Qualification Parameters Research Articles

Highly efficient MIM based SPR sensor for glucose detection using blueP/WS2 layers

In this article, a highly efficient surface plasmon resonance sensor for glucose detection in urine biosamples is presented. The proposed structure with the Ag-Si-Ag configuration was investigated and optimized using the transfer matrix method. In addition, blueP/WS2 and ZnO layers were implemented to further improve the sensitivity of the sensor by light-mater interaction enhancement in the sensing layer. The multilayer configuration of the optimized sensor consists of SiO2 prism /ZnO /Ag1/ Si/Ag2 /ZnO /blueP/WS2 layers, respectively and operates at λ = 633 nm. Different glucose concentrations of 0 to 15 mg dl−1 (for non-diabetic person), 0.625 gm dl−1, 1.25 gm/dL, 2.5 gm/dL, 5 gm/dL, and 10 gm dl−1 (for diabetic body), with refractive indices of 1.335, 1.336, 1.337, 1.338, 1.341, and 1.347, respectively have been regarded and the qualification parameters of S = 320 deg/RIU, FWHM = 1.5767 deg, FOM = 215.99 RIU−1, and minimum reflectance of 0.0318 have been evaluated. We believe that the proposed sensor could pave the way to easy and accurate detection of glucose concentration which is vital in control or treatment of diabetes.

Devising an approach for the automated restoration of shipmaster’s navigational qualification parameters under risk conditions

The object of this study is the safety control system of ship management, by identifying and restoring the qualification parameters of shipmasters in critical situations. The task solved in the study is the timely determination of an insufficient level of qualification for the performance of certain operations in controlling the movement of the ship, by applying a formal-logical model of detecting the intuitive actions of the operator-shipmaster and gradually restoring his/her qualification parameters using the devised method. The stages of development and the formal-logical structure of the model and method in terms of cognitive automation were described in detail as the study results. It was possible to ensure early detection of risks when controlling the movement of the ship in 56 % of cases, during a laboratory experiment on simulators, which in 24 % of cases turned out to be particularly dangerous. The interpretation of the results involved algorithmizing complex and formalized data on the actions of operators and the application of the method of restoring their qualification parameters, which allowed a comprehensive approach to safety management. The distinguishing features of the findings were to predict the level of danger by simulating maritime operations with input navigational and individual conditions. This made it possible to improve the effectiveness of operations to 89 %, reduce the phenomenon of loss of control over the course to 32 %, reduce critical situations to 7 % and the cost of resources. The scope and conditions of practical use involve a comprehensive assessment of external and internal influences on the level of danger, delay in decision-making by operators, as well as sailing conditions. The simulation results could be used to devise strategies for planning maneuvers, predicting risks, and developing maritime security systems

Introduction to qualification and validation of an immunoassay.

Immunoassays play an important role in drug development of products targeting the immune system. Consistent quality of the results from an immunoassay is essential to make unbiased and accurate claims about the drug product during preclinical and clinical development stages. Assay qualification and validation shed light on the performance of the assay. It is the first evaluation and the verification, respectively, of the assay's performance. This tutorial explains and illustrates the calculation methodology for important assay qualification parameters including precision, relative accuracy, linearity, the lower limit of quantification (LLOQ), the upper limit of quantification (ULOQ), the assay range and dilutability. This tutorial focuses on assays used for (pre-) clinical purposes, characterized by a lognormal distribution of the measurements on its original untransformed scale and by the lack of well characterized reference material. Statistical calculations are illustrated with qualification data from an enzyme-linked immunosorbent assay (ELISA) vaccine immunoassay.

Analysis of Pre-Olympic Middle School Mathematics Test Instruments Based on Item Response Theory

Junior high school of mathematics Olympiad is one of the routine activities every year in Indonesia. Analysis of the items on the Mathematical Olympiad test instrument has been carried out by several researchers using the concept of classical test theory. The theory has many weaknesses when compared to the concept Item Response theory (IRT). The purpose of this article is to describe the analysis of pre-Olympiad mathematics test instrument for junior high school students in Pacitan East Java based on the IRT. This analysis was carried out using a quantitative descriptive method. IRT-based item analysis was performed using R software with the package irtawsi. The results of the analysis with the package show that the instruments used fit to 2PL model. From the 15 items used, there were two items that did not fit, namely items 4 and 9. Furthermore, from the 13 test items that were fit, there were 3 items that did not meet the quality of the discriminant parameter used. These three items are 1, 6 and 13 items, these three items must be dropped because they can provide biased information when used to estimate students' math olympiad abilities. Based on this information it can be concluded that there are 10 test items that have quality that meets the qualification parameters of difficulty and discriminant with a standard error of 0.25.

An Algorithmic Approach to Reducing Taxonomic Detail from Actual Datasets to their Metadata Representation to Increase Findabilty

An Algorithmic Approach to Reducing Taxonomic Detail from Actual Datasets to their Metadata Representation to Increase Findabilty

Utility of SPR technology in biotherapeutic development: Qualification for intended use

Surface plasmon resonance (SPR) analysis provides important binding characteristic information for an antibody to its binding partner, such as binding specificity and affinity (KD). In recent years, SPR has been increasingly used in biosimilar development as part of the comparative analytical similarity assessment. Although there is no systematic study describing how to qualify SPR assays, there are various SPR result types (outputs) that have been used for assay qualification in publicly available regulatory documents. The mixed usage of SPR output can cause confusion and can be misleading when comparing binding attributes among antibody molecules. In this report, using a recombinant huIgG1 (mAb 1) antibody as an example, we performed assay qualification strictly based on the nature of the biomolecular interaction. We recommend that KD should be used as the output of assay qualification when the KD can be measured accurately by SPR. When KD cannot be accurately determined in a SPR setting, sensorgram comparison and Parallel Line Analysis (PLA) can be used to qualify the assay. We emphasize the importance of setting up appropriate SPR assay conditions for target and/or Fc receptor interactions to ensure the assay qualification parameters, such as accuracy and repeatability, to meet the criteria acceptable for regulatory filings. With increasing numbers of biotherapeutics being developed, the methods and guidelines provided here can help to align SPR application between the drug development industry and regulatory authorities which will benefit the scientific communities involved in biotherapeutic drug development.

ТЕХНОЛОГИЯ РАЗРАБОТКИ ГИБКИХ СИСТЕМ ОПЛАТЫ ТРУДА В УСЛОВИЯХ ВНЕДРЕНИЯ ПРОФЕССИОНАЛЬНЫХ СТАНДАРТОВ

The article highlights the essential aspects of flexible wage systems; technology for their development is presented, focused on accounting and evaluation of qualification parameters (powers, responsibilities, knowledge, skills) recorded in professional standards. The original approach to development of profile grids of qualification level based on substantiation of key differentiators and variable features of analysed qualification parameters is proposed; standard format of integral qualification grid has been developed. As a criterion for the distribution of the collective wage fund, the employee's individual performance coefficient is justified, reflecting the qualification level of his functionality (labor functions and actions), the quality of work and the working time worked during the calculated period. The method of calculating individual earnings and estimating relative gain (or loss) of an employee in conditions of full (or partial) use of his labour potential, illustrated on a conditional example, is proposed.

Quality of Life after Rectal Cancer Resection Comparing Anterior Resection, Abdominoperineal Resection, and Complicated Cases

Introduction: Compared to abdominoperineal resection (APR), sphincter preservation using low anterior resection (AR) for rectal cancer (RC) implies the risk of impaired functional outcome and postoperative complications associated with a persistent or additionally required ostomy. The aim of our study was to compare quality of life (QoL) after AR and APR with a special separate analysis of AR patients with a stoma. Methods: QoL of 84 APR, 356 AR, and 29 AR patients with complications and an additional stoma, termed converted therapy (COT) patients, was compared with regard to groups and effect of radiotherapy (RT). All patients received rectal resection between 1998 and 2013, and 47% of the patients had RT. QoL was assessed using extended EORTC QLQ-C30 and -CR38 questionnaires. Results: Questionnaires from 57 APR, 165 AR, and 25 COT patients alive were evaluated after a median time of 4 years after surgery. Global health status was equally high in AR and APR patients (score: 67), whereas COT patients turned out with a significantly lower score of 50 (p = 0.007). Compared to APR and COT, AR patients revealed less symptoms and higher functionality, especially for physical, role, and social functioning (p < 0.001). The reduction of QoL instances was significant in the COT group and in all patients treated by RT. Conclusion: QoL after RC resection may be further improved by avoiding additionally required ostomy after AR but also RT by a better individual selection of qualified patients. Qualification parameters urgently need to be defined by prospective studies.

A validated and discriminatory in vitro release test for evaluation of marketed Clotrimazole cream formulations

In vitro surrogate tests are broadly used for evaluation of the critical release characteristics of semi-solid dosage forms. In general, these tests are limited to assess the effect of crucial manufacturing process related steps on the physicochemical characteristics and overall drug product performance. In vitro release tests (IVRT) do not directly anticipate in vivo performance, but may detect in vitro changes that may correlate with in vivo performance. The objective of this work was to develop a suitable in vitro release test for evaluation of the similarity between two marketed Clotrimazole 1% Cream formulations. A systematic approach was used to address some essential qualification parameters and validation concepts described in EMA`s draft guideline on quality and equivalence of topical products. The procedure included suitable evaluation of the receptor medium, membrane qualification, followed by evaluation of method precision and method robustness. For evaluation of data, the comparison of Clotrimazole release profile met the relevant acceptance criteria for the 90% Confidence Interval for the ratio of means of the pairwise comparisons falling inside the limits of 90–111%. The linearity of the IVRT method as function of the drug concentration in the formulation was evaluated with 50% and 200% API formulations. In addition, the discriminatory power of the method was confirmed with formulation with altered viscosity as critical quality attribute. After validation of the method, the Clotrimazole 1% cream formulations were compared and their similarity was assessed. The approach was found to be useful and comprehensive in performing validation activities. Key words: IVRT, Clotrimazole cream formulation, method validation, discriminatory power

Data Mining to Identify Anomalies in Public Procurement Rating Parameters

The awarding of public procurement processes is one of the main causes of corruption in governments, due to the fact that in many cases, contracts are awarded to previously agreed suppliers (favouritism); for this selection, the qualification parameters of a process play a fundamental role, seeing as due to their manipulation, bidders with high prices win, causing prejudice to the state. This study identifies processes with anomalies and generates a model for detecting possible corruption in the assignment of process qualification parameters in public procurement. A multi-phase model was used (the identification of anomalies and generation of the detection model), which uses different algorithms, such as clustering (K-Means), Self-Organizing map (SOM), Support Vector Machine (SVM) and Principal Component Analysis (PCA). SOM was used to determine the level of influence of each rating parameter, K-Means to create groups by clustering, semi-supervised learning with SVM and PCA to generate a model to detect anomalies in the processes. By means of a case study, four groups of processes were obtained, highlighting the presence of the group “null economic offer” where the values for the economic offer do not exceed 1%, and a greater weight is given to other qualification parameters, which include direct contracting. The processes in this cluster are considered anomalous. Following this methodology, a semi-supervised learning model is built for the detection of anomalies, which obtains an accuracy of 95%, allowing the detection of procedures where the aim is to benefit a particular supplier by means of the qualification assignment parameters.

Contents of certain isoflavones in Glycine dolichocarpa, G. tabacina and G. tomentella collected in Taiwan

Glycine tabacina, G. tomentella and G. dolichocarpa are three wild perennial soybean species native to Taiwan. Glycine tabacina and G. tomentella are the source of I-Tiao-Gung, a Chinese herb. This study was commissioned to measure the presence of isoflavones in each and qualify/quantify isoflavone content using an appropriately configured multi-component HPLC method. Isoflavone in these soybean species was most heavily concentrated in the root systems. Daidzein was the predominant isoflavone found throughout plant structures, with the exception of G. tomentella seeds. Isoflavone concentrations were highest in the roots and stems of G. tabacina, in the leaves of G. tomentella, and in the seeds of G. dolichocarpa. Significant differences in isoflavone levels exist between species and structural components. The results of this study can help set selection and qualification parameters for Glycine germplasm and serve as reference when confirming genetic markers in Chinese herbs.

Legionella pneumophila in Thermal Spa – Methodological Aspects of Sampling and Analysis

The aim of the study was to check the occurrence of Legionella pneumophila in thermal water and to compare different analytical methods of its determination and/or quantification used in different laboratories. The research has shown that there are noticeable differences between results from culture method, qPCR, and FISH. Significant influence on the results has got analysts qualification, samples preparation, and equipment parameters. Very important is also the homogeneousness of the samples. qPCR or FISH method can be used as a preliminary, quick study, for identification of Legionella in water samples but the results obtained should be confirmed by culture method.

Equipment Qualification of a New Laboratory Tray Dryer

This qualification study deals with the Installation and Qualification of a New Tray Dryer. Granules in the pharmaceutical industry are dried using the different equipment like Fluid Bed Dryer, Belt Dryer, Tray Dryer, Vacuum Tray Dryer, Spray Dryer and Rotary Dryer. In this case, the study was conducted on the newly installed laboratory Tray Dryer. Various documentation requirements like User Requirement Specification, Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification and Performance Qualification were carried out for the equipment. Calibration of measuring devices, the prepared granules were dried using the tray drier and noted the time required to dry the granules. Equipment qualification of newly installed laboratory Tray Dryer was performed meeting all the qualification parameters.

Characteristics of Hydrogen Monitoring Systems for Severe Accident Management at a Nuclear Power Plant

One of the main objectives of severe accident management at a nuclear power plant is to protect the integrity of the containment, for which the most serious threat is possible ignition of the generated hydrogen. There should be a monitoring system providing information support of NPP personnel, ensuring data on the current state of a containment gaseous environment and trends in its composition changes. Monitoring systems’ requisite characteristics definition issues are considered by the example of a particular power unit. Major characteristics important for proper information support are discussed. Some features of progression of severe accident scenarios at considered power unit are described and a possible influence of the hydrogen concentration monitoring system performance on the information support reliability in a severe accident is analyzed. The analysis results show that the following technical characteristics of the combustible gas monitoring systems are important for the proper information support of NPP personnel in the event of a severe accident at a nuclear power plant: measured parameters, measuring ranges and errors, update rate, minimum detectable concentration of combustible gas, monitoring reference points, environmental qualification parameters of the system components. For NPP power units with WWER-440/270 (230) type reactors, which have a relatively small containment volume, the update period for measurement results is a critical characteristic of the containment combustible gas monitoring system, and the choice of monitoring reference points should be focused not so much on the definition of places of possible hydrogen pockets but rather on the definition of places of a possible combustible mixture formation. It may be necessary for the above-mentioned power units to include in the emergency operating procedures measures aimed at a timely heat removal reduction from the containment environment if there are signs of a severe accident phase approaching to prevent a combustible mixture formation in the containment.

A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5%

The rate of release of an active pharmaceutical ingredient (API) from a topical semisolid dosage form can be influenced by its physical and structural properties. An In Vitro Release Test (IVRT) is an established method to characterize this rate of API release and compare the underlying sameness in product quality characteristics. The purpose of this work was to validate an IVRT method to compare acyclovir cream, 5% products. However, despite widespread use of the IVRT since 1997, there has been no established approach to validate an IVRT method. Our approach included: 1) qualification of the diffusion cell apparatus, 2) qualification of the laboratory, 3) validation of the HPLC analytical method, and 4) validation of numerous critical parameters of the IVRT method, itself, and resulted in a comprehensive and successful IVRT method validation. Subsequent to the IVRT validation work described here, the U.S. Food and Drug Administration (FDA) drafted a guidance on the development and validation of an IVRT method for acyclovir cream, 5%. Although there are notable differences between our approach and the approach in that guidance, this report illustrates how many of the same essential qualification parameters and validation concepts were considered and systematically addressed in our approach to IVRT validation.

Introduction and Exploration of Qualification on Prototype Series of Nuclear Classified Heat Exchanger Tubes of RCC-M Specification

To ensure final product quality of nuclear classified heat exchanger tubes and satisfy requirement of batch process, RCC-M specification specify that prototype series qualification should be performed before manufacture. During qualification, manufacturing condition, technology process and technology parameters can be verified and solidified in order to establish manufacturing program. In the meantime，”defect catalogue” will be established by analyzing defects occurred in manufacturing. Finally, the aim of improving product quality and assure manufacturing process will be realized by qualification. How to perform qualification according to RCC-M specification with considering manufacturing process and test requirement of heat exchange tubes is also be presented in the article.

Managing measured vibration data for malfunction detection of an assembled mechanical coupling

Vibration data recorded by accelerometer fixed on a mechanical coupling were treated using different data processing techniques as estimating general root mean square, partial root means square, mean, variance, partial variance, kurtosis, full Fourier spectra, and partial spectra, as well as using sequential probability ratio test (SPRT). The numerical results of these methods measured on an electromotive drive train-coupling were collected into a common data set, and a search method of deviation from the normal behavior was elaborated. This selects the bad couplings if at least three of the presented qualification parameters crosses either theoretically or experimentally settled limits. It was shown that the confidence level of such classification of good and bad species was better than 95 % compared with the results of thoroughly tested ones by conventional methods.

Interlaboratory Standardization of the Sandwich Enzyme-Linked Immunosorbent Assay Designed for MATS, a Rapid, Reproducible Method for Estimating the Strain Coverage of Investigational Vaccines

The meningococcal antigen typing system (MATS) sandwich enzyme-linked immunosorbent assay (ELISA) was designed to measure the immunologic cross-reactivity and quantity of antigens in target strains of a pathogen. It was first used to measure the factor H-binding protein (fHbp), neisserial adhesin A (NadA), and neisserial heparin-binding antigen (NHBA) content of serogroup B meningococcal (MenB) isolates relative to a reference strain, or "relative potency" (RP). With the PorA genotype, the RPs were then used to assess strain coverage by 4CMenB, a multicomponent MenB vaccine. In preliminary studies, MATS accurately predicted killing in the serum bactericidal assay using human complement, an accepted correlate of protection for meningococcal vaccines. A study across seven laboratories assessed the reproducibility of RPs for fHbp, NadA, and NHBA and established qualification parameters for new laboratories. RPs were determined in replicate for 17 MenB reference strains at laboratories A to G. The reproducibility of RPs among laboratories and against consensus values across laboratories was evaluated using a mixed-model analysis of variance. Interlaboratory agreement was very good; the Pearson correlation coefficients, coefficients of accuracy, and concordance correlation coefficients exceeded 99%. The summary measures of reproducibility, expressed as between-laboratory coefficients of variation, were 7.85% (fHbp), 16.51% (NadA), and 12.60% (NHBA). The overall within-laboratory measures of variation adjusted for strain and laboratory were 19.8% (fHbp), 28.8% (NHBA), and 38.3% (NadA). The MATS ELISA was successfully transferred to six laboratories, and a further laboratory was successfully qualified.

Facts and Fiction in Cleanroom Metrology

This article discusses a number of cleanroom qualification parameters in terms of their proper specification. A critical analysis reveals that the useful operating range of some parameters is not appropriately considered by some early standards and guidelines, which are still used by regulatory authorities (the US Food and Drug Administration (FDA) and the European Union (EU)) and industry professionals. In practice, the windows of safely controlled cleanroom operation prove to be considerably larger than anticipated by existing regulations, especially with regard to unidirectional airflow velocity, pressure difference, and other parameters. Many measuring techniques, such as installed HEPA filter integrity testing and recovery time testing, are also regulated more strictly than necessary. Modern cleanroom testing requires more carefully defined targets and more flexibility in using advanced test procedures.

Acoustical vibration characterics of prefabricated panels employed in industrialized construction

With the development of industrialized steel construction, new constructive elements have been brought not only to the market, but to the everyday construction site as well and, in this way professionals and users have questioned their efficiency. In respect to vibrations in floors, what can be detected is that floor structures are thinner and a decrease of the mass in the horizontal closing panels and the utilization of new materials and systems have led them to have lower natural frequencies, and so are nearer to the frequencies produced by walking. This decrease of mass of the closing panels also lead to a considerable weakness in terms of acoustical insulation, which can cause unfavorable conditions and discomfort. Thus, it becomes necessary to do detailed studies of the efficiency of the vibration and acoustical performance of the new systems to obtain the characterization and the qualification parameters in order to optimize their use. This study does a comparative evaluation of some kinds of horizontal and vertical closing systems in respect to the vibrational and acoustical insulation performance.