Quality Control Stage Research Articles

Критерії вибору методу дослідження

Критерії вибору методу дослідження

Recent advances in Major Histocompatibility Complex (MHC) class I antigen presentation: Plastic MHC molecules and TAPBPR-mediated quality control.

We have known since the late 1980s that the function of classical major histocompatibility complex (MHC) class I molecules is to bind peptides and display them at the cell surface to cytotoxic T cells. Recognition by these sentinels of the immune system can lead to the destruction of the presenting cell, thus protecting the host from pathogens and cancer. Classical MHC class I molecules (MHC I hereafter) are co-dominantly expressed, polygenic, and exceptionally polymorphic and have significant sequence diversity. Thus, in most species, there are many different MHC I allotypes expressed, each with different peptide-binding specificity, which can have a dramatic effect on disease outcome. Although MHC allotypes vary in their primary sequence, they share common tertiary and quaternary structures. Here, we review the evidence that, despite this commonality, polymorphic amino acid differences between allotypes alter the ability of MHC I molecules to change shape (that is, their conformational plasticity). We discuss how the peptide loading co-factor tapasin might modify this plasticity to augment peptide loading. Lastly, we consider recent findings concerning the functions of the non-classical MHC I molecule HLA-E as well as the tapasin-related protein TAPBPR (transporter associated with antigen presentation binding protein-related), which has been shown to act as a second quality-control stage in MHC I antigen presentation.

Test biopsy is a stage of quality control of preimplantation genetic diagnostics

Test biopsy is a stage of quality control of preimplantation genetic diagnostics

Assessment of the Construction Welding Process

The paper presents the stages of quality control of welding processes, which is implemented through: visual inspection, testing, measurement using a checking apparatus, patterns and comparison of the results with clasped values (acceptance criteria). These activities are carried out to determine the compatibility of the produced welded joint with the objectives of quality resulting from the technology qualification process. The aim of the study is to analyze the level of quality manufacturing processes carried out in the company relating to the production of welded structures including analysis of the used materials quality.

Model of the process with piecewise-constant extremals to minimize losses of vitamins during the melting of melons and gourds

The extension of periods of storage of fruits of gourds is an urgent task processing industry. The most developed and available for injection is a method of dehydration of raw materials due to supply of heat transfer fluids. In addition to solid dry frame in raw materials is 80–90% water. In the period of moisture removal from raw material changes of thermal-physical and structural-mechanical and physicochemical characteristics. The ratio of water and dry matter in vegetative raw materials largely determines the modes of drying and storage conditions of the finished product. During drying, there are a number of limitations: the drying temperature should not exceed the degradation temperature of vitamins and proteins, and the magnitude of course, the moisture content of the product depends on the reaction prevention malonodinitrile sugars at the critical moisture content. An important problem of the drying of production is quality control stages of drying, the dynamics of which is quite difficult to describe using mathematical models. The main factors of optimization of industrial drying processes is preservation of valuable components of the feedstock, the drying time, energy and resource conservation. Development of effective control algorithm for the process of dehydration of raw materials described in the article on the example of drying of slices of melon. Experimental approach a two-stage process of drying of melon varieties Taman, the proposed regression model with the relaxation-based on humidity and content of vitamin C from the variable in time temperature and pressure, based on the available literature and own experimental data. According to the optimal control of the drying process to search for the thermobaric regime that maximizes the vitamin C content at the end of the drying, under specified conditions, the humidity. The main findings are the solution of the problem for the case of piecewise constant temperature and pressure in the separate N steps each 2 stages of experimental drying slices of melon.

Experimental investigation and prediction of the maximum edge longitudinal membrane strain and springback of Chain-die-formed AHSS U-channels using response surface methodology

Chain-die forming is a promising manufacturing technology that is emerging as an alternative to roll forming and stamping in fabricating advanced high-strength steel (AHSS) products. The maximum edge longitudinal membrane strain (MELMS) and the springback are regarded as the crucial indicators for evaluating the quality of fabricated AHSS products. As Chain-die forming is a newly developed sheet metal fabricating method, the evaluations and predictions of the effects of the independent product parameters on MELMS and springback are of high interest. This paper selects three important quantitative product parameters (tensile strength, flange height, and thickness) to investigate experimentally the effects of different product parameters on the quality of Chain-die-formed U-profile AHSS products. Experimental verification on a new group of experimental samples using the established mathematical expressions is also performed successfully. This study shows that response surface methodology with Box-Behnken design can be efficiently applied for evaluating and predicting the MELMS and springback of Chain-die-formed AHSS products. It is found that the most influential parameter which determines the severity of the MELMS is the linear effect of flange height. This study also indicates that the springback is largely determined by the linear effect of tensile strength. The findings are expected to help designers and researchers to identify the formability range and predict the quality of Chain-die-formed AHSS products in advance of the quality control and fabrication stages.

Language effects in international testing: the case of PISA 2006 science items

We investigate the extent to which language versions (English, French and Arabic) of the same science test are comparable in terms of item difficulty and demands. We argue that language is an inextricable part of the scientific literacy construct, be it intended or not by the examiner. This argument has considerable implications on methodologies used to address the equivalence of multiple language versions of the same assessment, including in the context of international assessment where cross-cultural fairness is a concern. We also argue that none of the available statistical or qualitative techniques are capable of teasing out the language variable and neutralising its potential effects on item difficulty and demands. Exploring the use of automated text analysis tools at the quality control stage may be successful in addressing some of these challenges.

The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline

BackgroundThe German COPD cohort study COSYCONET (“COPD and SYstemic consequences-COmorbidities NETwork”) investigates the interaction of lung disease, comorbidities and systemic inflammation. Recruitment took place from 2010 to 2013 in 31 study centers. In addition to the baseline visit, follow-up visits are scheduled at 6, 18, 36 and 54 months after baseline. The study also comprises a biobank, image bank, and includes health economic data. Here we describe the study design of COSYCONET and present baseline data of our COPD cohort. MethodsInclusion criteria were broad in order to cover a wide range of patterns of the disease. In each visit, patients undergo a large panel of assessments including e.g. clinical history, spirometry, body plethysmography, diffusing capacity, blood samples, 6-min walk-distance, electrocardiogram and echocardiography. Chest CTs are collected if available and CTs and MRIs are performed in a subcohort. Data are entered into eCRFs and subjected to several stages of quality control. ResultsOverall, 2741 subjects with a clinical diagnosis of COPD were included (59% male; mean age 65 ± 8.6 years (range 40–90)). Of these, 8/35/32/9% presented with GOLD stages I–IV; 16% were uncategorized, including the former GOLD-0 category. 24% were active smokers, 68% ex-smokers and 8% never-smokers. Data completeness was 96% for the baseline items. ConclusionThe German COPD cohort comprises patients with advanced and less advanced COPD. This is particularly useful for studying the time course of COPD in relation to comorbidities. Baseline data indicate that COSYCONET offers the opportunity to investigate our research questions in a large-scale, high-quality dataset.

Development of standard operating procedures and their introduction in compounding pharmacies

In accordance with the requirements of good manufacturing practices a proper keeping of documentation in compounding pharmacies licensed to prepare medicines should be an integral part of the quality assurance system and be a key element at all stages of preparation and quality control of compounding preparations. One of the important elements of proper documentation is the practice of using standard operating procedures (SOPs). The aim of this article is to describe the methodology of the SOP developing for licensed compounding pharmacies. Standard procedures should be developed according to the current regulatory framework and research. SOPs are developed by the staff involved in introduction of this procedure. SOPs should be reviewed by responsible persons and approved by the head. The following SOP structural elements have been identified: the title page (the name of institution, the name of the SOP, the classification number, the SOP version, the date on which the SOP enters into force, the signature of the responsible person); the goal; the scope of application; responsibility; stages of the procedure; revision (the term when the SOPs should be reviewed). The organizational structure of the quality assurance system is proposed for the SOP systematization: quality assurance, personnel, facilities and equipment, documentation, technology of preparation, quality control, carrying out works under the contract, complaints and recall, self-inspection. For each of the sections it has been proposed to develop SOPs focused on ensuring compliance with the procedure and to provide the quality aspect, which is the subject in this section.

A study on the recognition and classification of embroidered textile defects in manufacturing

Embroidered textile is a highly valued artwork. Three-dimensional patterns can be created by variable stitches and the material characteristics of embroidery thread. At present, computer plate-making is widely used in embroidery operation, allowing factories to mass-produce efficiently, but in the quality control stage, manpower is needed for visual inspections. The embroidered textile is classified after quality control. The conforming products are classified into three different categories: non-defective products, defective products but improvable after reworking and re-inspection, and disposable products when defective products cannot be improved. However, there is no specific standard for embroidered textile defects. In order to increase efficiency of human resources, elucidate the defects on embroidery, and achieve automated defect classification, we proposed methods on the recognition and classification of embroidered textile defects. After interviewing producers of embroidered textiles and manufacturers of computer embroidery machines, we identified four types of defect in embroidery textile patterns: foundation yarn floating knit, stitch missing, joint defect, and misregistration for defect recognition. The back-propagation neural network (BPNN) and characteristic procedure classification were used for defect classification. The characteristic procedure classification yielded more accurate results (accuracy rate: training: 100%, testing: 100%), but the process requires more time and cost for training. The BPNN requires the least amount of time, but the recognition rate is slightly lower (accuracy rate: training: 100%, testing: 98.80%) when compared to the characteristic procedure classification. The embroidered textile pattern recognition and classification methods proposed by this study are expected to provide an automated inspection procedure for the embroidery textile industry.

Surface acoustic wave biosensor as a functional quality method in pharmaceutics

With the recent successes of biopharmaceuticals, new bioanalytical tools are needed for the functional quality characterization of new biological entities and biosimilars towards marketing authorization approval and during the product life. Biosensors are emerging technologies in the pharmaceutical field in drug discovery, development and Quality Control (QC) stages; however, they are not yet included in any pharmacopoeia. Surface acoustic wave (SAW) biosensors allow the user to detect and quantify binding events, giving information not only on affinity (KD) and kinetics (kon and koff), but also on viscoelastic effects. We present here an analytical quality by design (aQbD) based approach using somatropin (rhGH, recombinant human growth hormone) and derivatives as model biotechnological drugs and an antibody interaction partner to evaluate the functional quality. Using techniques described in ICH Q2, Q5 and Q8–11, we evaluated the performance of this SAW biosensor technique from a pharmaceutical quality point of view. CMAs (Critical Method Attributes) such as sensitivity, selectivity and variability are evaluated as a function of different experimental variables using DoEs (design of experiments). We suggest qualification tests as well as SSTs (system suitability tests), as required by the pharmaceutical competent authorities and recommend the inclusion of biosensor techniques into the different pharmacopoeia and pharmaceutical guidelines.

Genome measures used for quality control are dependent on gene function and ancestry.

The transition/transversion (Ti/Tv) ratio and heterozygous/nonreference-homozygous (het/nonref-hom) ratio have been commonly computed in genetic studies as a quality control (QC) measurement. Additionally, these two ratios are helpful in our understanding of the patterns of DNA sequence evolution. To thoroughly understand these two genomic measures, we performed a study using 1000 Genomes Project (1000G) released genotype data (N=1092). An additional two datasets (N=581 and N=6) were used to validate our findings from the 1000G dataset. We compared the two ratios among continental ancestry, genome regions and gene functionality. We found that the Ti/Tv ratio can be used as a quality indicator for single nucleotide polymorphisms inferred from high-throughput sequencing data. The Ti/Tv ratio varies greatly by genome region and functionality, but not by ancestry. The het/nonref-hom ratio varies greatly by ancestry, but not by genome regions and functionality. Furthermore, extreme guanine + cytosine content (either high or low) is negatively associated with the Ti/Tv ratio magnitude. Thus, when performing QC assessment using these two measures, care must be taken to apply the correct thresholds based on ancestry and genome region. Failure to take these considerations into account at the QC stage will bias any following analysis. yan.guo@vanderbilt.edu Supplementary data are available at Bioinformatics online.

Methodology and development tool for robust control in open pit mines. Part I: decision-making system and mineral quality control

Topicality, concept, principles and tool of the robust control in open pit mining are given. It is shown that each stage of the product quality control must have permissible range of fluctuation for coal properties, loading equipment capacity and work area limits in open pit mines. The goal and capabilities of the robust control is the stable operation of the production system within the set limits and constraints. The article presents methodology and implementation tool for the robust control in open pit coal mines.

Neural network design and feature selection using principal component analysis and Taguchi method for identifying wood veneer defects

Nowadays, ensuring high quality can be considered the main strength for a company’s success. Especially, in a period of economic recession, quality control is crucial from the operational and strategic point of view. There are different quality control methods and it has been proven that on the whole companies using a continuous improvement approach, eliminating waste and maximizing productive flow, are more efficient and produce more with lower costs. This paper presents a method to optimize the quality control stage for a wood manufacturing firm. The method is based on the employment of the principal component analysis in order to reduce the number of critical variables to be given as input for an artificial neural network (ANN) to identify wood veneer defects. The proposed method allows the ANN classifier to identify defects in real time and increase the response speed during the quality control stage so that veneers with defects do not pass through the whole production cycle but are rejected at the beginning.

Optimization of Integrity Testing of Piping System in a Nuclear Fuel Cycle Facility

Abstract Nuclear fuel cycle facility under construction at Kalpakkam houses more than 200 process vessels and equipments of different capacity and configurations and about 62 Kms of piping of varying sizes from 8 DN to 250 DN in about 5000 m3 of concrete cell volume. Austenitic stainless steel 304L has been widely used as work horse material for this plant due to its resistance to corrosion in acidic environment. The fabrication works of this facility involves more than 70000 weld joints for interconnecting various vessels, equipment and associated piping system. Pneumatic pressure testing and soap bubble leak testing are the two methods effectively used to assess the final integrity of the system after fabrication and erection. Physical verification of entire piping system as per the approved as-built drawing is a pre pneumatic test requirement. During physical verification, entire piping system will be physically scanned by visual inspection methods for orientation, gradient and also to identify any surface imperfections. Even though all surfaces of the piping system are examined before giving clearance for welding, the surfaces will be re-examined prior to integrity testing to ensure that piping system orientation is as per approved design and its surfaces are free from damages. Orientation and slope plays an important role in nuclear fuel cycle facility. Because nuclear fuel cycle facility is designed in such a way that gravitational force is effectively used to transfer process fluid to avoid the usage of moving mechanical parts. This is one of the zero maintenance design feature of nuclear fuel cycle facility. Based on experience many procedures are developed to ensure the intended design requirements. Before proceeding to the integrity testing, one has to verify the completion of all quality control stage inspection activities during fabrication by way of documents verification pertaining to the weld joints and loop involved in the testing. All inspection documents right from raw material identification, fabrication and inspection of components are to be verified prior to integrity testing. Verification of large number of inspection related documents posses a very big challenge. To meet this herculean task in time, an asset management system is designed and developed in house. Asset management system plays a key role in storage and retrieval of all inspection credentials and NDE images involved in the system, and with least amount of time these can be retrieved and verified. The asset management system also plays a constructive role during the pre commissioning activities of the plant. This paper emphasis the optimization methodologies adopted during integrity testing.

UV-SPECTROPHOTOMETRIC ESTIMATION OF ACYCLOVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Analytical method development being a vital part of pre formulation - formulation research and development obviates the need to develop reliable, effective, e co friendly and cost effective methodologies for routine analysis of active pharmaceutical ingredients. UV spectroscopy is one of the earliest, yet of wide applications in drug analysis in different stages of formulations and quality control; despite the availabilities of sophisti cated chromatographic techniques and other hyphenated techniques. Current research attempts to develop simple, sensitiv e, accurate, precise and economical UV spectrophotometric methods for the routine analysis of acyclovir in bulk and pharmaceutical dosage forms using two separate alkaline medi a , 0.1N NaOH (method A) and 0.1N KOH (method B) and validate them as per ICH gui delines. In both the methods maximum absorbance was observed at 264 nm. Beer’s law was obeyed in the concentration of 2.5 - 40 µg / mL in method A and 2.5 - 30 µg / mL in method B with correlation co efficient of 0.999. The % recovery carried out by adding know n amount of standard drug to pre - analyzed tablet solutions was 98.75 ± 0.52 % to 99.78 ± 0.69 % (method A) and 98.55 ± 0.31 % to 99.78 ± 0.22 % (method B). Intra and interday precision expressed in % RSD were 0.38 ± 0.01 and 0.27 ± 0.02 - 0.44 ± 0.01 respe ctively and the percent purity was 99.85 ± 0.05 %. The methods were validated statistically as per ICH guidelines and the results obtained were within the acceptance criteria for the param eters relating to linearity, accuracy, precision.

Дослідження процесу виготовлення пакувальної продукції з гофрокартону

Recently it has been preferred packaging of corrugated cardboard and cardboard. Although the material of the packing will be made depending on the product that will be in it, and its characteristics. Nowadays the most common packaging material is cardboard. Notable among different types of this material is corrugated paperboard profile (corrugated cardboard). Modern printed packaging products are made from various grades of paper and paperboard. Great demand today is cardboard and corrugated packaging quality, primarily because consumers pay attention to the type of packaging. To ensure proper packaging of products, it is necessary to analyze the materials and the type of required packaging products and manufacturing quality control stages. Such quality control can eliminate potential problems in the manufacturing process with minimal losses. After considering the method of manufacturing of corrugated cardboard in this paper was built a block diagram of the process of manufacturing three-layer corrugated board and developed an algorithm for the process of manufacturing of corrugated cardboard packaging. Proper tracking of each stage of the manufacturing process allows us to determine what quality may suffer in the future, and to find the optimum how to fix this.

ANALYSIS OF DEFORMATION BEHAVIOR AND BENDING RESISTANCE OF DRY RICE VERMICELLI BASED ON COMPRESSIVE ROD POSTBUCKLING

AbstractThis work studied the deformation behavior and deformation parameters of dry rice vermicelli in the process of bending fracture based on the large‐deflection theory of compressive rod postbuckling. Dry rice vermicelli samples in five different lengths were investigated. Middle‐point deflection and bending angle in different axial displacements were measured using TA‐XT2i Texture Analyzer equipped with an in‐house‐built attachment. It was found that the end bending angle, the middle‐point deflection and the end axial displacement were in one‐to‐one correspondence with each other. The experimental results of middle‐point deflection and end bending angle were in good agreement with those from theoretical calculations and the errors of middle‐point deflection were below 2%. It was proposed that axial displacement instead of the middle‐point deflection or the bending angle should be used to predict bending fracture rate of straight dry rice vermicelli in different lengths as a new standard method.Practical ApplicationsBending fracture is an important indication to the ingredient components and processing quality of dry rice vermicelli. However, the actual determination by hand operation leaks scientificity on measuring the parameters, and the evaluation system should be more integrated and theoretical. Therefore, it is needed to theoretically demonstrate the deformation behavior of dry rice vermicelli in the process of bending fracture and to establish an instrumental method and the evaluation system to predict the bending fracture rate. The work demonstrates the deformation behavior by the large‐deflection theory of compressive rod postbuckling, clarifies the relationships between the three deformation parameters and develops a new method by measuring the axial displacement to predict the bending fracture rate. This method can be used in the quality control and quality detection stages. This study also contributes to develop a foundation of theory and method for predicting the bending resistance of slender straight food.

Characterization and identification of Labisia pumila by multi-steps infrared spectroscopy

This study investigated the feasibility of employing multi-steps IR spectroscopy combined with chemometrics in the authentication of three closely related varieties of Labisia pumila (L. pumila var. pumila, L. pumila var. alata and L. pumila var. lanceolata). A total of 84 samples consisted of 24 samples of L. pumila var. pumila, 42 samples of L. pumila var. alata and 18 samples of L. pumila var. lanceolata were collected from seven locations throughout Peninsular Malaysia for comparative IR analysis. The IR spectra were further grouped based on their varieties and locations by principal component analysis (PCA). Additionally, the second derivative IR and 2D-IR correlation spectra obtained through thermal perturbation were able to enhance the discriminant analysis of the three varieties more effectively. Consequently, the macroscopic IR spectroscopy associated with chemometrics has been found to be a useful and nondestructive approach in the first stage of quality control to characterize and identify the herbal materials.

FUNDAMENTAL FRACTURE PROPERTIES ASSOCIATED WITH SENSORY HARDNESS OF BRITTLE SOLID FOODS

ABSTRACTA series of biscuit‐like model foods that vary primarily in hardness, while keeping other sensory attributes less variable, was developed and used to investigate the relationship between fundamental fracture properties and the sensory perception of hardness of brittle solid foods. Fifteen biscuit samples were evaluated by both a trained sensory panel and three instrumental tests (three‐point bending test, single‐edge notched bend test and modified texture profile analysis), and their relationships were determined by simple linear regression analysis. Correlations revealed that the perceived hardness during biting or chewing is fracture related, and it is directly related to the amount of stress required to initiate and propagate a crack in a material (i.e., fracture stress [σ] and critical stress intensity factor [KIC], respectively). The fracturing of these hard and brittle biscuits appeared to be associated with the release of energy as sound, and thus, the perceived hardness and crunchiness were indistinguishable.PRACTICAL APPLICATIONSSensory evaluation is time consuming and expensive, and, therefore, reliable and practical (faster, less expensive and reproducible) instrumental methods are needed to accurately predict sensory texture attributes, at least, in the product development and quality control stages. This study demonstrated that the perceived hardness of biscuits can be tracked by σ and KIC with remarkable precision. These properties may be used as a reliable replacement for a sensory assessment of hardness in brittle solid foods, where applicable.