bar graphs showing IR absorbances, and FTIR spectra are presented.

  9. Shock Tunnel Tests of Arched Wall Panels

    DTIC Science & Technology

    1974-07-01

    NCNOR « LOT S/W ETC lOLT ANCMO« NOO IEE DETAIL* / tELOW , , METAL TIE* / I*" 0. C. VERT -HAiONRT «ALL...same as shown in Table 2-1. 2-6 m^ Table 2-1 SPACING OF WALL TIES i Moiimuffl Dittonc« Moiimum Spocing ef No 4 Gogt Wall Typ. I K«twHn Lot ...sides free to move), the flexural cracking occurs at the top, botton \\ and center, and the resistance to motion, induced by ’ wedging"or geometric

  10. Modulation of electrostatic interactions to improve controlled drug delivery from nanogels.

    PubMed

    Mauri, Emanuele; Chincarini, Giulia M F; Rigamonti, Riccardo; Magagnin, Luca; Sacchetti, Alessandro; Rossi, Filippo

    2017-03-01

    The synthesis of nanogels as devices capable to maintain the drug level within a desired range for a long and sustained period of time is a leading strategy in controlled drug delivery. However, with respect to the good results obtained with antibodies and peptides there are a lot of problems related to the quick and uncontrolled diffusion of small hydrophilic molecules through polymeric network pores. For these reasons research community is pointing toward the use of click strategies to reduce release rates of the linked drugs to the polymer chains. Here we propose an alternative method that considers the electrostatic interactions between polymeric chains and drugs to tune the release kinetics from nanogel network. The main advantage of these systems lies in the fact that the carried drugs are not modified and no chemical reactions take place during their loading and release. In this work we synthesized PEG-PEI based nanogels with different protonation degrees and the release kinetics with charged and uncharged drug mimetics (sodium fluorescein, SF, and rhodamine B, RhB) were studied. Moreover, also the effect of counterion used to induce protonation was taken into account in order to build a tunable drug delivery system able to provide multiple release rates with the same device. Copyright © 2016 Elsevier B.V. All rights reserved.

  11. Paradigm Diagnostics Salmonella Indicator Broth (PDX-SIB) for detection of Salmonella on selected environmental surfaces.

    PubMed

    Olstein, Alan; Griffith, Leena; Feirtag, Joellen; Pearson, Nicole

    2013-01-01

    The Paradigm Diagnostics Salmonella Indicator Broth (PDX-SIB) is intended as a single-step selective enrichment indicator broth to be used as a simple screening test for the presence of Salmonella spp. in environmental samples. This method permits the end user to avoid multistep sample processing to identify presumptively positive samples, as exemplified by standard U.S. reference methods. PDX-SIB permits the outgrowth of Salmonella while inhibiting the growth of competitive Gram-negative and -positive microflora. Growth of Salmonella-positive cultures results in a visual color change of the medium from purple to yellow when the sample is grown at 37 +/- 1 degree C. Performance of PDX-SIB has been evaluated in five different categories: inclusivity-exclusivity, methods comparison, ruggedness, lot-to-lot variability, and shelf stability. The inclusivity panel included 100 different Salmonella serovars, 98 of which were SIB-positive during the 30 to 48 h incubation period. The exclusivity panel included 33 different non-Salmonella microorganisms, 31 of which were SIB-negative during the incubation period. Methods comparison studies included four different surfaces: S. Newport on plastic, S. Anatum on sealed concrete, S. Abaetetuba on ceramic tile, and S. Typhimurium in the presence of 1 log excess of Citrobacter freundii. Results of the methods comparison studies demonstrated no statistical difference between the SIB method and the U.S. Food and Drug Administration-Bacteriological Analytical Manual reference method, as measured by the Mantel-Haenszel Chi-square test. Ruggedness studies demonstrated little variation in test results when SIB incubation temperatures were varied over a 34-40 degrees C range. Lot-to-lot consistency results suggest no detectable differences in manufactured goods using two reference Salmonella serovars and one non-Salmonella microorganism.

  12. BCI`s RBSM test methods: Eight years in the making

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

    NONE

    1993-03-01

    RBSM stands for recombinant battery separator mat. This is the acronym chosen after a lot of debate during eight years of committee work to develop test methods to characterize separators which are used in valve regulated lead acid batteries. This paper discusses the test methods.

  13. Samsung Salmonella Detection Kit. AOAC Performance Tested Method(SM) 021203.

    PubMed

    Li, Jun; Cheung, Win Den; Opdyke, Jason; Harvey, John; Chong, Songchun; Moon, Cheol Gon

    2012-01-01

    Salmonella, one of the most common causes of foodborne illness, is a significant public health concern worldwide. There is a need in the food industry for methods that are simple, rapid, and sensitive for the detection of foodborne pathogens. In this study, the Samsung Salmonella Detection Kit, a real-time PCR assay for the detection of Salmonella, was evaluated according to the current AOAC guidelines. The validation consisted of lot-to-lot consistency, stability, robustness, and inclusivity/exclusivity studies, as well as a method comparison of 10 different food matrixes. In the validation, the Samsung Salmonella Detection Kit was used in conjunction with the Applied Biosystems StepOnePlus PCR system and the Samsung Food Testing Software for the detection of Salmonella species. The performance of the assays was compared to the U.S. Department of Agriculture/Food Safety and Inspection Service-Microbiology Laboratory Guidebook (USDA/FSIS-MLG) 4.05: Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Catfish and the and U.S. Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Chapter 5 Salmonella reference methods. The validation was conducted using an unpaired study design for detection of Salmonella spp. in raw ground beef, raw pork, raw ground pork, raw chicken wings, raw salmon, alfalfa sprouts, pasteurized orange juice, peanut butter, pasteurized whole milk, and shell eggs. The Samsung Salmonella Detection Kit demonstrated lot-to-lot consistency among three independent lots as well as ruggedness with minor modifications to changes in enrichment incubation time, enrichment incubation temperature, and DNA sample volume for PCR reaction. Stability was observed for 13 months at -20 degrees C and 3 months at 5 degrees C. For the inclusivity/exclusivity study, the Samsung Salmonella Detection Kit correctly identified 147 Salmonella species isolates out of 147 isolates tested from each of three different enrichment broths (a total of 441 isolates detected), and correctly excluded all 31 nontarget strains analyzed. For the method comparison, statistical analysis was conducted according to the Mantel-Haenszel Chi-square formula for unpaired test portions, and there was no significant difference in the number of positive samples detected between the Samsung Salmonella Detection Kit and the USDA/FSIS-MLG and FDA/BAM reference methods for all 10 food matrixes.

  14. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  15. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  16. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  17. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  18. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  19. Teaching away from Test

    ERIC Educational Resources Information Center

    Kloos, Beth

    2006-01-01

    The focus in education in the past 10 years has been on proficiency tests. Every educator in the country is worried about providing opportunities for our students to pass the proficiency tests. Teachers try lots of things--open-ended questions, multi-step questions, essay questions--all in an attempt to get our students ready for The Test. But…

  20. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  1. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  2. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  3. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  4. 46 CFR 160.040-5 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

  5. 46 CFR 160.024-4 - Approval and production tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... every ten lots of signals produced, except that the number of technical tests must be at least one but... satisfactorily when shot from a pistol of the type described in subpart 160.028. The parachute and pyrotechnic...

  6. 46 CFR 160.024-4 - Approval and production tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... every ten lots of signals produced, except that the number of technical tests must be at least one but... satisfactorily when shot from a pistol of the type described in subpart 160.028. The parachute and pyrotechnic...

  7. Superconducting magnet

    NASA Technical Reports Server (NTRS)

    1985-01-01

    Extensive computer based engineering design effort resulted in optimization of a superconducting magnet design with an average bulk current density of approximately 12KA/cm(2). Twisted, stranded 0.0045 inch diameter NbTi superconductor in a copper matrix was selected. Winding the coil from this bundle facilitated uniform winding of the small diameter wire. Test coils were wound using a first lot of the wire. The actual packing density was measured from these. Interwinding voltage break down tests on the test coils indicated the need for adjustment of the wire insulation on the lot of wire subsequently ordered for construction of the delivered superconducting magnet. Using the actual packing densities from the test coils, a final magnet design, with the required enhancement and field profile, was generated. All mechanical and thermal design parameters were then also fixed. The superconducting magnet was then fabricated and tested. The first test was made with the magnet immersed in liquid helium at 4.2K. The second test was conducted at 2K in vacuum. In the latter test, the magnet was conduction cooled from the mounting flange end.

  8. Contribution by Macroalgal Mats to Primary Production of a Shallow Embayment Under High and Low Nitrogen-loading Rates

    NASA Astrophysics Data System (ADS)

    Peckol, P.; Rivers, J. S.

    1996-09-01

    The limits on primary production in areas undergoing eutrophication may be set by indirect effects of nitrogen loading, i.e. decreasing irradiances, associated with proliferating opportunistic algae. Using in situphoton flux density (PFD) availability estimates within unattached algal mats and photosynthetic parameters determined from photosynthesis vs.irradiance (P vs.I) curves generated for the dominant components of mat assemblages, Cladophora vagabundaand Gracilaria tikvahiae, seasonal net mat production rate for estuaries (Waquoit Bay, Massachusetts, U.S.A.) receiving high (Childs River) and low (Sage Lot Pond) N-loading rates were determined. Although abundance of C. vagabundawas 2× greater than G. tikvahiae, the former species contributed only about 50% of total mat productivity, due largely to rapid light attenuation within the dense algal mat. While mat production was low and similar at both sides during winter (≈0·35 g C m -2 day -1), for other seasons, the net mat daytime productivity at Childs River, the N-loaded site, was 2·5× higher than rates determined for Sage Lot Pond. Although annual net daytime production at Childs River (1094 g C m -2 year -1) was comparable to estimates for other algal mat assemblages in eutrophic systems, primary production of the Waquoit Bay system was found to become self-limiting as available PFD controls maximum productivity. In photosynthetically inactive portions of the algal mat, carbon release was estimated from tissue-loss measurements at 0·14 g C m -2 day -1for C. vagabundaand 0·05 g C m -2 day -1for G. tikvahiae. Annual in situC release of 73 g C m -2is ≈20% of annual net mat production (fixed carbon not respired by algae) in this embayment. Although both estuaries showed net autotrophy year round (Pg:R>1), the high metabolic cost of a large, inactive mat resulted in lower Pg:R ratios at Childs Rivers than at Sage Lot Pond, particularly during the summer period of peak production. Thus, it is predicted that the Waquoit Bay system will experience an overall decline in Pg:R ratios and consequent increase in anoxic events as eutrophication continues.

  9. 21 CFR 680.3 - Tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Tests. 680.3 Section 680.3 Food and Drugs FOOD AND... FOR MISCELLANEOUS PRODUCTS § 680.3 Tests. (a) Identity. When a specific identity test meeting the...) Safety. A safety test shall be performed on the contents of a final container of each lot of each product...

  10. 21 CFR 680.3 - Tests.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Tests. 680.3 Section 680.3 Food and Drugs FOOD AND... FOR MISCELLANEOUS PRODUCTS § 680.3 Tests. (a) Identity. When a specific identity test meeting the...) Safety. A safety test shall be performed on the contents of a final container of each lot of each product...

  11. 21 CFR 680.3 - Tests.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Tests. 680.3 Section 680.3 Food and Drugs FOOD AND... FOR MISCELLANEOUS PRODUCTS § 680.3 Tests. (a) Identity. When a specific identity test meeting the...) Safety. A safety test shall be performed on the contents of a final container of each lot of each product...

  12. 21 CFR 680.3 - Tests.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Tests. 680.3 Section 680.3 Food and Drugs FOOD AND... FOR MISCELLANEOUS PRODUCTS § 680.3 Tests. (a) Identity. When a specific identity test meeting the...) Safety. A safety test shall be performed on the contents of a final container of each lot of each product...

  13. 21 CFR 680.3 - Tests.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Tests. 680.3 Section 680.3 Food and Drugs FOOD AND... FOR MISCELLANEOUS PRODUCTS § 680.3 Tests. (a) Identity. When a specific identity test meeting the...) Safety. A safety test shall be performed on the contents of a final container of each lot of each product...

  14. JPL Administration Building

    NASA Image and Video Library

    2016-10-27

    This archival image was released as part of a gallery comparing JPL's past and present, commemorating the 80th anniversary of NASA's Jet Propulsion Laboratory on Oct. 31, 2016. The Administration Building of NASA's Jet Propulsion Laboratory (Building 180) is pictured in January 1965. What appears as a parking lot in this photograph later becomes "The Mall", a landscaped open-air gathering place. A small security control post can be seen at the left of the 1965 image. And Building 167, one of the lab's cafeterias, is on the right. http://photojournal.jpl.nasa.gov/catalog/PIA21121

  15. Transducer Workshop (17th) Held in San Diego, California on June 22-24, 1993

    DTIC Science & Technology

    1993-06-01

    weight in a drop tower, such as the primer tester shown in figure 1. The calibration procedure must be repeated for each lot of copper inserts, and small...force vs. time curve (i.e impulse = area unxer the curve). The FPyF can be used in the primer tester (shown in figure 1) as well as in a weapon...microphones. Plstonphone Output 124 dB, 250 Hz DEAD WEIGHT TESTIER USED AS A PRESSURE RELEASE CALIBRATOR The dead weight tester is designed and most

  16. Surface sampling for endotoxin assessment using electrostatic wiping cloths.

    PubMed

    Thorne, Peter S; Metwali, Nervana; Avol, Ed; McConnell, Rob S

    2005-07-01

    Much of the cost of exposure assessment for studies of residential cohorts is in scheduling and travel time for field staff. One way to reduce costs is to simplify methods such that subjects can sample their own residence. Analysis of settled dust is being widely used for assessment of exposures to allergens, lead and pesticides and can also be used for endotoxins. While vacuum sampling is the most common surface sampling method, wipe sampling has the advantage that it can be readily performed by the resident when convenient and samples can then be mailed to researchers. Thus, we evaluated the feasibility of wipe sampling for endotoxin environmental assessment using electrostatic wipes with or without the use of disposable examination gloves. Multiple lots of six types of commercial wipes and eight types of gloves were extracted and analyzed for endotoxin content using the kinetic chromogenic Limulus amebocyte lysate assay. Wipes were compared across brands, between lots, within lots, between pairs depending on proximity to cardboard packaging, and in wipe tests with or without gloves. Collected dust samples of known concentration were also tested in spiking assays for endotoxin recovery. The most striking finding was the high variability of endotoxin contamination of both wipes and gloves across brands and between various lots. The content of endotoxin in unused gloves ranged from <1.5 to 5810 endotoxin units (EU). The range for unused wipes was 3.6-87.8 EU. Surfaces of equal loading and area were sampled using three types of cloths that had low initial endotoxin contamination. The cloths were very good at collecting dust and endotoxin could be assayed from aqueous extracts of the wipes. Samples collected using cloths with bare washed hands yielded higher endotoxin loading per mass of collected dust versus samples collected wearing endotoxin-free gloves. This demonstrated additional endotoxin loading from the subject's hand. This study shows that wipe sampling while wearing medical gloves can be an effective method for collecting and assessing endotoxin on surfaces, so long as each lot of wipes and gloves have been tested and determined to be low in endotoxin.

  17. Multicenter evaluation of the Bayer Immuno I CA 15-3 assay.

    PubMed

    Cheli, C D; Morris, D L; Kish, L; Goldblatt, J; Neaman, I; Allard, W J; Yeung, K K; Wu, A H; Moore, R; Chan, D W; Fritsche, H A; Schwartz, M K; Very, D L

    1998-04-01

    We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1 CA 15-3 assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV < or = 4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT BR 27.29 and Centocor CA 15-3 RIAs (r > or = 0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.

  18. 7 CFR 29.426 - Collection of pesticide test samples.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Collection of pesticide test samples. 29.426 Section... CONTAINER REGULATIONS TOBACCO INSPECTION Regulations Miscellaneous § 29.426 Collection of pesticide test samples. Any lot of tobacco not certified by the importer as being free of prohibited pesticide residues...

  19. 7 CFR 29.426 - Collection of pesticide test samples.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Collection of pesticide test samples. 29.426 Section... CONTAINER REGULATIONS TOBACCO INSPECTION Regulations Miscellaneous § 29.426 Collection of pesticide test samples. Any lot of tobacco not certified by the importer as being free of prohibited pesticide residues...

  20. 7 CFR 29.426 - Collection of pesticide test samples.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Collection of pesticide test samples. 29.426 Section... CONTAINER REGULATIONS TOBACCO INSPECTION Regulations Miscellaneous § 29.426 Collection of pesticide test samples. Any lot of tobacco not certified by the importer as being free of prohibited pesticide residues...

  1. 7 CFR 29.426 - Collection of pesticide test samples.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Collection of pesticide test samples. 29.426 Section... CONTAINER REGULATIONS TOBACCO INSPECTION Regulations Miscellaneous § 29.426 Collection of pesticide test samples. Any lot of tobacco not certified by the importer as being free of prohibited pesticide residues...

  2. 7 CFR 29.426 - Collection of pesticide test samples.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Collection of pesticide test samples. 29.426 Section... CONTAINER REGULATIONS TOBACCO INSPECTION Regulations Miscellaneous § 29.426 Collection of pesticide test samples. Any lot of tobacco not certified by the importer as being free of prohibited pesticide residues...

  3. 27 CFR 19.453 - Testing of denaturants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Denaturation § 19.453 Testing of denaturants. (a) Testing. Proprietors shall ensure that the materials they... shall be taken in such manner as to represent a true composite of the total lot being sampled. When... part 21, the proprietor shall not use the material unless he treats or manipulates the denaturant to...

  4. Evaluation of Hematocrit Influence on Self-Monitoring of Blood Glucose Based on ISO 15197:2013: Comparison of a Novel System With Five Systems With Different Hematocrit Ranges.

    PubMed

    Hattemer, Andrew; Wardat, Sami

    2018-03-01

    ISO 15197:2013 recommends testing procedures and acceptance criteria for the evaluation of influence quantities such as hematocrit on measurement results with systems for self-monitoring of blood glucose (SMBG). In this study, hematocrit influence was evaluated for a novel SMBG system (system A) and five other systems with different hematocrit ranges based on ISO 15197:2013. Test procedures were performed with one test strip lot for each system. Each system was tested within the hematocrit range indicated in the manufacturer's labeling (system A: 10-65%, B: 15-65%, C: 20-60%, D: 35-60%, E: 30-60%, F: 30-55%). According to ISO 15197:2013, clause 6.4.2, venous blood samples were used for the evaluation of hematocrit influence. The evaluation was performed for three glucose concentration categories (30-50 mg/dL, 96-144 mg/dL, and 280-420 mg/dL). For each glucose concentration category, at least five different hematocrit levels were investigated. The novel system A and systems B, E, and F complied with the tested lot with the defined criteria and showed ≤10 mg/dL and ≤10% difference between the test sample and the respective control sample with a hematocrit value of 42% ± 2% for BG concentrations <100 mg/dL and ≥100 mg/dL, respectively. Two systems showed >10% difference at glucose concentrations ≥100 mg/dL. Remarkable hematocrit influence within the labeled hematocrit range was obtained in two systems with the tested reagent system lot. Adequate SMBG systems should be carefully chosen by patients and their health care professionals, particularly for patients with increased and decreased hematocrit values.

  5. 77 FR 53906 - Notice of Proposed Withdrawal and Opportunity for Public Meeting; California

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    ...\\; Sec. 32, lots 4 and 5; Sec. 34, lot 4. T. 13 N., R. 10 E., Sec. 2, lot 1, and lots 3 to 15, inclusive; Sec. 9, lots 8, 12, and 13, and SW\\1/4\\NE\\1/4\\; Sec. 10, lots 1 to 10, inclusive, E\\1/2\\NE\\1/4\\, E\\1/2..., inclusive, S\\1/2\\ of lot 5, S\\1/2\\ of lot 8, lots 11 and 13; Sec. 19, lot 24; Sec. 20, lots 1, 2, 3, and 8...

  6. Evaluation of scanning 2D barcoded vaccines to improve data accuracy of vaccines administered.

    PubMed

    Daily, Ashley; Kennedy, Erin D; Fierro, Leslie A; Reed, Jenica Huddleston; Greene, Michael; Williams, Warren W; Evanson, Heather V; Cox, Regina; Koeppl, Patrick; Gerlach, Ken

    2016-11-11

    Accurately recording vaccine lot number, expiration date, and product identifiers, in patient records is an important step in improving supply chain management and patient safety in the event of a recall. These data are being encoded on two-dimensional (2D) barcodes on most vaccine vials and syringes. Using electronic vaccine administration records, we evaluated the accuracy of lot number and expiration date entered using 2D barcode scanning compared to traditional manual or drop-down list entry methods. We analyzed 128,573 electronic records of vaccines administered at 32 facilities. We compared the accuracy of records entered using 2D barcode scanning with those entered using traditional methods using chi-square tests and multilevel logistic regression. When 2D barcodes were scanned, lot number data accuracy was 1.8 percentage points higher (94.3-96.1%, P<0.001) and expiration date data accuracy was 11 percentage points higher (84.8-95.8%, P<0.001) compared with traditional methods. In multivariate analysis, lot number was more likely to be accurate (aOR=1.75; 99% CI, 1.57-1.96) as was expiration date (aOR=2.39; 99% CI, 2.12-2.68). When controlling for scanning and other factors, manufacturer, month vaccine was administered, and vaccine type were associated with variation in accuracy for both lot number and expiration date. Two-dimensional barcode scanning shows promise for improving data accuracy of vaccine lot number and expiration date records. Adapting systems to further integrate with 2D barcoding could help increase adoption of 2D barcode scanning technology. Published by Elsevier Ltd.

  7. Current Good Manufacturing Practice Production of an Oncolytic Recombinant Vesicular Stomatitis Viral Vector for Cancer Treatment

    PubMed Central

    Meseck, M.; Derecho, I.; Lopez, P.; Knoblauch, C.; McMahon, R.; Anderson, J.; Dunphy, N.; Quezada, V.; Khan, R.; Huang, P.; Dang, W.; Luo, M.; Hsu, D.; Woo, S.L.C.; Couture, L.

    2011-01-01

    Abstract Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 109 plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 1010 PFU/ml (total yield, 1 × 1013 PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC. PMID:21083425

  8. Current good manufacturing practice production of an oncolytic recombinant vesicular stomatitis viral vector for cancer treatment.

    PubMed

    Ausubel, L J; Meseck, M; Derecho, I; Lopez, P; Knoblauch, C; McMahon, R; Anderson, J; Dunphy, N; Quezada, V; Khan, R; Huang, P; Dang, W; Luo, M; Hsu, D; Woo, S L C; Couture, L

    2011-04-01

    Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 10(9) plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 10(10) PFU/ml (total yield, 1 × 10(13) PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC.

  9. Distributions of typical contaminant species in urban short-term storm runoff and their fates during rain events: a case of Xiamen City.

    PubMed

    Wei, Qunshan; Zhu, Gefu; Wu, Peng; Cui, Li; Zhang, Kaisong; Zhou, Jingjing; Zhang, Wenru

    2010-01-01

    The pollutants in urban storm runoff, which lead to an non-point source contamination of water environment around cities, are of great concerns. The distributions of typical contaminants and the variations of their species in short term storm runoff from different land surfaces in Xiamen City were investigated. The concentrations of various contaminants, including organic matter, nutrients (i.e., N and P) and heavy metals, were significantly higher in parking lot and road runoff than those in roof and lawn runoff. The early runoff samples from traffic road and parking lot contained much high total nitrogen (TN 6-19 mg/L) and total phosphorus (TP 1-3 mg/L). A large proportion (around 60%) of TN existed as total dissolved nitrogen (TDN) species in most runoff. The percentage of TDN and the percentage of total dissolved phosphorus remained relatively stable during the rain events and did not decrease as dramatically as TN and TP. In addition, only parking lot and road runoff were contaminated by heavy metals, and both Pb (25-120 microg/L) and Zn (0.1-1.2 mg/L) were major heavy metals contaminating both runoff. Soluble Pb and Zn were predominantly existed as labile complex species (50%-99%), which may be adsorbed onto the surfaces of suspended particles and could be easily released out when pH decreased. This would have the great impact to the environment.

  10. The processing and collaborative assay of a reference endotoxin.

    PubMed

    Hochstein, H D; Mills, D F; Outschoorn, A S; Rastogi, S C

    1983-10-01

    A preparation of Escherichia coli bacterial endotoxin, the latest of successive lots drawn from bulk material which has been studied in laboratory tests and in animals and humans for suitability as a reference endotoxin, has been filled and lyophilized in a large number of vials. Details of its characterization, including stability studies, are given. A collaborative assay was conducted by 14 laboratories using gelation end-points with Limulus amebocyte lysates. Approximate continuity of the unit of potency with the existing national unit was achieved. The lot was made from the single final bulk but had to be freeze-dried in five sublimators. An assessment was therefore made for possible heterogeneity. The results indicate that the lot can be used as a large homogeneous quantity. The advantages of using it widely as a standard for endotoxins are discussed.

  11. Explorations in Statistics: Hypothesis Tests and P Values

    ERIC Educational Resources Information Center

    Curran-Everett, Douglas

    2009-01-01

    Learning about statistics is a lot like learning about science: the learning is more meaningful if you can actively explore. This second installment of "Explorations in Statistics" delves into test statistics and P values, two concepts fundamental to the test of a scientific null hypothesis. The essence of a test statistic is that it compares what…

  12. Scheduling viability tests for seeds in long-term storage based on a Bayesian Multi-Level Model

    USDA-ARS?s Scientific Manuscript database

    Genebank managers conduct viability tests on stored seeds so they can replace lots that have viability near a critical threshold, such as 50 or 85% germination. Currently, these tests are typically scheduled at uniform intervals; testing every 5 years is common. A manager needs to balance the cost...

  13. Real-time PCR-based infectivity assay for the titration of turkey hemorrhagic enteritis virus, an adenovirus, in live vaccines.

    PubMed

    Mahsoub, Hassan M; Evans, Nicholas P; Beach, Nathan M; Yuan, Lijuan; Zimmerman, Kurt; Pierson, Frank W

    2017-01-01

    The current in vitro titration method for turkey hemorrhagic enteritis virus (THEV) is the end-point dilution assay (EPD) in suspension cell culture (CC). This assay is subjective and results in high variability among vaccine lots. In this study, a new in vitro infectivity method combining a SYBR Green I-based qPCR assay and CC was developed for titration of live hemorrhagic enteritis (HE) CC vaccines. The qPCR was used to determine the virus genome copy number (vGCN) of the internalized virus particles following inoculation of susceptible RP19 cells with 1 vaccine label dose. The measured vGCN represents the number of infectious viral particles (IVP) per 1 dose. This method was used to compare 9 vaccine lots from 3 companies in the United States. Significant lot-to-lot variations within the same company and among the various companies were found in genomic and qPCR-based infectious titer per label dose. A positive linear relationship was found between qPCR infectious titer and genomic titer. Further, considerable variations in CCID 50 titers were found among tested vaccine lots, indicating the high variability of the current titration methods. The new method provides an alternative to classical titration assays and can help reduce variation among HE vaccine products. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. 40 CFR 792.3 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED... following terms shall have the meanings specified: Batch means a specific quantity or lot of a test, control... substance is combined for administration to a test system. Control substance means any chemical substance or...

  15. 40 CFR 792.3 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED... following terms shall have the meanings specified: Batch means a specific quantity or lot of a test, control... substance is combined for administration to a test system. Control substance means any chemical substance or...

  16. 40 CFR 792.3 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED... following terms shall have the meanings specified: Batch means a specific quantity or lot of a test, control... substance is combined for administration to a test system. Control substance means any chemical substance or...

  17. 40 CFR 792.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED... following terms shall have the meanings specified: Batch means a specific quantity or lot of a test, control... substance is combined for administration to a test system. Control substance means any chemical substance or...

  18. 40 CFR 792.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED... following terms shall have the meanings specified: Batch means a specific quantity or lot of a test, control... substance is combined for administration to a test system. Control substance means any chemical substance or...

  19. Passenger vehicles sustain huge damage in 5 Mph tests

    DOT National Transportation Integrated Search

    2000-04-15

    Seventeen new cars, all 1999 and 2000 models, turned in mostly disappointing results in 5 mph crash tests conducted to assess how well the bumpers resist costly damage in the kinds of impacts that frequently occur in commuter traffic and parking lots...

  20. AGARD Flight Test Instrumentation Series. Volume 13. Practical Aspects of Instrumentation System Installation

    DTIC Science & Technology

    1981-09-01

    III I’ CANOWN" AA HNE Figure 3.3-4 Rzxsqle. Block Diagrami 24 PI LOT AIRBORNE IGROUND AGC AMPLIFIER AGC AMPLIFIER BASE • FM BASEBAND LINKE SQUARE I OO...in that T 0- •,~ ao •, _4 U- - & - @ Figure 3.3-6 Point to Point Inter- Connect Diagram. 25 the wires are merged, or joined, into no @ Lot ".U~ AFT...result in a " bottoning -out" of the isolators during high amplitude vibration. For a properly selected rubber mount, the wearing should be conservative

  1. Evaluating Laboratory Performance on Point-of-Care Glucose Testing with Six Sigma Metric for 151 Institutions in China.

    PubMed

    Fei, Yang; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

    2015-10-01

    The aim of this study was to use Six Sigma(SM) (Motorola Trademark Holdings, Libertyville, IL) techniques to analyze the quality of point-of-care (POC) glucose testing measurements quantitatively and to provide suggestions for improvement. In total, 151 laboratories in China were included in this investigation in 2014. Bias and coefficient of variation were collected from an external quality assessment and an internal quality control program, respectively, for POC glucose testing organized by the National Center for Clinical Laboratories. The σ values and the Quality Goal Index were used to evaluate the performance of POC glucose meters. There were 27, 30, 57, and 37 participants in the groups using Optium Xceed™ (Abbott Diabetes Care, Alameda, CA), Accu-Chek(®) Performa (Roche, Basel, Switzerland), One Touch Ultra(®) (Abbott), and "other" meters, respectively. The median of the absolute value of percentage difference varied among different lots and different groups. Among all the groups, the Abbott One Touch Ultra group had the smallest median of absolute value of percentage difference except for lot 201411, whereas the "other" group had the largest median in all five lots. More than 85% of participate laboratories satisfied the total allowable error (TEa) requirement in International Organization for Standardization standard 15197:2013, and 85.43% (129/151) of laboratories obtained intralaboratory coefficient of variations less than 1/3TEa. However, Six Sigma techniques suggested that 41.72% (63/151) to 65.56% (99/151) of the laboratories needed to improve their POC glucose testing performance, in either precision, trueness, or both. Laboratories should pay more attention on the practice of POC glucose testing and take actions to improve their performance. Only in this way can POC glucose testing really function well in clinical practice.

  2. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility.

    PubMed

    Freckmann, Guido; Baumstark, Annette; Schmid, Christina; Pleus, Stefan; Link, Manuela; Haug, Cornelia

    2014-02-01

    Systems for self-monitoring of blood glucose (SMBG) have to provide accurate and reproducible blood glucose (BG) values in order to ensure adequate therapeutic decisions by people with diabetes. Twelve SMBG systems were compared in a standardized manner under controlled laboratory conditions: nine systems were available on the German market and were purchased from a local pharmacy, and three systems were obtained from the manufacturer (two systems were available on the U.S. market, and one system was not yet introduced to the German market). System accuracy was evaluated following DIN EN ISO (International Organization for Standardization) 15197:2003. In addition, measurement reproducibility was assessed following a modified TNO (Netherlands Organization for Applied Scientific Research) procedure. Comparison measurements were performed with either the glucose oxidase method (YSI 2300 STAT Plus™ glucose analyzer; YSI Life Sciences, Yellow Springs, OH) or the hexokinase method (cobas(®) c111; Roche Diagnostics GmbH, Mannheim, Germany) according to the manufacturer's measurement procedure. The 12 evaluated systems showed between 71.5% and 100% of the measurement results within the required system accuracy limits. Ten systems fulfilled with the evaluated test strip lot minimum accuracy requirements specified by DIN EN ISO 15197:2003. In addition, accuracy limits of the recently published revision ISO 15197:2013 were applied and showed between 54.5% and 100% of the systems' measurement results within the required accuracy limits. Regarding measurement reproducibility, each of the 12 tested systems met the applied performance criteria. In summary, 83% of the systems fulfilled with the evaluated test strip lot minimum system accuracy requirements of DIN EN ISO 15197:2003. Each of the tested systems showed acceptable measurement reproducibility. In order to ensure sufficient measurement quality of each distributed test strip lot, regular evaluations are required.

  3. 46 CFR 160.151-31 - Production inspections and tests of inflatable liferafts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... capacity. (2) A new lot must begin whenever the liferafts undergo changes of design, material, production... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests of inflatable liferafts... Liferafts (SOLAS) § 160.151-31 Production inspections and tests of inflatable liferafts. (a) Production...

  4. 7 CFR 51.3417 - Optional test for specific gravity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Optional test for specific gravity. 51.3417 Section 51... specific gravity. Tests to determine specific gravity shall be made in accordance with the procedures set.... The specific gravity for any lot of potatoes shall be the average of at least 3 corrected readings on...

  5. 7 CFR 51.3417 - Optional test for specific gravity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Optional test for specific gravity. 51.3417 Section 51... specific gravity. Tests to determine specific gravity shall be made in accordance with the procedures set.... The specific gravity for any lot of potatoes shall be the average of at least 3 corrected readings on...

  6. Importance of supply integrity for in vitro fertilization and embryo culture.

    PubMed

    Morbeck, Dean E

    2012-06-01

    The quality of in vitro culture conditions is a key component of a successful clinical embryology laboratory. Many, but not all, supplies used in the embryology laboratory are screened by the supplier with a bioassay. Embryology laboratories use a variety of approaches to verify the quality of mineral oil, protein, and disposables before clinical use; however, a best practice has not been determined. Some laboratories test every supply, even those already screened by the supplier, whereas other laboratories perform as little testing as possible. Despite screening by the supplier, recent reports of embryo toxicity, specifically with mineral oil, highlight that the integrity of the supply system has gaps. This review describes current bioassay quality control testing and discusses how it applies to screening of products with documented lot-to-lot variation. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  7. Evaluation and qualification of commercial opto-electronic components for the MOHA subsystem in ESA's SMOS mission

    NASA Astrophysics Data System (ADS)

    Gutierrez, Francisco; Cordero, Enrique; Sánchez, Carolina; Barbero, Juan; Mosberger, Martin; Boehle, Peter; Tornell, Manuel; Lundmark, Karin

    2017-11-01

    A dedicated evaluation and qualification campaign has been performed on several optical COTS components in order to use them on ESA's SMOS mission. The evaluation phase consisted of a set of critical tests and analyses and led to the selection of the flight lot component. After selection of the components, one lot of each component has been qualified for the SMOS mission. The overall approach is presented together with a summary of all activities performed. The whole task has been handled in a joint effort between ESA, EADS CASA Espacio (prime contractor), Contraves Space AG (MOHA subsystem), TECNOLOGICA SA (component qualification experts) and the respective manufacturers, each party providing their specific know-how. Test results are presented and the issues discovered and lessons learned are addressed. Special emphasis is given to particular tests for which dedicated setups had to be designed due to the unavailability of standard equipment.

  8. D and D: Dismantling and Release of Large Components at the GNS Premises in Duisburg on the Example of a CASTOR S1 Container - 13536

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

    Oehmigen, Steffen; Ambos, Frank

    There are a lot of metallic large components for the transport of radioactive waste in Germany. Some of these large components like for example the Castor S1 with 82 Mg are so old, that the transport via streets is not possible because the permission is not valid anymore. The application for a new permission is economically not reasonable. Out of this reason the large components need to be decontaminated and recycled to use them again in the economic cycle. Decontamination of large components by cleaning/removing the surface for example with beam technology is a very time-consuming release procedure. Manufacturing amore » specialized machine for decontamination and creation of a new surface was the intention of this project. The objective was to save interim storage and final repository volume and costs as well as developing a process that is nationally and internationally usable. 90% of the volume/mass of waste could be released and therefore possibly re-used. (authors)« less

  9. Serum free light chain reference values: a critical approach.

    PubMed

    Altinier, Sara; Seguso, Mara; Zaninotto, Martina; Varagnolo, Mariacristina; Adami, Fausto; Angeli, Paolo; Plebani, Mario

    2013-05-01

    The clinical usefulness of serum free light chain (FLC) measurement in the management of patients with plasma cell proliferative disorders has been reported in several papers, and most clinical studies use the reference ranges declared by the manufacturer. The aim of the present study was to evaluate the reproducibility of FLCs immunoassay and to validate the reference range, before introducing it in routine setting. Internal quality control materials and a pool of fresh serum samples were used to evaluate imprecision; 162 fresh sera from healthy blood donors were analyzed to evaluate the reference range for FLCs. In order to verify the κ/λ FLC ratio, 43 sera from patients with polyclonal hypergammaglobulinemia were tested. The FLC immunoassay was performed using a nephelometer with the Freelite reagents. The imprecision studies performed using a serum pool tested with two different lots of reagents showed a mean CV of 16.09% for κFLC and of 16.72% for λFLC. Lower CV%s and different mean values were found by calculating the results from each specific lot separately, while different results were obtained using the control materials provided by the manufacturer. In reference subjects, the 2.5-97.5th percentiles were found to be 4.52-22.33 and 4.84-21.88mg/L for κFLC and λFLC, respectively. The range for κ/λ ratio (0.65-2.36) was validated with the values obtained from subjects with polyclonal hypergammaglobulinemia. In retesting 15 samples from blood donor subjects with a different lot of reagents, mean bias percentages of 17.60 for κFLC and 15.26 for λFLC were obtained. These findings confirm the lot-to-lot variability of the FLC assays also in the measurement of polyclonal light chains, as well as the need to carefully validate the reference values. Published by Elsevier Inc.

  10. Stabilization of soils contaminated with explosives and metals from the ammunition demolition activity area and miscellaneous sites at the Umatilla Depot

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

    Lear, P.R.; Gemarr, D.

    1997-12-31

    The US Army Umatilla Depot (UMD) was established as an ordnance depot in 1941 to store, preserve, and perform minor maintenance on conventional and chemical munitions. From the 1940`s until the present, UMD operated periodically at the 32 miscellaneous sites identified as OU-5. OU-4 consists of twenty sites within the Ammunition Demolition Activity Area. Typical activities conducted at these sites consisted of operations to burn, detonate, and otherwise dispose of ordnance, munitions casings, and other solids wastes. Five sites were selected for remedial action. The remediation contaminants of concern for the sites encompassed both metallic and non-metallic elements and bothmore » inorganic and organic compounds. The remedial action selected for the contaminated soil at these sites was stabilization/solidification (S/S). The site remediation activities for the five sites were performed by OHM Remediation Services Corp. (OHM) under the supervision of the US Army Corps of Engineers (USACE) Seattle District. The remedial action included treatability mix design testing, mobilization and field setup, soil excavation and processing, and S/S treatment. Stabilized soil samples were collected as grab samples from the pugmill discharge conveyor at a rate of every 75 tons of soil feed, corresponding to an individual production lot. None of the 437 production lots failed to meet the UCS requirement of 50 psi, however, 31 (7%) of the 437 lots failed for either TCLP-leachable metals or explosives. With one exception, all production lots which failed were due to exceedances of the TCLP-leachable explosives requirements. Of these 30 lots, 22 lots were from the OU-5 metals sites and were not expected to contain significant amounts of explosives. The areas in the landfill corresponding to these lots were excavated and the material reprocessed.« less

  11. [Intestinal parasitic diseases in children].

    PubMed

    Mare, Anca; Man, A; Toma, Felicia; Székely, Edit; Lôrinczi, Lilla; Sipoş, Anca

    2007-01-01

    To compare the incidence of intestinal parasitosis between children with residence in urban and rural areas: to compare the efficacy of parasitologic diagnostic methods. In our study we included two lots of children. The first lot consisted in 74 children from rural areas from which we collected 44 samples of feces and 55 samples for the "Scotch tape" test. The second lot consisted in 214 children from urban areas from which we collected 44 samples of feces. We examined each sample of feces by three different methods. The study was performed between April to June 2006. The incidence of intestinal parasitosis increases in children from urban areas towards rural areas, and in children between 5 and 10 years. Ascariasis is the most frequent disease in both urban and rural areas. By examination of each fecal sample by three different methods, the number of positive cases increased. The residence in rural areas and age between 5 to 10 years are risk factors for intestinal parasitosis. The "Scotch tape" test was more efficient in Enterobius vermicularis infection than the methods performed from feces. We recommend using at the same time three diagnostic methods for feces examination to improve the diagnostic sensibility.

  12. MTS dye based colorimetric CTLL-2 cell proliferation assay for product release and stability monitoring of interleukin-15: assay qualification, standardization and statistical analysis.

    PubMed

    Soman, Gopalan; Yang, Xiaoyi; Jiang, Hengguang; Giardina, Steve; Vyas, Vinay; Mitra, George; Yovandich, Jason; Creekmore, Stephen P; Waldmann, Thomas A; Quiñones, Octavio; Alvord, W Gregory

    2009-08-31

    A colorimetric cell proliferation assay using soluble tetrazolium salt [(CellTiter 96(R) Aqueous One Solution) cell proliferation reagent, containing the (3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium, inner salt) and an electron coupling reagent phenazine ethosulfate], was optimized and qualified for quantitative determination of IL-15 dependent CTLL-2 cell proliferation activity. An in-house recombinant Human (rHu)IL-15 reference lot was standardized (IU/mg) against an international reference standard. Specificity of the assay for IL-15 was documented by illustrating the ability of neutralizing anti-IL-15 antibodies to block the product specific CTLL-2 cell proliferation and the lack of blocking effect with anti-IL-2 antibodies. Under the defined assay conditions, the linear dose-response concentration range was between 0.04 and 0.17ng/ml of the rHuIL-15 produced in-house and 0.5-3.0IU/ml for the international standard. Statistical analysis of the data was performed with the use of scripts written in the R Statistical Language and Environment utilizing a four-parameter logistic regression fit analysis procedure. The overall variation in the ED(50) values for the in-house reference standard from 55 independent estimates performed over the period of 1year was 12.3% of the average. Excellent intra-plate and within-day/inter-plate consistency was observed for all four parameter estimates in the model. Different preparations of rHuIL-15 showed excellent intra-plate consistency in the parameter estimates corresponding to the lower and upper asymptotes as well as to the 'slope' factor at the mid-point. The ED(50) values showed statistically significant differences for different lots and for control versus stressed samples. Three R-scripts improve data analysis capabilities allowing one to describe assay variations, to draw inferences between data sets from formal statistical tests, and to set up improved assay acceptance criteria based on comparability and consistency in the four parameters of the model. The assay is precise, accurate and robust and can be fully validated. Applications of the assay were established including process development support, release of the rHuIL-15 product for pre-clinical and clinical studies, and for monitoring storage stability.

  13. Multidrug Resistance among New Tuberculosis Cases: Detecting Local Variation through Lot Quality-Assurance Sampling

    PubMed Central

    Lynn Hedt, Bethany; van Leth, Frank; Zignol, Matteo; Cobelens, Frank; van Gemert, Wayne; Viet Nhung, Nguyen; Lyepshina, Svitlana; Egwaga, Saidi; Cohen, Ted

    2012-01-01

    Background Current methodology for multidrug-resistant TB (MDR TB) surveys endorsed by the World Health Organization provides estimates of MDR TB prevalence among new cases at the national level. On the aggregate, local variation in the burden of MDR TB may be masked. This paper investigates the utility of applying lot quality-assurance sampling to identify geographic heterogeneity in the proportion of new cases with multidrug resistance. Methods We simulated the performance of lot quality-assurance sampling by applying these classification-based approaches to data collected in the most recent TB drug-resistance surveys in Ukraine, Vietnam, and Tanzania. We explored three classification systems—two-way static, three-way static, and three-way truncated sequential sampling—at two sets of thresholds: low MDR TB = 2%, high MDR TB = 10%, and low MDR TB = 5%, high MDR TB = 20%. Results The lot quality-assurance sampling systems identified local variability in the prevalence of multidrug resistance in both high-resistance (Ukraine) and low-resistance settings (Vietnam). In Tanzania, prevalence was uniformly low, and the lot quality-assurance sampling approach did not reveal variability. The three-way classification systems provide additional information, but sample sizes may not be obtainable in some settings. New rapid drug-sensitivity testing methods may allow truncated sequential sampling designs and early stopping within static designs, producing even greater efficiency gains. Conclusions Lot quality-assurance sampling study designs may offer an efficient approach for collecting critical information on local variability in the burden of multidrug-resistant TB. Before this methodology is adopted, programs must determine appropriate classification thresholds, the most useful classification system, and appropriate weighting if unbiased national estimates are also desired. PMID:22249242

  14. Growth of enterotoxigenic Staphylococcus aureus in povi masima, a traditional Pacific island food.

    PubMed

    Wong, T L; Whyte, R J; Graham, C G; Saunders, D; Schumacher, J; Hudson, J A

    2004-01-01

    To obtain preliminary data on the microbiology and hurdles to pathogen growth in the traditional Pacific Island food, povi masima, which is essentially beef brisket cured in brine. Six containers of povi masima were prepared and two were inoculated with five enterotoxigenic strains of Staphyloccocus aureus. The povi masima were divided into two lots each containing two uninoculated control and an inoculated container. Lot 1 was incubated at room temperature (20 degrees C) and lot 2 under refrigeration (4-5 degrees C) for up to 98 days. During storage, samples were removed and tested for aerobic plate count, coagulase-producing Staphylococci, Clostridium perfringens, staphylococcal enterotoxin and various chemical parameters of the food. Coagulase-producing Staphylococci and aerobic plate counts grew to high levels in both the inoculated and uninoculated lots stored at room temperature, but enterotoxin was only detected at one time point in these lots and this may represent a false positive result. The concentration of NaCl in the meat increased with time as concentrations equilibrated, and nitrite was rapidly lost in those lots stored at room temperature. Storage at 4-5 degrees C prevented proliferation of coagulase-producing Staphylococci. For safe curing and storage, this food should be kept under refrigeration as this prevented growth of staphylococci. Optimum storage would also be achieved with improved attempts to ensure equal distribution of NaCl prior to storage. Under conditions traditionally used to cure and store this food, enterotoxigenic staphylococci can grow to numbers where toxigenesis might occur, especially during the early stages of curing where the salt has not diffused from the brine into the meat.

  15. Multidrug resistance among new tuberculosis cases: detecting local variation through lot quality-assurance sampling.

    PubMed

    Hedt, Bethany Lynn; van Leth, Frank; Zignol, Matteo; Cobelens, Frank; van Gemert, Wayne; Nhung, Nguyen Viet; Lyepshina, Svitlana; Egwaga, Saidi; Cohen, Ted

    2012-03-01

    Current methodology for multidrug-resistant tuberculosis (MDR TB) surveys endorsed by the World Health Organization provides estimates of MDR TB prevalence among new cases at the national level. On the aggregate, local variation in the burden of MDR TB may be masked. This paper investigates the utility of applying lot quality-assurance sampling to identify geographic heterogeneity in the proportion of new cases with multidrug resistance. We simulated the performance of lot quality-assurance sampling by applying these classification-based approaches to data collected in the most recent TB drug-resistance surveys in Ukraine, Vietnam, and Tanzania. We explored 3 classification systems- two-way static, three-way static, and three-way truncated sequential sampling-at 2 sets of thresholds: low MDR TB = 2%, high MDR TB = 10%, and low MDR TB = 5%, high MDR TB = 20%. The lot quality-assurance sampling systems identified local variability in the prevalence of multidrug resistance in both high-resistance (Ukraine) and low-resistance settings (Vietnam). In Tanzania, prevalence was uniformly low, and the lot quality-assurance sampling approach did not reveal variability. The three-way classification systems provide additional information, but sample sizes may not be obtainable in some settings. New rapid drug-sensitivity testing methods may allow truncated sequential sampling designs and early stopping within static designs, producing even greater efficiency gains. Lot quality-assurance sampling study designs may offer an efficient approach for collecting critical information on local variability in the burden of multidrug-resistant TB. Before this methodology is adopted, programs must determine appropriate classification thresholds, the most useful classification system, and appropriate weighting if unbiased national estimates are also desired.

  16. MAJOR TRANSPORT MECHANISMS OF PYRETHROIDS IN RESIDENTIAL SETTINGS AND EFFECTS OF MITIGATION MEASURES

    PubMed Central

    Davidson, Paul C; Jones, Russell L; Harbourt, Christopher M; Hendley, Paul; Goodwin, Gregory E; Sliz, Bradley A

    2014-01-01

    The major pathways for transport of pyrethroids were determined in runoff studies conducted at a full-scale test facility in central California, USA. The 6 replicate house lots were typical of front lawns and house fronts of California residential developments and consisted of stucco walls, garage doors, driveways, and residential lawn irrigation sprinkler systems. Each of the 6 lots also included a rainfall simulator to generate artificial rainfall events. Different pyrethroids were applied to 5 surfaces—driveway, garage door and adjacent walls, lawn, lawn perimeter (grass near the house walls), and house walls above grass. The volume of runoff water from each house lot was measured, sampled, and analyzed to determine the amount of pyrethroid mass lost from each surface. Applications to 3 of the house lots were made using the application practices typically used prior to recent label changes, and applications were made to the other 3 house lots according to the revised application procedures. Results from the house lots using the historic application procedures showed that losses of the compounds applied to the driveway and garage door (including the adjacent walls) were 99.75% of total measured runoff losses. The greatest losses were associated with significant rainfall events rather than lawn irrigation events. However, runoff losses were 40 times less using the revised application procedures recently specified on pyrethroid labels. Environ Toxicol Chem 2014;33:52–60. © 2013 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited. PMID:24105831

  17. Results of continuous synchronous orbit testing of sealed nickel-cadmium cells

    NASA Technical Reports Server (NTRS)

    Harkness, J. D.

    1981-01-01

    Test results from continuous synchronous orbit testing of sealed nickel cadmium cells are presented. The synchronous orbit regime simulates a space satellite maintaining a position over a fixed point on earth as the earth rotates on its axis and revolves about the sun. Characteristics of each lot of cells, test conditions, and charge control methods are described.

  18. A Framework for Optimizing Phytosanitary Thresholds in Seed Systems.

    PubMed

    Choudhury, Robin Alan; Garrett, Karen A; Klosterman, Steven J; Subbarao, Krishna V; McRoberts, Neil

    2017-10-01

    Seedborne pathogens and pests limit production in many agricultural systems. Quarantine programs help prevent the introduction of exotic pathogens into a country, but few regulations directly apply to reducing the reintroduction and spread of endemic pathogens. Use of phytosanitary thresholds helps limit the movement of pathogen inoculum through seed, but the costs associated with rejected seed lots can be prohibitive for voluntary implementation of phytosanitary thresholds. In this paper, we outline a framework to optimize thresholds for seedborne pathogens, balancing the cost of rejected seed lots and benefit of reduced inoculum levels. The method requires relatively small amounts of data, and the accuracy and robustness of the analysis improves over time as data accumulate from seed testing. We demonstrate the method first and illustrate it with a case study of seedborne oospores of Peronospora effusa, the causal agent of spinach downy mildew. A seed lot threshold of 0.23 oospores per seed could reduce the overall number of oospores entering the production system by 90% while removing 8% of seed lots destined for distribution. Alternative mitigation strategies may result in lower economic losses to seed producers, but have uncertain efficacy. We discuss future challenges and prospects for implementing this approach.

  19. Molecular and phenotypic analysis of a working seed lot of yellow fever virus 17DD vaccine strain produced from the secondary seed lot 102/84 with an additional passage in chicken embryos.

    PubMed

    Marchevsky, Renato S; da Luz Leal, Maria; Homma, Akira; Coutinho, Evandro S F; Camacho, Luis A B; Jabor, Alfredo V; Galler, Ricardo; Freire, Marcos S

    2006-09-01

    Over the last 17 years, the yellow fever (YF) 17DD vaccine secondary seed lot 102/84 was used to produce many million doses of vaccine but it was recently used up. In the absence of other lots at the same passage level a large vaccine batch produced from 102/84 was turned into a new working seed. This new seed was characterized with regard to attenuation in the recommended internationally accepted monkey neurovirulence test (MNVT) using the 102/84 virus as reference. All rhesus monkeys (Macaca mulatta) developed limited viremia and comparable neutralizing antibody titers. Clinical evaluation and histological examination of the central nervous system (CNS) according to WHO criteria for acceptability gave consistent data that demonstrated an attenuated phenotype for the YF 17DD 993FB013Z (13Z) vaccine batch. It is concluded that the additional chicken embryo passage did not lead to any genetic change and the new working seed virus retained its attenuation for monkeys comparable to the 102/84 reference virus.

  20. 42 CFR 493.1261 - Standard: Bacteriology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved...

  1. A computational analysis of lower bounds for the economic lot sizing problem in remanufacturing with separate setups

    NASA Astrophysics Data System (ADS)

    Aishah Syed Ali, Sharifah

    2017-09-01

    This paper considers economic lot sizing problem in remanufacturing with separate setup (ELSRs), where remanufactured and new products are produced on dedicated production lines. Since this problem is NP-hard in general, which leads to computationally inefficient and low-quality of solutions, we present (a) a multicommodity formulation and (b) a strengthened formulation based on a priori addition of valid inequalities in the space of original variables, which are then compared with the Wagner-Whitin based formulation available in the literature. Computational experiments on a large number of test data sets are performed to evaluate the different approaches. The numerical results show that our strengthened formulation outperforms all the other tested approaches in terms of linear relaxation bounds. Finally, we conclude with future research directions.

  2. Prediction of magnitude of minimum horizontal stress from extended leak-off test conducted by the riser vessel CHIKYU

    NASA Astrophysics Data System (ADS)

    Lin, W.; Masago, H.; Yamamoto, K.; Kawamura, Y.; Saito, S.; Kinoshita, M.

    2007-12-01

    By means of introduction of the drilling vessel 'CHIKYU', riser drilling operations using mud fluid will be carried out in NanTroSEIZE Stage 2 for the first time as an oceanic scientific-drilling. For determining drilling operation parameter such as a mud density, a downhole experiment, leak-off test (LOT) or extended leak-off test (XLOT), is going to be implemented next to casing and cementing at each casing shoe during the drilling process. Data of the downhole experiment aimed for operation can also be used for an important scientific application to obtain in-situ stress information which is necessary for various cases of scientific drillings such as seismogenic zone drillings etc. In order to examine feasibility of the application of the LOT or XLOT data, we analyzed an example of XLOT conducted by the riser vessel CHIKYU during its Shimokita shakedown cruise, 2006; and then estimated magnitude of minimum principal stress in horizontal plane, Shmin. Moreover, we will propose the test procedures to possibly improve the quality of stress result from the applications of LOT or XLOT. The XLOT of Shimokita cruise was conducted under following conditions; 1180 m water depth, 525 mbsf (meter below seafloor) depth, 1030 kg/m3 fluid density (seawater) and 80 litter/min injection flow-rate. Estimated magnitude of the Shmin is equal to 18.3 MPa based on the assumption that fracture closure pressure balances with the minimum principal stress perpendicular to the fracture plane. For comparison, the vertical stress magnitude at the depth was estimated from density profile of core samples retrieved from the same borehole; and was equal to 20 MPa approximately. These two values can be considered to be not disagreement. Therefore, we can say that the XLOT data is valuable and practical for estimating the magnitude of minimum horizontal stress. From the viewpoint of determining stress magnitude, the XLOT is more essential rather than the LOT because it might be hardly to obtain reliable Shmin magnitude only by leak-off pressure which is exclusive stress-related parameter obtained from the latter. In addition, implementation of the LOT/XLOT multi-cycles (3 cycles) is preferable if possible. The first cycle with a lower maximum injection pressure is for knowing permeable property of the formation and for examining whether there is pre-existing fracture(s). The second cycle is a normal XLOT; and the third one is the repeat of the second one for confirm the pressure values obtained from the XLOTs.

  3. Quantification of protein concentration using UV absorbance and Coomassie dyes.

    PubMed

    Noble, James E

    2014-01-01

    The measurement of a solubilized protein concentration in solution is an important assay in biochemistry research and development labs for applications ranging from enzymatic studies to providing data for biopharmaceutical lot release. Spectrophotometric protein quantification assays are methods that use UV and visible spectroscopy to rapidly determine the concentration of protein, relative to a standard, or using an assigned extinction coefficient. Where multiple samples need measurement, and/or the sample volume and concentration is limited, preparations of the Coomassie dye commonly known as the Bradford assay can be used. © 2014 Elsevier Inc. All rights reserved.

  4. [Advances in the effects of pH value of micro-environment on wound healing].

    PubMed

    Tian, Ruirui; Li, Na; Wei, Li

    2016-04-01

    Wound healing is a complex regeneration process, which is affected by lots of endogenous and exogenous factors. Researches have confirmed that acid environment could prevent wound infection and accelerate wound healing by inhibiting bacteria proliferation, promoting oxygen release, affecting keratinocyte proliferation and migration, etc. In this article, we review the literature to identify the potential relationship between the pH value of wound micro-environment and the progress of wound healing, and summarize the clinical application of variation of pH value of micro-environment in wound healing, thereby to provide new treatment strategy for wound healing.

  5. 9 CFR 113.100 - General requirements for inactivated bacterial products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... subserial shall be tested for viable bacteria and fungi as provided in § 113.26. (2) Each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the... of Master Seed Bacteria to the genus and species level by laboratory tests shall be sufficient to...

  6. 9 CFR 113.100 - General requirements for inactivated bacterial products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... subserial shall be tested for viable bacteria and fungi as provided in § 113.26. (2) Each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the... of Master Seed Bacteria to the genus and species level by laboratory tests shall be sufficient to...

  7. Testing tree seeds for vigor: a review

    Treesearch

    F.T. Bonner

    1998-01-01

    This review examines the use of vigor tests for tree seeds. It suggests that precise evaluations of these tests and their application with seeds of woody plants is not yet possible. This is due to the wide genetic variation, primarily manifested in variable maturity and dormancy, that exists in most tree seed lots. Sensitive measurements of germination rate during...

  8. How and How Not to Prepare Students for the New Tests

    ERIC Educational Resources Information Center

    Shanahan, Timothy

    2014-01-01

    "Data-driven school reform" emphasizes the idea that if teachers analyze the kinds of questions students miss on standardized reading comprehension tests, and then give students lots of practice with such items, they will end up with higher test scores. This approach is likely to be popular with the new Partnership for Assessment of…

  9. Three Essays In and Tests of Theoretical Urban Economics

    NASA Astrophysics Data System (ADS)

    Zhao, Weihua

    This dissertation consists of three essays on urban economics. The three essays are related to urban spatial structure change, energy consumption, greenhouse gas emissions, and housing redevelopment. Chapter 1 answers the question: Does the classic Standard Urban Model still describe the growth of cities? Chapter 2 derives the implications of telework on urban spatial structure, energy consumption, and greenhouse gas emissions. Chapter 3 investigates the long run effects of minimum lot size zoning on neighborhood redevelopment. Chapter 1 identifies a new implication of the classic Standard Urban Model, the "unitary elasticity property (UEP)", which is the sum of the elasticity of central density and the elasticity of land area with respect to population change is approximately equal to unity. When this implication of the SUM is tested, it fits US cities fairly well. Further analysis demonstrates that topographic barriers and age of housing stock are the key factors explaining deviation from the UEP. Chapter 2 develops a numerical urban simulation model with households that are able to telework to investigate the urban form, congestion, energy consumption and greenhouse gas emission implications of telework. Simulation results suggest that by reducing transportation costs, telework causes sprawl, with associated longer commutes and consumption of larger homes, both of which increase energy consumption. Overall effects depend on who captures the gains from telework (workers versus firms), urban land use regulation such as height limits or greenbelts, and the fraction of workers participating in telework. The net effects of telework on energy use and GHG emissions are generally negligible. Chapter 3 applies dynamic programming to investigate the long run effects of minimum lot size zoning on neighborhood redevelopment. With numerical simulation, comparative dynamic results show that minimum lot size zoning can delay initial land conversion and slow down demolition and housing redevelopment. Initially, minimum lot size zoning is not binding. However, as city grows, it becomes binding and can effectively distort housing supply. It can lower both floor area ratio and residential density, and reduce aggregate housing supply. Overall, minimum lot size zoning can stabilize the path of structure/land ratios, housing service levels, structure density, and housing prices. In addition, minimum lot size zoning provides more incentive for developer to maintain the building, slow structure deterioration, and raise the minimum level of housing services provided over the life cycle of development.

  10. Levonorgestrel release rates over 5 years with the Liletta® 52-mg intrauterine system.

    PubMed

    Creinin, Mitchell D; Jansen, Rolf; Starr, Robert M; Gobburu, Joga; Gopalakrishnan, Mathangi; Olariu, Andrea

    2016-10-01

    To understand the potential duration of action for Liletta®, we conducted this study to estimate levonorgestrel (LNG) release rates over approximately 5½years of product use. Clinical sites in the U.S. Phase 3 study of Liletta collected the LNG intrauterine systems (IUSs) from women who discontinued the study. We randomly selected samples within 90-day intervals after discontinuation of IUS use through 900days (approximately 2.5years) and 180-day intervals for the remaining duration through 5.4years (1980days) to evaluate residual LNG content. We also performed an initial LNG content analysis using 10 randomly selected samples from a single lot. We calculated the average ex vivo release rate using the residual LNG content over the duration of the analysis. We analyzed 64 samples within 90-day intervals (range 6-10 samples per interval) through 900days and 36 samples within 180-day intervals (6 samples per interval) for the remaining duration. The initial content analysis averaged 52.0±1.8mg. We calculated an average initial release rate of 19.5mcg/day that decreased to 17.0, 14.8, 12.9, 11.3 and 9.8mcg/day after 1, 2, 3, 4 and 5years, respectively. The 5-year average release rate is 14.7mcg/day. The estimated initial LNG release rate and gradual decay of the estimated release rate are consistent with the target design and function of the product. The calculated LNG content and release rate curves support the continued evaluation of Liletta as a contraceptive for 5 or more years of use. Liletta LNG content and release rates are comparable to published data for another LNG 52-mg IUS. The release rate at 5years is more than double the published release rate at 3years with an LNG 13.5-mg IUS, suggesting continued efficacy of Liletta beyond 5years. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    PubMed

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

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

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

    PubMed Central

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

    2017-01-01

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

  13. Evaluation of a Novel Renewable Hepatic Cell Model for Prediction of Clinical CYP3A4 Induction Using a Correlation-Based Relative Induction Score Approach.

    PubMed

    Zuo, Rongjun; Li, Feng; Parikh, Sweta; Cao, Li; Cooper, Kirsten L; Hong, Yulong; Liu, Jin; Faris, Ronald A; Li, Daochuan; Wang, Hongbing

    2017-02-01

    Metabolism enzyme induction-mediated drug-drug interactions need to be carefully characterized in vitro for drug candidates to predict in vivo safety risk and therapeutic efficiency. Currently, both the Food and Drug Administration and European Medicines Agency recommend using primary human hepatocytes as the gold standard in vitro test system for studying the induction potential of candidate drugs on cytochrome P450 (CYP), CYP3A4, CYP1A2, and CYP2B6. However, primary human hepatocytes are known to bear inherent limitations such as limited supply and large lot-to-lot variations, which result in an experimental burden to qualify new lots. To overcome these shortcomings, a renewable source of human hepatocytes (i.e., Corning HepatoCells) was developed from primary human hepatocytes and was evaluated for in vitro CYP3A4 induction using methods well established by the pharmaceutical industry. HepatoCells have shown mature hepatocyte-like morphology and demonstrated primary hepatocyte-like response to prototypical inducers of all three CYP enzymes with excellent consistency. Importantly, HepatoCells retain a phenobarbital-responsive nuclear translocation of human constitutive androstane receptor from the cytoplasm, characteristic to primary hepatocytes. To validate HepatoCells as a useful tool to predict potential clinical relevant CYP3A4 induction, we tested three different lots of HepatoCells with a group of clinical strong, moderate/weak CYP3A4 inducers, and noninducers. A relative induction score calibration curve-based approach was used for prediction. HepatoCells showed accurate prediction comparable to primary human hepatocytes. Together, these results demonstrate that Corning HepatoCells is a reliable in vitro model for drug-drug interaction studies during the early phase of drug testing. Copyright © 2017 by The Author(s).

  14. 40 CFR Appendix B to Part 60 - Performance Specifications

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 6216-98 is the reference for design specifications, manufacturer's performance specifications, and test... representative of a group of monitors produced during a specified period or lot, for conformance with the design... technique and a single analytical program are used. One Run may include results for more than one test...

  15. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  16. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  17. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  18. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  19. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  20. 41 CFR 101-25.101-2 - Supply through storage and issue.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... dangerous commodities of high weight and density, or commodities highly susceptible to damage normally... close inspection or testing is necessary to secure quality, or where repetitive inspection and test of small lots are prohibitive from the standpoint of cost or potential urgency of need. (3) Where advance...

  1. 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.

  2. Evaluating Measures of Optimism and Sport Confidence

    ERIC Educational Resources Information Center

    Fogarty, Gerard J.; Perera, Harsha N.; Furst, Andrea J.; Thomas, Patrick R.

    2016-01-01

    The psychometric properties of the Life Orientation Test-Revised (LOT-R), the Sport Confidence Inventory (SCI), and the Carolina SCI (CSCI) were examined in a study involving 260 athletes. The study aimed to test the dimensional structure, convergent and divergent validity, and invariance over competition level of scores generated by these…

  3. 76 FR 28076 - Notice of Inventory Completion: Museum of Anthropology, Washington State University, Pullman, WA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... scrapers, 1 bone scraper handle, 1 lot of mussel shells, 1 lot of red ochre, 2 bone awls, 1 lot of charcoal... lots of bag residue, 4 lots of animal bones, 1 stone net sinker, 1 lot of tin can fragments, 2...

  4. 30 CFR 7.25 - Critical characteristics.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.25 Critical characteristics. A sample of each batch or lot of brattice cloth and ventilation tubing...

  5. 30 CFR 7.25 - Critical characteristics.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.25 Critical characteristics. A sample of each batch or lot of brattice cloth and ventilation tubing...

  6. 30 CFR 7.25 - Critical characteristics.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.25 Critical characteristics. A sample of each batch or lot of brattice cloth and ventilation tubing...

  7. 30 CFR 7.25 - Critical characteristics.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.25 Critical characteristics. A sample of each batch or lot of brattice cloth and ventilation tubing...

  8. 30 CFR 7.25 - Critical characteristics.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Brattice Cloth and Ventilation Tubing § 7.25 Critical characteristics. A sample of each batch or lot of brattice cloth and ventilation tubing...

  9. Improving overlay control through proper use of multilevel query APC

    NASA Astrophysics Data System (ADS)

    Conway, Timothy H.; Carlson, Alan; Crow, David A.

    2003-06-01

    Many state-of-the-art fabs are operating with increasingly diversified product mixes. For example, at Cypress Semiconductor, it is not unusual to be concurrently running multiple technologies and many devices within each technology. This diverse product mix significantly increases the difficulty of manually controlling overlay process corrections. As a result, automated run-to-run feedforward-feedback control has become a necessary and vital component of manufacturing. However, traditional run-to-run controllers rely on highly correlated historical events to forecast process corrections. For example, the historical process events typically are constrained to match the current event for exposure tool, device, process level and reticle ID. This narrowly defined process stream can result in insufficient data when applied to lowvolume or new-release devices. The run-to-run controller implemented at Cypress utilizes a multi-level query (Level-N) correlation algorithm, where each subsequent level widens the search criteria for available historical data. The paper discusses how best to widen the search criteria and how to determine and apply a known bias to account for tool-to-tool and device-to-device differences. Specific applications include offloading lots from one tool to another when the first tool is down for preventive maintenance, utilizing related devices to determine a default feedback vector for new-release devices, and applying bias values to account for known reticle-to-reticle differences. In this study, we will show how historical data can be leveraged from related devices or tools to overcome the limitations of narrow process streams. In particular, this paper discusses how effectively handling narrow process streams allows Cypress to offload lots from a baseline tool to an alternate tool.

  10. Transforming information from silicon testing and design characterization into numerical data sets for yield learning

    NASA Astrophysics Data System (ADS)

    Yang, Thomas; Shen, Yang; Zhang, Yifan; Sweis, Jason; Lai, Ya-Chieh

    2017-03-01

    Silicon testing results are regularly collected for a particular lot of wafers to study yield loss from test result diagnostics. Product engineers will analyze the diagnostic results and perform a number of physical failure analyses to detect systematic defects which cause yield loss for these sets of wafers in order to feedback the information to process engineers for process improvements. Most of time, the systematic defects that are detected are major issues or just one of the causes for the overall yield loss. This paper will present a working flow for using design analysis techniques combined with diagnostic methods to systematically transform silicon testing information into physical layout information. A new set of the testing results are received from a new lot of wafers for the same product. We can then correlate all the diagnostic results from different periods of time to check which blocks or nets have been highlighted or stop occurring on the failure reports in order to monitor process changes which impact the yield. The design characteristic analysis flow is also implemented to find 1) the block connections on a design that have failed electrical test or 2) frequently used cells that been highlighted multiple times.

  11. Global survey of malaria rapid diagnostic test (RDT) sales, procurement and lot verification practices: assessing the use of the WHO-FIND Malaria RDT Evaluation Programme (2011-2014).

    PubMed

    Incardona, Sandra; Serra-Casas, Elisa; Champouillon, Nora; Nsanzabana, Christian; Cunningham, Jane; González, Iveth J

    2017-05-15

    Malaria rapid diagnostic tests (RDTs) play a critical role in malaria case management, and assurance of quality is a key factor to promote good adherence to test results. Since 2007, the World Health Organization (WHO) and the Foundation for Innovative New Diagnostics (FIND) have coordinated a Malaria RDT Evaluation Programme, comprising a pre-purchase performance evaluation (product testing, PT) and a pre-distribution quality control of lots (lot testing, LT), the former being the basis of WHO recommendations for RDT procurement. Comprehensive information on malaria RDTs sold worldwide based on manufacturers' data and linked to independent performance data is currently not available, and detailed knowledge of procurement practices remains limited. The use of the PT/LT Programme results as well as procurement and lot verification practices were assessed through a large-scale survey, gathering product-specific RDT sales and procurement data (2011-14 period) from a total of 32 manufacturers, 12 procurers and 68 National Malaria Control Programmes (NMCPs). Manufacturers' reports showed that RDT sales had more than doubled over the four years, and confirmed a trend towards increased compliance with the WHO procurement criteria (from 83% in 2011 to 93% in 2014). Country-level reports indicated that 74% of NMCPs procured only 'WHO-compliant' RDT products, although procurers' transactions datasets revealed a surprisingly frequent overlap of different products and even product types (e.g., Plasmodium falciparum-only and Plasmodium-pan) in the same year and country (60 and 46% of countries, respectively). Importantly, the proportion of 'non-complying' (i.e., PT low scored or not evaluated) products was found to be higher in the private health care sector than in the public sector (32% vs 5%), and increasing over time (from 22% of private sector sales in 2011 to 39% in 2014). An estimated 70% of the RDT market was covered by the LT programme. The opinion about the PT/LT Programmes was positive overall, and quality of RDTs as per the PT Programme was rated as the number one procurement criteria. This survey provided in-depth information on RDT sales and procurement dynamics, including the largely unstudied private sector, and demonstrated how the WHO-FIND Programme has positively influenced procurement practices in the public sector.

  12. Validation of the RIDASCREEN(®)FAST Milk Kit.

    PubMed

    Weiss, Thomas; Lacorn, Markus; Flannery, Jonathan; Benzinger, M Joseph; Bird, Patrick; Crowley, Erin S; Goins, Dave; Agin, James R; Gilani, Sarwar; Poepping, Bert; Garber, Eric

    2016-01-01

    The RIDASCREEN(®)FAST Milk test is a sandwich ELISA for the rapid quantification of milk proteins in various foods. The specific antibodies target casein and β-lactoglobulin. Samples are extracted and can then be analyzed in less than 40 min. The calibration curve covers a range from 2.5 to 67.5 mg/kg milk protein. The assay was validated with cookies, infant formula, chocolate dessert, ice cream, and sausages. All negative samples were found well below the LOQ of 2.5 mg/kg. Recoveries of the spiked samples were mostly in the range of 80-120%. The LOD of the ELISA was found below 1 mg/kg. The analysis of 39 different substances of interest revealed that no cross-reactivity above the LOQ occurred. Ruggedness testing proved that variations in incubation temperature, reagent volume, incubation time, extraction temperature, and extraction time had no significant influence. The stability at 4-8°C of three independent lots was investigated and found to exceed 18 months. Very good lot-to-lot consistency and no significant loss of the analytical capacity over the shelf life were observed. Incurred cookies and chocolate dessert samples were prepared and analyzed by an independent laboratory; mean recoveries of 94.4 and 102.2% and mean SDs of 10.9 and 6.3%, respectively, were found. For the 0 mg/kg level for both materials, all samples tested returned values of <2.5 mg/kg. Therefore, the analytical performance claims of the manufacturer were confirmed.

  13. Estimation of Microbial Concentration in Food Products from Qualitative, Microbiological Test Data with the MPN Technique.

    PubMed

    Fujikawa, Hiroshi

    2017-01-01

    Microbial concentration in samples of a food product lot has been generally assumed to follow the log-normal distribution in food sampling, but this distribution cannot accommodate the concentration of zero. In the present study, first, a probabilistic study with the most probable number (MPN) technique was done for a target microbe present at a low (or zero) concentration in food products. Namely, based on the number of target pathogen-positive samples in the total samples of a product found by a qualitative, microbiological examination, the concentration of the pathogen in the product was estimated by means of the MPN technique. The effects of the sample size and the total sample number of a product were then examined. Second, operating characteristic (OC) curves for the concentration of a target microbe in a product lot were generated on the assumption that the concentration of a target microbe could be expressed with the Poisson distribution. OC curves for Salmonella and Cronobacter sakazakii in powdered formulae for infants and young children were successfully generated. The present study suggested that the MPN technique and the Poisson distribution would be useful for qualitative microbiological test data analysis for a target microbe whose concentration in a lot is expected to be low.

  14. Work Done For the Safety and Assurance Directorate

    NASA Technical Reports Server (NTRS)

    Struhar, Paul T., Jr.

    2004-01-01

    The Safety and Assurance Directorate (SAAD) has a vision. The vision is to be an essential part of NASA Glenn's journey to excellence. SAAD is in charge of leading safety, security, and quality and is important to our customers. When it comes to programmatic and technical decision making and implementation, SAAD provides clear safety, reliability, maintainable, quality assurance and security. I worked on a couple different things during my internship with Sandra Hardy. I did a lot of logistics for meeting and trips. I helped run the budget for the SAAD directorate. I also worked with Rich Miller for one week and we took water samples and ran tests. We also calibrated the different equipment. There is a lot more to meetings than people see. I did one for a retirement party. I had to get work orders and set up the facilities where the event is going to take place. I also set up a trip to Plum Brook Station. I had to order vans and talk with the people up there to see when a good time was. I also had to make invitations and coordinate everything. I also help Sandy run the numbers in the budget. We use excel to do this, which makes it a lot easier. things. He is in the environmental safety office. I learned how to collaborate the equipment using alpha and beta sources. I went out with him and we took water samples and tested them for conductivity and chlorine. I have learned a lot in the short time I've been here. It has been a great experience and I have has the pleasure of meeting and working with great people.

  15. Effect of microporosity on scaffolds for bone tissue engineering

    PubMed Central

    Zhang, Ke; Fan, Yubo; Dunne, Nicholas; Li, Xiaoming

    2018-01-01

    Abstract Microporosity has a critical role in improving the osteogenesis of scaffolds for bone tissue engineering. Although the exact mechanism, by which it promotes new bone formation, is not well recognized yet, the related hypothesis can be found in many previous studies. This review presents those possible mechanisms about how the microporosity enhances the osteogenic-related functions of cells in vitro and the osteogenic activity of scaffolds in vivo. In summary, the increased specific surface areas by microporosity can offer more protein adsorption sites and accelerate the release of degradation products, which facilitate the interactions between scaffolds and cells. Meanwhile, the unique surface properties of microporous scaffolds have a considerable effect on the protein adsorption. Moreover, capillary force generated by the microporosity can improve the attachment of bone-related cells on the scaffolds surface, and even make the cells achieve penetration into the micropores smaller than them. This review also pays attention to the relationship between the biological and mechanical properties of microporous scaffolds. Although lots of achievements have been obtained, there is still a lot of work to do, some of which has been proposed in the conclusions and perspectives part. PMID:29644093

  16. [Method of fused sample preparation after nitrify-determination of primary and minor elements in manganese ore by X-ray fluorescence spectrometry].

    PubMed

    Song, Yi; Guo, Fen; Gu, Song-hai

    2007-02-01

    Eight components, i. e. Mn, SiO2, Fe, P, Al2O3, CaO, MgO and S, in manganese ore were determined by X-ray fluorescence spectrometer. Because manganese ore sample releases a lot of air bubbles during fusion which effect accuracy and reproducibility of determination, nitric acid was added to the sample to destroy organic matter before fusion by the mixture flux at 1000 degrees C. This method solved the problem that the flux splashed during fusion because organic matter volatilized brought out a lot of air bubbles, eliminated particle size effects and mineral effect, while solved the problem of volatilization of sulfur during fusion. The experiments for the selection of the sample preparation conditions, i. e. fusion flux, fusion time and volume of HNO3, were carried out. The matrix effects on absorption and enhancement were corrected by variable theoretical alpha coefficient to expand the range of determination. Moreover, the precision and accuracy experiments were performed. In comparison with chemical analysis method, the quantitative analytical results for each component are satisfactory. The method has proven rapid, precise and simple.

  17. Multi-Method Assessment of Metacognitive Skills in Elementary School Children: How You Test Is What You Get

    ERIC Educational Resources Information Center

    Desoete, Annemie

    2008-01-01

    Third grade elementary school children solved tests on mathematical reasoning and numerical facility. Metacognitive skillfulness was assessed through think aloud protocols, prospective and retrospective child ratings, teacher questionnaires, calibration measures and EPA2000. In our dataset metacognition has a lot in common with intelligence, but…

  18. Accelerated life testing and reliability of high K multilayer ceramic capacitors

    NASA Technical Reports Server (NTRS)

    Minford, W. J.

    1981-01-01

    The reliability of one lot of high K multilayer ceramic capacitors was evaluated using accelerated life testing. The degradation in insulation resistance was characterized as a function of voltage and temperature. The times to failure at a voltage-temperature stress conformed to a lognormal distribution with a standard deviation approximately 0.5.

  19. Reproducibility of polycarbonate reference material in toxicity evaluation

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Huttlinger, P. A.

    1981-01-01

    A specific lot of bisphenol A polycarbonate has been used for almost four years as the reference material for the NASA-USF-PSC toxicity screening test method. The reproducibility of the test results over this period of time indicate that certain plastics may be more suitable reference materials than the more traditional cellulosic materials.

  20. 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.

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

    PubMed

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

    2013-07-01

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

  2. Statistical Model Selection for TID Hardness Assurance

    NASA Technical Reports Server (NTRS)

    Ladbury, R.; Gorelick, J. L.; McClure, S.

    2010-01-01

    Radiation Hardness Assurance (RHA) methodologies against Total Ionizing Dose (TID) degradation impose rigorous statistical treatments for data from a part's Radiation Lot Acceptance Test (RLAT) and/or its historical performance. However, no similar methods exist for using "similarity" data - that is, data for similar parts fabricated in the same process as the part under qualification. This is despite the greater difficulty and potential risk in interpreting of similarity data. In this work, we develop methods to disentangle part-to-part, lot-to-lot and part-type-to-part-type variation. The methods we develop apply not just for qualification decisions, but also for quality control and detection of process changes and other "out-of-family" behavior. We begin by discussing the data used in ·the study and the challenges of developing a statistic providing a meaningful measure of degradation across multiple part types, each with its own performance specifications. We then develop analysis techniques and apply them to the different data sets.

  3. 75 FR 80872 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... which it handles and executes odd lot and mixed lot orders.\\3\\ If CBSX is not displaying the NBBO and... mixed lot orders will be handled and executed in a more consistent manner with round lot orders. \\3\\ A... lot'' order is an order for a quantity that is less than 100. A ``mixed lot'' order is an order for a...

  4. The Mafia Visits a Middle School: How a Fight over Cookies Turned into a Test of Democracy

    ERIC Educational Resources Information Center

    Strachota, Bob

    2008-01-01

    Democracy is an ultimate test for human beings, holding that people are clever, generous, and persistent enough to solve power issues among themselves. This, of course, says the writer, is asking a lot of people, and centuries of evidence posit the idea as too idealistic. In this article, the author describes what he calls a pragmatic test on…

  5. Business Testing = BT. Test and Evaluation Methodology for Business Systems

    DTIC Science & Technology

    2010-05-12

    Not Intuitive Hard to Use Extensive Contractor Tail Stove Piped Systems Intelligence Transportation Logistics / Supply Finance Medical Human Resources...Capability 5 Politics Funding Requirements Busine s “IT” Acquisition Speed bumps Contracts Leadership Finance Testing Acquisition Engineering Security Legal... intelligent fool can make things bigger and more complex... It takes a touch of genius - and a lot of courage to move in the opposite direction

  6. The Interface of Interim Assessment and Feedback: An Opinion Paper

    ERIC Educational Resources Information Center

    Nodoushan, Mohammad Ali Salmani

    2011-01-01

    Many schools and educators prefer to use state tests. However, teachers can benefit a lot from the tests and quizzes they give in their classes over the course of a term or year. The minimum such tests can do is to afford information that teachers can use to assess how their class is learning and which changes in instruction need to be made to…

  7. Comprehensive analysis of statistical and model-based overlay lot disposition methods

    NASA Astrophysics Data System (ADS)

    Crow, David A.; Flugaur, Ken; Pellegrini, Joseph C.; Joubert, Etienne L.

    2001-08-01

    Overlay lot disposition algorithms in lithography occupy some of the highest leverage decision points in the microelectronic manufacturing process. In a typical large volume sub-0.18micrometers fab the lithography lot disposition decision is made about 500 times per day. Each decision will send a lot of wafers either to the next irreversible process step or back to rework in an attempt to improve unacceptable overlay performance. In the case of rework, the intention is that the reworked lot will represent better yield (and thus more value) than the original lot and that the enhanced lot value will exceed the cost of rework. Given that the estimated cost of reworking a critical-level lot is around 10,000 (based upon the opportunity cost of consuming time on a state-of-the-art DUV scanner), we are faced with the implication that the lithography lot disposition decision process impacts up to 5 million per day in decisions. That means that a 1% error rate in this decision process represents over 18 million per year lost in profit for a representative sit. Remarkably, despite this huge leverage, the lithography lot disposition decision algorithm usually receives minimal attention. In many cases, this lack of attention has resulted in the retention of sub-optimal algorithms from earlier process generations and a significant negative impact on the economic output of many high-volume manufacturing sites. An ideal lot- dispositioning algorithm would be an algorithm that results into the best economic decision being made every time - lots would only be reworked where the expected value (EV) of the reworked lot minus the expected value of the original lot exceeds the cost of the rework: EV(reworked lot)- EV(original lot)>COST(rework process) Calculating the above expected values in real-time has generally been deemed too complicated and maintenance-intensive to be practical for fab operations, so a simplified rule is typically used.

  8. Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: a randomized, double-blind, lot-to-lot consistency trial.

    PubMed

    Umeh, Rich; Oguche, Stephen; Oguonu, Tagbo; Pitmang, Simon; Shu, Elvis; Onyia, Jude-Tony; Daniyam, Comfort A; Shwe, David; Ahmad, Abdullahi; Jongert, Erik; Catteau, Grégory; Lievens, Marc; Ofori-Anyinam, Opokua; Leach, Amanda

    2014-11-12

    For regulatory approval, consistency in manufacturing of vaccine lots is expected to be demonstrated in confirmatory immunogenicity studies using two-sided equivalence trials. This randomized, double-blind study (NCT01323972) assessed consistency of three RTS,S/AS01 malaria vaccine batches formulated from commercial-scale purified antigen bulk lots in terms of anti-CS-responses induced. Healthy children aged 5-17 months were randomized (1:1:1:1) to receive RTS,S/AS01 at 0-1-2 months from one of three commercial-scale purified antigen bulk lots (1600 litres-fermentation scale; commercial-scale lots), or a comparator vaccine batch made from pilot-scale purified antigen bulk lot (20 litres-fermentation scale; pilot-scale lot). The co-primary objectives were to first demonstrate consistency of antibody responses against circumsporozoite (CS) protein at one month post-dose 3 for the three commercial-scale lots and second demonstrate non-inferiority of anti-CS antibody responses at one month post-dose 3 for the commercial-scale lots compared to the pilot-scale lot. Safety and reactogenicity were evaluated as secondary endpoints. One month post-dose-3, anti-CS antibody geometric mean titres (GMT) for the 3 commercial scale lots were 319.6 EU/ml (95% confidence interval (CI): 268.9-379.8), 241.4 EU/ml (207.6-280.7), and 302.3 EU/ml (259.4-352.3). Consistency for the RTS,S/AS01 commercial-scale lots was demonstrated as the two-sided 95% CI of the anti-CS antibody GMT ratio between each pair of lots was within the range of 0.5-2.0. GMT of the pooled commercial-scale lots (285.8 EU/ml (260.7-313.3)) was non-inferior to the pilot-scale lot (271.7 EU/ml (228.5-323.1)). Each RTS,S/AS01 lot had an acceptable tolerability profile, with infrequent reports of grade 3 solicited symptoms. No safety signals were identified and no serious adverse events were considered related to vaccination. RTS,S/AS01 lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response, and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. Compatibility and infectivity of a Cercospora rodmanii formulation with enhancing agents. Final report

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

    Pennington, J.C.; Theriot, E.A.

    1983-06-01

    A formulation of the fungus Cercospora rodmanii Conway has been produced, as a biocontrol of waterhyacinth (Eichhornia crassipes (Mart.) Solms.). To ensure the most efficient germination of the formulation, 12 potential enhancing agents were tested for addition during the spray application. The agents were aspartic acid, glucose, glutamic acid, gum xanthan, nutrient agar, Ortho X-77 Spreader, Tween 20, Tween 60, Tween 80, sodium alginate, Super Slupper, and yeast extract. Compatibility of test agents and combinations of test agents with two lots of the formulation was determined in the laboratory. All combinations of test agents were compatible with both lots ofmore » the C. rodmanii formulation. The C. rodmanii formulation was sprayed with test agents on waterhyacinth pseudolaminae. Damage was monitored each week for 8 weeks by assigning a disease index to each original and new pseudolaminae. No spots having characteristics suggestive of C. rodmanii infection were observed at any time during the study. Lack of infectivity could be remedied by isolating a virulent strain of C. rodmanii from the field. Agents determined to be compatible in this study could then be reexamined for enhancing infectivity on a virulent C. rodmanii formulation. 14 references, 2 figures, 5 tables.« less

  10. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios. Each lot of substandard pistachios may be reworked to meet aflatoxin or quality requirements. The... reporting. If a lot fails to meet the aflatoxin and/or the quality requirements of this part, a failed lot...

  11. Design, fabrication and test of graphite/polyimide composite joints and attachments for advanced aerospace vehicles

    NASA Technical Reports Server (NTRS)

    1980-01-01

    Principal program activities dealt with the literature survey, design of joint concepts, assessment of GR/PI material quality, fabrication of test panels and specimens, and small specimen testing. Bonded and bolted designs are presented for each of the four major attachment types. Quality control data are presented for prepreg Lots 2W4651 and 3W2020. Preliminary design allowables test results for tension tests and compression tests of laminates are also presented.

  12. DuPont Qualicon BAX System assay for genus Listeria 24E.

    PubMed

    Wallace, F Morgan; Fallon, Dawn; DeMarco, Daniel; Varkey, Stephen

    2011-01-01

    The new BAX System PCR Assay for Genus Listeria 24E was evaluated for detecting Listeria spp. in frankfurters, spinach, cooked shrimp, queso fresco cheese, and on stainless steel surfaces with a single-stage enrichment in BAX System 24 Listeria Enrichment Broth (24 LEB). Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent or superior to the U.S. Food and Drug Administration's Bacteriological Analytical Manual and the U.S. Department of Agriculture-Food Safety and Inspection Service culture methods, but with a significantly shorter time to result. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined, within the range of deviations from specified parameters examined, affect the performance of the assay.

  13. Catching fly balls in virtual reality: a critical test of the outfielder problem.

    PubMed

    Fink, Philip W; Foo, Patrick S; Warren, William H

    2009-12-14

    How does a baseball outfielder know where to run to catch a fly ball? The "outfielder problem" remains unresolved, and its solution would provide a window into the visual control of action. It may seem obvious that human action is based on an internal model of the physical world, such that the fielder predicts the landing point based on a mental model of the ball's trajectory (TP). However, two alternative theories, Optical Acceleration Cancellation (OAC) and Linear Optical Trajectory (LOT), propose that fielders are led to the right place at the right time by coupling their movements to visual information in a continuous "online" manner. All three theories predict successful catches and similar running paths. We provide a critical test by using virtual reality to perturb the vertical motion of the ball in mid-flight. The results confirm the predictions of OAC but are at odds with LOT and TP.

  14. Assessing gull abundance and food availability in urban parking lots

    USGS Publications Warehouse

    Clark, Daniel E.; Whitney, Jillian J.; MacKenzie, Kenneth G.; Koenen, Kiana K. G.; DeStefano, Stephen

    2015-01-01

    Feeding birds is a common activity throughout the world; yet, little is known about the extent of feeding gulls in urban areas. We monitored 8 parking lots in central Massachusetts, USA, during the fall and winter of 2011 to 2013 in 4 monitoring sessions to document the number of gulls present, the frequency of human–gull feeding interactions, and the effectiveness of signage and direct interaction in reducing human-provisioned food. Parking lots were divided between “education” and “no-education” lots. In education lots, we erected signs about problems caused when people feed birds and also asked people to stop feeding birds. We did not erect signs or ask people to stop feeding birds at no-education lots. We spent >1,200 hours in parking lots (range = 136 to 200 hours per parking lot), and gulls were counted every 20 minutes. We conducted >4,000 counts, and ring-billed gulls (Lorus delawarensis) accounted for 98% of all gulls. Our educational efforts were minimally effective. There were fewer feedings (P = 0.01) in education lots during one of the monitoring sessions but significantly more gulls (P = 0.008) in education lots during 2 monitoring sessions. While there was a marginal decrease (P = 0.055) in the number of feedings after no-education lots were transformed into education lots, there was no difference in gull numbers in these lots (P = 0.16). Education appears to have some influence in reducing the number of people feeding gulls, but our efforts were not able to reduce the number of human feeders or the amount of food enough to influence the number of gulls using parking lots.

  15. Biological Rhythms Modelisation of Vigilance and Sleep in Microgravity State with COSINOR and Volterra's Kernels Methods

    NASA Astrophysics Data System (ADS)

    Gaudeua de Gerlicz, C.; Golding, J. G.; Bobola, Ph.; Moutarde, C.; Naji, S.

    2008-06-01

    The spaceflight under microgravity cause basically biological and physiological imbalance in human being. Lot of study has been yet release on this topic especially about sleep disturbances and on the circadian rhythms (alternation vigilance-sleep, body, temperature...). Factors like space motion sickness, noise, or excitement can cause severe sleep disturbances. For a stay of longer than four months in space, gradual increases in the planned duration of sleep were reported. [1] The average sleep in orbit was more than 1.5 hours shorter than the during control periods on earth, where sleep averaged 7.9 hours. [2] Alertness and calmness were unregistered yield clear circadian pattern of 24h but with a phase delay of 4h.The calmness showed a biphasic component (12h) mean sleep duration was 6.4 structured by 3-5 non REM/REM cycles. Modelisations of neurophysiologic mechanisms of stress and interactions between various physiological and psychological variables of rhythms have can be yet release with the COSINOR method. [3

  16. A review on oral liquid as an emerging technology in controlled drug delivery system.

    PubMed

    Torne, Sangmesh Raosaheb; Sheela, Angappan; Sarada, N C

    2017-12-03

    The oral liquid drug delivery system (OLDDS) remains as the primary choice of dosage form, though challenging, for the pharmaceutical scientists. In the last two decades, Oral Liquid Controlled Release (OLCR) formulation has gained a lot of attention because of its advantages over the conventional dosage forms. The world of nanotechnology has paved multiple ways to administer the drug through oral cavity in liquid dosage form with an additional advantage of control over the release. In the current study, the various approaches towards the same have been discussed comprehensively to understand the different mechanisms of OLCR. This review also emphasizes on the existing techniques and the developments that have been made to improve on its efficacy including various formulation related factors. It also provides valuable insights into the role of polymers in the development of OLCR formulation that can be used in the management of Gastroesophageal reflux disease (GERD). Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  17. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  18. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  19. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  20. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  1. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  2. The Impact of Use of Manipulatives on the Math Scores of Grade 2 Students

    ERIC Educational Resources Information Center

    Liggett, Robert Scott

    2017-01-01

    Today's society places a lot of pressure on schools, teachers, and students to improve test scores. This paper discusses the possibility of using mathematical manipulatives to improve student test scores and students' attitudes towards mathematics. Forty-three Grade 2 students with age ranges between six and eight from a rural town in Saskatchewan…

  3. A Confirmatory Factor Analysis of the Life Orientation Test-Revised with Competitive Athletes

    ERIC Educational Resources Information Center

    Appaneal, Renee N.

    2012-01-01

    Current reviews outside of sport indicate that the Life Orientation Test-Revised (LOT-R) items load on two separate factors (optimism and pessimism) and, therefore, should be treated as independent constructs. However, researchers in the sport sciences continue to use the single composite score reflecting a unidimensional definition of optimism.…

  4. The Language Policy of State Drivers' License Testing: Expediency, Symbolism, or Creeping Incrementalism?

    ERIC Educational Resources Information Center

    Schiffman, Harold F.; Weiner, Richard E.

    2012-01-01

    Until recently, educational language policy in the US has been the chief site of contention about language, as seen in recent initiatives, referenda, and state constitutional amendments. Provision for drivers' licensing testing in languages other than English (LotE), on the other hand, has often exemplified what we call expedient language policy,…

  5. 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.

  6. 46 CFR 160.024-4 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... every ten lots of signals produced, except that the number of technical tests must be at least one but.... (Table 160.024-4(c)(2)) is assigned a score (failure percent) in accordance with the table. In the case... satisfactorily when shot from a pistol of the type described in subpart 160.028. The parachute and pyrotechnic...

  7. 46 CFR 160.024-4 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... every ten lots of signals produced, except that the number of technical tests must be at least one but.... (Table 160.024-4(c)(2)) is assigned a score (failure percent) in accordance with the table. In the case... satisfactorily when shot from a pistol of the type described in subpart 160.028. The parachute and pyrotechnic...

  8. 46 CFR 160.024-4 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... every ten lots of signals produced, except that the number of technical tests must be at least one but.... (Table 160.024-4(c)(2)) is assigned a score (failure percent) in accordance with the table. In the case... satisfactorily when shot from a pistol of the type described in subpart 160.028. The parachute and pyrotechnic...

  9. 78 FR 51742 - Notice of Proposed Withdrawal and Opportunity for Public Meeting; California

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ..., inclusive, and SE\\1/ 4\\NE\\1/4\\; sec. 26, lots 11, 12, and 13, S\\1/2\\SE\\1/4\\NE\\1/4\\, and N\\1/ 2\\NE\\1/4\\SE\\1/4..., lots 13 to 16, inclusive, and 18 to 22, inclusive, and a portion of lot 8 as described in the Donation... platted. sec. 19, lots 11, 13, and 16 to 19, inclusive; sec. 20, lot 4; sec. 29, lots 7 and 11; sec. 32...

  10. Growth of Salmonella during sprouting of alfalfa seeds associated with salmonellosis outbreaks.

    PubMed

    Stewart, D S; Reineke, K F; Ulaszek, J M; Tortorello, M L

    2001-05-01

    Growth of Salmonella was assessed during sprouting of naturally contaminated alfalfa seeds associated with two outbreaks of salmonellosis. Salmonella was determined daily in sprouts and sprout rinse water samples by a three-tube most probable number (MPN) procedure and a commercial enzyme immunoassay (EIA). Growth of Salmonella in the sprouts was reflected in the rinse water, and the MPNs of the two samples were generally in agreement within approximately 1 log. The results from EIA testing of sprouts and water samples were also in agreement. The pathogen was present in the seed at less than 1 MPN/g, and it increased in number to maximum population levels of 102 to 10(3) MPN/g in one seed lot and 10(2) to 10(4) MPN/ g in the other seed lot. Maximum populations of the pathogen were apparent by day 2 of sprouting. These results show the ability of the pathogen to grow to detectable levels during the sprouting process, and they provide support for the recommendation to test the sprout water for the presence of pathogens 48 h after starting seed sprouting. The effectiveness of a 10-min, 20,0000-microg/ml (ppm) calcium hypochlorite treatment of the outbreak-associated seeds was studied. For both seed lots, the hypochlorite treatment caused a reduction, but not elimination, of Salmonella contamination in the finished sprouts. These results confirm the need to test each production batch for the presence of pathogens, even after 20,000 microg/ml (ppm) hypochlorite treatment of seeds, so that contaminated product is not distributed.

  11. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study.

    PubMed

    Torresi, Joseph; Heron, Leon G; Qiao, Ming; Marjason, Joanne; Chambonneau, Laurent; Bouckenooghe, Alain; Boaz, Mark; van der Vliet, Diane; Wallace, Derek; Hutagalung, Yanee; Nissen, Michael D; Richmond, Peter C

    2015-09-22

    The recombinant yellow fever-17D-dengue virus, live, attenuated, tetravalent dengue vaccine (CYD-TDV) has undergone extensive clinical trials. Here safety and consistency of immunogenicity of phase III manufacturing lots of CYD-TDV were evaluated and compared with a phase II lot and placebo in a dengue-naïve population. Healthy 18-60 year-olds were randomly assigned in a 3:3:3:3:1 ratio to receive three subcutaneous doses of either CYD-TDV from any one of three phase III lots or a phase II lot, or placebo, respectively in a 0, 6, 12 month dosing schedule. Neutralising antibody geometric mean titres (PRNT50 GMTs) for each of the four dengue serotypes were compared in sera collected 28 days after the third vaccination-equivalence among lots was demonstrated if the lower and upper limits of the two-sided 95% CIs of the GMT ratio were ≥0.5 and ≤2.0, respectively. 712 participants received vaccine or placebo and 614 (86%) completed the study; 17 (2.4%) participants withdrew after adverse events. Equivalence of phase III lots was demonstrated for 11 of 12 pairwise comparisons. One of three comparisons for serotype 2 was not statistically equivalent. GMTs for serotype 2 in phase III lots were close to each other (65.9, 44.1 and 58.1, respectively). Phase III lots can be produced in a consistent manner with predictable immune response and acceptable safety profile similar to previously characterised phase II lots. The phase III lots may be considered as not clinically different as statistical equivalence was shown for serotypes 1, 3 and 4 across the phase III lots. For serotype 2, although equivalence was not shown between two lots, the GMTs observed in the phase III lots were consistently higher than those for the phase II lot. As such, in our view, biological equivalence for all serotypes was demonstrated. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Ni-MH storage test and cycle life test

    NASA Technical Reports Server (NTRS)

    Dell, R. Dan; Klein, Glenn C.; Schmidt, David F.

    1994-01-01

    Gates Aerospace Batteries is conducting two long term test programs to fully characterize the NiMH cell technology for aerospace applications. The first program analyzes the effects of long term storage upon cell performance. The second program analyzes cycle life testing and preliminary production lot testing. This paper summarizes these approaches to testing the NiMH couple and culminates with initial storage and testing recommendations. Long term storage presents challenges to deter the adverse condition of capacity fade in NiMH cells. Elevated but stabilized pressures and elevated but stabilized end-of-charge voltages also appear to be a characteristic phenomenon of long term storage modes. However, the performance degradation is dependent upon specific characteristics of the metal-hydride alloy. To date, there is no objective evidence with which to recommend the proper method for storage and handling of NiMH cells upon shipment. This is particularly critical due to limited data points that indicate open circuit storage at room temperature for 60 to 90 days will result in irrecoverable capacity loss. Accordingly a test plan was developed to determine what method of mid-term to long-term storage will prevent irrecoverable capacity loss. The explicit assumption is that trickle charging at some rate above the self-discharge rate will prevent the irreversible chemical changes to the negative electrode that result in the irrecoverable capacity loss. Another premise is that lower storage temperatures, typically 0 C for aerospace customers, will impede any negative chemical reactions. Three different trickle charge rates are expected to yield a fairly flat response with respect to recoverable capacity versus baseline cells in two different modes of open circuit. Specific attributes monitored include: end-of-charge voltage, end-of-charge pressure, mid-point discharge voltage, capacity, and end-of-discharge pressure. Cycle life testing and preliminary production lot testing continue to dominate the overall technology development effort at GAB. The cell life test program reflects continuing improvements in baseline cell designs. Performance improvements include lower and more stable charge voltages and pressures. The continuing review of production lot testing assures conformance to the design criteria and expectations. This is especially critical during this period of transferring technology from research and development status to production.

  13. Facility or Facilities? That is the Question.

    NASA Astrophysics Data System (ADS)

    Viso, M.

    2018-04-01

    The management of the martian samples upon arrival on the Earth will require a lot of work to ensure a safe life detection and biohazard testing during the quarantine. This will induce a sharing of the load between several facilities.

  14. Dealing with Dementia: When Thinking and Behavior Decline

    MedlinePlus

    ... a lot of research is focusing on the pre-symptomatic stages of the disease, where we can see evidence of amyloid protein before a person has any symptoms. We can test to see if medications can slow or prevent ...

  15. 21 CFR 601.51 - Confidentiality of data and information in applications for biologics licenses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and... chapter. (8) All records showing the testing of and action on a particular lot by the Food and Drug...

  16. 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.

  17. The action of ether and methoxyflurane on synaptic transmission in isolated preparations of the mammalian cortex.

    PubMed Central

    Richards, C D; Russell, W J; Smaje, J C

    1975-01-01

    1. The actions of ether and methoxyflurane on the evoked potentials of in vitro preparations of the guinea-pig olfactory cortex were studied. Following stimulation of the lateral olfactory tract (l.o.t.) evoked potentials could be recorded from the cortical surface; these potentials consisted of an initial wave (the compound action potential of the l.o.t.) followed by a negative field potential which was associated with the synchronous excitation of many superficial excitatory synapses (population e.p.s.p.). Superimposed on the population e.p.s.p. was a number of positive peaks. These positive peaks reflect the synchronous discharge of many neurones and so have been called population spikes. 2. When ether or methoxyflurane was added to the gas stream that superfused the surface of the preparations, the population e.p.s.p.s. and population spikes were depressed at lower concentrations than those required to depress the compound action potential of the afferent fibres. 3. The evoked activity of individual cells in the cortex was depressed by ether and methoxyflurane. However, five of the twelve cells tested in ether showed an increase in their evoked activity at concentrations below 4-5%, but at higher concentrations these cells also became depressed. 4. Both ether and methoxyflurane depressed the sensitivity of cortical neurones to iontophoretically applied L-glutamate and may similarly depress the sensitivity of the post-synaptic membrane to the released transmitter substance. 5. Neither anaesthetic appeared to increase the threshold depolarization required for nerve impulse generation. Thus, the decrease of the discharge of the post-synaptic cells was primarily caused by a depression of chemical transmission. 6. Ether caused some cells in the cortex to alter their normal pattern of synaptically evoked discharge and both anaesthetics induced similar changes during excitation by glutamate. PMID:168356

  18. Statistical distribution of building lot frontage: application for Tokyo downtown districts

    NASA Astrophysics Data System (ADS)

    Usui, Hiroyuki

    2018-03-01

    The frontage of a building lot is the determinant factor of the residential environment. The statistical distribution of building lot frontages shows how the perimeters of urban blocks are shared by building lots for a given density of buildings and roads. For practitioners in urban planning, this is indispensable to identify potential districts which comprise a high percentage of building lots with narrow frontage after subdivision and to reconsider the appropriate criteria for the density of buildings and roads as residential environment indices. In the literature, however, the statistical distribution of building lot frontages and the density of buildings and roads has not been fully researched. In this paper, based on the empirical study in the downtown districts of Tokyo, it is found that (1) a log-normal distribution fits the observed distribution of building lot frontages better than a gamma distribution, which is the model of the size distribution of Poisson Voronoi cells on closed curves; (2) the statistical distribution of building lot frontages statistically follows a log-normal distribution, whose parameters are the gross building density, road density, average road width, the coefficient of variation of building lot frontage, and the ratio of the number of building lot frontages to the number of buildings; and (3) the values of the coefficient of variation of building lot frontages, and that of the ratio of the number of building lot frontages to that of buildings are approximately equal to 0.60 and 1.19, respectively.

  19. Experimental and computational correlation of fracture parameters KIc, JIc, and GIc for unimodular and bimodular graphite components

    NASA Astrophysics Data System (ADS)

    Bhushan, Awani; Panda, S. K.

    2018-05-01

    The influence of bimodularity (different stress ∼ strain behaviour in tension and compression) on fracture behaviour of graphite specimens has been studied with fracture toughness (KIc), critical J-integral (JIc) and critical strain energy release rate (GIc) as the characterizing parameter. Bimodularity index (ratio of tensile Young's modulus to compression Young's modulus) of graphite specimens has been obtained from the normalized test data of tensile and compression experimentation. Single edge notch bend (SENB) testing of pre-cracked specimens from the same lot have been carried out as per ASTM standard D7779-11 to determine the peak load and critical fracture parameters KIc, GIc and JIc using digital image correlation technology of crack opening displacements. Weibull weakest link theory has been used to evaluate the mean peak load, Weibull modulus and goodness of fit employing two parameter least square method (LIN2), biased (MLE2-B) and unbiased (MLE2-U) maximum likelihood estimator. The stress dependent elasticity problem of three-dimensional crack progression behaviour for the bimodular graphite components has been solved as an iterative finite element procedure. The crack characterizing parameters critical stress intensity factor and critical strain energy release rate have been estimated with the help of Weibull distribution plot between peak loads versus cumulative probability of failure. Experimental and Computational fracture parameters have been compared qualitatively to describe the significance of bimodularity. The bimodular influence on fracture behaviour of SENB graphite has been reflected on the experimental evaluation of GIc values only, which has been found to be different from the calculated JIc values. Numerical evaluation of bimodular 3D J-integral value is found to be close to the GIc value whereas the unimodular 3D J-value is nearer to the JIc value. The significant difference between the unimodular JIc and bimodular GIc indicates that GIc should be considered as the standard fracture parameter for bimodular brittle specimens.

  20. Molecular weight analyses and enzymatic degradation profiles of the soft-tissue fillers Belotero Balance, Restylane, and Juvéderm Ultra.

    PubMed

    Flynn, Timothy Corcoran; Thompson, David H; Hyun, Seok-Hee

    2013-10-01

    In this study, the authors sought to determine the molecular weight distribution of three hyaluronic acids-Belotero Balance, Restylane, and Juvéderm Ultra-and their rates of degradation following exposure to hyaluronidase. Lot consistency of Belotero Balance also was analyzed. Three lots of Belotero Balance were analyzed using liquid chromatography techniques. The product was found to have high-molecular-weight and low-molecular-weight species. One lot of Belotero Balance was compared to one lot each of Juvéderm Ultra and Restylane. Molecular weights of the species were analyzed. The hyaluronic acids were exposed to ovine testicular hyaluronidase at six time points-baseline and 0.5, 1, 2, 6, and 24 hours-to determine degradation rates. Belotero Balance lots were remarkably consistent. Belotero Balance had the largest high-molecular-weight species, followed by Juvéderm Ultra and Restylane (p < 0.001). Low-molecular-weight differences among all three hyaluronic acids were not statistically significant. Percentages of high-molecular-weight polymer differ among the three materials, with Belotero Balance having the highest fraction of high-molecular-weight polymer. Degradation of the high-molecular-weight species over time showed different molecular weights of the high-molecular-weight fraction. Rates of degradation of the hyaluronic acids following exposure to ovine testicular hyaluronidase were similar. All hyaluronic acids were fully degraded at 24 hours. Fractions of high-molecular-weight polymer differ across the hyaluronic acids tested. The low-molecular-weight differences are not statistically significant. The high-molecular-weight products have different molecular weights at the 0.5- and 2-hour time points when exposed to ovine testicular hyaluronidase and are not statistically different at 24 hours.

  1. Carbon dioxide and methane emissions from the scale model of open dairy lots.

    PubMed

    Ding, Luyu; Cao, Wei; Shi, Zhengxiang; Li, Baoming; Wang, Chaoyuan; Zhang, Guoqiang; Kristensen, Simon

    2016-07-01

    To investigate the impacts of major factors on carbon loss via gaseous emissions, carbon dioxide (CO2) and methane (CH4) emissions from the ground of open dairy lots were tested by a scale model experiment at various air temperatures (15, 25, and 35 °C), surface velocities (0.4, 0.7, 1.0, and 1.2 m sec(-1)), and floor types (unpaved soil floor and brick-paved floor) in controlled laboratory conditions using the wind tunnel method. Generally, CO2 and CH4 emissions were significantly enhanced with the increase of air temperature and velocity (P < 0.05). Floor type had different effects on the CO2 and CH4 emissions, which were also affected by air temperature and soil characteristics of the floor. Although different patterns were observed on CH4 emission from the soil and brick floors at different air temperature-velocity combinations, statistical analysis showed no significant difference in CH4 emissions from different floors (P > 0.05). For CO2, similar emissions were found from the soil and brick floors at 15 and 25 °C, whereas higher rates were detected from the brick floor at 35 °C (P < 0.05). Results showed that CH4 emission from the scale model was exponentially related to CO2 flux, which might be helpful in CH4 emission estimation from manure management. Gaseous emissions from the open lots are largely dependent on outdoor climate, floor systems, and management practices, which are quite different from those indoors. This study assessed the effects of floor types and air velocities on CO2 and CH4 emissions from the open dairy lots at various temperatures by a wind tunnel. It provided some valuable information for decision-making and further studies on gaseous emissions from open lots.

  2. Radiological effluents released from US continental tests, 1961 through 1992. Revision 1

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

    Schoengold, C.R.; DeMarre, M.E.; Kirkwood, E.M.

    1996-08-01

    This report documents all continental tests from September 15, 1961, through September 23, 1992, from which radioactive effluents were released. The report includes both updated information previously published in the publicly available May, 1990 report, DOE/NV-317, ``Radiological Effluents Released from Announced US Continental Tests 1961 through 1988``, and effluent release information on formerly unannounced tests. General information provided for each test includes the date, time, location, type of test, sponsoring laboratory and/or agency or other sponsor, depth of burial, purpose, yield or yield range, extent of release (onsite only or offsite), and category of release (detonation-time versus post-test operations). Wheremore » a test with simultaneous detonations is listed, location, depth of burial and yield information are given for each detonation if applicable, as well as the specific source of the release. A summary of each release incident by type of release is included. For a detonation-time release, the effluent curies are expressed at R+12 hours. For a controlled releases from tunnel-tests, the effluent curies are expressed at both time of release and at R+12 hours. All other types are listed at the time of the release. In addition, a qualitative statement of the isotopes in the effluent is included for detonation-time and controlled releases and a quantitative listing is included for all other types. Offsite release information includes the cloud direction, the maximum activity detected in the air offsite, the maximum gamma exposure rate detected offsite, the maximum iodine level detected offsite, and the maximum distance radiation was detected offsite. A release summary incudes whatever other pertinent information is available for each release incident. This document includes effluent release information for 433 tests, some of which have simultaneous detonations. However, only 52 of these are designated as having offsite releases.« less

  3. Forecast horizon of multi-item dynamic lot size model with perishable inventory.

    PubMed

    Jing, Fuying; Lan, Zirui

    2017-01-01

    This paper studies a multi-item dynamic lot size problem for perishable products where stock deterioration rates and inventory costs are age-dependent. We explore structural properties in an optimal solution under two cost structures and develop a dynamic programming algorithm to solve the problem in polynomial time when the number of products is fixed. We establish forecast horizon results that can help the operation manager to decide the precise forecast horizon in a rolling decision-making process. Finally, based on a detailed test bed of instance, we obtain useful managerial insights on the impact of deterioration rate and lifetime of products on the length of forecast horizon.

  4. Forecast horizon of multi-item dynamic lot size model with perishable inventory

    PubMed Central

    Jing, Fuying

    2017-01-01

    This paper studies a multi-item dynamic lot size problem for perishable products where stock deterioration rates and inventory costs are age-dependent. We explore structural properties in an optimal solution under two cost structures and develop a dynamic programming algorithm to solve the problem in polynomial time when the number of products is fixed. We establish forecast horizon results that can help the operation manager to decide the precise forecast horizon in a rolling decision-making process. Finally, based on a detailed test bed of instance, we obtain useful managerial insights on the impact of deterioration rate and lifetime of products on the length of forecast horizon. PMID:29125856

  5. [Characterization and comparison of interferon reference standards using UPLC-MS].

    PubMed

    Tao, Lei; Pei, De-ning; Han, Chun-mei; Chen, Wei; Rao, Chun-ming; Wang, Jun-zhi

    2015-01-01

    The study aims to characterize and compare interferon reference standards from 5 manufacturers. By testing molecular mass and trypsin-digested peptide mass mapping, the amino acid sequence was verified and post-translational modifications such as disulfide bond were identified. Results show that the molecular mass and amino acid sequence were consistent with theory; the disulfide bonds of 4 lots of interferon were Cys1-Cys98/Cys29-Cys138, 1 lot was Cys29-Cys139/Cys86-Cys99; N-terminal "+Met", acetyl N-terminal and Met oxidation were identified in part of the sample. UPLC-MS can be used to characterize and compare interferon reference standards from different manufacturers.

  6. Quality issues with malaria rapid diagnostic test accessories and buffer packaging: findings from a 5-country private sector project in Africa.

    PubMed

    Harvey, Steven A; Incardona, Sandra; Martin, Nina; Lussiana, Cristina; Streat, Elizabeth; Dolan, Stephanie; Champouillon, Nora; Kyabayinze, Daniel J; Mugerwa, Robert; Nakanwagi, Grace; Njoki, Nancy; Rova, Ratsimandisa; Cunningham, Jane

    2017-04-20

    Use of antigen-detecting malaria rapid diagnostic tests (RDTs) has increased exponentially over the last decade. WHO's Global Malaria Programme, FIND, and other collaborators have established a quality assurance scheme to guide product selection, lot verification, transport, storage, and training procedures. Recent concerns over the quality of buffer packaging and test accessories suggest a need to include these items in product assessments. This paper describes quality problems with buffer and accessories encountered in a project promoting private sector RDT use in five African countries and suggests steps to avoid or more rapidly identify and resolve such problems. Private provider complaints about RDT buffer vials and kit accessories were collected during supervisory visits, and a standard assessment process was developed. Using 100 tests drawn from six different lots produced by two manufacturers, lab technicians visually assessed alcohol swab packaging, blood transfer device (BTD) usability, and buffer appearance, then calculated mean blood volume from 10 BTD transfers and mean buffer volume from 10 individual buffer vials. WHO guided complaint reporting and follow-up with manufacturers. Supervisory visits confirmed user reports of dry alcohol swabs, poorly functioning BTDs, and non-uniform volumes of buffer. Lot testing revealed further evidence of quality problems, leading one manufacturer to replace buffer vials and accessories for 40,000 RDTs. In December 2014, WHO issued an Information Notice for Users regarding variable buffer volumes in single-use vials and recommended against procurement of these products until defects were addressed. Though not necessarily comprehensive or generalizable, the findings presented here highlight the need for extending quality assessment to all malaria RDT test kit contents. Defects such as those described in this paper could reduce test accuracy and increase probability of invalid, false positive, or false negative results. Such deficiencies could undermine provider confidence in RDTs, prompting a return to presumptive treatment or reliance on poor quality microscopy. In partial response to this experience, WHO, FIND, and other project partners have developed guidance on documenting, troubleshooting, reporting, and resolving such problems when they occur.

  7. 76 FR 72469 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ...-lot'' order is an order for a quantity that is less than 100. A ``mixed-lot'' order is an order for a... mixed-lot order) are processed in the same manner as are round-lot orders, except (i) If an incoming odd... mixed-lot orders of HOLDRS in accordance with Rule 52.8, as described above. However, the prospectuses...

  8. Can “Cleaned and Greened” Lots Take on the Role of Public Greenspace?

    Treesearch

    Megan Heckert; Michelle Kondo

    2018-01-01

    Cities are increasingly greening vacant lots to reduce blight. Such programs could reduce inequities in urban greenspace access, but whether and how greened lots are used remains unclear. We surveyed three hundred greened lots in Philadelphia for signs of use and compared characteristics of used and nonused lots. We found physical signs of use that might be found in...

  9. The use of knowledge-based Genetic Algorithm for starting time optimisation in a lot-bucket MRP

    NASA Astrophysics Data System (ADS)

    Ridwan, Muhammad; Purnomo, Andi

    2016-01-01

    In production planning, Material Requirement Planning (MRP) is usually developed based on time-bucket system, a period in the MRP is representing the time and usually weekly. MRP has been successfully implemented in Make To Stock (MTS) manufacturing, where production activity must be started before customer demand is received. However, to be implemented successfully in Make To Order (MTO) manufacturing, a modification is required on the conventional MRP in order to make it in line with the real situation. In MTO manufacturing, delivery schedule to the customers is defined strictly and must be fulfilled in order to increase customer satisfaction. On the other hand, company prefers to keep constant number of workers, hence production lot size should be constant as well. Since a bucket in conventional MRP system is representing time and usually weekly, hence, strict delivery schedule could not be accommodated. Fortunately, there is a modified time-bucket MRP system, called as lot-bucket MRP system that proposed by Casimir in 1999. In the lot-bucket MRP system, a bucket is representing a lot, and the lot size is preferably constant. The time to finish every lot could be varying depends on due date of lot. Starting time of a lot must be determined so that every lot has reasonable production time. So far there is no formal method to determine optimum starting time in the lot-bucket MRP system. Trial and error process usually used for it but some time, it causes several lots have very short production time and the lot-bucket MRP would be infeasible to be executed. This paper presents the use of Genetic Algorithm (GA) for optimisation of starting time in a lot-bucket MRP system. Even though GA is well known as powerful searching algorithm, however, improvement is still required in order to increase possibility of GA in finding optimum solution in shorter time. A knowledge-based system has been embedded in the proposed GA as the improvement effort, and it is proven that the improved GA has superior performance when used in solving a lot-bucket MRP problem.

  10. Single-Event Transient Testing of the Crane Aerospace and Electronics SMHF2812D Dual DC-DC Converter

    NASA Technical Reports Server (NTRS)

    Casey, Megan

    2015-01-01

    The purpose of this testing was to characterize the Crane Aerospace & Electronics (Crane) Interpoint SMHF2812D for single-event transient (SET) susceptibility. These data shall be used for flight lot evaluation, as well as qualification by similarity of the SMHF family of converters, all of which use the same active components.

  11. 75 FR 13332 - Office of Hazardous Materials Safety; Notice of Application for Special Permits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    ... months and in section 8.e. add ``e.e. radiation sensor'' after ``Each packaging manufactured''. 10049-M... the one-per- heat flawed cylinder pressure test with a one-per-lot burst test; and add 3 new drawings for pressure 4500, 5000, and 6000 psi with the new steel chemistry. 11489-M TRW, Washington, MI 49 CFR...

  12. A Portable Burn Pan for the Disposal of Gun Propellants

    DTIC Science & Technology

    2016-11-01

    Scorching of vegetation in vacinity of burn pan caused by radiant heat .............................. 39 11 Wet propellant (12-0 kg burn) and dry ...45 14 IR Camera thermal image 30 seconds after a test burn ........................................................ 46 15 Commander...so that setting up tests was a lot easier than anticipated. Dr. Packer also fully embraced the concept, requesting background reports and papers as

  13. Advanced Combat Helmet Technical Assessment

    DTIC Science & Technology

    2013-05-29

    Lastly, we assessed the participation of various stakeholders and industry experts such as active ACH manufacturers and test facilities. Findings... industrially accepted American National Standards Institute (ANSI Z1.4-2008, Sampling Visit us on the web at www.dodig.mil Results in Brief Advanced...statistically principled approach and the lot acceptance test protocol adopts a widely established and industrially accepted sampling procedure. We

  14. 21 CFR 601.51 - Confidentiality of data and information in applications for biologics licenses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... chapter. (8) All records showing the testing of and action on a particular lot by the Food and Drug... of a biological product on animals and humans and all studies and tests on the drug for identity... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Confidentiality of data and information in...

  15. 21 CFR 601.51 - Confidentiality of data and information in applications for biologics licenses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... chapter. (8) All records showing the testing of and action on a particular lot by the Food and Drug... of a biological product on animals and humans and all studies and tests on the drug for identity... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Confidentiality of data and information in...

  16. 21 CFR 601.51 - Confidentiality of data and information in applications for biologics licenses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... chapter. (8) All records showing the testing of and action on a particular lot by the Food and Drug... of a biological product on animals and humans and all studies and tests on the drug for identity... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Confidentiality of data and information in...

  17. Evaluation program for secondary spacecraft cells: Initial evaluation tests of General Electric Company 12.0 ampere-hour nickel-cadmium spacecraft cells for the international ultraviolet explorer

    NASA Technical Reports Server (NTRS)

    Harkness, J. D.

    1976-01-01

    An evaluation test program was conducted to insure that all cells put into the life cycle program are of high quality by the screening of cells found to have electrolyte leakage, internal shorts, low capacity, or inability of any cell to recover its open-circuit voltage above 1.150 volts during the internal short test. The 20 cells were manufactured for the National Aeronautics and Space Administration, Goddard Space Flight Center (GSFC). The cells are from a lot of 175 cells procured for the International Ultraviolet Explorer project. Due to a change in requirements, the project selected to use 6.0 ampere-hour cells. Therefore, the remaining cells of this lot have been placed in storage at GSFC for use on a future GSFC project. All the cells are rated at 12.0 ampere-hours and contain double ceramic seals. Test limits specify those values in which a cell is to be terminated from a particular charge or discharge. Requirements are referred to as normally expected values based on past performance of aerospace nickel cadmium cells with demonstrated life characteristics.

  18. Diagnostic Accuracy and Feasibility of Serological Tests on Filter Paper Samples for Outbreak Detection of T.b. gambiense Human African Trypanosomiasis

    PubMed Central

    Hasker, Epco; Lutumba, Pascal; Mumba, Dieudonné; Lejon, Veerle; Büscher, Phillipe; Kande, Victor; Muyembe, Jean Jacques; Menten, Joris; Robays, Jo; Boelaert, Marleen

    2010-01-01

    Control of human African trypanosomiasis (HAT) in the Democratic Republic of Congo is based on mass population screening by mobile teams; a costly and labor-intensive approach. We hypothesized that blood samples collected on filter paper by village health workers and processed in a central laboratory might be a cost-effective alternative. We estimated sensitivity and specificity of micro-card agglutination test for trypanosomiasis (micro-CATT) and enzyme-linked immunosorbent assay (ELISA)/T.b. gambiense on filter paper samples compared with parasitology-based case classification and used the results in a Monte Carlo simulation of a lot quality assurance sampling (LQAS) approach. Micro-CATT and ELISA/T.b. gambiense showed acceptable sensitivity (92.7% [95% CI 87.4–98.0%] and 82.2% [95% CI 75.3–90.4%]) and very high specificity (99.4% [95% CI 99.0–99.9%] and 99.8% [95% CI 99.5–100%]), respectively. Conditional on high sample size per lot (≥ 60%), both tests could reliably distinguish a 2% from a zero prevalence at village level. Alternatively, these tests could be used to identify individual HAT suspects for subsequent confirmation. PMID:20682885

  19. 12 CFR 1011.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... lot is suitable for a septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from...

  20. 12 CFR 1011.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... lot is suitable for a septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from...

  1. 12 CFR 1011.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... lot is suitable for a septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from...

  2. Statistical assessment of DNA extraction reagent lot variability in real-time quantitative PCR

    USGS Publications Warehouse

    Bushon, R.N.; Kephart, C.M.; Koltun, G.F.; Francy, D.S.; Schaefer, F. W.; Lindquist, H.D. Alan

    2010-01-01

    Aims: The aim of this study was to evaluate the variability in lots of a DNA extraction kit using real-time PCR assays for Bacillus anthracis, Francisella tularensis and Vibrio cholerae. Methods and Results: Replicate aliquots of three bacteria were processed in duplicate with three different lots of a commercial DNA extraction kit. This experiment was repeated in triplicate. Results showed that cycle threshold values were statistically different among the different lots. Conclusions: Differences in DNA extraction reagent lots were found to be a significant source of variability for qPCR results. Steps should be taken to ensure the quality and consistency of reagents. Minimally, we propose that standard curves should be constructed for each new lot of extraction reagents, so that lot-to-lot variation is accounted for in data interpretation. Significance and Impact of the Study: This study highlights the importance of evaluating variability in DNA extraction procedures, especially when different reagent lots are used. Consideration of this variability in data interpretation should be an integral part of studies investigating environmental samples with unknown concentrations of organisms. ?? 2010 The Society for Applied Microbiology.

  3. Exploring reserve lots of Cymbopogon citratus, Aloysia citrodora and Thymus × citriodorus as improved sources of phenolic compounds.

    PubMed

    Rita, Ingride; Pereira, Carla; Barros, Lillian; Ferreira, Isabel C F R

    2018-08-15

    Given the increasing consumers demand for novelty, tea companies have been presenting new added value products such as reserve lots of aromatic plants. Herein, infusions from different lots of three aromatic plants were assessed in terms of phenolic composition (HPLC-DAD-ESI/MS) and antioxidant properties (reducing power, free radical scavenging and lipid peroxidation inhibition capacity). Cymbopogon citratus (C. citratus; main compound 5-O-caffeoylquinic acid) and Aloysia citrodora (A. citrodora; prevalence of verbascoside) reserve lots revealed higher phenolic compounds concentration than the respective standard lots. Thymus × citriodorus (T. citriodorus; main compound rosmarinic acid) standard lot presented higher amounts of phenolic acids than the reserve lot, nonetheless, total flavonoids and phenolic compounds were not significantly different. The differences between both lots antioxidant activity were more noticeable in C. citratus, with the reserve lot presenting the highest activity. This study provides evidence of the differences between these plants chemical composition and bioactivity depending on the harvesting conditions. Copyright © 2018 Elsevier Ltd. All rights reserved.

  4. Featured Image: Tests of an MHD Code

    NASA Astrophysics Data System (ADS)

    Kohler, Susanna

    2016-09-01

    Creating the codes that are used to numerically model astrophysical systems takes a lot of work and a lot of testing! A new, publicly available moving-mesh magnetohydrodynamics (MHD) code, DISCO, is designed to model 2D and 3D orbital fluid motion, such as that of astrophysical disks. In a recent article, DISCO creator Paul Duffell (University of California, Berkeley) presents the code and the outcomes from a series of standard tests of DISCOs stability, accuracy, and scalability.From left to right and top to bottom, the test outputs shown above are: a cylindrical Kelvin-Helmholtz flow (showing off DISCOs numerical grid in 2D), a passive scalar in a smooth vortex (can DISCO maintain contact discontinuities?), a global look at the cylindrical Kelvin-Helmholtz flow, a Jupiter-mass planet opening a gap in a viscous disk, an MHD flywheel (a test of DISCOs stability), an MHD explosion revealing shock structures, an MHD rotor (a more challenging version of the explosion), a Flock 3D MRI test (can DISCO study linear growth of the magnetorotational instability in disks?), and a nonlinear 3D MRI test.Check out the gif below for a closer look at each of these images, or follow the link to the original article to see even more!CitationPaul C. Duffell 2016 ApJS 226 2. doi:10.3847/0067-0049/226/1/2

  5. Joint-use park-and-ride lots.

    DOT National Transportation Integrated Search

    1989-01-01

    Joint-use park-and-ride lots have proven successful in Virginia as well as other states. As expected, there are both positive and negative aspects of such lots; these are described in this report. In addition, information on incentives to lot owners,...

  6. Effect of Preconditioning and Soldering on Failures of Chip Tantalum Capacitors

    NASA Technical Reports Server (NTRS)

    Teverovsky, Alexander A.

    2014-01-01

    Soldering of molded case tantalum capacitors can result in damage to Ta205 dielectric and first turn-on failures due to thermo-mechanical stresses caused by CTE mismatch between materials used in the capacitors. It is also known that presence of moisture might cause damage to plastic cases due to the pop-corning effect. However, there are only scarce literature data on the effect of moisture content on the probability of post-soldering electrical failures. In this work, that is based on a case history, different groups of similar types of CWR tantalum capacitors from two lots were prepared for soldering by bake, moisture saturation, and longterm storage at room conditions. Results of the testing showed that both factors: initial quality of the lot, and preconditioning affect the probability of failures. Baking before soldering was shown to be effective to prevent failures even in lots susceptible to pop-corning damage. Mechanism of failures is discussed and recommendations for pre-soldering bake are suggested based on analysis of moisture characteristics of materials used in the capacitors' design.

  7. Cryogenic Fracture Toughness Improvement for the Super Lightweight Tank's Main Structural Alloy

    NASA Technical Reports Server (NTRS)

    Chen, P. S.; Stanton, W. P.

    2002-01-01

    Marshall Space Flight Center has developed a two-step (TS) artificial aging technique that can significantly enhance cryogenic fracture toughness and resistance to stress corrosion cracking (SCC) in aluminum-copper-lithium alloy 2195. The new TS aging treatment consists of exposures at 132 C (270 F)/20 hr + 138 C (280 F)/42 hr, which can be readily applied to flight hardware production. TS aging achieves the same yield strength levels as conventional aging, while providing much improved ductility in the short transverse direction. After TS aging, five previously rejected lots of alloy 2195 (lots 950M029B, 960M030F, 960M030J, 960M030K, and 960M030L) passed simulated service testing for use in the super lightweight tank program. Each lot exhibited higher fracture toughness at cryogenic temperature than at ambient temperature. Their SCC resistance was also enhanced. All SCC specimens passed the minimum 10-day requirement in 3.5-percent sodium chloride alternate immersion at a stress of 45 ksi. The SCC lives ranged from 57 to 83 days, with an average of 70 days.

  8. Practical use of high-speed cameras for research and development within the automotive industry: yesterday and today

    NASA Astrophysics Data System (ADS)

    Steinmetz, Klaus

    1995-05-01

    Within the automotive industry, especially for the development and improvement of safety systems, we find a lot of high accelerated motions, that can not be followed and consequently not be analyzed by human eye. For the vehicle safety tests at AUDI, which are performed as 'Crash Tests', 'Sled Tests' and 'Static Component Tests', 'Stalex', 'Hycam', and 'Locam' cameras are in use. Nowadays the automobile production is inconceivable without the use of high speed cameras.

  9. Seal Integrity of Selected Fuzes as Measured by Three Leak Test Methods

    DTIC Science & Technology

    1976-09-01

    the worst fuze from the seal standpoint. The M503A-2 fuze body is made from a cast aluminum alloy . The casting process leaves voids which, after...leak resistance of the joint. WDU4A/A The design of this fuze depends upon ultrasonic welding to seal lid to case. The specified leak test merely...test is probably one of the better leakage tests from an effectiveness standpoint. However, from lot quantities of 690 and 480, reject rates of 20% were

  10. Pumping and Depressurizing of Insulation Materials

    NASA Technical Reports Server (NTRS)

    Porter, Amber

    2010-01-01

    The Fluids Testing and Technology Branch is a group that researches and tests efficient ways to use various Cryogenic Fluids, such as Liquid Nitrogen or Liquid Helium, in ground and space systems. Their main goal is to develop new technologies involving Cryogenic temperatures as well as making sure the existing technologies are understood. During my time here a lot of insulation testing has been done which is where insulation systems are tested for cryogenic systems that are in space for long durations.

  11. Accelerated life testing effects on CMOS microcircuit characteristics, phase 1

    NASA Technical Reports Server (NTRS)

    Maximow, B.

    1976-01-01

    An accelerated life test of sufficient duration to generate a minimum of 50% cumulative failures in lots of CMOS devices was conducted to provide a basis for determining the consistency of activation energy at 250 C. An investigation was made to determine whether any thresholds were exceeded during the high temperature testing, which could trigger failure mechanisms unique to that temperature. The usefulness of the 250 C temperature test as a predictor of long term reliability was evaluated.

  12. Accumulation of mesalazine pills in the medium ileum in a patient with Crohn´s disease.

    PubMed

    Martínez Huertas, Carmen; Garcia-Villanova Ruiz, Paloma; Pozo Sánchez, José; Dávila Arias, Cristina

    2017-03-01

    Crohn´s disease is an inflammatory disease that can involve any portion of the gastrointestinal tract, although terminal ileum is the most commonly affected portion. It is characterized by a transmural and discontinuous distribution pattern, with alternating periods of active disease and remission. We present the case of a 23-year-old patient diagnosed with Crohn´s disease, in treatment with extended release Mesalazine and corticoids. The CT Enterography showed activity signs and a great dilatation of medium ileum with lots of Mesalazine pills accumulated inside. Pill accumulation occurred because of stenosis, which did not let the pills at this level progress to distal ileum, and be absorbed.

  13. Update to permeable pavement research at the Edison ...

    EPA Pesticide Factsheets

    Abstract: The EPA’s Urban Watershed Management Branch (UWMB) has been monitoring the permeable pavement demonstration site at the Edison Environmental Center, NJ since 2010. This site has three different types of permeable pavement including: interlocking concrete permeable pavers; porous concrete; and permeable asphalt. The parking lot is instrumented with water content reflectometers and thermistors for continuous monitoring and has four lined sections for each surface to capture permeable pavement infiltrate for water quality analyses.Previous technical releases concerning the demonstration site focused on monitoring techniques, observed chloride and nutrient concentrations, and infiltration and evaporation rates. Thispresentation summarizes past findings and addresses current water quality efforts. This presentation summarizes past findings and addresses current water quality efforts.

  14. Update to Permeable Pavement Research at the Edison ...

    EPA Pesticide Factsheets

    The EPA’s Urban Watershed Management Branch (UWMB) has been monitoring the permeable pavement demonstration site at the Edison Environmental Center, NJ since 2010. This site has three different types of permeable pavements including interlocking concrete permeable pavers, pervious concrete, and porous asphalt. The permeable pavements are limited to parking spaces while adjacent driving lanes are impermeable and drain to the permeable surfaces. The parking lot is instrumented for continuous monitoring with thermistors and water content reflectometers that measure moisture as infiltrate passes through the storage gallery beneath the permeable pavements into the underlying native soil. Each permeable surface of the parking lot has four lined sections that capture infiltrate in tanks for water quality analyses; these tanks are capable of holding volumes up to 4.1 m3, which represents up to 38 mm (1.5 in.) for direct rainfall on the porous pavement and runoff from adjacent driving lanes that drain into the permeable surface.Previous technical releases concerning the demonstration site focused on monitoring techniques, observed chloride and nutrient concentrations, surface hydrology, and infiltration and evaporation rates. This presentation summarizes these past findings and addresses current water quality efforts including pH, solids analysis, total organic carbon, and chemical oxygen demand. Stormwater runoff continues to be a major cause of water pollution in

  15. [Selecting methods of controls concentration for internal quality control and continuity of control chart between different reagent lots for HBsAg qualitative detection].

    PubMed

    Li, Jin-ming; Zheng, Huai-jing; Wang, Lu-nan; Deng, Wei

    2003-04-01

    To establish a model for one choosing controls with a suitable concentration for internal quality control (IQC) with qualitative ELISA detection, and a consecutive plotting method on Levey-Jennings control chart when reagent kit lot is changed. First, a series of control serum with 0.2, 0.5, 1.0, 2.0 and 5.0ng/ml HBsAg respectively were assessed for within-run and between-run precision according to NCCLs EP5 document. Then, a linear regression equation (y=bx + a) with best correlation coefficient (r > 0.99) was established based on S/CO values of the series of control serum. Finally, one could choose controls with S/CO value calculated from the equation (y = bx + a) minus the product of the S/CO value multiplying three-fold between-run CV to be still more than 1.0 for IQC use. For consecutive plotting on Levey-Jennings control chart when ELISA kit lot was changed, the new lot kits were used to detect the same series of HBsAg control serum as above. Then, a new linear regression equation (y2 = b2x2 + a2) with best correlation coefficient was obtained. The old one (y1 =b1x1 + a1) could be obtained based on the mean values from above precision assessment. The S/CO value of a control serum detected by new lot kit could be changed to that detected by old kit lot based on the factor of y2/y1. Therefore, the plotting on primary Levey-Jennings control chart could be continued. The within-run coefficient of variation CV of the ELISA method for control serum with 0.2, 0.5, 1.0, 2.0 and 5.0ng/ml HBsAg were 11.08%, 9.49%, 9.83%, 9.18% and 7.25%, respectively, and between-run CV were 13.25%, 14.03%, 15.11%, 13.29% and 9.92%. The linear regression equation with best correlation coefficient from a test at random was y = 3.509x + 0.180. The suitable concentration of control serum for IQC could be 0.5ng/ml or 1.0ng/ml. The linear regression equation from the old lot and other two new lots of the ELISA kits were y1 = 3.550(x1) + 0.226, y2 = 3.238(x2) +0.388, and y3 =3.428(x3) + 0.148, respectively. Then, the transferring factors of 0.960 (y2/y1) and 0.908 (y3/y1) were obtained. The results shows that the model established for IQC control serum concentration selecting and for consecutive plotting on control chart when the reagent lot is changed is effective and practical.

  16. Stress and Pore Pressure Measurement in IODP Riser Drilling: An Example from Expedition 319, Kumano Basin offshore SW Honshu, Japan

    NASA Astrophysics Data System (ADS)

    Saffer, D. M.; McNeill, L. C.; Byrne, T. B.; Araki, E.; Flemings, P. B.; Conin, M.; Eguchi, N. O.; Takahashi, K.; Toczko, S.; Boutt, D. F.; Doan, M.; Kano, Y.; Ito, T.; Lin, W.

    2009-12-01

    In summer 2009, Integrated Ocean Drilling Program (IODP) Expedition 319 drilled a 1600 m deep riser borehole (Site C0009) in the Kumano Basin offshore SW Japan, to investigate the properties, structure and state of stress in the hanging wall above the subduction plate boundary. The first riser-based scientific drilling in IODP history allowed us to make several new scientific measurements including in situ stress magnitude, pore pressure and permeability using the Modular Formation Dynamics Tester (MDT) wireline tool, and measurement of minimum stress magnitude from Leak-off Tests (LOT). In addition, continuous monitoring of mud weight, mud gas, annular pressure, and mud losses provided data to constrain formation pore fluid pressure and stress. At Site C0009, we conducted 2 LOTs below a casing shoe at 708.6 m depth and 11 successful MDT measurements, including 9 single probe tests to measure pore pressure and fluid mobility and 2 dual packer tests: 1 to measure permeability by a drawdown test, and 1 to measure in situ stress. Measured pore pressures are approximately hydrostatic to 1463.7 m depth. We observed only minor gas shows when drilling ahead (as in-place methane was liberated from the rock at the bit) but little or no gas during pipe connections. This indicates that the borehole mud pressure exceeded the formation pore pressure, and is consistent with the MDT measurements. Permeabilities range from ~10-16 m2 - 10-14 m2, and the observed variation is consistent with lithologic changes defined in gamma ray logs. The MDT measurement at 874.3 mbsf and the LOT at 708.6 m yield values for the least principal stress of 34.8 MPa and 30.2 MPa, respectively. Both are less than the vertical stress (Sv) computed from density logs. Partial mud circulation losses occurred when the borehole mud pressure exceeded the leak-off stress measured at the base of the casing shoe; this provides an additional indirect constraint on Shmin magnitude. Mud pressure slightly in excess of the leak-off stress may have also generated poorly-developed drilling-induced tensile fractures (DITF) observed in resistivity image logs between ~750 - 1000 m. From the presence of DITF, Shmin measurements, and assuming a rock tensile strength of 1 MPa, we determine that SHmax is 35.1 MPa for the MDT stress measurement, and 30.2 MPa for the LOT. Using the MDT measurement of Shmin, the resulting principal stress magnitudes define a strike-slip faulting regime with effective stresses of Shmax’ = 14 MPa, Sv' = 7.3 MPa, and Shmin’ = 6.4 MPa. In contrast, using the LOT measurement of Shmin, the stress magnitudes indicate a normal faulting regime in which Sv’ = 6.2 MPa, Shmax’ = 2.8 MPa, and Shmin’ = 2.6 MPa.

  17. LWH and ACH Helmet Hardware Study

    DTIC Science & Technology

    2015-11-30

    initial attempts to perform impact tests using screws mounted in Kevlar composite panels resulted in little damage to the screws, but a lot of...stiffer and stronger than Kevlar panels, does not plastically deform (and therefore Figure 11. Typical ductile fracture surface resulting from a

  18. Pedestrian and traffic safety in parking lots at SNL/NM : audit background report.

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

    Sanchez, Paul Ernest

    2009-03-01

    This report supplements audit 2008-E-0009, conducted by the ES&H, Quality, Safeguards & Security Audits Department, 12870, during fall and winter of FY 2008. The study evaluates slips, trips and falls, the leading cause of reportable injuries at Sandia. In 2007, almost half of over 100 of such incidents occurred in parking lots. During the course of the audit, over 5000 observations were collected in 10 parking lots across SNL/NM. Based on benchmarks and trends of pedestrian behavior, the report proposes pedestrian-friendly features and attributes to improve pedestrian safety in parking lots. Less safe pedestrian behavior is associated with older parkingmore » lots lacking pedestrian-friendly features and attributes, like those for buildings 823, 887 and 811. Conversely, safer pedestrian behavior is associated with newer parking lots that have designated walkways, intra-lot walkways and sidewalks. Observations also revealed that motorists are in widespread noncompliance with parking lot speed limits and stop signs and markers.« less

  19. Heuristic for Critical Machine Based a Lot Streaming for Two-Stage Hybrid Production Environment

    NASA Astrophysics Data System (ADS)

    Vivek, P.; Saravanan, R.; Chandrasekaran, M.; Pugazhenthi, R.

    2017-03-01

    Lot streaming in Hybrid flowshop [HFS] is encountered in many real world problems. This paper deals with a heuristic approach for Lot streaming based on critical machine consideration for a two stage Hybrid Flowshop. The first stage has two identical parallel machines and the second stage has only one machine. In the second stage machine is considered as a critical by valid reasons these kind of problems is known as NP hard. A mathematical model developed for the selected problem. The simulation modelling and analysis were carried out in Extend V6 software. The heuristic developed for obtaining optimal lot streaming schedule. The eleven cases of lot streaming were considered. The proposed heuristic was verified and validated by real time simulation experiments. All possible lot streaming strategies and possible sequence under each lot streaming strategy were simulated and examined. The heuristic consistently yielded optimal schedule consistently in all eleven cases. The identification procedure for select best lot streaming strategy was suggested.

  20. Follicular delivery of spironolactone via nanostructured lipid carriers for management of alopecia.

    PubMed

    Shamma, Rehab Nabil; Aburahma, Mona Hassan

    2014-01-01

    Spironolactone (SL) is a US Food and Drug Administration-approved drug for the treatment of hypertension and various edematous conditions. SL has gained a lot of attention for treating androgenic alopecia due to its potent antiandrogenic properties. Recently, there has been growing interest for follicular targeting of drug molecules for treatment of hair and scalp disorders using nanocolloidal lipid-based delivery systems to minimize unnecessary systemic side effects associated with oral drug administration. Accordingly, the objective of this study is to improve SL efficiency and safety in treating alopecia through the preparation of colloidal nanostructured lipid carriers (NLCs) for follicular drug delivery. SL-loaded NLCs were prepared by an emulsion solvent diffusion and evaporation method using 23 full factorial design. All of the prepared formulations were spherical in shape with nanometric size range (215.6-834.3 nm) and entrapment efficiency >74%. Differential scanning calorimetry thermograms and X-ray diffractograms revealed that SL exists in amorphous form within the NLC matrices. The drug release behavior from the NLCs displayed an initial burst release phase followed by sustained release of SL. Confocal laser scanning microscopy confirmed the potential of delivering the fluorolabeled NLCs within the follicles, suggesting the possibility of using SL-loaded NLCs for localized delivery of SL into the scalp hair follicles.

  1. Follicular delivery of spironolactone via nanostructured lipid carriers for management of alopecia

    PubMed Central

    Shamma, Rehab Nabil; Aburahma, Mona Hassan

    2014-01-01

    Spironolactone (SL) is a US Food and Drug Administration-approved drug for the treatment of hypertension and various edematous conditions. SL has gained a lot of attention for treating androgenic alopecia due to its potent antiandrogenic properties. Recently, there has been growing interest for follicular targeting of drug molecules for treatment of hair and scalp disorders using nanocolloidal lipid-based delivery systems to minimize unnecessary systemic side effects associated with oral drug administration. Accordingly, the objective of this study is to improve SL efficiency and safety in treating alopecia through the preparation of colloidal nanostructured lipid carriers (NLCs) for follicular drug delivery. SL-loaded NLCs were prepared by an emulsion solvent diffusion and evaporation method using 23 full factorial design. All of the prepared formulations were spherical in shape with nanometric size range (215.6–834.3 nm) and entrapment efficiency >74%. Differential scanning calorimetry thermograms and X-ray diffractograms revealed that SL exists in amorphous form within the NLC matrices. The drug release behavior from the NLCs displayed an initial burst release phase followed by sustained release of SL. Confocal laser scanning microscopy confirmed the potential of delivering the fluorolabeled NLCs within the follicles, suggesting the possibility of using SL-loaded NLCs for localized delivery of SL into the scalp hair follicles. PMID:25473283

  2. Myths Concerning Alpine Skiing Injuries

    PubMed Central

    Johnson, Robert J.; Ettlinger, Carl F.; Shealy, Jasper E.

    2009-01-01

    There are many commonly discussed myths about ski safety that are propagated by industry, physicians, and skiers. Through a review of the literature concerning 12 such topics, this article demonstrates that the following are untrue: (1) Broken legs have been traded for blown-out knees. (2) If you know your DIN (a slang term for release indicator value), you can adjust your own bindings. (3) Toe and heel piece settings must be the same to function properly. (4) Formal ski instruction will make you safer. (5) Very short skis do not need release bindings. (6) Spending a lot of money on children’s equipment is not worth the cost. (7) Children need plenty of room in ski boots for their growing feet. (8) If you think you are going to fall, just relax. (9) Exercise can prevent skiing injuries. (10) Lower release settings can reduce the risk of anterior cruciate ligament injury. (11) Buying new ski equipment is safer than renting. (12) Skiing is among the most dangerous of activities. It is important for the skiing public, physicians, and all those interested in improving skiing safety to verify the measures they advocate. The statements analyzed here are simply untrue and have the potential to cause harm if taken as fact by those exposed to these unsupported opinions. PMID:23015911

  3. Controllable generation of reactive oxygen species by femtosecond-laser irradiation

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

    Yan, Wei; He, Hao, E-mail: haohe@tju.edu.cn; Wang, Yintao

    Femtosecond lasers have been advancing Biophotonics research in the past two decades with multiphoton microscopy, microsurgery, and photodynamic therapy. Nevertheless, laser irradiation is identified to bring photodamage to cells via reactive oxygen species (ROS) generation with unclear mechanism. Meanwhile, currently in biological researches, there is no effective method to provide controllable ROS production precisely, which originally is leaked from mitochondria during respiration and plays a key role in a lot of important cellular processes and cellular signaling pathways. In this study, we show the process of how the tightly focused femtosecond-laser induces ROS generation solely in mitochondria at the verymore » beginning and then release to cytosol if the stimulus is intense enough. At certain weak power levels, the laser pulses induce merely moderate Ca{sup 2+} release but this is necessary for the laser to generate ROS in mitochondria. Cellular original ROS are also involved with a small contribution. When the power is above a threshold, ROS are then released to cytosol, indicating photodamage overwhelming cellular repair ability. The mechanisms in those two cases are quite different. Those results clarify parts of the mechanism in laser-induced ROS generation. Hence, it is possible to further this optical scheme to provide controllable ROS generation for ROS-related biological researches including mitochondrial diseases and aging.« less

  4. Lessons learned in preparing method 29 filters for compliance testing audits.

    PubMed

    Martz, R F; McCartney, J E; Bursey, J T; Riley, C E

    2000-01-01

    Companies conducting compliance testing are required to analyze audit samples at the time they collect and analyze the stack samples if audit samples are available. Eastern Research Group (ERG) provides technical support to the EPA's Emission Measurements Center's Stationary Source Audit Program (SSAP) for developing, preparing, and distributing performance evaluation samples and audit materials. These audit samples are requested via the regulatory Agency and include spiked audit materials for EPA Method 29-Metals Emissions from Stationary Sources, as well as other methods. To provide appropriate audit materials to federal, state, tribal, and local governments, as well as agencies performing environmental activities and conducting emission compliance tests, ERG has recently performed testing of blank filter materials and preparation of spiked filters for EPA Method 29. For sampling stationary sources using an EPA Method 29 sampling train, the use of filters without organic binders containing less than 1.3 microg/in.2 of each of the metals to be measured is required. Risk Assessment testing imposes even stricter requirements for clean filter background levels. Three vendor sources of quartz fiber filters were evaluated for background contamination to ensure that audit samples would be prepared using filters with the lowest metal background levels. A procedure was developed to test new filters, and a cleaning procedure was evaluated to see if a greater level of cleanliness could be achieved using an acid rinse with new filters. Background levels for filters supplied by different vendors and within lots of filters from the same vendor showed a wide variation, confirmed through contact with several analytical laboratories that frequently perform EPA Method 29 analyses. It has been necessary to repeat more than one compliance test because of suspect metals background contamination levels. An acid cleaning step produced improvement in contamination level, but the difference was not significant for most of the Method 29 target metals. As a result of our studies, we conclude: Filters for Method 29 testing should be purchased in lots as large as possible. Testing firms should pre-screen new boxes and/or new lots of filters used for Method 29 testing. Random analysis of three filters (top, middle, bottom of the box) from a new box of vendor filters before allowing them to be used in field tests is a prudent approach. A box of filters from a given vendor should be screened, and filters from this screened box should be used both for testing and as field blanks in each test scenario to provide the level of quality assurance required for stationary source testing.

  5. Elimination of falsely reactive results in a commercially-available West Nile virus IgM capture enzyme-linked immunosorbent assay by heterophilic antibody blocking reagents.

    PubMed

    Prince, Harry E; Lapé-Nixon, Mary; Givens, Tara S; Bradshaw, Tiffany; Nowicki, Marek J

    2017-05-01

    All sera initially reactive in the Focus Diagnostics West Nile virus IgM capture enzyme-linked immunosorbent assay (WNV IgM ELISA) must be retested with background subtraction to identify falsely-reactive (FR) samples due to antibodies that bind to immunoglobulins of other animal species (heterophilic antibodies). In some settings, such as pre-transplant testing of organ donors, the reporting delay associated with retesting can have an adverse impact on donor procurement and organ placement. We sought to determine if inclusion of heterophilic antibody blockers in assay conjugate could eliminate the nonspecific reactivity of FR samples. Of 6 blocking reagents evaluated using a well-characterized FR sample, immunoglobulin inhibiting reagent from Bioreclamation (IIR) and blocker from Fitzgerald Industries (BFI) were superior in their ability to inhibit false reactivity; these 2 blockers were then used to evaluate 20 additional FR and 21 truly-reactive (TR) samples. Both blockers eliminated the reactivity of 20/21 FR samples, whereas all 21 TR samples remained reactive; further, all 13 truly non-reactive (NR) samples evaluated remained non-reactive when using blocker-containing conjugate. A subset of 22 samples were tested in parallel using the initial lot and a second lot of IIR and BFI; with one exception, all samples showed the same qualitative result using both lots of a given blocker. These findings demonstrate that modification of the Focus WNV IgM screening ELISA to include heterophilic antibody blocker IIR or BFI in assay conjugate eliminates the reactivity of most FR samples, markedly reducing the number of samples requiring further testing by background subtraction. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.

    PubMed

    Akbas, Neval; Schryver, Patricia G; Algeciras-Schimnich, Alicia; Baumann, Nikola A; Block, Darci R; Budd, Jeffrey R; Gaston, S J Stephen; Klee, George G

    2014-11-01

    We evaluated the analytical performance of 24 immunoassays using the Beckman Coulter DxI 800 immunoassay systems at Mayo Clinic, Rochester, MN for trueness, precision, detection limits, linearity, and consistency (across instruments and reagent lots). Clinically oriented performance goals were defined using the following methods: trueness-published desirable accuracy limits, precision-published desirable biologic variation; detection limits - 0.1 percentile of patient test values, linearity - 50% of total error, and consistency-percentage test values crossing key decision points. Local data were collected for precision, linearity, and consistency. Data were provided by Beckman Coulter, Inc. for trueness and detection limits. All evaluated assays except total thyroxine were within the proposed goals for trueness. Most of the assays met the proposed goals for precision (86% of intra-assay results and 75% of inter-assay results). Five assays had more than 15% of the test results below the minimum detection limits. Carcinoembryonic antigen, total thyroxine and free triiodothyronine exceeded the proposed goals of ±6.3%, ±5% and ±5.7% for dilution linearity. All evaluated assays were within the proposed goals for instrument consistency. Lot-to-lot consistency results for cortisol, ferritin and total thyroxine exceeded the proposed goals of 3.3%, 11.4% and 7% at one medical decision level, while vitamin B12 exceeded the proposed goals of 5.2% and 3.8% at two decision levels. The Beckman Coulter DxI 800 immunoassay system meets most of these proposed goals, even though these clinically focused performance goals represent relatively stringent limits. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  7. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  8. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  9. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  10. 7 CFR 29.35 - Lot seal.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Lot seal. 29.35 Section 29.35 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... INSPECTION Regulations Definitions § 29.35 Lot seal. A seal approved by the Director for sealing lots of...

  11. 7 CFR 29.35 - Lot seal.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Lot seal. 29.35 Section 29.35 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... INSPECTION Regulations Definitions § 29.35 Lot seal. A seal approved by the Director for sealing lots of...

  12. Chemical analysis of DC745 Materials: DEV Lot 1 reinvestigation; barcodes P053387, P053388, and P053389

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

    Dirmyer, Matthew R.

    This report serves as a follow up to our initial development lot 1 chemical analysis report (LA-UR-16-21970). The purpose of that report was to determine whether or not certain combinations of resin lots and curing agent lots resulted in chemical differences in the final material. One finding of that report suggested that pad P053389 was different from the three other pads analyzed. This report consists of chemical analysis of P053387, P053388, and a reinvestigation of P053389 all of which came from the potentially suspect combination of resin and curing agents lot. The goal of this report is to determine whethermore » the observations relating to P053389 were isolated to that particular pad or systemic to that combination of resin and curing agent lot. The following suite of analyses were performed on the pads: Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Fourier Transform Infrared Spectroscopy (FT-IR), and Solid State Nuclear Magnetic Resonance (NMR). The overall conclusions of the study are that pads P053387 and P053388 behave more consistently with the pads of other resin lot and curing agent lot combinations and that the chemical observations made regarding pad P053389 are isolated to that pad and not representative of an issue with that resin lot and curing agent lot combination.« less

  13. Humidity Steady State Low Voltage Testing of MLCCs (Based on NESC Technical Assessment Report)

    NASA Technical Reports Server (NTRS)

    Sampson, Mike; Brusse, Jay; Teverovsky, Alexander

    2011-01-01

    Review of the low voltage reduced Insulation Resistance (IR) failure phenomenon in Multilayer ceramic capacitors (MLCCs)and NASA approaches to contend with this risk. 1. Analyze published materials on root cause mechanisms. 2. Investigate suitability of current test methods to assess MLCC lots for susceptibility. 3. Review current NASA parts selection and application guidelines in consideration of benefits vs. disadvantages.

  14. Evapotranspiration from selected fallowed agricultural fields on the Tule Lake National Wildlife Refuge, California, during May to October 2000

    USGS Publications Warehouse

    Bidlake, W.R.

    2002-01-01

    An investigation of evapotranspiration, vegetation quantity and composition, and depth to the water table below the land surface was made at three sites in two fallowed agricultural lots on the 15,800-hectare Tule Lake National Wildlife Refuge in northern California during the 2000 growing season. All three sites had been farmed during 1999, but were not irrigated since the 1999 growing season. Vegetation at the lot C1B and lot 6 stubble sites included weedy species and small grain plants. The lot 6 cover crop site supported a crop of cereal rye that had been planted during the previous winter. Percentage of coverage by live vegetation ranged from 0 to 43.2 percent at the lot C1B site, from approximately 0 to 63.2 percent at the lot 6 stubble site, and it was estimated to range from 0 to greater than 90 percent at the lot 6 cover crop site. Evapotranspiration was measured using the Bowen ratio energy balance technique and it was estimated using a model that was based on the Priestley-Taylor equation and a model that was based on reference evapotranspiration with grass as the reference crop. Total evapotranspiration during May to October varied little among the three evapotranspiration measurement sites, although the timing of evapotranspiration losses did vary among the sites. Total evapotranspiration from the lot C1B site was 426 millimeters, total evapotranspiration from the lot 6 stubble site was 444 millimeters, and total evapotranspiration from the lot 6 cover crop site was 435 millimeters. The months of May to July accounted for approximately 78 percent of the total evapotranspiration from the lot C1B site, approximately 63 percent of the evapotranspiration from the lot 6 stubble site, and approximately 86 percent of the total evapotranspiration from the lot 6 cover crop site. Estimated growing season precipitation accounted for 16 percent of the growing-season evapotranspiration at the lot C1B site and for 17 percent of the growing-season evapotranspiration at the lot 6 stubble and cover crop sites. The ratio of evapotranspiration rate to the reference evapotranspiration rate was strongly correlated with percentage of site coverage by vegetation at the lot C1B and lot 6 stubble sites (correlation coefficient = 0.95, sample size = 6), where percentage of site coverage was determined from quantitative vegetation surveys. It is concluded that evapotranspiration was mediated by the vegetation at all three sites, and that the differences in seasonal timing of evapotranspiration losses were caused by differences in timing of vegetation growth and development and senescence among the sites. Depth to the water table below the land surface at lot C1B ranged from 0.67 meters in early July to greater than 1.39 meters in late August. Depth to the water table at lot 6 ranged from 0.77 meter in late May to greater than 1.40 meters in late August.

  15. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  16. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  17. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  18. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  19. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  20. Replacement Non-Toxic Sealants for Standard Chromated Sealants

    DTIC Science & Technology

    2005-02-01

    material’s mechanical or physical properties and resistance to degradation. As sealant formulations for the Class B-2 worklife were developed by PRC...results ofthis testing, Class B-1I2 and C-12 worklife materials were formulated and are being tested. In addition to the testing that UDRI conducted, two...successfully accomplished in this program. An optimized Class B-2 worklife of the sealant compound designated RW3758-71, Lot no. RT0946, completed

  1. Statistical quality control and quality assurance evaluation of structural & paving concrete : phase I final report.

    DOT National Transportation Integrated Search

    2001-08-01

    This report discusses the variability associated with the production, construction, and testing of structural and paving concrete. The study evaluated data from over 900 projects constructed between 1992 and 1999, representing over 25,000 lots. The d...

  2. Bringing the fathead minnow (Pimephales promelas) into the genomic era

    EPA Science Inventory

    The fathead minnow (Pimephales promelas) is a well-established ecotoxicological model organism that has been widely used for regulatory ecotoxicity testing and research for over a half century. Throughout this time, a lot of knowledge has been gained about the fathead minnow&rsqu...

  3. Catching fly balls in virtual reality: a critical test of the outfielder problem

    PubMed Central

    Fink, Philip W.; Foo, Patrick S.; Warren, William H.

    2013-01-01

    How does a baseball outfielder know where to run to catch a fly ball? The “outfielder problem” remains unresolved, and its solution would provide a window into the visual control of action. It may seem obvious that human action is based on an internal model of the physical world, such that the fielder predicts the landing point based on a mental model of the ball’s trajectory (TP). But two alternative theories, Optical Acceleration Cancellation (OAC) and Linear Optical Trajectory (LOT), propose that fielders are led to the right place at the right time by coupling their movements to visual information in a continuous “online” manner. All three theories predict successful catches and similar running paths. We provide a critical test by using virtual reality to perturb the vertical motion of the ball in mid-flight. The results confirm the predictions of OAC, but are at odds with LOT and TP. PMID:20055547

  4. Sampling, testing and modeling particle size distribution in urban catch basins.

    PubMed

    Garofalo, G; Carbone, M; Piro, P

    2014-01-01

    The study analyzed the particle size distribution of particulate matter (PM) retained in two catch basins located, respectively, near a parking lot and a traffic intersection with common high levels of traffic activity. Also, the treatment performance of a filter medium was evaluated by laboratory testing. The experimental treatment results and the field data were then used as inputs to a numerical model which described on a qualitative basis the hydrological response of the two catchments draining into each catch basin, respectively, and the quality of treatment provided by the filter during the measured rainfall. The results show that PM concentrations were on average around 300 mg/L (parking lot site) and 400 mg/L (road site) for the 10 rainfall-runoff events observed. PM with a particle diameter of <45 μm represented 40-50% of the total PM mass. The numerical model showed that a catch basin with a filter unit can remove 30 to 40% of the PM load depending on the storm characteristics.

  5. Evaluation of a computer-assisted, kinetics-based enzyme-linked immunosorbent assay for detection of coronavirus antibodies in cats.

    PubMed Central

    Barlough, J E; Jacobson, R H; Downing, D R; Marcella, K L; Lynch, T J; Scott, F W

    1983-01-01

    A computer-assisted, kinetics-based enzyme-linked immunosorbent assay was adapted for the detection of coronavirus antibodies in feline serum. An alkaline antigen diluent (carbonate-bicarbonate buffer, pH 9.6) used in initial experiments produced diffuse, nonspecific color reactions in both viral and control antigen cuvettes which were correlated, paradoxically, with coronavirus antibody levels in test sera. These interfering reactions were minimized by use of lower-pH antigen diluents such as water and phosphate-buffered saline. Background kinetics-based enzyme-linked immunosorbent assay reactivity directed against a noncoronaviral component of antigen tissue culture fluids could then detected in numerous sera, particularly in samples with lower titers. Much of this reactivity was shown to be associated with bovine gamma globulins in cell culture fluid. It was not serum lot or species specific, since a variety of bovine serum lots as well as individual lots of serum from other mammalian and avian species reacted. Reactivity was markedly reduced when cells for antigen preparation were grown in gamma globulin-free bovine serum. Generation of corrected slope values from the kinetics-based enzyme-linked immunosorbent assay made it possible to correct for residual background reactivity in individual test sera and thus eliminate a potentially major source of false-positive reactions. Collectively, these studies indicated that the control of nonspecific reactivity in feline coronavirus serology is absolutely essential to obtain useful estimates of specific antibody responses. PMID:6300184

  6. Composition and Potency Characterization of Mycobacterium avium subsp. paratuberculosis Purified Protein Derivatives

    PubMed Central

    Capsel, Randal T.; Thoen, Charles O.; Reinhardt, Timothy A.; Lippolis, John D.; Olsen, Renee; Stabel, Judith R.; Bannantine, John P.

    2016-01-01

    Mycobacterium avium subsp. paratuberculosis (MAP) purified protein derivatives (PPDs) are immunologic reagents prepared from cultured filtrates of the type strain. Traditional production consists of floating culture incubation at 37°C, organism inactivation by autoclaving, coarse filtration, and protein precipitation. Three traditional production PPDs were used in this study including lot 9801, which served as a reference and has been used in the field for decades. Alternative production PPDs (0902A and 0902B), in which the autoclaving step was removed, were also analyzed in this study. SDS-PAGE analysis revealed protein smearing in traditional PPDs, but distinct bands were observed in the alternative PPD preparations. Antibody bound distinct protein bands in the alternative PPDs by immunoblot analysis, whereas an immunoreactive smear was observed with the traditional PPDs. Mass spectrometry identified 194 proteins among three PPD lots representing the two different production methods, ten of which were present in all PPDs examined. Selected proteins identified by mass spectrometry were recombinantly expressed and purified from E. coli and evaluated by the guinea pig potency test. Seven recombinant proteins showed greater erythema as compared to the reference PPD lot 9801 in paired guinea pigs and were able to stimulate interferon-gamma production in blood from Johne’s positive animals. These results suggest that autoclaving culture suspensions is not a necessary step in PPD production and specific proteins could supplant the PPD antigen for intradermal skin testing procedures and for use as in-vitro assay reagents. PMID:27136199

  7. Evaluation of a computer-assisted, kinetics-based enzyme-linked immunosorbent assay for detection of coronavirus antibodies in cats.

    PubMed

    Barlough, J E; Jacobson, R H; Downing, D R; Marcella, K L; Lynch, T J; Scott, F W

    1983-02-01

    A computer-assisted, kinetics-based enzyme-linked immunosorbent assay was adapted for the detection of coronavirus antibodies in feline serum. An alkaline antigen diluent (carbonate-bicarbonate buffer, pH 9.6) used in initial experiments produced diffuse, nonspecific color reactions in both viral and control antigen cuvettes which were correlated, paradoxically, with coronavirus antibody levels in test sera. These interfering reactions were minimized by use of lower-pH antigen diluents such as water and phosphate-buffered saline. Background kinetics-based enzyme-linked immunosorbent assay reactivity directed against a noncoronaviral component of antigen tissue culture fluids could then detected in numerous sera, particularly in samples with lower titers. Much of this reactivity was shown to be associated with bovine gamma globulins in cell culture fluid. It was not serum lot or species specific, since a variety of bovine serum lots as well as individual lots of serum from other mammalian and avian species reacted. Reactivity was markedly reduced when cells for antigen preparation were grown in gamma globulin-free bovine serum. Generation of corrected slope values from the kinetics-based enzyme-linked immunosorbent assay made it possible to correct for residual background reactivity in individual test sera and thus eliminate a potentially major source of false-positive reactions. Collectively, these studies indicated that the control of nonspecific reactivity in feline coronavirus serology is absolutely essential to obtain useful estimates of specific antibody responses.

  8. Comparison of particle sizes between 238PuO 2 before aqueous processing, after aqueous processing, and after ball milling

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

    Mulford, Roberta Nancy

    Particle sizes determined for a single lot of incoming Russian fuel and for a lot of fuel after aqueous processing are compared with particle sizes measured on fuel after ball-milling. The single samples of each type are believed to have particle size distributions typical of oxide from similar lots, as the processing of fuel lots is fairly uniform. Variation between lots is, as yet, uncharacterized. Sampling and particle size measurement methods are discussed elsewhere.

  9. Lifetime assessment analysis of Galileo Li/SO2 cells: Final report

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

    Levy, S.C.; Jaeger, C.D.; Bouchard, D.A.

    Galileo Li/SO2 cells from five lots and five storage temperatures were studied to establish a database from which the performance of flight modules may be predicted. Nondestructive tests consisting of complex impedance analysis and a 15-s pulse were performed on all cells. Chemical analysis was performed on one cell from each lot/storage group, and the remaining cells were discharged at Galileo mission loads. An additional number of cells were placed on high-temperature accelerated aging storage for 6 months and then discharged. All data were statistically analyzed. Results indicate that the present Galileo design Li/SO2 cell will satisfy electrical requirements formore » a 10-year mission. 10 figs., 4 tabs.« less

  10. What Initiates Lightning?

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

    None

    Lightning is an energetic electric discharge, creating a current that flows briefly within a cloud--or between a cloud and the ground--and heating the air to temperatures about five times hotter than the sun’s surface. But there’s a lot about lightning that’s still a mystery. Los Alamos National Laboratory is working to change that. Because lightning produces optical and radio frequency signals similar to those from a nuclear explosion, it’s important to be able to distinguish whether such signals are caused by lightning or a nuclear event. As part of the global security mission at Los Alamos, scientists use lightning tomore » help develop better instruments for nuclear test-ban treaty monitoring and, in the process, have learned a lot about lightning itself.« less

  11. The Carbon Crisis in 90 Seconds

    NASA Technical Reports Server (NTRS)

    Griffith, Peter

    2011-01-01

    This is a banana; and this is a chunk of coal. The banana is sweet and delicious and fun to eat... the coal is ... none of those things. But they are much more alike than they seem. Both were made by plants and store energy from the sun and carbon gas from the air around us. When you eat the banana, you use the energy stored in the banana to run and jump; and you release carbon gas back into the air around you. Now, carbon in the banana is young fast carbon: just weeks ago the banana was carbon gas in the air, and hours after you eat it, you breathe out the same carbon back into the air. When we burn coal in power plants, we use the energy stored in the coal to generate electricity that powers our homes and factories; and we release carbon gas back into the air around us. But, the carbon in the coal is old slow carbon. Plants took the coal carbon out of the air hundreds of millions of years ago. That carbon has been locked up ever since, and would stay locked up, if people hadn't dug up the coal and burned it. So now by burning coal and oil, people are adding lots and lots of old carbon to the atmosphere, faster than plants and the oceans can take it out. Why do I care? Because carbon gas in the atmosphere acts like a blanket, trapping heat, and making the whole planet warmer. My name is Peter, and I'm a carbon cycle scientist at NASA. We use satellites to watch how the world is warming. We can see the glaciers and the ice caps melting; and the air, land, and oceans warming. So we know we all have to change the way we produce and use energy, to burn less coal and oil, to prevent the planet from getting too warm.

  12. 7 CFR 932.151 - Incoming regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... inspection station other than the one where the lot was sampled. (b) Lot identification. Immediately upon... complete Form COC 3A or 3C, weight and grade report or such other lot identification form as may be... performance of all actions connected with the identification of lots of olives, the weighing of boxes or bins...

  13. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  14. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  15. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  16. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  17. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  18. 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.

  19. 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

  20. ENVIRONMENTAL TECHNOLOGY VERIFICATION PROGRAM: Stormwater Source Area Treatment Device - Arkal Pressurized Stormwater Filtration System

    EPA Science Inventory

    Performance verification testing of the Arkal Pressurized Stormwater Filtration System was conducted under EPA's Environmental Technology Verification Program on a 5.5-acre parking lot and grounds of St. Mary's Hospital in Milwaukee, Wisconsin. The system consists of a water sto...

  1. 46 CFR 160.050-5 - Sampling, tests, and inspection.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

  2. 46 CFR 160.050-5 - Sampling, tests, and inspection.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

  3. 46 CFR 160.050-5 - Sampling, tests, and inspection.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

  4. 46 CFR 160.050-5 - Sampling, tests, and inspection.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

  5. 46 CFR 160.050-5 - Sampling, tests, and inspection.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

  6. 21 CFR 660.36 - Samples and protocols.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Reagent Red Blood Cells § 660.36 Samples... a cell panel intended for identification of unexpected antibodies. The sample shall be packaged as... distribution of each lot of Reagent Red Blood Cells for detection or identification of unexpected antibodies...

  7. High Performance Computing Modernization Program Kerberos Throughput Test Report

    DTIC Science & Technology

    2017-10-26

    functionality as Kerberos plugins. The pre -release production kit was used in these tests to compare against the current release kit. YubiKey support...HPCMP Kerberos Throughput Test Report 3 2. THROUGHPUT TESTING 2.1 Testing Components Throughput testing was done to determine the benefits of the pre ...both the current release kit and the pre -release production kit for a total of 378 individual tests in order to note any improvements. Based on work

  8. Creating poly(ethylene glycol) film on the surface of NiTi alloy by gamma irradiation

    NASA Astrophysics Data System (ADS)

    Yu, Hongyan; Yan, Jin; Ma, Huiling; Zeng, Xinmiao; Liu, Yang; Zhao, Xinqing

    2015-07-01

    NiTi alloy has been extensively utilized as biomaterials owing to its unique shape memory effect, superelasticity and biocompatibility. However, concern with the toxic and allergic responses of nickel potentially releasing from implants stimulated lots of researches of modification on NiTi alloy surface. Creating chemical bond attachment of bioorganic film on NiTi alloy surface could effectively inhibit Ni releasing and obtain bioactive functions for further application. In this work, to get a bioorganic surface, NiTi alloy was modified with poly(ethylene glycol) (PEG) film by gamma ray induced grafting or crosslinking. X-ray diffraction (XRD) spectrum, water contact angle geometer and X-ray photoelectron spectroscopy (XPS) techniques were used to characterize the NiTi surface. The results indicated that PEG was covalent bonded on NiTi alloy surface. Fluorescence microscope (FM) images for morphology of 1 day osteoblast culture on the PEG coated NiTi surface showed that PEG could improve cell proliferation on NiTi surface. Our work offers a way to introduce a bioorganic metal surface by gamma irradiation.

  9. Reliability Analysis and Optimal Release Problem Considering Maintenance Time of Software Components for an Embedded OSS Porting Phase

    NASA Astrophysics Data System (ADS)

    Tamura, Yoshinobu; Yamada, Shigeru

    OSS (open source software) systems which serve as key components of critical infrastructures in our social life are still ever-expanding now. Especially, embedded OSS systems have been gaining a lot of attention in the embedded system area, i.e., Android, BusyBox, TRON, etc. However, the poor handling of quality problem and customer support prohibit the progress of embedded OSS. Also, it is difficult for developers to assess the reliability and portability of embedded OSS on a single-board computer. In this paper, we propose a method of software reliability assessment based on flexible hazard rates for the embedded OSS. Also, we analyze actual data of software failure-occurrence time-intervals to show numerical examples of software reliability assessment for the embedded OSS. Moreover, we compare the proposed hazard rate model for the embedded OSS with the typical conventional hazard rate models by using the comparison criteria of goodness-of-fit. Furthermore, we discuss the optimal software release problem for the porting-phase based on the total expected software maintenance cost.

  10. Cubic and Hexagonal Liquid Crystals as Drug Delivery Systems

    PubMed Central

    Chen, Yulin; Ma, Ping; Gui, Shuangying

    2014-01-01

    Lipids have been widely used as main constituents in various drug delivery systems, such as liposomes, solid lipid nanoparticles, nanostructured lipid carriers, and lipid-based lyotropic liquid crystals. Among them, lipid-based lyotropic liquid crystals have highly ordered, thermodynamically stable internal nanostructure, thereby offering the potential as a sustained drug release matrix. The intricate nanostructures of the cubic phase and hexagonal phase have been shown to provide diffusion controlled release of active pharmaceutical ingredients with a wide range of molecular weights and polarities. In addition, the biodegradable and biocompatible nature of lipids demonstrates the minimum toxicity and thus they are used for various routes of administration. Therefore, the research on lipid-based lyotropic liquid crystalline phases has attracted a lot of attention in recent years. This review will provide an overview of the lipids used to prepare cubic phase and hexagonal phase at physiological temperature, as well as the influencing factors on the phase transition of liquid crystals. In particular, the most current research progresses on cubic and hexagonal phases as drug delivery systems will be discussed. PMID:24995330

  11. Education Myths: What Special Interest Groups Want You to Believe about Our Schools--And Why It Isn't So

    ERIC Educational Resources Information Center

    Green, Jay P.

    2005-01-01

    How can we fix America's floundering public schools? The conventional wisdom says that schools need a lot more money, that poor and immigrant children cannot do as well as most American kids, that high-stakes tests just produce teaching to the test, and that vouchers do little to help students while undermining our democracy. But what if the…

  12. Two-stage selection in slash pine produces good gains in fusiform rust resistance

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

    Sluder, E.R.

    The best 6 of 21 progeny-tested first-generation slash pine selections were crossed in a half diallel to study inheritance patterns of their superior fusiform rust resistance (5 trees) and height (1 tree). Their six first-test progenies were duplicated and included in the study. These two groups of progenies, along with two commercial check lots, were planted on an Upper Coastal Plain and a Flatwoods site in Georgia. At age 10 yr, the 15 progenies in the half diallel averaged 23% rust-infected compared with 54% for the check lots. First-test progenies averaged 30% infected. For percentage infection, the six parents differedmore » in general combining ability (GCA) (0.01>P>0.001) on both test sites and in specific combining ability (0.05>P>0.01) on one site. GCA variation for height was significant (0.05>P>0.01) on one site. The parent selected for height had the highest breeding value for height at age 10 yr. These results show that resistance to the fusiform rust disease, a serious problem in management of the species, can be improved in slash pine. These 6 parents and their 15 progenies in the half-diallel cross are a good source of rust resistance genes for use in slash pine improvement programs.« less

  13. Effects of Space Radiation on Humoral and Cellular Immunity in Rhesus Monkeys.

    DTIC Science & Technology

    1992-12-01

    55318-1084) immunoplates that are routinely used for quantitative assays of human Ig levels. It seemed justified to use the human system to test the...of Ig between the irradiated and control monkeys of different ages. The tests were set up and read at 18 and 72 h by the same operator, taking careful...note of the lot number and the standard reference curves for each test kit. The samples were suitably diluted to obtain clear-cut reactions (i.e

  14. Development and evaluation of accelerated drug release testing methods for a matrix-type intravaginal ring.

    PubMed

    Externbrink, Anna; Eggenreich, Karin; Eder, Simone; Mohr, Stefan; Nickisch, Klaus; Klein, Sandra

    2017-01-01

    Accelerated drug release testing is a valuable quality control tool for long-acting non-oral extended release formulations. Currently, several intravaginal ring candidates designed for the long-term delivery of steroids or anti-infective drugs are being in the developing pipeline. The present article addresses the demand for accelerated drug release methods for these formulations. We describe the development and evaluation of accelerated release methods for a steroid releasing matrix-type intravaginal ring. The drug release properties of the formulation were evaluated under real-time and accelerated test conditions. Under real-time test conditions drug release from the intravaginal ring was strongly affected by the steroid solubility in the release medium. Under sufficient sink conditions that were provided in release media containing surfactants drug release was Fickian diffusion driven. Both temperature and hydro-organic dissolution media were successfully employed to accelerate drug release from the formulation. Drug release could be further increased by combining the temperature effect with the application of a hydro-organic release medium. The formulation continued to exhibit a diffusion controlled release kinetic under the investigated accelerated conditions. Moreover, the accelerated methods were able to differentiate between different prototypes of the intravaginal ring that exhibited different release profiles under real-time test conditions. Overall, the results of the present study indicate that both temperature and hydro-organic release media are valid parameters for accelerating drug release from the intravaginal ring. Variation of either a single or both parameters yielded release profiles that correlated well with real-time release. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Inverse modeling of the Chernobyl source term using atmospheric concentration and deposition measurements

    NASA Astrophysics Data System (ADS)

    Evangeliou, Nikolaos; Hamburger, Thomas; Cozic, Anne; Balkanski, Yves; Stohl, Andreas

    2017-07-01

    This paper describes the results of an inverse modeling study for the determination of the source term of the radionuclides 134Cs, 137Cs and 131I released after the Chernobyl accident. The accident occurred on 26 April 1986 in the Former Soviet Union and released about 1019 Bq of radioactive materials that were transported as far away as the USA and Japan. Thereafter, several attempts to assess the magnitude of the emissions were made that were based on the knowledge of the core inventory and the levels of the spent fuel. More recently, when modeling tools were further developed, inverse modeling techniques were applied to the Chernobyl case for source term quantification. However, because radioactivity is a sensitive topic for the public and attracts a lot of attention, high-quality measurements, which are essential for inverse modeling, were not made available except for a few sparse activity concentration measurements far from the source and far from the main direction of the radioactive fallout. For the first time, we apply Bayesian inversion of the Chernobyl source term using not only activity concentrations but also deposition measurements from the most recent public data set. These observations refer to a data rescue attempt that started more than 10 years ago, with a final goal to provide available measurements to anyone interested. In regards to our inverse modeling results, emissions of 134Cs were estimated to be 80 PBq or 30-50 % higher than what was previously published. From the released amount of 134Cs, about 70 PBq were deposited all over Europe. Similar to 134Cs, emissions of 137Cs were estimated as 86 PBq, on the same order as previously reported results. Finally, 131I emissions of 1365 PBq were found, which are about 10 % less than the prior total releases. The inversion pushes the injection heights of the three radionuclides to higher altitudes (up to about 3 km) than previously assumed (≈ 2.2 km) in order to better match both concentration and deposition observations over Europe. The results of the present inversion were confirmed using an independent Eulerian model, for which deposition patterns were also improved when using the estimated posterior releases. Although the independent model tends to underestimate deposition in countries that are not in the main direction of the plume, it reproduces country levels of deposition very efficiently. The results were also tested for robustness against different setups of the inversion through sensitivity runs. The source term data from this study are publicly available.

  16. A stepwise, 'test-all-positives' methodology to assess gluten-kernel contamination at the serving-size level in gluten-free (GF) oat production.

    PubMed

    Chen, Yumin; Fritz, Ronald D; Kock, Lindsay; Garg, Dinesh; Davis, R Mark; Kasturi, Prabhakar

    2018-02-01

    A step-wise, 'test-all-positive-gluten' analytical methodology has been developed and verified to assess kernel-based gluten contamination (i.e., wheat, barley and rye kernels) during gluten-free (GF) oat production. It targets GF claim compliance at the serving-size level (of a pouch or approximately 40-50g). Oat groats are collected from GF oat production following a robust attribute-based sampling plan then split into 75-g subsamples, and ground. R-Biopharm R5 sandwich ELISA R7001 is used for analysis of all the first15-g portions of the ground sample. A >20-ppm result disqualifies the production lot, while a >5 to <20-ppm result triggers complete analysis of the remaining 60-g of ground sample, analyzed in 15-g portions. If all five 15-g test results are <20ppm, and their average is <10.67ppm (since a 20-ppm contaminant in 40g of oats would dilute to 10.67ppm in 75-g), the lot is passed. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. Emperical Tests of Acceptance Sampling Plans

    NASA Technical Reports Server (NTRS)

    White, K. Preston, Jr.; Johnson, Kenneth L.

    2012-01-01

    Acceptance sampling is a quality control procedure applied as an alternative to 100% inspection. A random sample of items is drawn from a lot to determine the fraction of items which have a required quality characteristic. Both the number of items to be inspected and the criterion for determining conformance of the lot to the requirement are given by an appropriate sampling plan with specified risks of Type I and Type II sampling errors. In this paper, we present the results of empirical tests of the accuracy of selected sampling plans reported in the literature. These plans are for measureable quality characteristics which are known have either binomial, exponential, normal, gamma, Weibull, inverse Gaussian, or Poisson distributions. In the main, results support the accepted wisdom that variables acceptance plans are superior to attributes (binomial) acceptance plans, in the sense that these provide comparable protection against risks at reduced sampling cost. For the Gaussian and Weibull plans, however, there are ranges of the shape parameters for which the required sample sizes are in fact larger than the corresponding attributes plans, dramatically so for instances of large skew. Tests further confirm that the published inverse-Gaussian (IG) plan is flawed, as reported by White and Johnson (2011).

  18. Associations with HIV testing in Uganda: an analysis of the Lot Quality Assurance Sampling database 2003-2012.

    PubMed

    Jeffery, Caroline; Beckworth, Colin; Hadden, Wilbur C; Ouma, Joseph; Lwanga, Stephen K; Valadez, Joseph J

    2016-01-01

    Beginning in 2003, Uganda used Lot Quality Assurance Sampling (LQAS) to assist district managers collect and use data to improve their human immunodeficiency virus (HIV)/AIDS program. Uganda's LQAS-database (2003-2012) covers up to 73 of 112 districts. Our multidistrict analysis of the LQAS data-set at 2003-2004 and 2012 examined gender variation among adults who ever tested for HIV over time, and attributes associated with testing. Conditional logistic regression matched men and women by community with seven model effect variables. HIV testing prevalence rose from 14% (men) and 12% (women) in 2003-2004 to 62% (men) and 80% (women) in 2012. In 2003-2004, knowing the benefits of testing (Odds Ratio [OR] = 6.09, 95% CI = 3.01-12.35), knowing where to get tested (OR = 2.83, 95% CI = 1.44-5.56), and secondary education (OR = 3.04, 95% CI = 1.19-7.77) were significantly associated with HIV testing. By 2012, knowing the benefits of testing (OR = 3.63, 95% CI = 2.25-5.83), where to get tested (OR = 5.15, 95% CI = 3.26-8.14), primary education (OR = 2.01, 95% CI = 1.39-2.91), being female (OR = 3.03, 95% CI = 2.53-3.62), and being married (OR = 1.81, 95% CI = 1.17-2.8) were significantly associated with HIV testing. HIV testing prevalence in Uganda has increased dramatically, more for women than men. Our results concurred with other authors that education, knowledge of HIV, and marriage (women only) are associated with testing for HIV and suggest that couples testing is more prevalent than other authors.

  19. Monitoring health interventions – who's afraid of LQAS?

    PubMed Central

    Pezzoli, Lorenzo; Kim, Sung Hye

    2013-01-01

    Lot quality assurance sampling (LQAS) is used to evaluate health services. Subunits of a population (lots) are accepted or rejected according to the number of failures in a random sample (N) of a given lot. If failures are greater than decision value (d), we reject the lot and recommend corrective actions in the lot (i.e. intervention area); if they are equal to or less than d, we accept it. We used LQAS to monitor coverage during the last 3 days of a meningitis vaccination campaign in Niger. We selected one health area (lot) per day reporting the lowest administrative coverage in the previous 2 days. In the sampling plan we considered: N to be small enough to allow us to evaluate one lot per day, deciding to sample 16 individuals from the selected villages of each health area, using probability proportionate to population size; thresholds and d to vary according to administrative coverage reported; α ≤5% (meaning that, if we would have conducted the survey 100 times, we would have accepted the lot up to five times when real coverage was at an unacceptable level) and β ≤20% (meaning that we would have rejected the lot up to 20 times, when real coverage was equal or above the satisfactory level). We classified all three lots as with the acceptable coverage. LQAS appeared to be a rapid, simple, and statistically sound method for in-process coverage assessment. We encourage colleagues in the field to consider using LQAS in complement with other monitoring techniques such as house-to-house monitoring. PMID:24206650

  20. Monitoring health interventions--who's afraid of LQAS?

    PubMed

    Pezzoli, Lorenzo; Kim, Sung Hye

    2013-11-08

    Lot quality assurance sampling (LQAS) is used to evaluate health services. Subunits of a population (lots) are accepted or rejected according to the number of failures in a random sample (N) of a given lot. If failures are greater than decision value (d), we reject the lot and recommend corrective actions in the lot (i.e. intervention area); if they are equal to or less than d, we accept it. We used LQAS to monitor coverage during the last 3 days of a meningitis vaccination campaign in Niger. We selected one health area (lot) per day reporting the lowest administrative coverage in the previous 2 days. In the sampling plan we considered: N to be small enough to allow us to evaluate one lot per day, deciding to sample 16 individuals from the selected villages of each health area, using probability proportionate to population size; thresholds and d to vary according to administrative coverage reported; α ≤5% (meaning that, if we would have conducted the survey 100 times, we would have accepted the lot up to five times when real coverage was at an unacceptable level) and β ≤20% (meaning that we would have rejected the lot up to 20 times, when real coverage was equal or above the satisfactory level). We classified all three lots as with the acceptable coverage. LQAS appeared to be a rapid, simple, and statistically sound method for in-process coverage assessment. We encourage colleagues in the field to consider using LQAS in complement with other monitoring techniques such as house-to-house monitoring.

  1. Development of small scale cell culture models for screening poloxamer 188 lot-to-lot variation.

    PubMed

    Peng, Haofan; Hall, Kaitlyn M; Clayton, Blake; Wiltberger, Kelly; Hu, Weiwei; Hughes, Erik; Kane, John; Ney, Rachel; Ryll, Thomas

    2014-01-01

    Shear protectants such as poloxamer 188 play a critical role in protecting cells during cell culture bioprocessing. Lot-to-lot variation of poloxamer 188 was experienced during a routine technology transfer across sites of similar scale and equipment. Cell culture medium containing a specific poloxamer 188 lot resulted in an unusual drop in cell growth, viability, and titer during manufacturing runs. After switching poloxamer lots, culture performance returned to the expected level. In order to control the quality of poloxamer 188 and thus maintain better consistency in manufacturing, multiple small scale screening models were developed. Initially, a 5L bioreactor model was established to evaluate cell damage by high sparge rates with different poloxamer 188 lots. Subsequently, a more robust, simple, and efficient baffled shake flask model was developed. The baffled shake flask model can be performed in a high throughput manner to investigate the cell damage in a bubbling environment. The main cause of the poor performance was the loss of protection, rather than toxicity. It was also suggested that suspicious lots can be identified using different cell line and media. The screening methods provide easy, yet remarkable models for understanding and controlling cell damage due to raw material lot variation as well as studying the interaction between poloxamer 188 and cells. © 2014 American Institute of Chemical Engineers.

  2. Mentha spicata L. infusions as sources of antioxidant phenolic compounds: emerging reserve lots with special harvest requirements.

    PubMed

    Rita, Ingride; Pereira, Carla; Barros, Lillian; Santos-Buelga, Celestino; Ferreira, Isabel C F R

    2016-10-12

    Mentha spicata L., commonly known as spearmint, is widely used in both fresh and dry forms, for infusion preparation or in European and Indian cuisines. Recently, with the evolution of the tea market, several novel products with added value are emerging, and the standard lots have evolved to reserve lots, with special harvest requirements that confer them with enhanced organoleptic and sensorial characteristics. The apical leaves of these batches are collected in specific conditions having, then, a different chemical profile. In the present study, standard and reserve lots of M. spicata were assessed in terms of the antioxidants present in infusions prepared from the different lots. The reserve lots presented the highest concentration in all the compounds identified in relation to the standard lots, with 326 and 188 μg mL -1 of total phenolic compounds, respectively. Both types of samples presented rosmarinic acid as the most abundant phenolic compound, at concentrations of 169 and 101 μg mL -1 for reserve and standard lots, respectively. The antioxidant activity was higher in the reserve lots which had the highest total phenolic compounds content, with EC 50 values ranging from 152 to 336 μg mL -1 . The obtained results provide scientific information that may allow the consumer to make a conscientious choice.

  3. Detection of bovine viral diarrhoea virus nucleic acid, but not infectious virus, in bovine serum used for human vaccine manufacture.

    PubMed

    Laassri, Majid; Mee, Edward T; Connaughton, Sarah M; Manukyan, Hasmik; Gruber, Marion; Rodriguez-Hernandez, Carmen; Minor, Philip D; Schepelmann, Silke; Chumakov, Konstantin; Wood, David J

    2018-06-22

    Bovine viral diarrhoea virus (BVDV) is a cattle pathogen that has previously been reported to be present in bovine raw materials used in the manufacture of biological products for human use. Seven lots of trivalent measles, mumps and rubella (MMR) vaccine and 1 lot of measles vaccine from the same manufacturer, together with 17 lots of foetal bovine serum (FBS) from different vendors, 4 lots of horse serum, 2 lots of bovine trypsin and 5 lots of porcine trypsin were analysed for BVDV using recently developed techniques, including PCR assays for BVDV detection, a qRT-PCR and immunofluorescence-based virus replication assays, and deep sequencing to identify and genotype BVDV genomes. All FBS lots and one lot of bovine-derived trypsin were PCR-positive for the presence of BVDV genome; in contrast all vaccine lots and the other samples were negative. qRT-PCR based virus replication assay and immunofluorescence-based infection assay detected no infectious BVDV in the PCR-positive samples. Complete BVDV genomes were generated from FBS samples by deep sequencing, and all were BVDV type 1. These data confirmed that BVDV nucleic acid may be present in bovine-derived raw materials, but no infectious virus or genomic RNA was detected in the final vaccine products. Copyright © 2018 International Alliance for Biological Standardization. All rights reserved.

  4. 7 CFR 983.18 - Lot.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE PISTACHIOS GROWN IN CALIFORNIA, ARIZONA, AND NEW MEXICO Definitions § 983.18 Lot. Lot means any quantity of pistachios that is submitted for...

  5. 75 FR 36673 - Notice of Inventory Completion: Public Museum of West Michigan, Grand Rapids, MI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... red ochre, 1 shell bracelet, 1 lot of bird bone, 1 flint flake, and 1 projectile point fragment. At an... 33 associated funerary objects are 1 Busycon shell dipper, 16 lots of bone awls and fragments, 1... lots of polished bone, 1 pottery vessel, and 1 lot of turtle carapace fragments. In 1879, human remains...

  6. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  7. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  8. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  9. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  10. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  11. Scintillation Breakdowns in Chip Tantalum Capacitors

    NASA Technical Reports Server (NTRS)

    Teverovsky, Alexander

    2008-01-01

    Scintillations in solid tantalum capacitors are momentarily local breakdowns terminated by a self-healing or conversion to a high-resistive state of the manganese oxide cathode. This conversion effectively caps the defective area of the tantalum pentoxide dielectric and prevents short-circuit failures. Typically, this type of breakdown has no immediate catastrophic consequences and is often considered as nuisance rather than a failure. Scintillation breakdowns likely do not affect failures of parts under surge current conditions, and so-called "proofing" of tantalum chip capacitors, which is a controllable exposure of the part after soldering to voltages slightly higher than the operating voltage to verify that possible scintillations are self-healed, has been shown to improve the quality of the parts. However, no in-depth studies of the effect of scintillations on reliability of tantalum capacitors have been performed so far. KEMET is using scintillation breakdown testing as a tool for assessing process improvements and to compare quality of different manufacturing lots. Nevertheless, the relationship between failures and scintillation breakdowns is not clear, and this test is not considered as suitable for lot acceptance testing. In this work, scintillation breakdowns in different military-graded and commercial tantalum capacitors were characterized and related to the rated voltages and to life test failures. A model for assessment of times to failure, based on distributions of breakdown voltages, and accelerating factors of life testing are discussed.

  12. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  13. Perspectives on Senate Bill 55.

    ERIC Educational Resources Information Center

    Massarelli, Corey L.

    1999-01-01

    Surveys parents, students, teachers, and administrators in one Ohio school district about Senate Bill 55, which prohibits promoting to fifth grade any fourth grade student who fails the fourth grade proficiency test. Argues that legislators determined what is best for students without educators' input, and that the public still has a lot to learn…

  14. Explorations in Statistics: Power

    ERIC Educational Resources Information Center

    Curran-Everett, Douglas

    2010-01-01

    Learning about statistics is a lot like learning about science: the learning is more meaningful if you can actively explore. This fifth installment of "Explorations in Statistics" revisits power, a concept fundamental to the test of a null hypothesis. Power is the probability that we reject the null hypothesis when it is false. Four…

  15. 9 CFR 355.25 - Canning with heat processing and hermetically sealed containers; closures; code marking; heat...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... hermetically sealed containers; closures; code marking; heat processing; incubation. 355.25 Section 355.25... processing and hermetically sealed containers; closures; code marking; heat processing; incubation. (a... storage and transportation as evidenced by the incubation test. (h) Lots of canned products shall be...

  16. 9 CFR 355.25 - Canning with heat processing and hermetically sealed containers; closures; code marking; heat...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... hermetically sealed containers; closures; code marking; heat processing; incubation. 355.25 Section 355.25... processing and hermetically sealed containers; closures; code marking; heat processing; incubation. (a... storage and transportation as evidenced by the incubation test. (h) Lots of canned products shall be...

  17. 9 CFR 355.25 - Canning with heat processing and hermetically sealed containers; closures; code marking; heat...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... hermetically sealed containers; closures; code marking; heat processing; incubation. 355.25 Section 355.25... processing and hermetically sealed containers; closures; code marking; heat processing; incubation. (a... storage and transportation as evidenced by the incubation test. (h) Lots of canned products shall be...

  18. 9 CFR 355.25 - Canning with heat processing and hermetically sealed containers; closures; code marking; heat...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... hermetically sealed containers; closures; code marking; heat processing; incubation. 355.25 Section 355.25... processing and hermetically sealed containers; closures; code marking; heat processing; incubation. (a... storage and transportation as evidenced by the incubation test. (h) Lots of canned products shall be...

  19. 9 CFR 355.25 - Canning with heat processing and hermetically sealed containers; closures; code marking; heat...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... hermetically sealed containers; closures; code marking; heat processing; incubation. 355.25 Section 355.25... processing and hermetically sealed containers; closures; code marking; heat processing; incubation. (a... storage and transportation as evidenced by the incubation test. (h) Lots of canned products shall be...

  20. [Ocular findings in patients with Steinert myotonic dystrophy].

    PubMed

    Markowska, Elzbieta; Zalewska, Renata; Mariak, Zofia; Wojnar, Małgorzata

    2006-01-01

    The authors present one of many myotonic dystrophies: Steinert myotonic dystrophy (Steinert disease), which is a disease occuring seldom, and causing a lot of problems during the diagnostic and treatment process. Genetic factors, results of the histopathology tests, main clinical symptoms, particularly ophtalmic manifestation are described in this article.

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