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.

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...

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...

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...

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...

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...

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.

Irradiate-anneal screening of total dose effects in semiconductor devices. [radiation hardening of spacecraft components of Mariner spacecraft

NASA Technical Reports Server (NTRS)

Stanley, A. G.; Price, W. E.

1976-01-01

An extensive investigation of irradiate-anneal (IRAN) screening against total dose radiation effects was carried out as part of a program to harden the Mariner Jupiter/Saturn 1977 (MJS'77) spacecraft to survive the Jupiter radiation belts. The method consists of irradiating semiconductor devices with Cobalt-60 to a suitable total dose under representative bias conditions and of separating the parts in the undesired tail of the distribution from the bulk of the parts by means of a predetermined acceptance limit. The acceptable devices are then restored close to their preirradiation condition by annealing them at an elevated temperature. IRAN was used when lot screen methods were impracticable due to lack of time, and when members of a lot showed a diversity of radiation response. The feasibility of the technique was determined by testing of a number of types of linear bipolar integrated circuits, analog switches, n-channel JFETS and bipolar transistors. Based on the results of these experiments a number of device types were selected for IRAN of flight parts in the MJS'77 spacecraft systems. The part types, screening doses, acceptance criteria, number of parts tested and rejected as well as the program steps are detailed.

Optimal Inspection of Imports to Prevent Invasive Pest Introduction.

PubMed

Chen, Cuicui; Epanchin-Niell, Rebecca S; Haight, Robert G

2018-03-01

The United States imports more than 1 billion live plants annually-an important and growing pathway for introduction of damaging nonnative invertebrates and pathogens. Inspection of imports is one safeguard for reducing pest introductions, but capacity constraints limit inspection effort. We develop an optimal sampling strategy to minimize the costs of pest introductions from trade by posing inspection as an acceptance sampling problem that incorporates key features of the decision context, including (i) simultaneous inspection of many heterogeneous lots, (ii) a lot-specific sampling effort, (iii) a budget constraint that limits total inspection effort, (iv) inspection error, and (v) an objective of minimizing cost from accepted defective units. We derive a formula for expected number of accepted infested units (expected slippage) given lot size, sample size, infestation rate, and detection rate, and we formulate and analyze the inspector's optimization problem of allocating a sampling budget among incoming lots to minimize the cost of slippage. We conduct an empirical analysis of live plant inspection, including estimation of plant infestation rates from historical data, and find that inspections optimally target the largest lots with the highest plant infestation rates, leaving some lots unsampled. We also consider that USDA-APHIS, which administers inspections, may want to continue inspecting all lots at a baseline level; we find that allocating any additional capacity, beyond a comprehensive baseline inspection, to the largest lots with the highest infestation rates allows inspectors to meet the dual goals of minimizing the costs of slippage and maintaining baseline sampling without substantial compromise. © 2017 Society for Risk Analysis.

7 CFR 42.103 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... CONDITION OF FOOD CONTAINERS Procedures for Stationary Lot Sampling and Inspection § 42.103 Purpose and... stationary lots of packaged foods. This subpart shall be used to determine the acceptability of a lot based...

7 CFR 42.141 - Obtaining Operating Characteristic (OC) curve information for skip lot sampling and inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., and read the new Percent of Lots Expected to be Accepted, Pas, which results when using these skip lot... point, proceed vertically to the curve and then horizontally to the left to the vertical axis. From this...

7 CFR 42.141 - Obtaining Operating Characteristic (OC) curve information for skip lot sampling and inspection.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., and read the new Percent of Lots Expected to be Accepted, Pas, which results when using these skip lot... point, proceed vertically to the curve and then horizontally to the left to the vertical axis. From this...

Evaluation of Engineering Properties of AL-Li Alloy X2096-T8A3 Extrusion Products

NASA Technical Reports Server (NTRS)

Flom, Y.; Viens, M.; Wang, L.

1999-01-01

Mechanical, thermal fatigue and stress corrosion properties were determined for the two lots of Al-Li X2096-T8A3 extruded beams. Based on the test results, the beams were accepted as the construction material for fabrication of the Hubble Space Telescope new Solar Array Support Structure.

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 CFR 42.107 - Lot acceptance criteria.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY STANDARDS AND STANDARD CONTAINER REGULATIONS STANDARDS FOR CONDITION OF FOOD CONTAINERS Procedures for Stationary Lot Sampling and Inspection...

Quality control developments for graphite/PMR15 polyimide composites materials

NASA Technical Reports Server (NTRS)

Sheppard, C. H.; Hoggatt, J. T.

1979-01-01

The problem of lot-to-lot and within-lot variability of graphite/PMR-15 prepreg was investigated. The PMR-15 chemical characterization data were evaluated along with the processing conditions controlling the manufacture of PMR-15 resin and monomers. Manufacturing procedures were selected to yield a consistently reproducible graphite prepreg that could be processed into acceptable structural elements.

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.

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.

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.

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.

21 CFR 820.80 - Receiving, in-process, and finished device acceptance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Receiving, in-process, and finished device acceptance. 820.80 Section 820.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria...

21 CFR 820.80 - Receiving, in-process, and finished device acceptance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Receiving, in-process, and finished device acceptance. 820.80 Section 820.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria...

[Acceptance of lot sampling: its applicability to the evaluation of the primary care services portfolio].

PubMed

López-Picazo Ferrer, J

2001-05-15

To determine the applicability of the acceptance of lot quality assurance sampling (LQAS) in the primary care service portfolio, comparing its results with those given by classic evaluation. Compliance with the minimum technical norms (MTN) of the service of diabetic care was evaluated through the classic methodology (confidence 95%, accuracy 5%, representativeness of area, sample of 376 histories) and by LQAS (confidence 95%, power 80%, representativeness of primary care team (PCT), defining a lot by MTN and PCT, sample of 13 histories/PCT). Effort, information obtained and its operative nature were assessed. 44 PCTs from Murcia Primary Care Region. Classic methodology: compliance with MTN ranged between 91.1% (diagnosis, 95% CI, 84.2-94.0) and 30% (repercussion in viscera, 95% CI, 25.4-34.6). Objectives in three MTN were reached (diagnosis, history and EKG). LQAS: no MTN was accepted in all the PCTs, <01-diagnosis> being the most accepted (42 PCT, 95.6%) and <07-Funduscopy> the least accepted (24 PCT, 55.6%). In 9 PCT all were accepted (20.4%), and in 2 none were accepted (4.5%). Data were analysed through Pareto charts. Classic methodology offered accurate results, but did not identify which centres were those that did not comply (general focus). LQAS was preferable for evaluating MTN and probably coverage because: 1) it uses small samples, which foment internal quality-improvement initiatives; 2) it is easy and rapid to execute; 3) it identifies the PCT and criteria where there is an opportunity for improvement (specific focus), and 4) it can be used operatively for monitoring.

Random Vibration Testing of Advanced Wet Tantalum Capacitors

NASA Technical Reports Server (NTRS)

Teverovsky, Alexander

2015-01-01

Advanced wet tantalum capacitors allow for improved performance of power supply systems along with substantial reduction of size and weight of the systems that is especially beneficial for space electronics. Due to launch-related stresses, acceptance testing of all space systems includes random vibration test (RVT). However, many types of advanced wet tantalum capacitors cannot pass consistently RVT at conditions specified in MIL-PRF-39006, which impedes their use in space projects. This requires a closer look at the existing requirements, modes and mechanisms of failures, specifics of test conditions, and acceptance criteria. In this work, different lots of advanced wet tantalum capacitors from four manufacturers have been tested at step stress random vibration conditions while their currents were monitored before, during, and after the testing. It has been shown that the robustness of the parts and their reliability are mostly due to effective self-healing processes and limited current spiking or minor scintillations caused by RVT do not increase the risk of failures during operation. A simple model for scintillations events has been used to simulate current spiking during RVT and optimize test conditions. The significance of scintillations and possible effects of gas generation have been discussed and test acceptance criteria for limited current spiking have been suggested.

Cluster-sample surveys and lot quality assurance sampling to evaluate yellow fever immunisation coverage following a national campaign, Bolivia, 2007.

PubMed

Pezzoli, Lorenzo; Pineda, Silvia; Halkyer, Percy; Crespo, Gladys; Andrews, Nick; Ronveaux, Olivier

2009-03-01

To estimate the yellow fever (YF) vaccine coverage for the endemic and non-endemic areas of Bolivia and to determine whether selected districts had acceptable levels of coverage (>70%). We conducted two surveys of 600 individuals (25 x 12 clusters) to estimate coverage in the endemic and non-endemic areas. We assessed 11 districts using lot quality assurance sampling (LQAS). The lot (district) sample was 35 individuals with six as decision value (alpha error 6% if true coverage 70%; beta error 6% if true coverage 90%). To increase feasibility, we divided the lots into five clusters of seven individuals; to investigate the effect of clustering, we calculated alpha and beta by conducting simulations where each cluster's true coverage was sampled from a normal distribution with a mean of 70% or 90% and standard deviations of 5% or 10%. Estimated coverage was 84.3% (95% CI: 78.9-89.7) in endemic areas, 86.8% (82.5-91.0) in non-endemic and 86.0% (82.8-89.1) nationally. LQAS showed that four lots had unacceptable coverage levels. In six lots, results were inconsistent with the estimated administrative coverage. The simulations suggested that the effect of clustering the lots is unlikely to have significantly increased the risk of making incorrect accept/reject decisions. Estimated YF coverage was high. Discrepancies between administrative coverage and LQAS results may be due to incorrect population data. Even allowing for clustering in LQAS, the statistical errors would remain low. Catch-up campaigns are recommended in districts with unacceptable coverage.

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

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.

A Computer Solution of the Parking Lot Problem.

ERIC Educational Resources Information Center

Rumble, Richard T.

A computer program has been developed that will accept as inputs the physical description of a portion of land, and the parking design standards to be followed. The program will then give as outputs the numerical and graphical descriptions of the maximum-density parking lot for that portion of land. The problem has been treated as a standard…

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

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.

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...

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

Evaluation of the black light test for screening aflatoxin-contaminated maize in the Brazilian food industry.

PubMed

Gloria, E M; Fonseca, H; Calori-Domingues, M A; Souza, I M

1998-01-01

The results of the black light test for aflatoxin-contaminated maize carried out in a large food factory in the State of São Paulo was evaluated against bi-directional thin layer chromatography (TLC) analysis for 286 samples of maize. All 286 samples were accepted by the black light test (< 7 fluorescent points), however, the results from TLC analysis showed that 96 samples were contaminated and 14 showed aflatoxin B1 contamination levels higher than 20 micrograms/kg. There were 14 false negative results and no false positives and out of the 14 samples, six did not show visible fluorescent points. If the rejection criterion of one or more fluorescent points were applied, the six samples would be accepted by the black light test. But, in this case, 95 samples would be rejected and 87 results would be false positives because they did not have contamination levels over 20 micrograms/kg which is the acceptance limit of the black light test. The results indicate that the black light test, as utilized by this factory, was not able to indicate lots with possible contamination and the black light test, as recommended in the literature, would produce a high number of false positives. It is necessary to make more studies on the use of black light as a screening test for possible aflatoxin B1-contaminated maize.

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.

7 CFR 43.102 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... SAMPLING PLANS Definitions § 43.102 Definitions. Statistical and inspection or sampling terms and their... probability of acceptance (Pa) for the Limited Quality (LQ) lots. The consumer protection is 90 percent in... the standards of this subpart that have a ten percent probability of acceptance are referred to as a...

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

PubMed

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

2016-11-01

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

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

PubMed Central

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

2016-01-01

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

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...

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...

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...

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...

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.

Acceptance sampling for attributes via hypothesis testing and the hypergeometric distribution

NASA Astrophysics Data System (ADS)

Samohyl, Robert Wayne

2017-10-01

This paper questions some aspects of attribute acceptance sampling in light of the original concepts of hypothesis testing from Neyman and Pearson (NP). Attribute acceptance sampling in industry, as developed by Dodge and Romig (DR), generally follows the international standards of ISO 2859, and similarly the Brazilian standards NBR 5425 to NBR 5427 and the United States Standards ANSI/ASQC Z1.4. The paper evaluates and extends the area of acceptance sampling in two directions. First, by suggesting the use of the hypergeometric distribution to calculate the parameters of sampling plans avoiding the unnecessary use of approximations such as the binomial or Poisson distributions. We show that, under usual conditions, discrepancies can be large. The conclusion is that the hypergeometric distribution, ubiquitously available in commonly used software, is more appropriate than other distributions for acceptance sampling. Second, and more importantly, we elaborate the theory of acceptance sampling in terms of hypothesis testing rigorously following the original concepts of NP. By offering a common theoretical structure, hypothesis testing from NP can produce a better understanding of applications even beyond the usual areas of industry and commerce such as public health and political polling. With the new procedures, both sample size and sample error can be reduced. What is unclear in traditional acceptance sampling is the necessity of linking the acceptable quality limit (AQL) exclusively to the producer and the lot quality percent defective (LTPD) exclusively to the consumer. In reality, the consumer should also be preoccupied with a value of AQL, as should the producer with LTPD. Furthermore, we can also question why type I error is always uniquely associated with the producer as producer risk, and likewise, the same question arises with consumer risk which is necessarily associated with type II error. The resolution of these questions is new to the literature. The article presents R code throughout.

Thermal Analysis in Support of the Booster Separation Motor Crack Investigation

NASA Technical Reports Server (NTRS)

Davis, Darrell; Prickett, Terry; Turner, Larry D. (Technical Monitor)

2001-01-01

During a post-test inspection of a Booster Separation Motor (BSM) from a Lot Acceptance Test (LAT), a crack was noticed in the graphite throat. Since this was an out-of-family occurrence, an investigation team was formed to determine the cause of the crack. This paper will describe thermal analysis techniques used in support of this investigation. Models were generated to predict gradients in nominal motor conditions, as well as potentially anomalous conditions. Analysis was also performed on throats that were tested in the Laser Hardened Material Evaluation Laboratory (LHMEL). Some of these throats were pre-cracked, while others represented configurations designed to amplify effects of thermal stresses. Results from these analyses will be presented in this paper.

Thermal Analysis in Support of the Booster Separation Motor Crack Investigation

NASA Technical Reports Server (NTRS)

Davis, Darrell; Prickett, Terry

2002-01-01

During a post-test inspection of a Booster Separation Motor (BSM) from a Lot Acceptance Test (LAT), a crack was noticed in the graphite throat. Since this was an out-of-family occurrence, an investigation team was formed to determine the cause of the crack. This paper will describe thermal analysis techniques used in support of this investigation. Models were generated to predict gradients in nominal motor conditions, as well as potentially anomalous conditions. Analysis was also performed on throats that were tested in the Laser Hardened Material Evaluation Laboratory (LHMEL). Some of these throats were pre-cracked, while others represented configurations designed to amplify effects of thermal stresses. Results from these analyses will be presented in this paper.

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.

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.

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...

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...

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...

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...

PEM-INST-001: Instructions for Plastic Encapsulated Microcircuit (PEM) Selection, Screening, and Qualification

NASA Technical Reports Server (NTRS)

Teverovsky, Alexander; Sahu, Kusum

2003-01-01

Potential users of plastic encapsulated microcircuits (PEMs) need to be reminded that unlike the military system of producing robust high-reliability microcircuits that are designed to perform acceptably in a variety of harsh environments, PEMs are primarily designed for use in benign environments where equipment is easily accessed for repair or replacement. The methods of analysis applied to military products to demonstrate high reliability cannot always be applied to PEMs. This makes it difficult for users to characterize PEMs for two reasons: 1. Due to the major differences in design and construction, the standard test practices used to ensure that military devices are robust and have high reliability often cannot be applied to PEMs that have a smaller operating temperature range and are typically more frail and susceptible to moisture absorption. In contrast, high-reliability military microcircuits usually utilize large, robust, high-temperature packages that are hermetically sealed. 2. Unlike the military high-reliability system, users of PEMs have little visibility into commercial manufacturers proprietary design, materials, die traceability, and production processes and procedures. There is no central authority that monitors PEM commercial product for quality, and there are no controls in place that can be imposed across all commercial manufacturers to provide confidence to high-reliability users that a common acceptable level of quality exists for all PEMs manufacturers. Consequently, there is no guaranteed control over the type of reliability that is built into commercial product, and there is no guarantee that different lots from the same manufacturer are equally acceptable. And regarding application, there is no guarantee that commercial products intended for use in benign environments will provide acceptable performance and reliability in harsh space environments. The qualification and screening processes contained in this document are intended to detect poor-quality lots and screen out early random failures from use in space flight hardware. However, since it cannot be guaranteed that quality was designed and built into PEMs that are appropriate for space applications, users cannot screen in quality that may not exist. It must be understood that due to the variety of materials, processes, and technologies used to design and produce PEMs, this test process may not accelerate and detect all failure mechanisms. While the tests herein will increase user confidence that PEMs with otherwise unknown reliability can be used in space environments, such testing may not guarantee the same level of reliability offered by military microcircuits. PEMs should only be used where due to performance needs there are no alternatives in the military high-reliability market, and projects are willing to accept higher risk.

An Update on C458 Al-Li

NASA Technical Reports Server (NTRS)

Babel, Hank; Rioja, Robert

2003-01-01

The 1.8 Li content and consequently the 0.0945 lb.cu in density of C458 along with its higher modulus and good strength and toughness at ambient and cryogenic temperatures made it an attractive alloy for single and multiple use cryogenic tankage and unpressurized structure for space launch and operational vehicles. A major effort during the past year was directed towards establishing a production capability for C458 plate. Alcoa established a production ingot casting capability under Air Force Research Laboratory and NASA's Space Launch Initiative (SLI) sponsorship. Three heat lots of material were rolled so that the criterion for S-basis allowables could be met for AMS specifications. Lot acceptance testing showed that the strength and toughness values equaled and exceeded those obtained under the earlier Air Force Program when the alloy was developed. The details of this effort and the results achieved will be described. During the testing of compact tension specimens, particularly at cryogenic temperatures, delaminations were noted on the fractured surface. An investigation was initiated to better understand this condition. The results of this investigation will be presented which includes some of the successful production application of alloys with and without Li that exhibit this type of behavior.

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

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...

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...

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...

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...

BSA Delta Qualification 2, volume 3, book 1

NASA Technical Reports Server (NTRS)

1994-01-01

This report, presented in three volumes, provides the results of a two-motor Delta Qualification 2 program conducted in 1993 to certify the following enhancements for incorporation into booster separation motor (BSM) flight hardware: vulcanized-in-place nozzle aft closure insulation; new iso-static ATJ bulk graphite throat insert material; adhesive EA 9394 for bonding the nozzle throat, igniter grain rod/centering insert/igniter case; deletion of the igniter adapter insulator ring; deletion of the igniter adapter/igniter case interface RTV; and deletion of Loctite from igniter retainer plate threads. The enhancements above directly resulted from (1) the BSM total quality management (TQM) team initiatives to enhance the BSM producibility, and (2) the necessity to qualify new throat insert and adhesive systems to replace existing materials that will not be available. Testing was completed at both the component and motor levels. Component testing was accomplished to screen candidate materials (e.g., throat materials, adhesive systems) and to optimize processes (e.g., aft closure insulator vulcanization approach) prior to their incorporation into the test motors. Motor tests -- consisting of two motors, randomly selected by USBI's on-site quality personnel from production lot AAY, which were modified to accept the enhancements -- were completed to provide the final qualification of the enhancements for incorporation into flight hardware. Volume 3 book 1 provides supporting documentation to the analyses and plans of testing the two Delta Qualification units including thermal cycling planning/data acceptance records, environmental test procedures and pretest temperature conditioning history, Delta Qualification test plan, and specification SE0837 -- mix acceptance test specification.

Clustered lot quality assurance sampling: a pragmatic tool for timely assessment of vaccination coverage.

PubMed

Greenland, K; Rondy, M; Chevez, A; Sadozai, N; Gasasira, A; Abanida, E A; Pate, M A; Ronveaux, O; Okayasu, H; Pedalino, B; Pezzoli, L

2011-07-01

To evaluate oral poliovirus vaccine (OPV) coverage of the November 2009 round in five Northern Nigeria states with ongoing wild poliovirus transmission using clustered lot quality assurance sampling (CLQAS). We selected four local government areas in each pre-selected state and sampled six clusters of 10 children in each Local Government Area, defined as the lot area. We used three decision thresholds to classify OPV coverage: 75-90%, 55-70% and 35-50%. A full lot was completed, but we also assessed in retrospect the potential time-saving benefits of stopping sampling when a lot had been classified. We accepted two local government areas (LGAs) with vaccination coverage above 75%. Of the remaining 18 rejected LGAs, 11 also failed to reach 70% coverage, of which four also failed to reach 50%. The average time taken to complete a lot was 10 h. By stopping sampling when a decision was reached, we could have classified lots in 5.3, 7.7 and 7.3 h on average at the 90%, 70% and 50% coverage targets, respectively. Clustered lot quality assurance sampling was feasible and useful to estimate OPV coverage in Northern Nigeria. The multi-threshold approach provided useful information on the variation of IPD vaccination coverage. CLQAS is a very timely tool, allowing corrective actions to be directly taken in insufficiently covered areas. © 2011 Blackwell Publishing Ltd.

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.

Towards the Acceptance of RSS to Support Learning: An Empirical Study to Validate the Technology Acceptance Model in Lebanon

ERIC Educational Resources Information Center

Tarhini, Ali; Hassouna, Mohammad; Abbasi, Muhammad Sharif; Orozco, Jorge

2015-01-01

Simpler is better. There are a lot of "needs" in e-Learning, and there's often a limit to the time, talent, and money that can be thrown at them individually. Contemporary pedagogy in technology and engineering disciplines, within the higher education context, champion instructional designs that emphasize peer instruction and rich…

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.

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

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.

Multisite reproducibility of the broth microdilution method for susceptibility testing of Nocardia species.

PubMed

Conville, Patricia S; Brown-Elliott, Barbara A; Wallace, Richard J; Witebsky, Frank G; Koziol, Deloris; Hall, Geraldine S; Killian, Scott B; Knapp, Cindy C; Warshauer, David; Van, Tam; Wengenack, Nancy L; Deml, Sharon; Woods, Gail L

2012-04-01

Antimicrobial susceptibility testing (AST) of clinical isolates of Nocardia is recommended to detect resistance to commonly used antimicrobial agents; such testing is complicated by difficulties in inoculum preparation and test interpretation. In this study, six laboratories performed repetitive broth microdilution testing on single strains of Nocardia brasiliensis, Nocardia cyriacigeorgica, Nocardia farcinica, Nocardia nova, and Nocardia wallacei. For each isolate, a total of 30 microdilution panels from three different lots were tested at most sites. The goal of the study was to determine the inter- and intralaboratory reproducibility of susceptibility testing of this group of isolates. Acceptable agreement (>90% agreement at ±1 dilution of the MIC mode) was found for amikacin, ciprofloxacin, clarithromycin, and moxifloxacin. After eliminating MIC values from single laboratories whose results showed the greatest deviation from those of the remaining laboratories, acceptable agreement was also found for amoxicillin-clavulanic acid, linezolid, minocycline, and tobramycin. Results showed unsatisfactory reproducibility of broth microdilution testing of ceftriaxone with N. cyriacigeorgica and N. wallacei, tigecycline with N. brasiliensis and N. cyriacigeorgica, and sulfonamides with N. farcinica and N. wallacei. N. nova ATCC BAA-2227 is proposed as a quality control organism for AST of Nocardia sp., and the use of a disk diffusion test for sulfisoxazole is proposed as a check of the adequacy of the inoculum and to confirm sulfonamide MIC results.

Measuring Technology Acceptance Level of Teachers by Using Unified Theory of Acceptance and Use of Technology

ERIC Educational Resources Information Center

Koral Gümüsoglu, Eylem; Akay, Emel

2017-01-01

Technology has undergone a lot of radical changes in the last years which have caused the implemention of new paradigms in different sectors. It is almost impossible for education not to be affected from this change in technology. It has shifted from the traditional applications to the technology use in the classrooms. In this case, teachers' role…

Sampling requirements for forage quality characterization of rectangular hay bales

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

Sheaffer, C.C.; Martin, N.P.; Jewett, J.G.

2000-02-01

Commercial lots of alfalfa (Medicago sativa L.) hay are often bought and sold on the basis of forage quality. Proper sampling is essential to obtain accurate forage quality results for pricing of alfalfa hay, but information about sampling is limited to small, 20- to 40-kg rectangular bales. Their objectives were to determine the within-bale variation in 400-kg rectangular bales and to determine the number and distribution of core samples required to represent the crude protein (CP), acid detergent fiber (ADF), neutral detergent fiber (NDF), and dry matter (DM) concentration in commercial lots of alfalfa hay. Four bales were selected frommore » each of three hay lots and core sampled nine times per side for a total of 54 cores per bale. There was no consistent pattern of forage quality variation within bales. Averaged across lots, any portion of a bale was highly correlated with bale grand means for CP, ADF, NDF, and DM. Three lots of hay were probed six times per bale, one core per bale side from 55, 14, and 14 bales per lot. For determination of CP, ADF, NDF, and DM concentration, total core numbers required to achieve an acceptable standard error (SE) were minimized by sampling once per bale. Bootstrap analysis of data from the most variable hay lot suggested that forage quality of any lot of 400-kg alfalfa hay bales should be adequately represented by 12 bales sampled once per bale.« less

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

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

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

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

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

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

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...

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...

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...

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...

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...

Using lot quality assurance sampling to improve immunization coverage in Bangladesh.

PubMed Central

Tawfik, Y.; Hoque, S.; Siddiqi, M.

2001-01-01

OBJECTIVE: To determine areas of low vaccination coverage in five cities in Bangladesh (Chittagong, Dhaka, Khulna, Rajshahi, and Syedpur). METHODS: Six studies using lot quality assurance sampling were conducted between 1995 and 1997 by Basic Support for Institutionalizing Child Survival and the Bangladesh National Expanded Programme on Immunization. FINDINGS: BCG vaccination coverage was acceptable in all lots studied; however, the proportion of lots rejected because coverage of measles vaccination was low ranged from 0% of lots in Syedpur to 12% in Chittagong and 20% in Dhaka's zones 7 and 8. The proportion of lots rejected because an inadequate number of children in the sample had been fully vaccinated varied from 11% in Syedpur to 30% in Dhaka. Additionally, analysis of aggregated, weighted immunization coverage showed that there was a high BCG vaccination coverage (the first administered vaccine) and a low measles vaccination coverage (the last administered vaccine) indicating a high drop-out rate, ranging from 14% in Syedpur to 36% in Dhaka's zone 8. CONCLUSION: In Bangladesh, where resources are limited, results from surveys using lot quality assurance sampling enabled managers of the National Expanded Programme on Immunization to identify areas with poor vaccination coverage. Those areas were targeted to receive focused interventions to improve coverage. Since this sampling method requires only a small sample size and was easy for staff to use, it is feasible for routine monitoring of vaccination coverage. PMID:11436470

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.

Results of the performance verification of the CoaguChek XS system.

PubMed

Plesch, W; Wolf, T; Breitenbeck, N; Dikkeschei, L D; Cervero, A; Perez, P L; van den Besselaar, A M H P

2008-01-01

This is the first paper reporting a performance verification study of a point-of-care (POC) monitor for prothrombin time (PT) testing according to the requirements given in chapter 8 of the International Organization for Standardization (ISO) 17593:2007 standard "Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy". The monitor under investigation was the new CoaguChek XS system which is designed for use in patient self testing. Its detection principle is based on the amperometric measurement of the thrombin activity generated by starting the coagulation cascade using a recombinant human thromboplastin. The system performance verification study was performed at four study centers using venous and capillary blood samples on two test strip lots. Laboratory testing was performed from corresponding frozen plasma samples with six commercial thromboplastins. Samples from 73 normal donors and 297 patients on oral anticoagulation therapy were collected. Results were assessed using a refined data set of 260 subjects according to the ISO 17593:2007 standard. Each of the two test strip lots met the acceptance criteria of ISO 17593:2007 versus all thromboplastins (bias -0.19 to 0.18 INR; >97% of data within accuracy limits). The coefficient of variation for imprecision of the PT determinations in INR ranged from 2.0% to 3.2% in venous, and from 2.9% to 4.0% in capillary blood testing. Capillary versus venous INR data showed agreement of results with regression lines equal to the line of identity. The new system demonstrated a high level of trueness and accuracy, and low imprecision in INR testing. It can be concluded that the CoaguChek XS system complies with the requirements in chapter 8 of the ISO standard 17593:2007.

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

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

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.

38 CFR 36.4275 - Events constituting default and acceptability of partial payments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... provides assistance to a veteran for the acquisition of a mobile home or lot. Such loans will not be... relate to a transfer of rights of occupancy in the property; (B) The creation of a purchase money...

38 CFR 36.4275 - Events constituting default and acceptability of partial payments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... provides assistance to a veteran for the acquisition of a mobile home or lot. Such loans will not be... relate to a transfer of rights of occupancy in the property; (B) The creation of a purchase money...

38 CFR 36.4275 - Events constituting default and acceptability of partial payments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... provides assistance to a veteran for the acquisition of a mobile home or lot. Such loans will not be... relate to a transfer of rights of occupancy in the property; (B) The creation of a purchase money...

38 CFR 36.4275 - Events constituting default and acceptability of partial payments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... provides assistance to a veteran for the acquisition of a mobile home or lot. Such loans will not be... relate to a transfer of rights of occupancy in the property; (B) The creation of a purchase money...

38 CFR 36.4275 - Events constituting default and acceptability of partial payments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... provides assistance to a veteran for the acquisition of a mobile home or lot. Such loans will not be... relate to a transfer of rights of occupancy in the property; (B) The creation of a purchase money...

Possible Employee Wariness Stifles Telehealth's Acceptance.

PubMed

Diamond, Frank

2017-04-01

Workers still haven't bought in. A lot hinges on this question: Do you feel comfortable getting a diagnosis or being treated for a condition by someone on a screen? Large employers especially are willing to bet that the answer is yes.

The produsing expert consumer: Co-constructing, resisting and accepting health-related claims on social media in response to an infotainment show about food.

PubMed

Declercq, Jana; Tulkens, Stéphan; Van Leuven, Sarah

2018-03-01

This article examines the Twitter and Facebook uptake of health messages from an infotainment TV show on food, as broadcasted on Belgium's Dutch-language public broadcaster. The interest in and amount of health-related media coverage is rising, and this media coverage is an important source of information for laypeople, and impacts their health behaviours and therapy compliance. However, the role of the audience has also changed; consumers of media content increasingly are produsers, and, in the case of health, expert consumers. To explore how current audiences react to health claims, we have conducted a quantitative and qualitative content analysis of Twitter and Facebook reactions to an infotainment show about food and nutrition. We examine (1) to which elements in the show the audience reacts, to gain insight in the traction the nutrition-related content generates and (2) whether audience members are accepting or resisting the health information in the show. Our findings show that the information on health and production elicit the most reactions, and that health information incites a lot of refutation, low acceptance and a lot of suggestions on new information or new angles to complement the show's information.

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...

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

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.

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...

Scheduling revisited workstations in integrated-circuit fabrication

NASA Technical Reports Server (NTRS)

Kline, Paul J.

1992-01-01

The cost of building new semiconductor wafer fabrication factories has grown rapidly, and a state-of-the-art fab may cost 250 million dollars or more. Obtaining an acceptable return on this investment requires high productivity from the fabrication facilities. This paper describes the Photo Dispatcher system which was developed to make machine-loading recommendations on a set of key fab machines. Dispatching policies that generally perform well in job shops (e.g., Shortest Remaining Processing Time) perform poorly for workstations such as photolithography which are visited several times by the same lot of silicon wafers. The Photo Dispatcher evaluates the history of workloads throughout the fab and identifies bottleneck areas. The scheduler then assigns priorities to lots depending on where they are headed after photolithography. These priorities are designed to avoid starving bottleneck workstations and to give preference to lots that are headed to areas where they can be processed with minimal waiting. Other factors considered by the scheduler to establish priorities are the nearness of a lot to the end of its process flow and the time that the lot has already been waiting in queue. Simulations that model the equipment and products in one of Texas Instrument's wafer fabs show the Photo Dispatcher can produce a 10 percent improvement in the time required to fabricate integrated circuits.

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...

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 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...

Further observations on comparison of immunization coverage by lot quality assurance sampling and 30 cluster sampling.

PubMed

Singh, J; Jain, D C; Sharma, R S; Verghese, T

1996-06-01

Lot Quality Assurance Sampling (LQAS) and standard EPI methodology (30 cluster sampling) were used to evaluate immunization coverage in a Primary Health Center (PHC) where coverage levels were reported to be more than 85%. Of 27 sub-centers (lots) evaluated by LQAS, only 2 were accepted for child coverage, whereas none was accepted for tetanus toxoid (TT) coverage in mothers. LQAS data were combined to obtain an estimate of coverage in the entire population; 41% (95% CI 36-46) infants were immunized appropriately for their ages, while 42% (95% CI 37-47) of their mothers had received a second/ booster dose of TT. TT coverage in 149 contemporary mothers sampled in EPI survey was also 42% (95% CI 31-52). Although results by the two sampling methods were consistent with each other, a big gap was evident between reported coverage (in children as well as mothers) and survey results. LQAS was found to be operationally feasible, but it cost 40% more and required 2.5 times more time than the EPI survey. LQAS therefore, is not a good substitute for current EPI methodology to evaluate immunization coverage in a large administrative area. However, LQAS has potential as method to monitor health programs on a routine basis in small population sub-units, especially in areas with high and heterogeneously distributed immunization coverage.

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.

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…

Intervene before leaving: clustered lot quality assurance sampling to monitor vaccination coverage at health district level before the end of a yellow fever and measles vaccination campaign in Sierra Leone in 2009.

PubMed

Pezzoli, Lorenzo; Conteh, Ishata; Kamara, Wogba; Gacic-Dobo, Marta; Ronveaux, Olivier; Perea, William A; Lewis, Rosamund F

2012-06-07

In November 2009, Sierra Leone conducted a preventive yellow fever (YF) vaccination campaign targeting individuals aged nine months and older in six health districts. The campaign was integrated with a measles follow-up campaign throughout the country targeting children aged 9-59 months. For both campaigns, the operational objective was to reach 95% of the target population. During the campaign, we used clustered lot quality assurance sampling (C-LQAS) to identify areas of low coverage to recommend timely mop-up actions. We divided the country in 20 non-overlapping lots. Twelve lots were targeted by both vaccinations, while eight only by measles. In each lot, five clusters of ten eligible individuals were selected for each vaccine. The upper threshold (UT) was set at 90% and the lower threshold (LT) at 75%. A lot was rejected for low vaccination coverage if more than 7 unvaccinated individuals (not presenting vaccination card) were found. After the campaign, we plotted the C-LQAS results against the post-campaign coverage estimations to assess if early interventions were successful enough to increase coverage in the lots that were at the level of rejection before the end of the campaign. During the last two days of campaign, based on card-confirmed vaccination status, five lots out of 20 (25.0%) failed for having low measles vaccination coverage and three lots out of 12 (25.0%) for low YF coverage. In one district, estimated post-campaign vaccination coverage for both vaccines was still not significantly above the minimum acceptable level (LT = 75%) even after vaccination mop-up activities. C-LQAS during the vaccination campaign was informative to identify areas requiring mop-up activities to reach the coverage target prior to leaving the region. The only district where mop-up activities seemed to be unsuccessful might have had logistical difficulties that should be further investigated and resolved.

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

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.

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...

49 CFR 229.5 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the Association of American Railroads. Acceptable quality level (AQL). The AQL is expressed in terms of percent defective or defects per 100 units. Lots having a quality level equal to a specified AQL... intersection of the side wall and the roof sheathing. Sand delivery system means a permanently stationed or...

7 CFR 42.102 - Definitions, general.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGULATIONS STANDARDS FOR CONDITION OF FOOD CONTAINERS Definitions § 42.102 Definitions, general. For the... plan consists of first and total sample sizes with associated acceptance and rejection criteria. The... collection of filled food containers of the same size, type, and style. The term shall mean “inspection lot...

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.

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...

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.

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

Data Acceptance Criteria for Standardized Human-Associated Fecal Source Identification Quantitative Real-Time PCR Methods.

PubMed

Shanks, Orin C; Kelty, Catherine A; Oshiro, Robin; Haugland, Richard A; Madi, Tania; Brooks, Lauren; Field, Katharine G; Sivaganesan, Mano

2016-05-01

There is growing interest in the application of human-associated fecal source identification quantitative real-time PCR (qPCR) technologies for water quality management. The transition from a research tool to a standardized protocol requires a high degree of confidence in data quality across laboratories. Data quality is typically determined through a series of specifications that ensure good experimental practice and the absence of bias in the results due to DNA isolation and amplification interferences. However, there is currently a lack of consensus on how best to evaluate and interpret human fecal source identification qPCR experiments. This is, in part, due to the lack of standardized protocols and information on interlaboratory variability under conditions for data acceptance. The aim of this study is to provide users and reviewers with a complete series of conditions for data acceptance derived from a multiple laboratory data set using standardized procedures. To establish these benchmarks, data from HF183/BacR287 and HumM2 human-associated qPCR methods were generated across 14 laboratories. Each laboratory followed a standardized protocol utilizing the same lot of reference DNA materials, DNA isolation kits, amplification reagents, and test samples to generate comparable data. After removal of outliers, a nested analysis of variance (ANOVA) was used to establish proficiency metrics that include lab-to-lab, replicate testing within a lab, and random error for amplification inhibition and sample processing controls. Other data acceptance measurements included extraneous DNA contamination assessments (no-template and extraction blank controls) and calibration model performance (correlation coefficient, amplification efficiency, and lower limit of quantification). To demonstrate the implementation of the proposed standardized protocols and data acceptance criteria, comparable data from two additional laboratories were reviewed. The data acceptance criteria proposed in this study should help scientists, managers, reviewers, and the public evaluate the technical quality of future findings against an established benchmark. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

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...

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...

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...

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

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...

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...

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...

Modeling of a lot scale rainwater tank system in XP-SWMM: a case study in Western Sydney, Australia.

PubMed

van der Sterren, Marlène; Rahman, Ataur; Ryan, Garry

2014-08-01

Lot scale rainwater tank system modeling is often used in sustainable urban storm water management, particularly to estimate the reduction in the storm water run-off and pollutant wash-off at the lot scale. These rainwater tank models often cannot be adequately calibrated and validated due to limited availability of observed rainwater tank quantity and quality data. This paper presents calibration and validation of a lot scale rainwater tank system model using XP-SWMM utilizing data collected from two rainwater tank systems located in Western Sydney, Australia. The modeling considers run-off peak and volume in and out of the rainwater tank system and also a number of water quality parameters (Total Phosphorus (TP), Total Nitrogen (TN) and Total Solids (TS)). It has been found that XP-SWMM can be used successfully to develop a lot scale rainwater system model within an acceptable error margin. It has been shown that TP and TS can be predicted more accurately than TN using the developed model. In addition, it was found that a significant reduction in storm water run-off discharge can be achieved as a result of the rainwater tank up to about one year average recurrence interval rainfall event. The model parameter set assembled in this study can be used for developing lot scale rainwater tank system models at other locations in the Western Sydney region and in other parts of Australia with necessary adjustments for the local site characteristics. Copyright © 2014 Elsevier Ltd. All rights reserved.

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...

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

E-Learning: Investigating Students' Acceptance of Online Learning in Hospitality Programs

ERIC Educational Resources Information Center

Song, Sung Mi

2010-01-01

Students' perceptions and satisfaction with online learning courses have drawn a lot of attention from educational practitioners and researchers. However, an empirical study of perception and satisfaction with online learning is yet to be found in the hospitality area. Thus, this study addresses gaps in previous studies. This study was…

Lithuanian Astronomy

NASA Astrophysics Data System (ADS)

Sudzius, J.; Murdin, P.

2002-01-01

Lithuanian folklore, archaic calendars and terminology show that Lithuanians were interested in astronomy from ancient times. A lot of celestial bodies have names of Lithuanian origin that are not related to widely accepted ancient Greek mythology. For example, the Milky Way is named `Pauksciu Takas' (literally the way of birds), the constellation of the Great Bear `Didieji Grizulo Ratai' (literal...

Defining old growth in the Southeast: example of cypress

Treesearch

Margaret S. Devall; Paul C. van Deusen; Gregory A. Reams

1999-01-01

There is a lot of misunderstanding over what comprises an old growth stand, because there is no well accepted definition of old growth. Malcolm Hunter proposed a broad conceptual definition: "old-growth forests are relatively old and relatively undisturbed by humans." Because there can be large differences among forest types, Hunter suggested that specific...

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

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

Growth of Aeromonas hydrophila on fresh vegetables stored under a controlled atmosphere.

PubMed Central

Berrang, M E; Brackett, R E; Beuchat, L R

1989-01-01

The effects of controlled-atmosphere storage (CAS) on the survival and growth of Aeromonas hydrophila on fresh asparagus, broccoli, and cauliflower were examined. Two lots of each vegetable were inoculated with A. hydrophila 1653 or K144. A third lot served as an uninoculated control. Following inoculation, vegetables were stored at 4 or 15 degrees C under a CAS system previously shown to extend the shelf life of each commodity or under ambient air. Populations of A. hydrophila were enumerated on the initial day of inoculation and at various intervals for 10 days (15 degrees C) or 21 days (4 degrees C) of storage. Direct plating of samples with selective media was used to enumerate A. hydrophila. The organism was detected on most lots of vegetables as they were received from a commercial produce supplier. Without exception, the CAS system lengthened the time vegetables were subjectively considered acceptable for consumption. However, CAS did not significantly affect populations of A. hydrophila which survived or grew on inoculated vegetables. PMID:2802601

Comparison of the efficiency between two sampling plans for aflatoxins analysis in maize

PubMed Central

Mallmann, Adriano Olnei; Marchioro, Alexandro; Oliveira, Maurício Schneider; Rauber, Ricardo Hummes; Dilkin, Paulo; Mallmann, Carlos Augusto

2014-01-01

Variance and performance of two sampling plans for aflatoxins quantification in maize were evaluated. Eight lots of maize were sampled using two plans: manual, using sampling spear for kernels; and automatic, using a continuous flow to collect milled maize. Total variance and sampling, preparation, and analysis variance were determined and compared between plans through multifactor analysis of variance. Four theoretical distribution models were used to compare aflatoxins quantification distributions in eight maize lots. The acceptance and rejection probabilities for a lot under certain aflatoxin concentration were determined using variance and the information on the selected distribution model to build the operational characteristic curves (OC). Sampling and total variance were lower at the automatic plan. The OC curve from the automatic plan reduced both consumer and producer risks in comparison to the manual plan. The automatic plan is more efficient than the manual one because it expresses more accurately the real aflatoxin contamination in maize. PMID:24948911

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...

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...

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...

Intervene before leaving: clustered lot quality assurance sampling to monitor vaccination coverage at health district level before the end of a yellow fever and measles vaccination campaign in Sierra Leone in 2009

PubMed Central

2012-01-01

Background In November 2009, Sierra Leone conducted a preventive yellow fever (YF) vaccination campaign targeting individuals aged nine months and older in six health districts. The campaign was integrated with a measles follow-up campaign throughout the country targeting children aged 9–59 months. For both campaigns, the operational objective was to reach 95% of the target population. During the campaign, we used clustered lot quality assurance sampling (C-LQAS) to identify areas of low coverage to recommend timely mop-up actions. Methods We divided the country in 20 non-overlapping lots. Twelve lots were targeted by both vaccinations, while eight only by measles. In each lot, five clusters of ten eligible individuals were selected for each vaccine. The upper threshold (UT) was set at 90% and the lower threshold (LT) at 75%. A lot was rejected for low vaccination coverage if more than 7 unvaccinated individuals (not presenting vaccination card) were found. After the campaign, we plotted the C-LQAS results against the post-campaign coverage estimations to assess if early interventions were successful enough to increase coverage in the lots that were at the level of rejection before the end of the campaign. Results During the last two days of campaign, based on card-confirmed vaccination status, five lots out of 20 (25.0%) failed for having low measles vaccination coverage and three lots out of 12 (25.0%) for low YF coverage. In one district, estimated post-campaign vaccination coverage for both vaccines was still not significantly above the minimum acceptable level (LT = 75%) even after vaccination mop-up activities. Conclusion C-LQAS during the vaccination campaign was informative to identify areas requiring mop-up activities to reach the coverage target prior to leaving the region. The only district where mop-up activities seemed to be unsuccessful might have had logistical difficulties that should be further investigated and resolved. PMID:22676225

A New Aging Treatment for Improving Cryogenic Toughness of the Main Structural Alloy of the Super Lightweight Tank

NASA Technical Reports Server (NTRS)

Chen, P. S.; Stanton, W. P.

1996-01-01

Marshall Space Flight Center (MSFC) has developed a new technique that can enhance cryogenic fracture toughness and reduce the statistical spread of toughness values in alloy 2195. This aging treatment can control the location and size of strengthening precipitate T1, making improvements possible in cryogenic fracture toughness (CFT) and fracture toughness ratio (FTR). At the start of this program, design of experiments (DOE) ingot No. 10 was used as a baseline for aging process development and optimization. The new aging treatment was found to be very effective, improving CFT by approximately 15 to 20 percent for DOE ingot No. 10. To further evaluate the repeatability and effectiveness of this new treatment, the investigators selected and tested three more lots of alloy 2195, using 1.75-in-thick gauge plates with FTR values ranging from 0.85 to 1.07. The new aging treatment effectively enhanced CFT and FTR values for all three lots. In one instance, the material was considered rejectable because it did not meet the minimum FTR value (1.0) of the super lightweight tank (SLWT). The new aging treatment improved its FTR from 0.85 to 1.01, making this material acceptable for use in the SLWT.

Speaking up for Better Schools

ERIC Educational Resources Information Center

Hess, Frederick M.

2015-01-01

Teachers have a lot of frustrating things to deal with in school--obdurate administrators, inane work rules, and ham-fisted policies, to name a few. Instead of speaking up for change, many teachers have just come to accept all the dysfunction and take refuge in their classrooms. But teachers have it in their power to bust out of that classroom…

24 CFR 1710.558 - Previously accepted state filings-notice of revocation rights on property report cover page.

Code of Federal Regulations, 2010 CFR

2010-04-01

... will give the purchaser written notification of purchaser's default or breach of contract and the... purchaser loses rights and interest in the lot because of the purchaser's default or breach of contract... Report prior to signing a contract or agreement, you may cancel your contract or agreement by giving...

High School Mathematics Teaching in the USA

ERIC Educational Resources Information Center

Sherman, Brian

2010-01-01

The United States of America is a large and diverse country; nevertheless, high schools have a lot in common across the nation. In particular, mathematics teaching in American high schools, while not stereotyped, has some accepted norms which would be seen as unusual here in Australia. In order for the Australians to learn from the Americans, as…

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.

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.

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.

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

BSM Delta Qualification 2, volume 3, book 2

NASA Technical Reports Server (NTRS)

1994-01-01

This report, presented in three volumes, provides the results of a two-motor Delta Qualification 2 program conducted in 1993 to certify the following enhancements for incorporation into booster separation motor (BSM0 flight hardware: vulcanized-in-place nozzle aft closure insulation; new iso-static ATJ bulk graphite throat insert material, adhesive EA9394 for bonding the nozzle throat, igniter grain rod/centering insert/igniter case; deletion of the igniter adapter insulator ring; deletion of the igniter adapter/igniter case interface RTV; and deletion of loctite from igniter retainer plate threads. The enhancements above directly resulted from (1) the BSM total quality management (TQM) team initiatives to enhance the BSM producibility, and (2) the necessity to qualify new throat insert and adhesive systems to replace existing materials that will not be available. Testing was completed at both the component and motor levels. Component testing was accomplished to screen candidate materials (e.g., throat materials, adhesive systems) and to optimize processes (e.g., aft closure insulator vulcanization approach) prior to their incorporation into the test motors. Motor testing--consisting of two motors, randomly selected by USBI's on-site quality personnel from production lot AAY, which were modified to accept the enhancements -- was completed to provide the final qualification of the enhancements for incorporation into flight hardware. Volume 3, Book 2 provides various supporting documentation to the previous volumes with regards to the testing of the two Delta qualification units: data acceptance records, thermal conditioning analysis, igniter adapter thermal flake analysis, laboratory adhesive (EA-9394) qualification report, throat insert thermal/structural analysis, Delta Qualification Nonconformance Reports (NCR's), O-ring seating tests, and interim test report for vulcanization process qualification.

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.

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

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.

The language of nature matters: we need a more public ecology

Treesearch

Bruce R. Hull; David P. Robertson

2000-01-01

The language we use to describe nature matters. It is used by policy analysts to set goals for ecological restoration and management, by scientists to describe the nature that did, does, or could exist, and by all of us to imagine possible and acceptable conditions of environmental quality. Participants in environmental decision making demand a lot of the language and...

Acceptance and Transformation of English Educational Theory in Japan: On Student-Centered Education

ERIC Educational Resources Information Center

Kuwamura, Teresa

2014-01-01

In Japan, various theories and methodologies of English education born in other countries have been practiced, but the result has left a lot to be desired. Still, each theory has its own sociocultural background. When theory goes beyond its culture and locality, it transforms by losing its originality and absorbing new elements from a different…

Computer-Assisted Cognitive Behavioral Therapy for Child Anxiety: Results of a Randomized Clinical Trial

ERIC Educational Resources Information Center

Khanna, Muniya S.; Kendall, Philip C.

2010-01-01

Objective: This study examined the feasibility, acceptability, and effects of Camp Cope-A-Lot (CCAL), a computer-assisted cognitive behavioral therapy (CBT) for anxiety in youth. Method: Children (49; 33 males) ages 7-13 (M = 10.1 [plus or minus] 1.6; 83.7% Caucasian, 14.2% African American, 2% Hispanic) with a principal anxiety disorder were…

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…

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.

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.

Yellow fever vaccine: comparison of the neurovirulence of new 17D-204 Stamaril™ seed lots and RK 168-73 strain.

PubMed

Moulin, Jean-Claude; Silvano, Jérémy; Barban, Véronique; Riou, Patrice; Allain, Caroline

2013-07-01

The neurovirulence of two new candidate 17D-204 Stamaril™ working seed lots and that of two reference preparations were compared. The Stamaril™ working seed lots have been used for more than twenty years for the manufacturing of vaccines of acceptable safety and efficacy. The preparation designated RK 168-73 and provided by the Robert Koch Institute was used as a reference. It was confirmed that RK 168-73 strain was not a good virus control in our study because it has a very low neurovirulence regarding both the clinical and histopathological scores in comparison with Stamaril™ strain and is not representative of a vaccine known to be satisfactory in use. The results were reinforced by the phenotypic characterization by plaque assay demonstrating that RK 168-73 was very different from the Stamaril™ vaccine, and by sequencing results showing 4 mutations between Stamaril™ and RK 168-73 viruses leading to amino acid differences in the NS4B and envelop proteins. Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

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.

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.

Advanced overlay: sampling and modeling for optimized run-to-run control

NASA Astrophysics Data System (ADS)

Subramany, Lokesh; Chung, WoongJae; Samudrala, Pavan; Gao, Haiyong; Aung, Nyan; Gomez, Juan Manuel; Gutjahr, Karsten; Park, DongSuk; Snow, Patrick; Garcia-Medina, Miguel; Yap, Lipkong; Demirer, Onur Nihat; Pierson, Bill; Robinson, John C.

2016-03-01

In recent years overlay (OVL) control schemes have become more complicated in order to meet the ever shrinking margins of advanced technology nodes. As a result, this brings up new challenges to be addressed for effective run-to- run OVL control. This work addresses two of these challenges by new advanced analysis techniques: (1) sampling optimization for run-to-run control and (2) bias-variance tradeoff in modeling. The first challenge in a high order OVL control strategy is to optimize the number of measurements and the locations on the wafer, so that the "sample plan" of measurements provides high quality information about the OVL signature on the wafer with acceptable metrology throughput. We solve this tradeoff between accuracy and throughput by using a smart sampling scheme which utilizes various design-based and data-based metrics to increase model accuracy and reduce model uncertainty while avoiding wafer to wafer and within wafer measurement noise caused by metrology, scanner or process. This sort of sampling scheme, combined with an advanced field by field extrapolated modeling algorithm helps to maximize model stability and minimize on product overlay (OPO). Second, the use of higher order overlay models means more degrees of freedom, which enables increased capability to correct for complicated overlay signatures, but also increases sensitivity to process or metrology induced noise. This is also known as the bias-variance trade-off. A high order model that minimizes the bias between the modeled and raw overlay signature on a single wafer will also have a higher variation from wafer to wafer or lot to lot, that is unless an advanced modeling approach is used. In this paper, we characterize the bias-variance trade off to find the optimal scheme. The sampling and modeling solutions proposed in this study are validated by advanced process control (APC) simulations to estimate run-to-run performance, lot-to-lot and wafer-to- wafer model term monitoring to estimate stability and ultimately high volume manufacturing tests to monitor OPO by densely measured OVL data.

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.

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

Lessons Learned from the Node 1 Atmosphere Control and Storage and Water Recovery and Management Subsystem Design

NASA Technical Reports Server (NTRS)

Williams, David E.

2010-01-01

Node 1 flew to the International Space Station (ISS) on Flight 2A during December 1998. To date the National Aeronautics and Space Administration (NASA) has learned a lot of lessons from this module based on its history of approximately two years of acceptance testing on the ground and currently its twelve years on-orbit. This paper will provide an overview of the ISS Environmental Control and Life Support (ECLS) design of the Node 1 Atmosphere Control and Storage (ACS) and Water Recovery and Management (WRM) subsystems and it will document some of the lessons that have been learned to date for these subsystems based on problems prelaunch, problems encountered on-orbit, and operational problems/concerns. It is hoped that documenting these lessons learned from ISS will help in preventing them in future Programs.

Hobbs 3T MRI

DTIC Science & Technology

2009-08-01

A .  3T MRI Installation and Testing    The  Philips Achieva 3.0T MRI system was  installed  on  September 1, 2007 and was accepted...access to  a  dedicated parking  lot.  The  clinic  is  located  on   the  same  level as  the  DHS‐2  Imaging  Center, which contains  the  3T MRI, DEXA scanner... the   acoustical  activities of  the  heart. Our pilot data using this technique is based  on   a  study of 36 subjects with systolic  heart  failure. 

Lessons Learned from the Node 1 Atmosphere Control and Storage and Water Recovery and Management Subsystem Design

NASA Technical Reports Server (NTRS)

Williams, David E.

2011-01-01

Node 1 flew to the International Space Station (ISS) on Flight 2A during December 1998. To date the National Aeronautics and Space Administration (NASA) has learned a lot of lessons from this module based on its history of approximately two years of acceptance testing on the ground and currently its twelve years on-orbit. This paper will provide an overview of the ISS Environmental Control and Life Support (ECLS) design of the Node 1 Atmosphere Control and Storage (ACS) and Water Recovery and Management (WRM) subsystems and it will document some of the lessons that have been learned to date for these subsystems based on problems prelaunch, problems encountered on-orbit, and operational problems/concerns. It is hoped that documenting these lessons learned from ISS will help in preventing them in future Programs.

Bringing Standardized Processes in Atom-Probe Tomography: I Establishing Standardized Terminology

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

Anderson, Ian M; Danoix, F; Forbes, Richard

2011-01-01

Defining standardized methods requires careful consideration of the entire field and its applications. The International Field Emission Society (IFES) has elected a Standards Committee, whose task is to determine the needed steps to establish atom-probe tomography as an accepted metrology technique. Specific tasks include developing protocols or standards for: terminology and nomenclature; metrology and instrumentation, including specifications for reference materials; test methodologies; modeling and simulations; and science-based health, safety, and environmental practices. The Committee is currently working on defining terminology related to atom-probe tomography with the goal to include terms into a document published by the International Organization for Standardsmore » (ISO). A lot of terms also used in other disciplines have already been defined) and will be discussed for adoption in the context of atom-probe tomography.« less

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

PubMed

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

2013-12-01

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

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.

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.

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

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...

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.

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.

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

LQAS usefulness in an emergency department.

PubMed

de la Orden, Susana Granado; Rodríguez-Rieiro, Cristina; Sánchez-Gómez, Amaya; García, Ana Chacón; Hernández-Fernández, Tomás; Revilla, Angel Abad; Escribano, Dolores Vigil; Pérez, Paz Rodríguez

2008-01-01

This paper aims to explore lot quality assurance sampling (LQAS) applicability and usefulness in the evaluation of quality indicators in a hospital emergency department (ED) and to determine the degree of compliance with quality standards according to this sampling method. Descriptive observational research in the Hospital General Universitario Gregorio Marañón (HGUGM) emergency department (ED). Patients older than 15 years, diagnosed with dyspnoea, chest pain, urinary tract colic or bronchial asthma attending the HGUGM ED from December 2005 to May 2006, and patients admitted during 2005 with exacerbation of chronic obstructive pulmonary disease or acute meningitis were included in the study. Sample sizes were calculated using LQAS. Different quality indicators, one for each process, were selected. The upper (acceptable quality level (AQL)) and lower thresholds (rejectable quality level (RQL)) were established considering risk alpha = 5 per cent and beta = 20 per cent, and the minimum number of observations required was calculated. It was impossible to reach the necessary sample size for bronchial asthma and urinary tract colic patients. For chest pain, acute exacerbation of chronic obstructive pulmonary disease, and acute meningitis, quality problems were detected. The lot was accepted only for the dyspnoea indicator. The usefulness of LQAS to detect quality problems in the management of health processes in one hospital's ED. The LQAS could complement traditional sampling methods.

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.

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.

Are Thai MSM Willing to Take PrEP for HIV Prevention? An Analysis of Attitudes, Preferences and Acceptance

PubMed Central

Ananworanich, Jintanat; Gomez, Gabriela B.; Hallett, Timothy B.; Dybul, Mark R.; Piot, Peter

2013-01-01

Objective We aimed to understand the attitudes, preferences and acceptance of oral and parenteral PrEP among men who have sex with men (MSM) in Thailand. Background Pre-exposure prophylaxis (PrEP), the use of antiretrovirals to prevent HIV acquisition, has shown promising results in recent trials. To assess the potential impact of this new HIV prevention method, in addition to efficacy data, we need to understand which psychosocial factors are likely to determine its uptake among members of potential user groups. Methods and Findings Surveys of willingness to use PrEP products were administered to MSM. Spearman’s rank tests were used to uncover associations between questionnaire items. Mann-Whitney tests were performed to ascertain differences between groups. Conjoint analysis was used to examine the attitudes and preferences of MSM towards PrEP attributes. Most participants were willing to consider taking PrEP (39.2% “yes, definitely” and 49.2% “yes, probably”) and perceived PrEP as giving them new possibilities in their lives (38.5% “a lot of hope” and 55.8% “some hope”), even after being instructed of potential side effects and costs. HIV testing was considered the most important attribute and a daily pill and longer lasting injection in the arm were the preferred routes of administration. Conclusions Despite its multiple challenges, MSM in Thailand would be willing to take PrEP, even if they had to experience inconvenience and expense. If PrEP were to be implemented in Thailand, our findings show that its uptake could be considerable. PMID:23342121

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...

Development and pilot test of a new set of good practice indicators for chronic cancer pain management.

PubMed

Saturno, P J; Martinez-Nicolas, I; Robles-Garcia, I S; López-Soriano, F; Angel-García, D

2015-01-01

Pain is among the most important symptoms in terms of prevalence and cause of distress for cancer patients and their families. However, there is a lack of clearly defined measures of quality pain management to identify problems and monitor changes in improvement initiatives. We built a comprehensive set of evidence-based indicators following a four-step model: (1) review and systematization of existing guidelines to list evidence-based recommendations; (2) review and systematization of existing indicators matching the recommendations; (3) development of new indicators to complete a set of measures for the identified recommendations; and (4) pilot test (in hospital and primary care settings) for feasibility, reliability (kappa), and usefulness for the identification of quality problems using the lot quality acceptance sampling (LQAS) method and estimates of compliance. Twenty-two indicators were eventually pilot tested. Seventeen were feasible in hospitals and 12 in all settings. Feasibility barriers included difficulties in identifying target patients, deficient clinical records and low prevalence of cases for some indicators. Reliability was mostly very good or excellent (k > 0.8). Four indicators, all of them related to medication and prevention of side effects, had acceptable compliance at 75%/40% LQAS level. Other important medication-related indicators (i.e., adjustment to pain intensity, prescription for breakthrough pain) and indicators concerning patient-centred care (i.e., attention to psychological distress and educational needs) had very low compliance, highlighting specific quality gaps. A set of good practice indicators has been built and pilot tested as a feasible, reliable and useful quality monitoring tool, and underscoring particular and important areas for improvement. © 2014 European Pain Federation - EFIC®

Lessons Learned from the Node 1 Temperature and Humidity Control Subsystem Design

NASA Technical Reports Server (NTRS)

Williams, David E.

2010-01-01

Node 1 flew to the International Space Station (ISS) on Flight 2A during December 1998. To date the National Aeronautics and Space Administration (NASA) has learned a lot of lessons from this module based on its history of approximately two years of acceptance testing on the ground and currently its twelve years on-orbit. This paper will provide an overview of the ISS Environmental Control and Life Support (ECLS) design of the Node 1 Temperature and Humidity Control (THC) subsystem and it will document some of the lessons that have been learned to date for this subsystem and it will document some of the lessons that have been learned to date for these subsystems based on problems prelaunch, problems encountered on-orbit, and operational problems/concerns. It is hoped that documenting these lessons learned from ISS will help in preventing them in future Programs. 1

Viral Vectors for In Vivo Gene Transfer in Parkinson’s disease: Properties and Clinical Grade Production

PubMed Central

Burger, Corinna; Snyder, Richard O.

2009-01-01

Because Parkinson’s disease is a progressive degenerative disorder that is mainly confined to the basal ganglia, gene transfer to deliver therapeutic molecules is an attractive treatment avenue. The present review focuses on direct in vivo gene transfer vectors that have been developed to a degree that they have been successfully used in animal model of Parkinson’s disease. Accordingly, the properties of recombinant adenovirus, recombinant adeno-associated virus, herpes simplex virus, and lentivirus are described and contrasted. In order for viral vectors to be developed into clinical grade reagents, they must be manufactured and tested to precise regulatory standards. Indeed, clinical lots of viral vectors can be produced in compliance with current Good Manufacturing Practices (cGMPs) regulations using industry accepted manufacturing methodologies, manufacturing controls, and quality systems. The viral vector properties themselves combined with physiological product formulations facilitate long-term storage and direct in vivo administration. PMID:17916354

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.

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.

An Empirical Assessment of a Technology Acceptance Model for Apps in Medical Education.

PubMed

Briz-Ponce, Laura; García-Peñalvo, Francisco José

2015-11-01

The evolution and the growth of mobile applications ("apps") in our society is a reality. This general trend is still upward and the app use has also penetrated the medical education community. However, there is a lot of unawareness of the students' and professionals' point of view about introducing "apps" within Medical School curriculum. The aim of this research is to design, implement and verify that the Technology Acceptance Model (TAM) can be employed to measure and explain the acceptance of mobile technology and "apps" within Medical Education. The methodology was based on a survey distributed to students and medical professionals from University of Salamanca. This model explains 46.7% of behavioral intention to use mobile devise or "apps" for learning and will help us to justify and understand the current situation of introducing "apps" into the Medical School curriculum.

Preprints, Impact Factors, and Unethical Behavior, but also Lots of Good News.

PubMed

Gölitz, Peter

2016-10-24

Preprints as well? There is already the Accepted Article (published directly after refereeing and author revision), the Early-View/ASAP-Version (after refereeing, editing and proofing), and the final Version of Record. The problems with preprints are discussed in this Editorial along with the undeclared resubmission of previously rejected manuscripts: publication times, color costs, and Angewandte Symposia are further topics. © 2016 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

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.

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.

Solutions to Address Diabetes-Related Financial Burden and Cost-Related Nonadherence: Results From a Pilot Study.

PubMed

Patel, Minal R; Resnicow, Kenneth; Lang, Ian; Kraus, Kathleen; Heisler, Michele

2018-02-01

Cost-related nonadherence (CRN) to recommended self-management behaviors among adults with chronic conditions such as diabetes is prevalent. Few behavioral interventions to mitigate CRN have been tested and evaluated. We developed a financial burden resource tool and examined its acceptability and the preliminary effects on patient-centered outcomes among adults with diabetes or prediabetes seen in a clinical setting. We report a pre-post one-group design pilot study. From an endocrinology clinic, we recruited 104 adults with diabetes who reported financial burdens with their diabetes management or engaged in CRN behaviors. We offered participants the financial burden resource tool we developed, which provided tailored, low-cost resource options for diabetes management and other social needs. Acceptability and self-reported outcomes were assessed 2 months after use of the tool. Mean age of participants was 50.5 years ( SD = 15.3). Participants found the tool highly acceptable across 15 indicators (e.g., 93% "learned a lot," 98% "topics relevant" 95% "applicable to their lives," 98% "liked the information"). Significant improvements between baseline and 2-month follow-up were observed for discussion of cost concerns with nurses (19% to 29%, p < .05) and pharmacists (13% to 25.5%, p < .01), not skipping doses of medicines due to cost (11% to 4%, p < .03), and financial management (33.83 to 39.62, p < .007). There were no significant changes in perception of financial burden. A financial burden resource tool is highly acceptable to patients, is easy to administer, and can prompt behavior change. This pilot study supports the need for well-powered trials with longer follow-up to further evaluate the effectiveness of such tools in improving CRN and key outcomes.

Solutions to Address Diabetes-Related Financial Burden and Cost-Related Nonadherence: Results From a Pilot Study

PubMed Central

Patel, Minal R.; Resnicow, Kenneth; Lang, Ian; Kraus, Kathleen; Heisler, Michele

2018-01-01

Background Cost-related nonadherence (CRN) to recommended self-management behaviors among adults with chronic conditions such as diabetes is prevalent. Few behavioral interventions to mitigate CRN have been tested and evaluated. Aims We developed a financial burden resource tool and examined its acceptability and the preliminary effects on patient-centered outcomes among adults with diabetes or prediabetes seen in a clinical setting. Method We report a pre–post one-group design pilot study. From an endocrinology clinic, we recruited 104 adults with diabetes who reported financial burdens with their diabetes management or engaged in CRN behaviors. We offered participants the financial burden resource tool we developed, which provided tailored, low-cost resource options for diabetes management and other social needs. Acceptability and self-reported outcomes were assessed 2 months after use of the tool. Results Mean age of participants was 50.5 years (SD = 15.3). Participants found the tool highly acceptable across 15 indicators (e.g., 93% “learned a lot,” 98% “topics relevant” 95% “applicable to their lives,” 98% “liked the information”). Significant improvements between baseline and 2-month followup were observed for discussion of cost concerns with nurses (19% to 29%, p < .05) and pharmacists (13% to 25.5%, p < .01), not skipping doses of medicines due to cost (11% to 4%, p < .03), and financial management (33.83 to 39.62, p < .007). There were no significant changes in perception of financial burden. Conclusion A financial burden resource tool is highly acceptable to patients, is easy to administer, and can prompt behavior change. This pilot study supports the need for well-powered trials with longer follow-up to further evaluate the effectiveness of such tools in improving CRN and key outcomes. PMID:28443371

Graphical tests for Hardy-Weinberg equilibrium based on the ternary plot.

PubMed

Graffelman, Jan; Camarena, Jair Morales

2008-01-01

We design a graphical test for Hardy-Weinberg equilibrium. This can circumvent the calculation of p values and the statistical (non)significance of a large number of bi-allelic markers can be inferred from their position in a graph. By rewriting expressions for the chi(2) statistic (with and without continuity correction) in terms of the heterozygote frequency an acceptance region for Hardy-Weinberg equilibrium is obtained that can be depicted in a ternary plot. We obtain equations for curves in the ternary plot that separate markers that are out of Hardy-Weinberg equilibrium from those that are in equilibrium. The curves depend on the chosen significance level, the sample size and on a continuity correction parameter. Some examples of graphical tests using a set of 106 SNPs on the long arm of human chromosome 22 are described. Significant markers and poor markers with a lot of missing values are easily identified in the proposed plots. R software for making the diagrams is provided. The proposed graphs can be used as control charts for spotting problematic markers in large scale genotyping studies, and constitute an excellent tool for the graphical exploration of bi-allelic marker data. (c) 2007 S. Karger AG, Basel.

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

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.

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

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.

Acceptability and feasibility of CyberSenga, an Internet-based HIV prevention program for adolescents in Mbarara, Uganda

PubMed Central

Bull, Sheana; Prescott, Tonya L.; Birungi, Ruth

2013-01-01

Capitalizing on emerging data suggesting that HIV preventive behaviors can be positively affected by Internet-based programs, we developed and tested CyberSenga, an Internet-based, comprehensive sexuality education program for adolescents in Mbarara, Uganda. Three hundred and sixty-six secondary school students were randomly assigned to either the 5-lesson program (+ booster) or a treatment-as-usual control. At three-month follow-up, intervention participants provided feedback on program acceptability. Six focus groups with intervention participants were additionally conducted after the final follow-up at 6 months. Data support a hypothesis of feasibility: Despite schedule interruptions, 95% of intervention participants completed all 5 modules; only 17% deviated from the once-a-week intended delivery schedule. Internet service was uninterrupted during the field period and, in general, the technology performed to specifications. The intervention also appears to be acceptable: 94% of intervention youth somewhat or strongly agreed that they learned a lot and 93% said they were somewhat or very likely to recommend the program. Although more than two in three youth somewhat or strongly agreed that the program talked too much about sex (70%) and condoms (75%), 89% somewhat or strongly disagreed that “I do not think kids like me should do the CyberSenga program”. Feedback from focus group participants further suggested that the content was generally acceptable and did not contradict local norms in most cases. In fact, despite concerns from some local stakeholders to the contrary, information about condoms did not appear to be confusing or contradictory for youth who were abstinent. Nonetheless, some of the sexual topics seemed to be unfamiliar or uncomfortable for some participants – particularly brief references to oral and anal sex. Together, both qualitative and quantitative data suggest that the program is a feasible and acceptable way of delivering HIV preventive information to both sexually experienced and inexperienced adolescents in Mbarara, Uganda. PMID:24093828

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

Performance evaluation of the microINR® point-of-care INR-testing system.

PubMed

Joubert, J; van Zyl, M C; Raubenheimer, J

2018-04-01

Point-of-care International Normalised Ratio (INR) testing is used frequently. We evaluated the microINR ® POC system for accuracy, precision and measurement repeatability, and investigated instrument and test chip variability and error rates. Venous blood INRs of 210 patients on warfarin were obtained with Thromborel ® S on the Sysmex CS-2100i ® analyser and compared with capillary blood microINR ® values. Precision was assessed using control materials. Measurement repeatability was calculated on 51 duplicate finger-prick INRs. Triplicate finger-prick INRs using three different instruments (30 patients) and three different test chip lots (29 patients) were used to evaluate instrument and test chip variability. Linear regression analysis of microINR ® and Sysmex CS2100i ® values showed a correlation coefficient of 0.96 (P < .0001) and a positive proportional bias of 4.4%. Dosage concordance was 93.8% and clinical agreement 95.7%. All acceptance criteria based on ISO standard 17593:2007 system accuracy requirements were met. Control material coefficients of variation (CV) varied from 6.2% to 16.7%. The capillary blood measurement repeatability CV was 7.5%. No significant instrument (P = .93) or test chip (P = .81) variability was found, and the error rate was low (2.8%). The microINR ® instrument is accurate and precise for monitoring warfarin therapy. © 2017 John Wiley & Sons Ltd.

BSM Delta Qualification 2, volume 2

NASA Technical Reports Server (NTRS)

1994-01-01

This report, presented in three volumes, provides the results of a two-motor Delta Qualification 2 program conducted in 1993 to certify the following enhancements for incorporation into booster separation motor (BSM) flight hardware: vulcanized-in-place nozzle aft closure insulation; new iso-static ATJ bulk graphite throat insert material; adhesive EA 9394 for bonding the nozzle throat, igniter grain rod/centering insert/igniter case; deletion of the igniter adapter insulator ring; deletion of the igniter adapter/igniter case interface RTV; and deletion of loctite from igniter retainer plate threads. The enhancements above directly resulted from (1) the BSM total quality management (TQM) team initiatives to enhance the BSM producibility, and (2) the necessity to qualify new throat insert and adhesive systems to replace existing materials that will not be available. Testing was completed at both the component and motor levels. Component testing was accomplished to screen candidate materials (e.g., throat materials, adhesive systems) and to optimize processes (e.g., aft closure insulator vulcanization approach) prior to their incorporation into the test motors. Motor tests -- consisting of two motors, randomly selected by USBI's on-site quality personnel from production lot AAY, which were modified to accept the enhancements -- were completed to provide the final qualification of the enhancements for incorporation into flight hardware. Volume 2 details the environmental testing (vibration and shock) conducted at Marshall Space Flight Center (MSFC) to which the motors were subjected prior to static tests.

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

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

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

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

Assessing a computerized routine health information system in Mali using LQAS.

PubMed

Stewart, J C; Schroeder, D G; Marsh, D R; Allhasane, S; Kone, D

2001-09-01

Between 1987 and 1998 Save the Children conducted a child survival programme in Mali with the goal of reducing maternal and child morbidity and mortality. An integral part of this programme was a computerized demographic surveillance and health information system (HIS) that gathered data on individuals on an on-going basis. To assess the overall coverage and quality of the data in the HIS, to identify specific health districts that needed improvements in data collection methods, and to determine particular areas of weakness in data collection. Random samples of 20 mothers with children <5 years were selected in each of 14 health districts. Mothers were interviewed about pregnancies, live births, deaths of children <5, and children's growth monitoring and immunization status. The Lot Quality Assurance Method (LQAS) was used to identify districts in which records and interview results did not meet predetermined levels of acceptability. Data collected in the interviews were combined to estimate overall coverage and quality. When all variables were analyzed, all 14 lots were rejected, and it was estimated that 52% of all events occurring in the community were registered in ProMIS. Much of this poor performance was due to immunization and growth monitoring data, which were not updated due to printer problems. Coverage of events increased (92%) when immunizations and growth monitoring were excluded, and no lots were rejected. When all variables were analyzed for quality of data recorded, six lots were rejected and the overall estimation was 83%. With immunizations and growth monitoring excluded, overall quality was 86% and no lots were rejected. The comprehensive computerized HIS did not meet expectations. This may be due, in part, to the ambitious objective of complete and intensive monitoring of a large population without adequate staff and equipment. Future efforts should consider employing a more targeted and streamlined HIS so that data can be more complete and useful.

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.

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

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...

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...

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...

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.

Consumer acceptable risk: how cigarette companies have responded to accusations that their products are defective

PubMed Central

Cummings, K Michael; Brown, Anthony; Douglas, Clifford E

2006-01-01

Objective To describe arguments used by cigarette companies to defend themselves against charges that their cigarettes were defective and that they could and should have done more to make cigarettes less hazardous. Methods The data for this paper come from the opening statements made by defendants in four court cases: two class action lawsuits (Engle 1999, and Blankenship 2001) and two individual cases (Boeken 2001, and Schwarz 2002). The transcripts of opening statements were reviewed and statements about product defect claims, product testing, and safe cigarette research were excerpted and coded. Results Responses by cigarette companies to charges that their products were defective has been presented consistently across different cases and by different companies. Essentially the arguments made by cigarette companies boil down to three claims: (1) smoking is risky, but nothing the companies have done has made cigarettes more dangerous than might otherwise be the case; (2) nothing the companies have done or said has kept someone from stopping smoking; and (3) the companies have spent lots of money to make the safest cigarette acceptable to the smoker. Conclusions Cigarette companies have argued that their products are inherently dangerous but not defective, and that they have worked hard to make their products safer by lowering the tar and nicotine content of cigarettes as recommended by members of the public health community. As a counter argument, plaintiff attorneys should focus on how cigarette design changes have actually made smoking more acceptable to smokers, thereby discouraging smoking cessation. PMID:17130628

Hotline Complaint Involving Auditor Independence at a Field Audit Office in the Defense Contract Audit Agency Western Region

DTIC Science & Technology

2011-10-06

the Comptroller General issued a “2011 Internet Version” of the standards on August 19, 2011, the new standards do not take effect until December 15...and make improvements to help ensure future compliance. Management Action: On August 3, 2011, DCAA issued revised training on GAGAS independence...a significant noncompliance willl Generally Accepted Government Auditing StAndards. During our review of’ a Defense I lot line comt >laint, we

BSM Delta qualification 2, volume 1

NASA Technical Reports Server (NTRS)

1994-01-01

This report, presented in three volumes, provides the results of a two-motor Delta Qualification 2 program conducted in 1993 to certify the following enhancements for incorporation into Booster Separation Motor (BSM) flight hardware: (1) vulcanized-in-place nozzle aft closure insulation; (2) new isostatic ATJ bulk graphite throat insert material; (3) adhesive EA 9394 for bonding the nozzle throat, igniter grain rod/centering insert/igniter case; (4) deletion of the igniter adapter insulator ring; (5) deletion of igniter adapter/igniter case interface RTV; and (6) deletion of Loctite from igniter retainer plate threads. The enhancements above directly resulted from (1) the BSM Total Quality Management (TQM) Team initiatives to enhance the BSM producibility, and (2) the necessity to qualify new throat insert and adhesive systems to replace existing materials that will not be available. Testing was completed at both the component and motor levels. Component testing was accomplished to screen candidate materials (e.g., throat materials, adhesive systems) and to optimize processes (e.g., aft closure insulator vulcanization approach) prior to their incorporation into the test motors. Motor testing - consisting of two motors, randomly selected by USBI's onsite quality personnel from production lot AAY, which were modified to accept the enhancements - were completed to provide the final qualification of the enhancements for incorporation into flight hardware. It is concluded that all of the enhancements herein tested are qualified to be incorporated into flight hardware for the BSM.

[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.

The USER: Utilizing Scientific Environments for Research

NASA Astrophysics Data System (ADS)

Walker, Lakeisha

A lot of hard work goes into submitting a proposal for access to equipment in our nation's top science research facilities. It seems the biggest focus for a facility USER should be on the acceptance of the proposal, however, the job of a facility USER actually begins after the acceptance letter arrives. In order to make the most of the Awarded experiment time and cultivate collaborations for the future, facility USERs need to look beyond the proposal. From experiment scheduling to arrival to data analysis the entire USER experience is valuable and worth doing well. This presentation will discuss best practices for facility USERs and highlight successful USER collaborations at ORNL's High Flux Isotope Reactor. Funded by the Office of Basic Energy Sciences, U.S. DOE. ORNL is managed by UT-Battelle, LLC for US DOE.

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

Detecting water in aviation honeycomb structures by using transient infrared thermographic NDT

NASA Astrophysics Data System (ADS)

Vavilov, Vladimir P.; Klimov, Alexey G.; Nesteruk, Dmitry; Shiryaev, Vladimir V.

2003-04-01

A lot of structural key elements of many modern civilian and military airplanes, such as flaps, keel, etc., are made of honeycomb structures. Honeycombs involve a combination of some materials including aluminum, Nomex, glass and graphite epoxy composites. During exploitation, atmosphere water could penetrate these structures due to possible imperfections in various junctions, and, thus, deteriorate airplane durability. In Russia, water in honeycombs is typically detected by using the X ray and ultrasonic technique. However, the X ray equipment is hardly accepted by commercial airlines because of the safety reason, and the point-by-point ultrasonic inspection is low-productive. Since 2002, we develop the IR thermographic method of detecting water by thermally stimulating aviation panels under test. Unlike the technique accepted by Airbus Industry, Inc., that uses 'a warm blanket', we use a powerful optical heater assembled with an IR camera into a single set. The first stage of research included modeling the detection process and optimizing the experimental procedure. As a result, we have demonstrated that, due to the high heat capacity of water, a temperature signal over moist areas evolves in time during a relatively long period that relaxes the requirements to the test protocol. Thus, even aluminum panels can be thermally stimulated during few seconds with a delay time being also in a few second range. A similar protocol can be applied to the inspection of composite honeycombs where the image quality resembles that obtained by X rays. The paper will describe all stages of the research starting from modeling and finishing with the preliminary experimental results obtained in situ on civilian airplanes.

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

Hemoglobin A1c Point-of-Care Assays; a New World with a Lot of Consequences!

PubMed Central

Lenters-Westra, Erna; Slingerland, Robbert J.

2009-01-01

Background Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly. PMID:20144277

Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles.

PubMed

Jiang, Canping; Flansburg, Lisa; Ghose, Sanchayita; Jorjorian, Paul; Shukla, Abhinav A

2010-12-15

The concept of design space has been taking root under the quality by design paradigm as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. This paper outlines the development of a design space for a hydrophobic interaction chromatography (HIC) process step. The design space included the impact of raw material lot-to-lot variability and variations in the feed stream from cell culture. A failure modes and effects analysis was employed as the basis for the process characterization exercise. During mapping of the process design space, the multi-dimensional combination of operational variables were studied to quantify the impact on process performance in terms of yield and product quality. Variability in resin hydrophobicity was found to have a significant influence on step yield and high-molecular weight aggregate clearance through the HIC step. A robust operating window was identified for this process step that enabled a higher step yield while ensuring acceptable product quality. © 2010 Wiley Periodicals, Inc.

Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment

PubMed Central

Wright, J. Fraser

2014-01-01

Adeno-associated virus (AAV)-based vectors expressing therapeutic genes continue to demonstrate great promise for the treatment of a wide variety of diseases and together with other gene transfer vectors represent an emerging new therapeutic paradigm comparable in potential impact on human health to that achieved by recombinant proteins and vaccines. A challenge for the current pipeline of AAV-based investigational products as they advance through clinical development is the identification, characterization and lot-to-lot control of the process- and product-related impurities present in even highly purified preparations. Especially challenging are AAV vector product-related impurities that closely resemble the vector itself and are, in some cases, without clear precedent in established biotherapeutic products. The determination of acceptable levels of these impurities in vectors prepared for human clinical product development, with the goal of new product licensure, requires careful risk and feasibility assessment. This review focuses primarily on the AAV product-related impurities that have been described in vectors prepared for clinical development. PMID:28548061

Automated technical validation--a real time expert system for decision support.

PubMed

de Graeve, J S; Cambus, J P; Gruson, A; Valdiguié, P M

1996-04-15

Dealing daily with various machines and various control specimens provides a lot of data that cannot be processed manually. In order to help decision-making we wrote specific software coping with the traditional QC, with patient data (mean of normals, delta check) and with criteria related to the analytical equipment (flags and alarms). Four machines (3 Ektachem 700 and 1 Hitachi 911) analysing 25 common chemical tests are controlled. Every day, three different control specimens and one more once a week (regional survey) are run on the various pieces of equipment. The data are collected on a 486 microcomputer connected to the central computer. For every parameter the standard deviation is compared with the published acceptable limits and the Westgard's rules are computed. The mean of normals is continuously monitored. The final decision induces either an alarm sound and the print-out of the cause of rejection or, if no alarms happen, the daily print-out of recorded data, with or without the Levey Jennings graphs.

Machine vision method for online surface inspection of easy open can ends

NASA Astrophysics Data System (ADS)

Mariño, Perfecto; Pastoriza, Vicente; Santamaría, Miguel

2006-10-01

Easy open can end manufacturing process in the food canning sector currently makes use of a manual, non-destructive testing procedure to guarantee can end repair coating quality. This surface inspection is based on a visual inspection made by human inspectors. Due to the high production rate (100 to 500 ends per minute) only a small part of each lot is verified (statistical sampling), then an automatic, online, inspection system, based on machine vision, has been developed to improve this quality control. The inspection system uses a fuzzy model to make the acceptance/rejection decision for each can end from the information obtained by the vision sensor. In this work, the inspection method is presented. This surface inspection system checks the total production, classifies the ends in agreement with an expert human inspector, supplies interpretability to the operators in order to find out the failure causes and reduce mean time to repair during failures, and allows to modify the minimum can end repair coating quality.

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

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.

Decision theory applied to image quality control in radiology.

PubMed

Lessa, Patrícia S; Caous, Cristofer A; Arantes, Paula R; Amaro, Edson; de Souza, Fernando M Campello

2008-11-13

The present work aims at the application of the decision theory to radiological image quality control (QC) in diagnostic routine. The main problem addressed in the framework of decision theory is to accept or reject a film lot of a radiology service. The probability of each decision of a determined set of variables was obtained from the selected films. Based on a radiology service routine a decision probability function was determined for each considered group of combination characteristics. These characteristics were related to the film quality control. These parameters were also framed in a set of 8 possibilities, resulting in 256 possible decision rules. In order to determine a general utility application function to access the decision risk, we have used a simple unique parameter called r. The payoffs chosen were: diagnostic's result (correct/incorrect), cost (high/low), and patient satisfaction (yes/no) resulting in eight possible combinations. Depending on the value of r, more or less risk will occur related to the decision-making. The utility function was evaluated in order to determine the probability of a decision. The decision was made with patients or administrators' opinions from a radiology service center. The model is a formal quantitative approach to make a decision related to the medical imaging quality, providing an instrument to discriminate what is really necessary to accept or reject a film or a film lot. The method presented herein can help to access the risk level of an incorrect radiological diagnosis decision.

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

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.

Methodology For Reduction Of Sampling On The Visual Inspection Of Developed And Etched Wafers

NASA Astrophysics Data System (ADS)

van de Ven, Jamie S.; Khorasani, Fred

1989-07-01

There is a lot of inspection in the manufacturing of semiconductor devices. Generally, the more important a manufacturing step, the higher is the level of inspection. In some cases 100% of the wafers are inspected after certain steps. Inspection is a non-value added and expensive activity. It requires an army of "inspectors," often times expensive equipment and becomes a "bottle neck" when the level of inspection is high. Although inspection helps identify quality problems, it hurts productivity. The new management, quality and productivity philosophies recommend against over inspection. [Point #3 in Dr. Deming's 14 Points for Management (1)] 100% inspection is quite unnecessary . Often the nature of a process allows us to reduce inspection drastically and still maintain a high level of confidence in quality. In section 2, we discuss such situations and show that some elementary probability theory allows us to determine sample sizes and measure the chances of catching a bad "lot" and accepting a good lot. In section 3, we provide an example and application of the theory, and make a few comments on money and time saved because of this work. Finally, in section 4, we draw some conclusions about the new quality and productivity philosophies and how applied statisticians and engineers should study every situation individually and avoid blindly using methods and tables given in books.

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.

Acceptance Test Data for BWXT Coated Particle Batches 93172B and 93173B—Defective IPyC and Pyrocarbon Anisotropy

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

Hunn, John D.; Helmreich, Grant W.; Dyer, John A.

Coated particle batches J52O-16-93172B and J52O-16-93173B were produced by Babcock and Wilcox Technologies (BWXT) as part of the production campaign for the Advanced Gas Reactor Fuel Development and Qualification (AGR) Program’s AGR-5/6/7 irradiation test in the Idaho National Laboratory (INL) Advanced Test Reactor (ATR), but were not used in the final fuel composite. However, these batches may be used as demonstration production-scale coated particle fuel for other experiments. Each batch was coated in a 150-mm-diameter production-scale fluidized-bed chemical vapor deposition (CVD) furnace. Tristructural isotropic (TRISO) coatings were deposited on 425-μm-nominal-diameter spherical kernels from BWXT lot J52R-16-69317 containing a mixture ofmore » 15.5%-enriched uranium carbide and uranium oxide (UCO). The TRISO coatings consisted of four consecutive CVD layers: a ~50% dense carbon buffer layer with 100-μm-nominal thickness, a dense inner pyrolytic carbon (IPyC) layer with 40-μm-nominal thickness, a silicon carbide (SiC) layer with 35-μm-nominal thickness, and a dense outer pyrolytic carbon (OPyC) layer with 40-μm-nominal thickness. The TRISO-coated particle batches were sieved to upgrade the particles by removing over-sized and under-sized material, and the upgraded batches were designated by appending the letter A to the end of the batch number (e.g., 93172A). Secondary upgrading by sieving was performed on the A-designated batches to remove particles with missing or very-thin buffer layers that were identified during previous analysis of the individual batches for defective IPyC, as reported in the acceptance test data report for the AGR-5/6/7 production batches [Hunn et al. 2017b]. The additionally-upgraded batches were designated by appending the letter B to the end of the batch number (e.g., 93172B).« less

Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study.

PubMed

Perrett, Kirsten P; McVernon, Jodie; Richmond, Peter C; Marshall, Helen; Nissen, Michael; August, Allison; Percell, Sandra; Toneatto, Daniela; Nolan, Terry

2015-09-22

For decades, a broadly effective vaccine against serogroup B Neisseria meningitidis (MenB) has remained elusive. Recently, a four-component recombinant vaccine (4CMenB) has been developed and is now approved in Europe, Canada, Australia and some Latin American countries. This phase III, randomized study evaluated the lot consistency, early immune responses and the safety profile of 4CMenB in 11 to 17-year-old adolescents in Australia and Canada (NCT01423084). In total, 344 adolescents received two doses of one of 2 lots of 4CMenB, 1-month apart. Immunogenicity was assessed before, 2-weeks and 1-month following the second vaccination. Serum bactericidal activity using human complement (hSBA) was measured against three reference strains 44/76-SL, 5/99 and NZ98/254, selected to express one of the vaccine antigens; Neisseria adhesin A (NadA), factor H binding protein (fHbp) and porin A (PorA) containing outer membrane vesicle (OMV), respectively. Responses to the Neisseria heparin binding antigen (NHBA) were assessed with enzyme linked immunosorbent assay (ELISA). Local and systemic reactions were recorded for 7 days following each vaccination; unsolicited adverse events were monitored throughout the study. Immunological equivalence of the two lots of 4CMenB was established at 1-month. At baseline, ≤7% of participants had hSBA titers ≥5 to all three reference strains. Two weeks following the second dose of 4CMenB, all participants had hSBA titers ≥5 against fHbp and NadA compared with 84-96% against the PorA reference strains. At 1-month, corresponding proportions were 99%, 100% and 70-79%, respectively. Both lots were generally well tolerated and had similar adverse event profiles. Two doses of 4CMenB had an acceptable safety profile and induced a robust immune response in adolescents. Peak antibody responses were observed at 14 days following vaccination. While a substantial non-uniform antigen-dependent early decline in antibody titers was seen thereafter, a significant percentage of participants continued to maintain protective hSBA titers at 1-month. Copyright © 2015 Elsevier Ltd. All rights reserved.

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...

Transgenic mice as an alternative to monkeys for neurovirulence testing of live oral poliovirus vaccine: validation by a WHO collaborative study.

PubMed Central

Dragunsky, Eugenia; Nomura, Tatsuji; Karpinski, Kazimir; Furesz, John; Wood, David J.; Pervikov, Yuri; Abe, Shinobu; Kurata, Takeshi; Vanloocke, Olivier; Karganova, Galina; Taffs, Rolf; Heath, Alan; Ivshina, Anna; Levenbook, Inessa

2003-01-01

OBJECTIVE: Extensive WHO collaborative studies were performed to evaluate the suitability of transgenic mice susceptible to poliovirus (TgPVR mice, strain 21, bred and provided by the Central Institute for Experimental Animals, Japan) as an alternative to monkeys in the neurovirulence test (NVT) of oral poliovirus vaccine (OPV). METHODS: Nine laboratories participated in the collaborative study on testing neurovirulence of 94 preparations of OPV and vaccine derivatives of all three serotypes in TgPVR21 mice. FINDINGS: Statistical analysis of the data demonstrated that the TgPVR21 mouse NVT was of comparable sensitivity and reproducibility to the conventional WHO NVT in simians. A statistical model for acceptance/rejection of OPV lots in the mouse test was developed, validated, and shown to be suitable for all three vaccine types. The assessment of the transgenic mouse NVT is based on clinical evaluation of paralysed mice. Unlike the monkey NVT, histological examination of central nervous system tissue of each mouse offered no advantage over careful and detailed clinical observation. CONCLUSIONS: Based on data from the collaborative studies the WHO Expert Committee for Biological Standardization approved the mouse NVT as an alternative to the monkey test for all three OPV types and defined a standard implementation process for laboratories that wish to use the test. This represents the first successful introduction of transgenic animals into control of biologicals. PMID:12764491

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.

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.

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

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 ...

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.

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...

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.

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.

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.

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...

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.

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

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.

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.

Stability of ionized calcium measurements at concentrations less than 0.3 mmol/L by point-of-care blood gas instruments: application for postfilter calcium quality control in patients with citrate anticoagulation during extracorporeal circulation.

PubMed

Averina, Maria; Jakobsen, Raymond

2017-05-01

Background Measurements of ionized calcium (Ca 2+ ) at concentrations less than 0.3 mmol/L are required for postfilter control in patients who receive extracorporeal circulation with sodium citrate anticoagulation. This study evaluates the stability of the Ca 2+ measurements at such concentrations. Methods The stability of the Ca 2+ measurements was tested by measuring daily the external standard Qualicheck concentration 3 s7950, Radiometer (0.22-0.25 mmol/L) by blood gas instruments ABL800 and ABL90, Radiometer. Two different Ca 2+ membrane lots were tested for the usual membrane lifetime of 12 weeks at ABL800 instruments. For the ABL90 instrument, the sensor cassette (with Ca 2+ membrane and electrode) was replaced after four weeks as required. Results We observed over 40% Ca 2+ increase within the usual 12 weeks lifetime of the Ca 2+ membrane at the ABL800 instruments. Measurements of Ca 2+ at concentrations less than 0.3 mmol/L were within acceptable limits for both ABL800 and ABL90 instruments when Ca 2+ membrane and sensor cassette were replaced after four weeks. Conclusions For ABL800 instruments, it is necessary to use an extra quality control (<0.3 mmol/L) in addition to the usual quality controls to monitor Ca 2+ measurements below 0.3 mmol/L. The acceptable stability of the Ca 2+ measurements can be achieved by the Ca 2+ membrane and sensor cassette replacement after four weeks. If the usual 12 weeks of Ca 2+ membrane lifetime is maintained, it may result in a clinically significant overestimation of Ca 2+ by ABL800 instruments.

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...

[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.

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.

Coping Styles in Heart Failure Patients with Depressive Symptoms

PubMed Central

Trivedi, Ranak B.; Blumenthal, James A.; O'Connor, Christopher; Adams, Kirkwood; Hinderliter, Alan; Sueta-Dupree, Carla; Johnson, Kristy; Sherwood, Andrew

2009-01-01

Objective Elevated depressive symptoms have been linked to poorer prognosis in heart failure (HF) patients. Our objective was to identify coping styles associated with depressive symptoms in HF patients. Methods 222 stable HF patients (32.75% female, 45.4% non-Hispanic Black) completed multiple questionnaires. Beck Depression Inventory (BDI) assessed depressive symptoms, Life Orientation Test (LOT-R) assessed optimism, ENRICHD Social Support Inventory (ESSI) and Perceived Social Support Scale (PSSS) assessed social support, and COPE assessed coping styles. Linear regression analyses were employed to assess the association of coping styles with continuous BDI scores. Logistic regression analyses were performed using BDI scores dichotomized into BDI<10 versus BDI≥10, to identify coping styles accompanying clinically significant depressive symptoms. Results In linear regression models, higher BDI scores were associated with lower scores on the acceptance (β=-.14), humor (β=-.15), planning (β=-.15), and emotional support (β=-.14) subscales of the COPE, and higher scores on the behavioral disengagement (β=.41), denial (β=.33), venting (β=.25), and mental disengagement (β=.22) subscales. Higher PSSS and ESSI scores were associated with lower BDI scores (β=-.32 and -.25, respectively). Higher LOT-R scores were associated with higher BDI scores (β=.39, p<.001). In logistical regression models, BDI≥10 was associated with greater likelihood of behavioral disengagement (OR=1.3), denial (OR=1.2), mental disengagement (OR=1.3), venting (OR=1.2), and pessimism (OR=1.2), and lower perceived social support measured by PSSS (OR=.92) and ESSI (OR=.92). Conclusion Depressive symptoms in HF patients are associated with avoidant coping, lower perceived social support, and pessimism. Results raise the possibility that interventions designed to improve coping may reduce depressive symptoms. PMID:19773027

Coping styles in heart failure patients with depressive symptoms.

PubMed

Trivedi, Ranak B; Blumenthal, James A; O'Connor, Christopher; Adams, Kirkwood; Hinderliter, Alan; Dupree, Carla; Johnson, Kristy; Sherwood, Andrew

2009-10-01

Elevated depressive symptoms have been linked to poorer prognosis in heart failure (HF) patients. Our objective was to identify coping styles associated with depressive symptoms in HF patients. A total of 222 stable HF patients (32.75% female, 45.4% non-Hispanic black) completed multiple questionnaires. Beck Depression Inventory (BDI) assessed depressive symptoms, Life Orientation Test (LOT-R) assessed optimism, ENRICHD Social Support Inventory (ESSI) and Perceived Social Support Scale (PSSS) assessed social support, and COPE assessed coping styles. Linear regression analyses were employed to assess the association of coping styles with continuous BDI scores. Logistic regression analyses were performed using BDI scores dichotomized into BDI<10 vs. BDI> or =10, to identify coping styles accompanying clinically significant depressive symptoms. In linear regression models, higher BDI scores were associated with lower scores on the acceptance (beta=-.14), humor (beta=-.15), planning (beta=-.15), and emotional support (beta=-.14) subscales of the COPE, and higher scores on the behavioral disengagement (beta=.41), denial (beta=.33), venting (beta=.25), and mental disengagement (beta=.22) subscales. Higher PSSS and ESSI scores were associated with lower BDI scores (beta=-.32 and -.25, respectively). Higher LOT-R scores were associated with higher BDI scores (beta=.39, P<.001). In logistical regression models, BDI> or =10 was associated with greater likelihood of behavioral disengagement (OR=1.3), denial (OR=1.2), mental disengagement (OR=1.3), venting (OR=1.2), and pessimism (OR=1.2), and lower perceived social support measured by PSSS (OR=.92) and ESSI (OR=.92). Depressive symptoms in HF patients are associated with avoidant coping, lower perceived social support, and pessimism. Results raise the possibility that interventions designed to improve coping may reduce depressive symptoms.

Cluster lot quality assurance sampling: effect of increasing the number of clusters on classification precision and operational feasibility.

PubMed

Okayasu, Hiromasa; Brown, Alexandra E; Nzioki, Michael M; Gasasira, Alex N; Takane, Marina; Mkanda, Pascal; Wassilak, Steven G F; Sutter, Roland W

2014-11-01

To assess the quality of supplementary immunization activities (SIAs), the Global Polio Eradication Initiative (GPEI) has used cluster lot quality assurance sampling (C-LQAS) methods since 2009. However, since the inception of C-LQAS, questions have been raised about the optimal balance between operational feasibility and precision of classification of lots to identify areas with low SIA quality that require corrective programmatic action. To determine if an increased precision in classification would result in differential programmatic decision making, we conducted a pilot evaluation in 4 local government areas (LGAs) in Nigeria with an expanded LQAS sample size of 16 clusters (instead of the standard 6 clusters) of 10 subjects each. The results showed greater heterogeneity between clusters than the assumed standard deviation of 10%, ranging from 12% to 23%. Comparing the distribution of 4-outcome classifications obtained from all possible combinations of 6-cluster subsamples to the observed classification of the 16-cluster sample, we obtained an exact match in classification in 56% to 85% of instances. We concluded that the 6-cluster C-LQAS provides acceptable classification precision for programmatic action. Considering the greater resources required to implement an expanded C-LQAS, the improvement in precision was deemed insufficient to warrant the effort. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

[Kaiseijutsu and obstetrics in Osaka during the Yedo era: focusing mainly on the development of surgical operations in obstetrics].

PubMed

Uchino, Hanna

2009-03-01

In the Yedo era, the Kamigata area was the place of dispatch of new cultures and was the seat of the economy. However, because natural disasters happened frequently, the economic differential between the central area and the provinces grew wider. The families who suffered poverty sold their daughters to the licensed quarters. Moreover, among the general public, there were a lot of foundlings and women who had abortions. Indeed, we can find these phenomena throughout the Yedo era. Early in the era, such cases were regarded as very common; for example, in IHARA Saikaku works, which describes scenes in Osaka early in the Yedo era, there are a lot of descriptions of foundlings and women who had abortions as common social phenomena. However, in the middle of the era, these phenomena came to be considered sins, as they were in Saikaku's works. This transition period of conceptions about foundlings or abortions coincided with changes in technology in obstetrics. Early in the era when dystocia occurred, both mothers and babies could only be expected to die, and in the middle, after the invention of Kaiseijutsu, which was designed by KAGAWA Gen'etsu, obstetricians could help a lot of women in childbirth. However, when abortions came to be regarded as a sin, people accepted Kaiseijutsu because of the concept of life and because it could help women in childbed and babies as medicine, before everything else.

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.

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

Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

PubMed Central

Hund, Lauren; Pagano, Marcello

2014-01-01

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible non-parametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. PMID:24633656

Extending cluster lot quality assurance sampling designs for surveillance programs.

PubMed

Hund, Lauren; Pagano, Marcello

2014-07-20

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. Copyright © 2014 John Wiley & Sons, Ltd.

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

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.

Acceptance Test Data for the AGR-5/6/7 Irradiation Test Fuel Composite Defective IPyC Fraction and Pyrocarbon Anisotropy

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

Helmreich, Grant W.; Hunn, John D.; Skitt, Darren J.

Coated particle composite J52R-16-98005 was produced by Babcock and Wilcox Technologies (BWXT) as fuel for the Advanced Gas Reactor Fuel Development and Qualification (AGR) Program’s AGR-5/6/7 irradiation test in the Idaho National Laboratory (INL) Advanced Test Reactor (ATR). This composite was comprised of four coated particle fuel batches J52O-16-93165B (26%), 93168B (26%), 93169B (24%), and 93170B (24%), chosen based on the Quality Control (QC) data acquired for each individual candidate AGR-5/6/7 batch. Each batch was coated in a 150-mm-diameter production-scale fluidized-bed chemical vapor deposition (CVD) furnace. Tristructural isotropic (TRISO) coatings were deposited on 425-μm-nominal-diameter spherical kernels from BWXT Lot J52R-16-69317more » containing a mixture of 15.5%-enriched uranium carbide and uranium oxide (UCO). The TRISO coatings consisted of four consecutive CVD layers: a ~50% dense carbon buffer layer with 100-μm-nominal thickness, a dense inner pyrolytic carbon (IPyC) layer with 40-μm-nominal thickness, a silicon carbide (SiC) layer with 35-μm-nominal thickness, and a dense outer pyrolytic carbon (OPyC) layer with 40-μm-nominal thickness. The TRISO-coated particle batches were sieved to upgrade the particles by removing over-sized and under-sized material, and the upgraded batches were designated by appending the letter A to the end of the batch number (e.g., 93165A). Secondary upgrading by sieving was performed on the A-designated batches to remove particles with missing or very-thin buffer layers that were identified during previous analysis of the individual batches for defective IPyC, as reported in the acceptance test data report for the AGR-5/6/7 production batches [Hunn et al. 2017]. The additionally-upgraded batches were designated by appending the letter B to the end of the batch number (e.g., 93165B).« less

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.

NEPP Evaluation of Automotive Grade Tantalum Chip Capacitors

NASA Technical Reports Server (NTRS)

Sampson, Mike; Brusse, Jay

2018-01-01

Automotive grade tantalum (Ta) chip capacitors are available at lower cost with smaller physical size and higher volumetric efficiency compared to military/space grade capacitors. Designers of high reliability aerospace and military systems would like to take advantage of these attributes while maintaining the high standards for long-term reliable operation they are accustomed to when selecting military-qualified established reliability tantalum chip capacitors (e.g., MIL-PRF-55365). The objective for this evaluation was to assess the long-term performance of off-the-shelf automotive grade Ta chip capacitors (i.e., manufacturer self-qualified per AEC Q-200). Two (2) lots of case size D manganese dioxide (MnO2) cathode Ta chip capacitors from 1 manufacturer were evaluated. The evaluation consisted of construction analysis, basic electrical parameter characterization, extended long-term (2000 hours) life testing and some accelerated stress testing. Tests and acceptance criteria were based upon manufacturer datasheets and the Automotive Electronics Council's AEC Q-200 qualification specification for passive electronic components. As-received a few capacitors were marginally above the specified tolerance for capacitance and ESR. X-ray inspection found that the anodes for some devices may not be properly aligned within the molded encapsulation leaving less than 1 mil thickness of the encapsulation. This evaluation found that the long-term life performance of automotive grade Ta chip capacitors is generally within specification limits suggesting these capacitors may be suitable for some space applications.

Electronic tracking system and wandering in Alzheimer's disease: a case study.

PubMed

Faucounau, V; Riguet, M; Orvoen, G; Lacombe, A; Rialle, V; Extra, J; Rigaud, A-S

2009-01-01

Wandering is a behavioural disorder, which occurs in Alzheimer's disease or other dementia. People who wander are at risk of physical harm and untimely death. Moreover, wandering behaviour causes a lot of stress to the caregivers. In the last few years, different geolocation devices have been developed in order to minimise risk and manage unsafe wandering. These detection systems rarely meet patients and caregivers' needs because they are not involved in the devices building process. The aim is to explore the needs and perceptions of wandering persons and their caregivers towards existing tracking devices as well as their acceptability and usability. This paper reports a dyad case. The tracking system tested is presented as a mobile Global Positioning System (GPS) receiver-shaped, including function of telephony and data transfer via GSM/GPRS. Dyad patient/caregiver expressed their needs and perceptions towards tracking devices and gave their impressions about the functioning of the tested device at the end of the test. The patient focused on the device's shape which he found too voluminous and unaesthetic, and was unable to give an opinion about the device's functioning. The spouse highlighted malfunctions and usage difficulties, which made the device not appropriate to her needs. Involving end-users in the co-design of new technologies is necessary for building tailored devices. Moreover, in this area of dementia care, the person-centred approach is essential to a tailored wandering management.

Acceptance Test Data for BWXT Coated Particle Batch 93164A Defective IPyC Fraction and Pyrocarbon Anisotropy

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

Helmreich, Grant W.; Hunn, John D.; Skitt, Darren J.

2017-02-01

Coated particle fuel batch J52O-16-93164 was produced by Babcock and Wilcox Technologies (BWXT) for possible selection as fuel for the Advanced Gas Reactor Fuel Development and Qualification (AGR) Program’s AGR-5/6/7 irradiation test in the Idaho National Laboratory (INL) Advanced Test Reactor (ATR), or may be used as demonstration production-scale coated particle fuel for other experiments. The tristructural-isotropic (TRISO) coatings were deposited in a 150-mm-diameter production-scale fluidizedbed chemical vapor deposition (CVD) furnace onto 425-μm-nominal-diameter spherical kernels from BWXT lot J52L-16-69316. Each kernel contained a mixture of 15.5%-enriched uranium carbide and uranium oxide (UCO) and was coated with four consecutive CVD layers:more » a ~50% dense carbon buffer layer with 100-μm-nominal thickness, a dense inner pyrolytic carbon (IPyC) layer with 40-μm-nominal thickness, a silicon carbide (SiC) layer with 35-μm-nominal thickness, and a dense outer pyrolytic carbon (OPyC) layer with 40-μm-nominal thickness. The TRISO-coated particle batch was sieved to upgrade the particles by removing over-sized and under-sized material, and the upgraded batch was designated by appending the letter A to the end of the batch number (i.e., 93164A).« less

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.

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...

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...

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...

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...

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...

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…

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...

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...

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...

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...

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...

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...

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...

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.

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...

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...

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...

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...

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...

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.

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.

Establishment and application of event-specific polymerase chain reaction methods for two genetically modified soybean events, A2704-12 and A5547-127.

PubMed

Li, Xiang; Pan, Liangwen; Li, Junyi; Zhang, Qigang; Zhang, Shuya; Lv, Rong; Yang, Litao

2011-12-28

For implementation of the issued regulations and labeling policies for genetically modified organism (GMO) supervision, the polymerase chain reaction (PCR) method has been widely used due to its high specificity and sensitivity. In particular, use of the event-specific PCR method based on the flanking sequence of transgenes has become the primary trend. In this study, both qualitative and quantitative PCR methods were established on the basis of the 5' flanking sequence of transgenic soybean A2704-12 and the 3' flanking sequence of transgenic soybean A5547-127, respectively. In qualitative PCR assays, the limits of detection (LODs) were 10 copies of haploid soybean genomic DNA for both A2704-12 and A5547-127. In quantitative real-time PCR assays, the LODs were 5 copies of haploid soybean genomic DNA for both A2704-12 and A5547-127, and the limits of quantification (LOQs) were 10 copies for both. Low bias and acceptable SD and RSD values were also achieved in quantification of four blind samples using the developed real-time PCR assays. In addition, the developed PCR assays for the two transgenic soybean events were used for routine analysis of soybean samples imported to Shanghai in a 6 month period from October 2010 to March 2011. A total of 27 lots of soybean from the United States and Argentina were analyzed: 8 lots from the Unites States were found to have the GM soybean A2704-12 event, and the GM contents were <1.5% in all eight analyzed lots. On the contrary, no GM soybean A5547-127 content was found in any of the eight lots. These results demonstrated that the established event-specific qualitative and quantitative PCR methods could be used effectively in routine identification and quantification of GM soybeans A2704-12 and A5547-127 and their derived products.

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...

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...

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...

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...

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...

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...

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...

Video segmentation using keywords

NASA Astrophysics Data System (ADS)

Ton-That, Vinh; Vong, Chi-Tai; Nguyen-Dao, Xuan-Truong; Tran, Minh-Triet

2018-04-01

At DAVIS-2016 Challenge, many state-of-art video segmentation methods achieve potential results, but they still much depend on annotated frames to distinguish between background and foreground. It takes a lot of time and efforts to create these frames exactly. In this paper, we introduce a method to segment objects from video based on keywords given by user. First, we use a real-time object detection system - YOLOv2 to identify regions containing objects that have labels match with the given keywords in the first frame. Then, for each region identified from the previous step, we use Pyramid Scene Parsing Network to assign each pixel as foreground or background. These frames can be used as input frames for Object Flow algorithm to perform segmentation on entire video. We conduct experiments on a subset of DAVIS-2016 dataset in half the size of its original size, which shows that our method can handle many popular classes in PASCAL VOC 2012 dataset with acceptable accuracy, about 75.03%. We suggest widely testing by combining other methods to improve this result in the future.

[Psychometric Testing of a New Scale Assessing the Reasons for Non-Utilisation of Health Care Services by People with Migration Backgrounds].

PubMed

Maier, I; Kriston, L; Härter, M; Hölzel, L P; Bermejo, I

2015-10-01

In Germany live a lot of migrants. Cultural and migration specific aspects seem to have an effect on utilisation of health care. There are no instruments that measure such factors of influence. A systematic literature research or article that identify the difficulties of the migrants in using the health care system, was made. The relevant aspects were explored during a health related opinion survey of migrants from former USSR, Turkey, Italy and Spain. The psychometric qualities of this questionnaire were investigated with factor and reliability analyses. There were 24 reasons identified for non-utilisation health care. They were combined in a questionnaire. The factor analysis showed 2-factor structure ("janguage und information related Reasons" Chronbach's α=0.928 and "experience with/attitude toward health care system", Chronbach's α=0.879). Furthermore, there was a total scale with Chronbach's α=0.945. The acceptance was between 80.0 and 96.3%. The results confirm the psychometric quality of this measuring instrument. For further generalisability more verification will be necessary. © Georg Thieme Verlag KG Stuttgart · New York.

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

Brown, Nigel; Lodge, Mike; Hilton, Linda

The nuclear industry is not a provider of oils and solvents but uses them in motors, equipment and even in chemical processes to extract valuable products. Currently, for old and contaminated oils and solvents, techniques still exist, such as incineration, but not all the oils and solvents are compatible with this technique because the activities of some components inside the oils are too high to be accepted at the incineration facility. For these oils, an alternative technique needs to be found for treatment. A process developed for water treatment using a technique of adsorption coupled with electrochemical regeneration has beenmore » investigated to assess its capability to treat these organic wastes. One of the strengths of the process is its flexibility and adaptation to different compositions of oils. This point is important because, in the AREVA case, there are a lot of small volumes of old oils which need to be re-characterized. It takes time and money to do it especially when oils are contaminated; this is one reason why the technique is interesting to investigate. Tests have been performed with different oils coming from different sites to test the feasibility. Results demonstrate the destruction of a range of organics with regeneration energy requirements of 13.4 - 68.7 kWh/l and offer confidence for the future potential of the process. (authors)« less

Department of the Navy Justification of Estimates for Fiscal Years 1988 and 1989 Submitted to Congress January 1987. Operation & Maintenance, Navy. Book 2 of 3. Budget Activity 7: Central Supply and Maintenance

DTIC Science & Technology

1987-01-01

training, customer service, small/uneconomilcal lot manufacturing, preservation and depreservation, aircraft salvage and recovery, and support of depot...for the commercial modification programs. 1,260 4) Increase in commercial A/C preservation ,and customer service effort. 69 9. Program Derr.eas~s...3,499 Salvage 703 459 712 845 Acceptance/Transfer 2,587 1,645- 2,376 2,453 Customer /Fleet Training 2,838 2,008 3,058 2,997 Customer Services 17,276

The Decision to Accept or Decline Command: An Analysis of Considerations by FY 82 05/06 Selectees and a CGSC Sample

DTIC Science & Technology

1982-06-01

the bills. The days of packing mama and the baby up, picking up vy foc’t locler and moving out are over for us -- and a lot of other Jbrvy fclks in...don’t regret the decision and will stay in command for 18 months without dependants even though my family is terribly depressed and disappointed. "Some...cervical cancer and was operated upon. Indications were that it was successful, but she required follow-up checks every 3 months at Walter Reed Army

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.

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.

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…

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...

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.

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...

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...

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...

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...

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...

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...

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

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.

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...

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...

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...

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.

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.

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.

Factors influencing the adoption of health information technologies: a systematic review

PubMed Central

Garavand, Ali; Mohseni, Mohammah; Asadi, Heshmatollah; Etemadi, Manal; Moradi-Joo, Mohammad; Moosavi, Ahmad

2016-01-01

Introduction The successful implementation of health information technologies requires investigating the factors affecting the acceptance and use of them. The aim of this study was to determine the most important factors affecting the adoption of health information technologies by doing a systematic review on the factors affecting the acceptance of health information technology. Methods This systematic review was conducted by searching the major databases, such as Google Scholar, Emerald, Science Direct, Web of Science, Pubmed, and Scopus. We used various keywords, such as adoption, use, acceptance of IT in medicine, hospitals, and IT theories in health services, and we also searched on the basis of several important technologies, such as Electronic Health Records (HER), Electronic Patient Records (EPR), Electronic Medical Records (EMR), Computerized Physician Order Entry (CPOE), Hospital Information System (HIS), Picture Archiving and Communication System (PACS), and others in the 2004–2014 period. Results The technology acceptance model (TAM) is the most important model used to identify the factors influencing the adoption of information technologies in the health system; also, the unified theory of acceptance and use of technology (UTAUT) model has had a lot of applications in recent years in the health system. Ease of use, usefulness, social impact, facilitating conditions, attitudes and behavior of users are effective in the adoption of health information technologies. Conclusion By considering various factors, including ease of use, usefulness, and social impact, the rate of the adoption of health information technology can be increased. PMID:27757179

Factors influencing the adoption of health information technologies: a systematic review.

PubMed

Garavand, Ali; Mohseni, Mohammah; Asadi, Heshmatollah; Etemadi, Manal; Moradi-Joo, Mohammad; Moosavi, Ahmad

2016-08-01

The successful implementation of health information technologies requires investigating the factors affecting the acceptance and use of them. The aim of this study was to determine the most important factors affecting the adoption of health information technologies by doing a systematic review on the factors affecting the acceptance of health information technology. This systematic review was conducted by searching the major databases, such as Google Scholar, Emerald, Science Direct, Web of Science, Pubmed, and Scopus. We used various keywords, such as adoption, use, acceptance of IT in medicine, hospitals, and IT theories in health services, and we also searched on the basis of several important technologies, such as Electronic Health Records (HER), Electronic Patient Records (EPR), Electronic Medical Records (EMR), Computerized Physician Order Entry (CPOE), Hospital Information System (HIS), Picture Archiving and Communication System (PACS), and others in the 2004-2014 period. The technology acceptance model (TAM) is the most important model used to identify the factors influencing the adoption of information technologies in the health system; also, the unified theory of acceptance and use of technology (UTAUT) model has had a lot of applications in recent years in the health system. Ease of use, usefulness, social impact, facilitating conditions, attitudes and behavior of users are effective in the adoption of health information technologies. By considering various factors, including ease of use, usefulness, and social impact, the rate of the adoption of health information technology can be increased.

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

Improvement of sampling plans for Salmonella detection in pooled table eggs by use of real-time PCR.

PubMed

Pasquali, Frédérique; De Cesare, Alessandra; Valero, Antonio; Olsen, John Emerdhal; Manfreda, Gerardo

2014-08-01

Eggs and egg products have been described as the most critical food vehicles of salmonellosis. The prevalence and level of contamination of Salmonella on table eggs are low, which severely affects the sensitivity of sampling plans applied voluntarily in some European countries, where one to five pools of 10 eggs are tested by the culture based reference method ISO 6579:2004. In the current study we have compared the testing-sensitivity of the reference culture method ISO 6579:2004 and an alternative real-time PCR method on Salmonella contaminated egg-pool of different sizes (4-9 uninfected eggs mixed with one contaminated egg) and contamination levels (10°-10(1), 10(1)-10(2), 10(2)-10(3)CFU/eggshell). Two hundred and seventy samples corresponding to 15 replicates per pool size and inoculum level were tested. At the lowest contamination level real-time PCR detected Salmonella in 40% of contaminated pools vs 12% using ISO 6579. The results were used to estimate the lowest number of sample units needed to be tested in order to have a 95% certainty not falsely to accept a contaminated lot by Monte Carlo simulation. According to this simulation, at least 16 pools of 10 eggs each are needed to be tested by ISO 6579 in order to obtain this confidence level, while the minimum number of pools to be tested was reduced to 8 pools of 9 eggs each, when real-time PCR was applied as analytical method. This result underlines the importance of including analytical methods with higher sensitivity in order to improve the efficiency of sampling and reduce the number of samples to be tested. Copyright © 2013 Elsevier B.V. All rights reserved.

[Classification and monitoring of the appropriateness of emergency admissions in a tertiary hospital].

PubMed

López-Picazo Ferrer, J J; Tomás García, N; Cubillana Herrero, J D; Gómez Company, J A; de Dios Cánovas García, J

2014-01-01

To measure the appropriateness of hospital admissions, to classify its Clinical Services (CS) according to the level of inappropriateness, and to determine the usefulness of applying rapid assessment techniques (lot quality assurance sampling) in these types of measurements. A descriptive, retrospective study was conducted in a tertiary hospital to assess the clinical records of emergency admissions to the 12 CS with a higher volume of admissions, using the Appropriateness Evaluation Protocol (AEP). A four-level («A» to «D») increasingly inadequate admissions scale was constructed setting both standard and threshold values in every stratum. Every CS was classified in one of them using lot quality assurance sampling (LQAS). A total of 156 cases (13 cases from every CS) were assessed. The assessment effort (devoted time) was also estimated. There were 22.4±6.3% of inadequate admissions. In the CS classification, 9 (75%) got a good or acceptable appropriateness level, and only 1 (8%) got an inacceptable level. The time devoted was estimated at 17 hours. AEP is useful to assess the admission appropriateness and may be included in the «Emergencies» process management, although its variability prevents the use for external comparisons. If both LQAS and the appropriateness classification level and the global estimation (by unifying lot samples) are combined, the monitoring is affordable without a great effort. To extend these tools to other quality indicators requiring direct observation or clinical records, manual assessment could improve the monitoring efficiency. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

[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.

Sharing Data between Mobile Devices, Connected Vehicles and Infrastructure Task 6: Prototype Acceptance Test Summary Report

DOT National Transportation Integrated Search

2017-10-30

The Task 6 Prototype Acceptance Test Summary Report summarizes the results of Acceptance Testing carried out at Battelle facilities in accordance with the Task 6 Acceptance Test Plan. The Acceptance Tests were designed to verify that the prototype sy...

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

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.

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.

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

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.

Evaluation of IgY Antibody as a Polyspecific Coombs-Reagent.

PubMed

Calzado, Esteban Justo Gutiérrez; Heredia, Marlene Toledano; Duharte, Jeorge Fernadez; Zarnani, Amir-Hassan

2017-01-01

During the last twenty years, the extraction of specific egg yolk (IgY) antibodies from the immunized chickens has been accepted as a useful alternative to the immunization of mammals. The aim of the present study was immunizing the chickens with Human Umbilical Cord Serum (HUCS) and the extraction of specific anti-human globulins (IgG, C3b, and C3d) antibodies from egg yolk in order to obtain polyspecific Coombs reagent. The novelty of this work was the achievement of a polyclonal reagent through a very cheap alternative method in accordance with all ethical regulations required for obtaining it. Three Leghorn hens (21 weeks old) were immunized four times for a period of 66 days with 20uL of HUCS mixed with PBS/FCA or FIA each time. The extraction of IgY antibodies was performed according to the method of lipid precipitation of yolk and using water soluble fraction as the reagent material. The resulting IgY antibody was characterized by SDS-PAGE and immunoelectrophoresis and tested for the presence of hetero-agglutinins by means of direct agglutination using human erythrocytes of all blood groups treated with 0.1% papain and for indirect Coombs-test to evaluate its specificity to fractions (C3b, C3d, C4d) of human complement and human IgG, respectively. Our findings show, that, the reagent obtained contains IgY and other 3 proteins (SDS-PAGE), and reacts specifically with plasma proteins, that migrate in β and ϒ regions. In immunoelectrophoresis, in addition, there is the presence of low hetero-agglutinins levels in IgY-preparation (3 lots), and the possibility to produce high amount (more than 500 ml/egg ) of polyspecific Coombs-reagent in chickens is also discussed. IgY-preparation (3 lots), and the possibility to produce high amount (more than 500 ml/egg ) of polyspecific Coombs-reagent in chickens with the originality to achieve a polyclonal reagent through a very cheap alternative method in accordance with all ethical regulations required for obtaining it, was also discussed.

Evaluation of IgY Antibody as a Polyspecific Coombs-Reagent

PubMed Central

Calzado, Esteban Justo Gutiérrez; Heredia, Marlene Toledano; Duharte, Jeorge Fernadez; Zarnani, Amir-Hassan

2017-01-01

Background: During the last twenty years, the extraction of specific egg yolk (IgY) antibodies from the immunized chickens has been accepted as a useful alternative to the immunization of mammals. The aim of the present study was immunizing the chickens with Human Umbilical Cord Serum (HUCS) and the extraction of specific anti-human globulins (IgG, C3b, and C3d) antibodies from egg yolk in order to obtain polyspecific Coombs reagent. Methods: The novelty of this work was the achievement of a polyclonal reagent through a very cheap alternative method in accordance with all ethical regulations required for obtaining it. Three Leghorn hens (21 weeks old) were immunized four times for a period of 66 days with 20uL of HUCS mixed with PBS/FCA or FIA each time. The extraction of IgY antibodies was performed according to the method of lipid precipitation of yolk and using water soluble fraction as the reagent material. The resulting IgY antibody was characterized by SDS-PAGE and immunoelectrophoresis and tested for the presence of hetero-agglutinins by means of direct agglutination using human erythrocytes of all blood groups treated with 0.1% papain and for indirect Coombs-test to evaluate its specificity to fractions (C3b, C3d, C4d) of human complement and human IgG, respectively. Results: Our findings show, that, the reagent obtained contains IgY and other 3 proteins (SDS-PAGE), and reacts specifically with plasma proteins, that migrate in β and ϒ regions. In immunoelectrophoresis, in addition, there is the presence of low hetero-agglutinins levels in IgY-preparation (3 lots), and the possibility to produce high amount (more than 500 ml/egg) of polyspecific Coombs-reagent in chickens is also discussed. Conclusion: IgY-preparation (3 lots), and the possibility to produce high amount (more than 500 ml/egg) of polyspecific Coombs-reagent in chickens with the originality to achieve a polyclonal reagent through a very cheap alternative method in accordance with all ethical regulations required for obtaining it, was also discussed. PMID:28496948

Evaluation of immunization coverage by lot quality assurance sampling compared with 30-cluster sampling in a primary health centre in India.

PubMed

Singh, J; Jain, D C; Sharma, R S; Verghese, T

1996-01-01

The immunization coverage of infants, children and women residing in a primary health centre (PHC) area in Rajasthan was evaluated both by lot quality assurance sampling (LQAS) and by the 30-cluster sampling method recommended by WHO's Expanded Programme on Immunization (EPI). The LQAS survey was used to classify 27 mutually exclusive subunits of the population, defined as residents in health subcentre areas, on the basis of acceptable or unacceptable levels of immunization coverage among infants and their mothers. The LQAS results from the 27 subcentres were also combined to obtain an overall estimate of coverage for the entire population of the primary health centre, and these results were compared with the EPI cluster survey results. The LQAS survey did not identify any subcentre with a level of immunization among infants high enough to be classified as acceptable; only three subcentres were classified as having acceptable levels of tetanus toxoid (TT) coverage among women. The estimated overall coverage in the PHC population from the combined LQAS results showed that a quarter of the infants were immunized appropriately for their ages and that 46% of their mothers had been adequately immunized with TT. Although the age groups and the periods of time during which the children were immunized differed for the LQAS and EPI survey populations, the characteristics of the mothers were largely similar. About 57% (95% CI, 46-67) of them were found to be fully immunized with TT by 30-cluster sampling, compared with 46% (95% CI, 41-51) by stratified random sampling. The difference was not statistically significant. The field work to collect LQAS data took about three times longer, and cost 60% more than the EPI survey. The apparently homogeneous and low level of immunization coverage in the 27 subcentres makes this an impractical situation in which to apply LQAS, and the results obtained were therefore not particularly useful. However, if LQAS had been applied by local staff in an area with overall high coverage and population subunits with heterogeneous coverage, the method would have been less costly and should have produced useful results.

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.

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...

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.

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.

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...

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...

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...

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…

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.

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

PubMed

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

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

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

PubMed Central

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

2017-01-01

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

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.

Designing for Cost

NASA Technical Reports Server (NTRS)

Dean, Edwin B.; Unal, Resit

1991-01-01

Designing for cost is a state of mind. Of course, a lot of technical knowledge is required and the use of appropriate tools will improve the process. Unfortunately, the extensive use of weight based cost estimating relationships has generated a perception in the aerospace community that the primary way to reduce cost is to reduce weight. Wrong! Based upon an approximation of an industry accepted formula, the PRICE H (tm) production-production equation, Dean demonstrated theoretically that the optimal trajectory for cost reduction is predominantly in the direction of system complexity reduction, not system weight reduction. Thus the phrase "keep it simple" is a primary state of mind required for reducing cost throughout the design process.

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).

Dibasic calcium phosphate dihydrate, USP material compatibility with gamma radiation

NASA Astrophysics Data System (ADS)

Betancourt Quiles, Maritza

Gamma radiation is a commonly used method to reduce the microbial bioburden in compatible materials when it is applied at appropriate dose levels. Gamma irradiation kills bacteria and mold by breaking down the organism’s DNA and inhibiting cell division. The purpose of this study is to determine the radiation dosage to be used to treat Dibasic Calcium Phosphate Dihydrate, USP (DCPD) and to evaluate its physicochemical effects if any, on this material. This material will be submitted to various doses of gamma radiation that were selected based on literature review and existing regulations that demonstrate that this method is effective to reduce or eliminate microbial bioburden in natural source and synthetic materials. Analytical testing was conducted to the DCPD exposed material in order to demonstrate that gamma radiation does not alter the physicochemical properties and material still acceptable for use in the manufacture of pharmaceutical products. The results obtained through this study were satisfactory and demonstrated that the gamma irradiation dosages from 5 to 30 kGy can be applied to DCPD without altering its physicochemical properties. These are supported by the Assay test data evaluation of lots tested before and after gamma irradiation implementation that show no significant statistical difference between irradiated and non irradiated assay results. The results of this study represent an achievement for the industry since they provide as an alternative the use of Gamma irradiation technology to control the microbial growth in DCPD.

Acceptance Test Data for Candidate AGR-5/6/7 TRISO Particle Batches BWXT Coater Batches 93165 93172 Defective IPyC Fraction and Pyrocarbon Anisotropy

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

Helmreich, Grant W.; Hunn, John D.; Skitt, Darren J.

2017-03-01

Coated particle fuel batches J52O-16-93165, 93166, 93168, 93169, 93170, and 93172 were produced by Babcock and Wilcox Technologies (BWXT) for possible selection as fuel for the Advanced Gas Reactor Fuel Development and Qualification (AGR) Program’s AGR-5/6/7 irradiation test in the Idaho National Laboratory (INL) Advanced Test Reactor (ATR). Some of these batches may alternately be used as demonstration coated particle fuel for other experiments. Each batch was coated in a 150-mm-diameter production-scale fluidized-bed chemical vapor deposition (CVD) furnace. Tristructural isotropic (TRISO) coatings were deposited on 425-μm-nominal-diameter spherical kernels from BWXT lot J52R-16-69317 containing a mixture of 15.5%-enriched uranium carbide andmore » uranium oxide (UCO). The TRISO coatings consisted of four consecutive CVD layers: a ~50% dense carbon buffer layer with 100-μm-nominal thickness, a dense inner pyrolytic carbon (IPyC) layer with 40-μm-nominal thickness, a silicon carbide (SiC) layer with 35-μm-nominal thickness, and a dense outer pyrolytic carbon (OPyC) layer with 40-μmnominal thickness. The TRISO-coated particle batches were sieved to upgrade the particles by removing over-sized and under-sized material, and the upgraded batches were designated by appending the letter A to the end of the batch number (e.g., 93165A).« less

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...

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...

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...

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...

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...

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...

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...

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.

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…

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...

Environmental Assessment -- Hydrothermal Geothermal Subprogram

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

None

1979-06-01

This environmental impact assessment addresses the design, construction, and operation of an electric generating plant (3 to 4 MWe) and research station (Hawaii Geothermal Research Station (HGRS)) in the Puna district on the Island of Hawaii. The facility will include control and support buildings, parking lots, cooling towers, settling and seepage ponds, the generating plant, and a visitors center. Research activities at the facility will evaluate the ability of a successfully flow-tested well (42-day flow test) to provide steam for power generation over an extended period of time (two years). In future expansion, research activities may include direct heat applicationsmore » such as aquaculture and the effects of geothermal fluids on various plant components and specially designed equipment on test modules. Construction-related impacts would be relatively minor. Construction of the facility will require the distance of about 1.7 ha (4.1 acres). No further disturbance is anticipated, unless it becomes necessary to replace the seepage pond with an injection well, because the production well is in service and adjacent roads and transmission lines are adequate. Disruption of competing land uses will be minimal, and loss of wildlife habitat will be acceptable. Noise should not significantly affect wildlife and local residents; the most noise activities (well drilling and flow testing) have been completed. Water use during construction will not be large, and impacts on competing uses are unlikely. Socio-economic impacts will be small because the project will not employ a large number of local residents and few construction workers will need to find local housing.« less

Can online conference systems improve veterinary education? A study about the capability of online conferencing and its acceptance.

PubMed

Koch, Michael; Fischer, Martin R; Tipold, Andrea; Ehlers, Jan P

2012-01-01

In veterinary medicine, there is an ongoing need for students, educators, and veterinarians to exchange the latest knowledge in their respective fields and to learn about unusual cases, emerging diseases, and treatment. Networking among veterinary faculties is developing rapidly, but conferences and meetings can be difficult to attend because of time limitations and travel costs. The current study examines acceptance of synchronous online conferences, seminars, meetings, and lectures by veterinarians and students. First, an online survey on the use of communication technology in veterinary medicine was made available for 15 weeks to every German-speaking veterinary university and via professional journals and an online veterinary forum. A total of 1,776 persons (620 veterinarians and 1,156 students) participated. Most reported using the Internet at least once per day; more than half reported using instant messengers. Most participants used the Internet for communication, but less than half used Skype. Second, to test the spectrum of tools for online conferences, a variety of "virtual classroom" systems (netucate systems iLinc, Adobe Acrobat Connect Pro, Cisco WebEx, Skype) were used to deliver student lectures, veterinary continuing-education courses, and academic conferences at the University of Veterinary Medicine, Hannover (TiHo). Of 591 participants in 63 online events, 99.4% rated the virtual events as enjoyable, 96.1% found them useful, and 92.4% said that they learned a lot. Participants noted that the courses were not tied to a certain place, and thus saved time and travel costs. Online conference systems thus offer new opportunities to provide information in veterinary medicine.

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...

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...

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...

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...

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...

A phased approach to clinical testing: criteria for progressing from Phase I to Phase II to Phase III studies.

PubMed

André, F E; Foulkes, M A

1998-01-01

The overall intent of clinical testing is to establish, in a series of phased studies, the clinical tolerance and acceptable "safety" of the candidate vaccine, as well as the type, level and persistence of the immune response after its inoculation, to a representative target population, according to a convenient administration schedule. The final stages involve the direct or indirect demonstration of protective efficacy, if possible in the population(s) for which the vaccine is intended. In addition, consistency of production must be demonstrated. At all these stages, the amount of prior information from preclinical and other studies affects and informs the objectives and design of subsequent studies. Progression from one testing phase to the next is dependent upon attaining the pre-set objectives of each series of studies. The precise objectives to be met will be decided on a case-by-case basis. The earliest assessments in humans (Phase I) involve evaluation of short-term clinical tolerance as measured by local and general reactogenicity, and gross assessments of immunogenicity, in a small number of highly selected individuals in an idealised situation. The selection of "optimal" dose and schedule are the result of further dose-ranging investigations (Phase II), involving more volunteers, with longer, more detailed follow-up assessments. It is at this stage that the accumulated evidence on its immunogenicity profile should be sufficient to assess whether or not the vaccine is worthy of further development. The next level of investigation (Phase III) aims to measure with greater precision the vaccine protective efficacy in the intended target population(s) by comparison of infection and/or disease attack rates in vaccine and placebo recipients. In consistency studies different production lots, manufactured at commercial scale, are tested to demonstrate consistency of manufacture. Additional bridging studies to establish similarity of lots at different production scales, or studies of the duration of the immunity conferred, are conducted in parallel with the progression of the studies in the different phases mentioned above. These latter types of studies are usually carried out concurrently with Phase III studies. This progression continues into the post-marketing period (Phase IV) with surveillance of long term efficacy and observational studies of possible rare adverse events to establish "safety" with more confidence. This paper examines, in general, the aims and designs of studies in each phase as an introduction to the more specific publications that follow.

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.

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.

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.

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.

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.

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…

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.

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.

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.

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.

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.

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...

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…

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

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…

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.

77 FR 51880 - Requirements for Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria AGENCY: Nuclear Regulatory Commission... construction activities through inspections, tests, analyses, and acceptance criteria (ITAAC) under a combined... inspections, tests, or analyses were performed as required, or that acceptance criteria are met, and to notify...

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

Apollo experience report environmental acceptance testing

NASA Technical Reports Server (NTRS)

Laubach, C. H. M.

1976-01-01

Environmental acceptance testing was used extensively to screen selected spacecraft hardware for workmanship defects and manufacturing flaws. The minimum acceptance levels and durations and methods for their establishment are described. Component selection and test monitoring, as well as test implementation requirements, are included. Apollo spacecraft environmental acceptance test results are summarized, and recommendations for future programs are presented.

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...

49 CFR 232.505 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Pre-revenue service acceptance testing plan. 232... § 232.505 Pre-revenue service acceptance testing plan. (a) General; submission of plan. Except as... its system the operating railroad or railroads shall submit a pre-revenue service acceptance testing...

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.

Particulate contamination of local anesthetic solutions.

PubMed

Cooley, R L; Lubow, R M

1981-05-01

Particulate contamination was found in one particular lot number of local anesthetic, lidocaine with 1:100,000 epinephrine. The contaminants were noticed in several cartridges of each container and varied in size from minute to several millimeters. Analysis of the foreign matter revealed the particles to be of a way or puttylike consistency; however, the sterility of the solution was not altered and the pH was still within acceptable limits. The contaminant was most likely wax or a combination of wax, silicone, and glycerin, which are constituents of the rubber stopper and its associated lubricants. This problem was most likely due to temperature changes during storage and shipment, but it was also possibly due to manufacturing discrepancies.

Gender equity.

PubMed

Shiva, M

1999-01-01

This paper focuses on gender equity. Gender equity is difficult to achieve when there is no economic, social, or political equity. The Gender Development Index evidenced this. There were a lot of instances where women are psychologically traumatized, whether it is through domestic rape, purchased sexual services in the red light area, and seduction or violation of neighbors, relatives, daughter or child. The economic changes linked with globalization and media's influence have worsened women's position. The policy for empowerment of women is an attempt toward ensuring equity. Furthermore, many women and women's organizations are trying to address these inequities; wherein they fight for strong acceptance of women's rights, social, economic, and political rights, as well as equities between gender and within gender.

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.

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.

The clinical utility of lung clearance index in early cystic fibrosis lung disease is not impacted by the number of multiple-breath washout trials

PubMed Central

Foong, Rachel E.; Harper, Alana J.; King, Louise; Turkovic, Lidija; Davis, Miriam; Clem, Charles C.; Davis, Stephanie D.; Ranganathan, Sarath; Hall, Graham L.

2018-01-01

The lung clearance index (LCI) from the multiple-breath washout (MBW) test is a promising surveillance tool for pre-school children with cystic fibrosis (CF). Current guidelines for MBW testing recommend that three acceptable trials are required. However, success rates to achieve these criteria are low in children aged <7 years and feasibility may improve with modified pre-school criteria that accepts tests with two acceptable trials. This study aimed to determine if relationships between LCI and clinical outcomes of CF lung disease differ when only two acceptable MBW trials are assessed. Healthy children and children with CF aged 3–6 years were recruited for MBW testing. Children with CF also underwent bronchoalveolar lavage fluid collection and a chest computed tomography scan. MBW feasibility increased from 46% to 75% when tests with two trials were deemed acceptable compared with tests where three acceptable trials were required. Relationships between MBW outcomes and markers of pulmonary inflammation, infection and structural lung disease were not different between tests with three acceptable trials compared with tests with two acceptable trials. This study indicates that pre-school MBW data from two acceptable trials may provide sufficient information on ventilation distribution if three acceptable trials are not possible. PMID:29707562

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.

Post-abortion care and voluntary HIV counselling and testing--an example of integrating HIV prevention into reproductive health services.

PubMed

Rasch, Vibeke; Yambesi, Fortunata; Massawe, Siriel

2006-05-01

To assess the acceptance and outcome of voluntary HIV counselling and testing (VCT) among women who had an unsafe abortion. 706 women were provided with post-abortion contraceptive service and offered VCT. We collected data on socioeconomic characteristics and contraceptive use and determined the HIV status of those who accepted VCT. Using a nested case-control design, we compared women who accepted HIV testing with women who did not. To study the association between socioeconomic factors, HIV testing acceptance and condom use in more detail, we did stratified analyses based on age and marital status. 58% of the women who had an unsafe abortion accepted HIV testing. Women who earned an income were more likely to accept testing than housewives. Women who accepted testing were more likely to accept using a condom. The HIV prevalence rate was 19% among single women aged 20-24 years and 25% among single women aged 25-45 years. HIV testing and condoms were accepted by most women who had an unsafe abortion. The poor reproductive health of these women could be improved by good post-abortion care that includes contraceptive counselling, VCT and condom promotion.

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...

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...

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...

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...

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...

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…

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.…

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,…

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.

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...

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...

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...

Lot quality assurance sampling (LQAS) for monitoring leprosy elimination in an endemic district in Tamilnadu.

PubMed

Murthy, B N; Subbiah, M; Boopathi, K; Ramakrishnan, R; Gupte, M D

2001-01-01

This paper examines whether the health administration can use lot quality assurance sampling (LQAS) for identifying high prevalence areas for leprosy for initiating necessary corrective measures. The null hypothesis was that leprosy prevalence in the district was at or above ten per 10,000 and the alternative hypothesis was that it was at or below five per 10,000. A total of 25,500 individuals were to be examined with 17 as an acceptable maximum number of cases (critical value). Two-stage cluster sample design was adopted. The sample size need not be escalated as the estimated design effect was 1. During the first phase, the survey covered a population of 4,837 individuals out of whom 4,329 (89.5%) were examined. Thirty-five cases were detected and this number far exceeded the critical value. It was concluded that leprosy prevalence in the district should be regarded as having prevalence of more than ten per 10,000 and further examination of the population in the sample was discontinued. LQAS may be used as a tool by which one can identify high prevalence districts and target them for necessary strengthening of the programme. It may also be considered for certifying elimination achievement for a given area.

The Effect of Plug-in Electric Vehicles on Harmonic Analysis of Smart Grid

NASA Astrophysics Data System (ADS)

Heidarian, T.; Joorabian, M.; Reza, A.

2015-12-01

In this paper, the effect of plug-in electric vehicles is studied on the smart distribution system with a standard IEEE 30-bus network. At first, harmonic power flow analysis is performed by Newton-Raphson method and by considering distorted substation voltage. Afterward, proper sizes of capacitors is selected by cuckoo optimization algorithm to reduce the power losses and cost and by imposing acceptable limit for total harmonic distortion and RMS voltages. It is proposed that the impact of generated current harmonics by electric vehicle battery chargers should be factored into overall load control strategies of smart appliances. This study is generalized to the different hours of a day by using daily load curve, and then optimum time for charging of electric vehicles batteries in the parking lots are determined by cuckoo optimization algorithm. The results show that injecting harmonic currents of plug-in electric vehicles causes a drop in the voltage profile and increases power loss. Moreover, charging the vehicle batteries has more impact on increasing the power losses rather than the harmonic currents effect. Also, the findings showed that the current harmonics has a great influence on increasing of THD. Finally, optimum working times of all parking lots was obtained for the utilization cost reduction.

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...

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.

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.

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.

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 ...

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...

An Investigation to Improve Quality Evaluations of Primers and Propellant for 20mm Munitions

NASA Technical Reports Server (NTRS)

Bement, L. J.; Holmes, C.; McGrory, J.; Schimmel, M. L.

1997-01-01

To reduce the frequency of electrically initiated, 20mm munition hangfires (delayed ignitions), a joint Army/NASA investigation was conducted to recommend quality evaluation improvements for acceptance of both primers and gun propellant. This effort focused only on evaluating ignition and combustion performance as potential causes of hangfires: poor electrical initiation of the primer, low output performance of the primer, low ignition sensitivity of the gun propellant, and the effects of cold temperature. The goal was to determine the "best" of the Army and NASA test methods to assess the functional performance of primers and gun propellants. The approach was to evaluate the performance of both high-quality and deliberately defective primers to challenge the sensitivity of test methods. In addition, the ignition sensitivity of different manufacturing batches of gun propellants was evaluated. The results of the investigation revealed that improvements can be made in functional evaluations that can assist in identifying and reducing ignition and performance variations. The "best" functional evaluation of primers and propellant is achieved through a combination of both Army and NASA test methods. Incorporating the recommendations offered in this report may provide for considerable savings in reducing the number of cartridge firings, while significantly lowering the rejection rate of primer, propellant and cartridge lots. The most probable causes for ignition and combustion-related hangfires were the lack of calcium silicide in the primer mix, a low output performance of primers, and finally, poor ignition sensitivity of gun propellant. Cold temperatures further reduce propellant ignition sensitivity, as well as reducing burn rate and chamber pressures.

Docking screens: right for the right reasons?

PubMed

Kolb, Peter; Irwin, John J

2009-01-01

Whereas docking screens have emerged as the most practical way to use protein structure for ligand discovery, an inconsistent track record raises questions about how well docking actually works. In its favor, a growing number of publications report the successful discovery of new ligands, often supported by experimental affinity data and controls for artifacts. Few reports, however, actually test the underlying structural hypotheses that docking makes. To be successful and not just lucky, prospective docking must not only rank a true ligand among the top scoring compounds, it must also correctly orient the ligand so the score it receives is biophysically sound. If the correct binding pose is not predicted, a skeptic might well infer that the discovery was serendipitous. Surveying over 15 years of the docking literature, we were surprised to discover how rarely sufficient evidence is presented to establish whether docking actually worked for the right reasons. The paucity of experimental tests of theoretically predicted poses undermines confidence in a technique that has otherwise become widely accepted. Of course, solving a crystal structure is not always possible, and even when it is, it can be a lot of work, and is not readily accessible to all groups. Even when a structure can be determined, investigators may prefer to gloss over an erroneous structural prediction to better focus on their discovery. Still, the absence of a direct test of theory by experiment is a loss for method developers seeking to understand and improve docking methods. We hope this review will motivate investigators to solve structures and compare them with their predictions whenever possible, to advance the field.

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.

Acceptance-test report for El Toro Library solar heating and cooling demonstration project (SHAC no. 1501)

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

Not Available

A partial acceptance test was conducted on the El Toro Library Solar Energy System, and the detailed results of the various mode acceptance tests are given. All the modes tested function as designed. Collector array efficiencies were calculated at approximately 40%. Chiller COP was estimated at .50, with chiller loop flow rates approximately 85 to 90% of design flow. The acceptance test included visual inspection, preoperational testing and procedure verification, operational mode checkout, and performance testing. (LEW)

Development and pilot test of a new set of good practice indicators for chronic non-malignant pain management.

PubMed

Saturno, Pedro Jesus; Angel-García, Daniel; Martínez-Nicolás, Ismael; López Soriano, Francisco; Escolar Reina, Maria Pilar; Guerrero Díaz, María Beatriz; Ros Martínez, María Encarnación; Medina Mirapeix, Francesc; Saturno Marcos, Mayo

2018-06-08

This study was designed to address the current relative void of valid measures by developing evidence-based quality indicators for pain management of chronic non-malignant pain. We performed a 10-year literature search to identify guidelines and review articles on chronic pain management to identify evidence-based recommendations for the different conditions associated to chronic pain. A complementary search of indicators and indicator-related articles was also performed. Then, we built new indicators or adapted existing ones to cover all the evidence-based recommendations we found. The resulting set was pilot-tested for feasibility, reliability (kappa) and usefulness to identify quality problems, using the Lot Quality Acceptance method, α≤0.05 y β≤0.01, for 75% (40% threshold) and 95% (70% threshold) compliance standards, and estimates with binomial exact 95% confidence intervals. The study reviews clinical records from a primary-care centre, a medium-size hospital (250 beds) and a large hospital (500 beds). Forty-six indicators were developed (six general and forty condition-specific). Thirty-three were feasible in primary care and/or hospitals. Feasible indicators were also reliable (most kappa>0.7). Regarding compliance, four quality indicators obtained compliance levels over 60%, addressing pharmacological treatment, multimodal approach and appropriate use of neuro-image tests; while sixteen obtained compliance scores under 15% (six with 0% compliance). The created set has tested to be feasible, reliable, and useful, with the capacity to serve as the baseline for developing the necessary strategies to improve the management of chronic non-malignant pain, by monitoring and evaluating quality of care. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

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.

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.

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

[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.

Food safety education using an interactive multimedia kiosk in a WIC setting: correlates of client satisfaction and practical issues.

PubMed

Trepka, Mary Jo; Newman, Frederick L; Huffman, Fatma G; Dixon, Zisca

2010-01-01

To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Female clients or caregivers (n=176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk. Satisfaction with program, participant demographics, and change in food-handling behavior were assessed by univariate analyses. Over 90% of the participants enjoyed the kiosk, and most (87.5%) reported using computers a lot. Compared with participants with education beyond high school, participants with less education were more likely to report enjoying the kiosk (98.2% vs 88.1%, P = .007), preferred learning with the kiosk (91.7% vs 79.1%, P = .02), and would like to learn about other topics using IMM (95.4% vs 86.6%, P = .04). Food safety education delivered by IMM was well accepted by inner-city WIC clinic clients, including those with less education. Copyright 2010 Society for Nutrition Education. Published by Elsevier Inc. All rights reserved.

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.

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...

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...

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.

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.

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...

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

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...

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...

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...

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.

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.

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...

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...

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...

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.

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.

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

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,...

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.

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.

49 CFR 238.111 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the times and places of the pre-revenue service tests to permit FRA observation of such tests. For... 49 Transportation 4 2010-10-01 2010-10-01 false Pre-revenue service acceptance testing plan. 238... and General Requirements § 238.111 Pre-revenue service acceptance testing plan. (a) Passenger...

49 CFR 238.111 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2011 CFR

2011-10-01

... the times and places of the pre-revenue service tests to permit FRA observation of such tests. For... 49 Transportation 4 2011-10-01 2011-10-01 false Pre-revenue service acceptance testing plan. 238... and General Requirements § 238.111 Pre-revenue service acceptance testing plan. (a) Passenger...

49 CFR 238.111 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the times and places of the pre-revenue service tests to permit FRA observation of such tests. For... 49 Transportation 4 2012-10-01 2012-10-01 false Pre-revenue service acceptance testing plan. 238... and General Requirements § 238.111 Pre-revenue service acceptance testing plan. (a) Passenger...

49 CFR 238.111 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2014 CFR

2014-10-01

... the times and places of the pre-revenue service tests to permit FRA observation of such tests. For... 49 Transportation 4 2014-10-01 2014-10-01 false Pre-revenue service acceptance testing plan. 238... and General Requirements § 238.111 Pre-revenue service acceptance testing plan. (a) Passenger...

49 CFR 238.111 - Pre-revenue service acceptance testing plan.

Code of Federal Regulations, 2013 CFR

2013-10-01

... the times and places of the pre-revenue service tests to permit FRA observation of such tests. For... 49 Transportation 4 2013-10-01 2013-10-01 false Pre-revenue service acceptance testing plan. 238... and General Requirements § 238.111 Pre-revenue service acceptance testing plan. (a) Passenger...

Proposed acceptance, qualification, and characterization tests for thin-film PV modules

NASA Technical Reports Server (NTRS)

Waddington, D.; Mrig, L.; Deblasio, R.; Ross, R.

1988-01-01

Details of a proposed test program for PV thin-film modules which the Department of Energy has directed the Solar Energy Research Institute (SERI) to prepare are presented. Results of one of the characterization tests that SERI has performed are also presented. The objective is to establish a common approach to testing modules that will be acceptable to both users and manufacturers. The tests include acceptance, qualification, and characterization tests. Acceptance tests verify that randomly selected modules have similar characteristics. Qualification tests are based on accelerated test methods designed to simulate adverse conditions. Characterization tests provide data on performance in a predefined environment.

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.

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

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.

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.

[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.

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.

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

LIMS user acceptance testing.

PubMed

Klein, Corbett S

2003-01-01

Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

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

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.

78 FR 38411 - Vogtle Electric Generating Plant, Unit 4; Inspections, Tests, Analyses, and Acceptance Criteria

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

... Plant, Unit 4; Inspections, Tests, Analyses, and Acceptance Criteria AGENCY: Nuclear Regulatory Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

Aerojet - Attitude Control Engines. Chapter 3, Appendix E

NASA Technical Reports Server (NTRS)

Pfeifer, Gerald R.

2009-01-01

All the engines were both qualification and acceptance tested at Marquardt s facilities. After we won the Apollo Program contract, we went off and built two vacuum test facilities, which simulated altitude continuous firing for as long as we wanted to run an engine. They would run days and days with the same capability we had on steam ejection. We did all of the testing in both for the qualification and the acceptance test. One of them was a large ball, which was an eighteen-foot diameter sphere, evacuated again with a big steam ejector system that could be used for system testing; that s where we did the Lunar Excursion Module testing. We put the whole cluster in there and tested the entire cluster at the simulated altitude conditions. The lowest altitude we tested at - typically an acceptance test - was 105,000 feet simulated altitude. The big ball - because people were interested in what they called goop formation, which is an unburned hydrazine product migrating to cold surfaces on different parts of spacecraft - was built to address those kinds of issues. We ran long-life tests in a simulated space environment with the entire inside of the test cell around the test article, liquid nitrogen cooled, so it could act as getter for any of the exhaust products. That particular facility could pull down to about 350,000 feet (atmosphere) equivalent altitude, which was pushing pretty close to the thermodynamic triple point of the MMH. It was a good test facility. Those facilities are no longer there. When the guys at Marquardt sold the company to what eventually became part of Aerojet, all those test facilities were cut off at the roots. I think they have a movie studio there at this point. That part of it is truly not recoverable, but it did some excellent high-altitude, space-equivalent testing at the time. Surprisingly, we had very few problems while testing in the San Fernando Valley. In the early 1960s, nobody had ever seen dinitrogen tetroxide (N2O4), so that wasn't too big a deal. We really did only make small, red clouds. In all the hundreds of thousands of tests and probably well over one million firings that I was around that place for, in all that thirty-something years, we had a total of one serious injury associated with rocket engine testing and propellants. Because we were trying to figure out what propellants would really be good, we tried all of the fun stuff like the carbon tetrafluoride, chlorine pentafluoride, and pure fluorine. The materials knowledge wasn't all that great at the time. On one test, the fluorine we had didn't react well with the copper they were using for tubing, and it managed to cause another unscheduled disassembly of the facility. It was very serious. It's like one of those Korean War stories. The technician happened to be walking past the test facility when it decided to blow itself up. A piece of copper tubing pierced one cheek and came out the other. That was the only serious accident in all of the engines handled in all those years. Now, we did have a problem with the EPA later because they figured out what the brown clouds were about. We built a whole bunch of exhaust mitigation scrubbers to take care of engine testing in the daytime. In general, we operated the big shuttle (RCS) engine, the 870- pounder at nominal conditions; they scrubbed the effluents pretty well. If you operated that same 870-pound force engine at a level where you get a lot of excess oxidizer, yeah, there s a brown cloud. But, you know, it doesn't show up well in the dark. They did do some of that. But, that s gone; it was addressed one way or another. RELEASED -

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.

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.

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.

46 CFR 164.023-11 - Acceptance tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Acceptance tests. 164.023-11 Section 164.023-11 Shipping...: SPECIFICATIONS AND APPROVAL MATERIALS Thread for Personal Flotation Devices § 164.023-11 Acceptance tests. (a) Performance testing. Manufacturers shall ensure that the performance tests described in § 164.023-7 (a) or (b...

A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia.

PubMed

Lim, Fong Seng; Koh, Mia Tuang; Tan, Kah Kee; Chan, Poh Chong; Chong, Chia Yin; Shung Yehudi, Yeo Wee; Teoh, Yee Leong; Shafi, Fakrudeen; Hezareh, Marjan; Swinnen, Kristien; Borys, Dorota

2014-10-02

The immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed. In the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA. Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, ≥93.6% and ≥88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations ≥0.2 μg/mL and OPA titres ≥8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, ≥60.8% and ≥98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations ≥0.2 μg/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was ≤11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study. PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625.

Cargo Movement Operations System (CMOS). Software Test Description

DTIC Science & Technology

1990-10-28

resulting in errors in paragraph numbers and titles. CMOS PMO ACCEPTS COMMENT: YES [ ] NO [ ] ERCI ACCEPTS COMMENT: YES [ ] NO [ ] COMMENT DISPOSITION...location to test the update of the truck manifest. CMOS PMO ACCEPTS COMMENT: YES [ ] NO [ ] ERCI ACCEPTS COMMENT: YES [ ] NO [ ] COMMENT DISPOSITION...CMOS PMO ACCEPTS COMMENT: YES [ ] NO [ ] ERCI ACCEPTS COMMENT: YES [ ] NO ] COMMENT DISPOSITION: COMMENT STATUS: OPEN [ ] CLOSED [

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...

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...

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...

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...

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...

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

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.

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.

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

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

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.