Relevant bibliographies by topics / Equipment qualification

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Equipment qualification'

Author: Grafiati
Published: 4 June 2021
Last updated: 11 February 2022

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Journal articles on the topic "Equipment qualification"

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Hartman, Barbara D. "Laboratory Equipment/Instrument Qualification." Microscopy and Microanalysis 10, S02 (August 2004): 1348–49. http://dx.doi.org/10.1017/s1431927604880243.

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Avinasha S, Gangadharappa H V, Hemanth Kumar S, and Gowrav M P. "A Review on qualification of the tablet compression machine." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (April 18, 2020): 1961–67. http://dx.doi.org/10.26452/ijrps.v11i2.2124.

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Validation is the art of designing andpracticing the designed steps alongside with the documentation. Validation is one of themostimportant steps in maintaining &achievingthe quality of the final product group after batch. The qualification of the equipment and systems are planning to carry out the tests and record the tests. We cannot be manufacturing the product, without an equipment. If the equipment is validated, we can ensure that our product is of the top-quality. Validation of the equipment is known as Qualification. To making different kinds of dosage forms, various equipment’s are used. Here, this article concentrates on the equipment qualification for theTablet compression machine. It gives in detail, qualification steps of the equipment, which is used for the manufacturing process through wet granulation. Qualification, an ideal step for equipment validation, is the action undertaken to demonstrate the intended use and performance of the utilities and equipment.The individual steps of qualification such as design, installation, operational and performance qualification, were done in order to qualify the equipment. Blueprint of equipment validation was also included and the tablets were tested for physical parameters such asappearance, punch Shape, punch diameter, upper punch, lower punch, hardness, weight variation, friability, and thickness.
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Caillet, Christine, Yves Pegon, Tanguy Le Neel, Delphine Morin, Cecile Baudiment, and Alain Truchaud. "Qualification of Robotic Laboratory Equipment." JALA: Journal of the Association for Laboratory Automation 10, no. 1 (February 2005): 48–53. http://dx.doi.org/10.1016/j.jala.2004.11.004.

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Robotic laboratory equipment malfunctions may affect the performance of integrated laboratory instruments. Thus, the qualification of robotics is necessary to ensure adequate performance of complete integrated systems. In this JALA Tutorial, we adapt the methods used in production processes to laboratory robotics and propose guidelines for performing the various steps required for qualification (i.e., installation, operational, and performance qualification), while emphasizing specific aspects of laboratory robotics. We think that the application of such guidelines will help in standardizing the acceptance of robotic equipment, facilitate their operation and performance evaluation, and improve traceability with quality assurance documentation.
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Mali, Mamta R., O. G. Bhusnure, Shrikrishna T. Mule, and S. S. Waghmare. "A Review on Life Cycle Management Approach on Asset Qualification." Journal of Drug Delivery and Therapeutics 10, no. 4 (July 15, 2020): 253–59. http://dx.doi.org/10.22270/jddt.v10i4.4146.

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All equipment’s used in the production of products shall be properly Validated, Qualified and Calibrated to demonstrate that it is suitable for its intended purpose. Qualification is an important aspect of the pharmaceutical quality system. When the equipment is properly qualified, verified and maintained, there is the possibility of Consistent performance of the equipment. A well designed qualification program saves valuable time and cost. Qualification is called a cyclic process because it is a never ending process. Appropriate documentation of the qualification program is very important as lack of the documented evidence does not give any meaning to qualification (Not documented it means not done). The current programs and procedures of equipment qualification used within any pharmaceutical and bioscience industry are based on ‘regulatory requirements’, ‘voluntary standards’, ‘vendor practices’, and ‘industry practices’. The output is considerable variation in the way any pharmaceutical and biotechnological companies approach for the laboratory equipment. The lifecycle management approach of equipment qualification covers entire life cycle for the specification, design, manufacturing, installation, commissioning, qualification (4Qs Model DQ, IQ, OQ, PQ), operation & maintenance of equipment in a risk based life cycle management approach. The goal of any regulated pharmaceutical and bioscience company is to provide reliable and valid data suitable for its intended purpose. Main goal of equipment qualification is to form the basis for written procedures for production and process control which are designed to assure that the drug products have the SISPQ (Safety, Identity, Strength, Purity and Quality) Keywords: Validation, Calibration, Life cycle management approach, Qualification (4Qs Model- DQ, IQ, OQ & PQ), SISPQ (Safety, Identity, Strength, Purity and Quality)
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Hale, Dermot, Enda F. Fallon, and Christine FitzGerald. "An equipment qualification framework for healthcare." IISE Transactions on Healthcare Systems Engineering 10, no. 1 (October 7, 2019): 47–59. http://dx.doi.org/10.1080/24725579.2019.1671925.

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Unruh, J. F., and D. D. Kana. "Power/Response Spectrum Transformations in Equipment Qualification." Journal of Pressure Vessel Technology 107, no. 2 (May 1, 1985): 197–202. http://dx.doi.org/10.1115/1.3264434.

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Since its introduction a few years ago the use of the power/response spectrum transformation has gained considerable interest and acceptance, and a number of new applications of the transformation have been developed in the equipment qualification area. A brief review of the power/response spectrum transformation is given with a discussion of the input/output relationships for linear systems required for elevated power spectrum generation. Frequency content of earthquakelike signals is discussed with emphasis on the resolution given by the PSD. The problem of excessive ZPA due to inconsistent spectra enveloping and mechanical nonlinearities is also discussed. The PSD/RS transformation is applied to the problems of combining various dynamic load events, developing bounding spectra, and developing damping consistent test spectra. Development of elevated component spectra corrected for base overtest and generation from in-situ measurements is reviewed.
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Sliter, George, and S. Kasturi. "Role of training in maintaining equipment qualification." IEEE Transactions on Nuclear Science 40, no. 4 (1993): 1263–66. http://dx.doi.org/10.1109/tns.1993.8526575.

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Denney, Dennis. "Reliability Qualification Testing for Permanently Installed Wellbore Equipment." Journal of Petroleum Technology 52, no. 10 (October 1, 2000): 60–61. http://dx.doi.org/10.2118/1000-0060-jpt.

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Patil, Bahubali N., Vamshi Krishna Tippavajhala, and K. Girish Pai. "Equipment Qualification of a New Laboratory Tray Dryer." Research Journal of Pharmacy and Technology 12, no. 2 (2019): 805. http://dx.doi.org/10.5958/0974-360x.2019.00140.9.

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Huber, L., and Lou Welebob. "Selecting parameters and limits for equipment operational qualification." Accreditation and Quality Assurance 2, no. 7 (October 16, 1997): 316–22. http://dx.doi.org/10.1007/s007690050156.

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Dissertations / Theses on the topic "Equipment qualification"

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Horpestad, Eirik. "TECHNOLOGY QUALIFICATION OF EQUIPMENT IN SUBSEA PRODUCTION SYSTEMS." Thesis, Norges Teknisk-Naturvitenskaplige Universitet, 2012. http://urn.kb.se/resolve?urn=urn:nbn:no:ntnu:diva-21095.

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Development of new technology has always been an important activity for the oil and gas in- dustry. New technologies can streamline the production, improve the recovery rate and provide economic benefits. The implementation cost may be regarded as high, but the end result may totally easily turn out to have great economical advantages.The challenge is that new technology usually involves potential threats with high uncer- tainty. These factors must be managed prior to implementation. This is achieved through tech- nology qualification. The aim of technology qualification, is to provide sufficient evidence that the technology is fit for purpose.The master thesis begins to describe relevant key terms, qualification, verification and vali- dation. Each of these are discussed and compared which increases the understanding of quali- fication. In addition, different qualification methods are introduce and discussed. The methods describe how the qualification evidence is provided, through physical testing, analytical evalu- ation, or a combination as integrated qualification.An in-depth literature survey is introduced, where relevant qualification standards, recom- mendations and other governing documents are presented. General qualification documents provide guidance of how a general qualification should be executed in a project. Business- specific documents illustrate how the general documents are implemented into the business- specific procedures, as well as own guidance. Guidance for qualification of safety instrumented systems, and supplementary qualification documents are also mentioned.Some of the documents introduce technology qualification program and technology qualifi- cation process. A technology qualification program is the framework of how a technology qual- ification process should be executed. The process deals with a structured set off steps, intended to reduce threats, predict future outcomes, and provide evidence in order to determine whether the qualification requirements are met or not. A more detailed description of the qualification process presented by DNV-RP-A203 is provided. This process represents the recent and most up to date version of qualification, and is today considered as state of the art by the oil industry. The process includes six steps, that are, technology qualification basis, technology assessment, threat assessment, technology qualification plan, execution of the plan, and performance assessment.Companies that develop technology, needs guidelines for qualification. The thesis describeshow and which documents that should be followed through the qualification, and identifies possible challenges, in more specific Aker Solutions and Statoil procedures.At the end of the thesis, a extensive qualification case study is documented based on the technology qualification process provided in DNV-RP-A203. A passive subsea inlet cooler unit is selected as case equipment. Such subsea technology are adopted from existing topside solu- tions, but modified to withstand other hostile operational and environmental conditions. Quali- fication requirements for the inlet cooler unit are identified in the technology qualification basis. The maturity of the unit is defined in the technology assessment, and critical failures found in the threat assessment. A qualification plan is developed with four different activities intended to reduce the critical failures. The plan is executed, and the performance assessment consid- ers to what extent the qualification requirements are met. Due to insufficient material, the last process step is inadequately reached.In addition, an extension of the case study is carried out in terms of a productions assur- ance analysis. The analysis is conducted using MIRIAM Regina, where a model is modulated with respect to failure modes identified in the threat assessment. Each failure mode is assigned different parameters, like failure rates and restoration time. The model is validated by com- petent staff at Aker Solutions. The simulation is carrier out with 25-year perspective, through 1000 replications. The simulated results shows that the average technical availability for the in- let cooler unit is 98,93%. Due to no availability requirement stated for the inlet cooler unit, the thesis does not draw any qualification conclusions. However, it indicates that, if this simulated value is higher than required availability, and additional requirements are met, then the inlet cooler unit is considered as qualified.
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Corbell, Randall D. "Shock qualification of combat systems equipment using tuned mounting fixtures on the U.S. Navy Mediumweight Shock Machine." Thesis, Monterey, California. Naval Postgraduate School, 1992. http://hdl.handle.net/10945/23772.

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Hilgert, Romeu Nedel. "Qualificação do desempenho e validação do processo de obtenção de comprimidos por compressão direta em escala piloto." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2009. http://hdl.handle.net/10183/29559.

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Estudos de qualificação e validação de processos são amplamente requisitados por agências regulatórias na produção de medicamentos. Entretando, uma abordagem pouco explorada pela literatura é o emprego de equipamentos qualificados e processos validados em estudos de formulação. O presente trabalho objetiva desenvolver uma proposta de qualificação do desempenho e validação do processo de compressão direta em escala piloto e aplicar o processo validado, como uma ferramenta de garantia da qualidade, com auxílio de um fármaco-modelo. Primeiramente, foi obtida e caracterizada uma mistura padronizada de adjuvantes farmacêuticos de referência. Em seguida, realizou-se a qualificação de uma máquina de comprimir rotativa instrumentada pela avaliação dos principais parâmetros, sejam eles Altura do Rodete Superior, Volume da Câmara de Compressão, Velocidade da Platina, e Pré-compressão, em condições reais de produção. Após análise estatística, concluiu-se que os parâmetros avaliados produzem o efeito esperado sobre as variáveis Peso, Dureza, Espessura, Forças de Compressão, Ejeção e Précompressão dos compactos produzidos, de maneira reprodutível e que o processo de compressão direta demonstrou estabilidade estatística e elevada capacidade em originar comprimidos com características de qualidade previamente definidas. O processo validado foi, então, aplicado a um estudo de formulação de comprimidos de carbamazepina obtidos pela compressão direta de nove misturas físicas, binárias e ternárias, com celulose microcristalina e macrogol 8000, em diferentes proporções. A carbamazepina utilizada foi caracterizada como a forma cristalina B. Os estudos físico-químicos dos componentes, misturas, e comprimidos revelou manutenção da forma cristalina da carbamazepina durante o processo de compressão. A avaliação dos perfis de liberação in vitro do fármaco corroborou com o apresentado na literatura para as formulações binárias. Os perfis de dissolução inesperados das formulações ternárias, com cinética de liberação semelhante a de ordem zero, puderam ser explicados pela formação de diferentes cristais de CBZ diidrato com hábito cristalino isométrico.
Qualification and process validation studies are currently required by regulatory agencies in pharmaceutical manufacturing. However, little attention has been given to the way How these procedures should be conduced and the lack of more specific literature become evident. Thus, in the present work a practicable approach for a rotary press qualification and its insertion in a direct compression process validation strategy are described. Additionally, the equipment performance qualification was assessed in the tabletting of the model-drug carbamazepine at pilotscale production. Thus, a standard powders mixture was obtained and characterized. The qualification of a rotary tablet press was conducted concerning the main equipment parameters, namely Upper Compaction Roll Height, Die Cavity Volume, Compression Rate and Pre-compression, at real manufacturing situations. After proper statistical analysis, it was observed that the equipment parameters had the expected effect over the variables Weight, Hardness, Thickness, Compression, Ejection and Pre-compression force, in a reproducible manner and that the tabletting process undergoes with statistical stability and has elevated capability in originate tablets with previous determined specifications. The validated process was then applied to a CBZ tablet formulation study. The tablets were obtained by the direct compression of nine binary and ternary physical mixtures of CBZ, microcrystalline cellulose and polyoxyethylene glycol 8000. The CBZ raw material was characterized as the monoclinic form B. The physico-chemical studies of the components, mixtures and tablets revealed no CBZ polymorphic transition during the tabletting process. The evaluation of the in vitro dissolution profiles corroborated with the literature concerning the binary physical mixtures. The unexpected dissolution behavior of the ternary formulations, with apparent zero-order kinetic process, was ascribed to the formation of new and large CBZ dihydrate crystals, with an unusual isomeric crystal habit.
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Valente, Patrícia Alexandra Fernandez. "Cova da Moura. Qualificação do bairro através do espaço público e do equipamento." Master's thesis, Faculdade de Arquitetura de Lisboa, 2012. http://hdl.handle.net/10400.5/5752.

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Mapagha, Saül. "Qualification de la prédiction du comportement vibratoire d'un sous-système sur véhicule." Phd thesis, INSA de Rouen, 2010. http://tel.archives-ouvertes.fr/tel-00557906.

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Le présent travail de thèse porte sur la prédiction des efforts vibratoires transmis à l'interface entre deux structures mécaniques. L'étude relève de la dynamique des structures en basses fréquences et concerne des aspects relatifs à la modélisation de couplages structuraux, notamment en présence de paramètres incertains et d'aspects expérimentaux. Les équipements automobiles actifs sont des sources vibratoires qui agissent sur la structure d'accueil (souvent le châssis) sur laquelle ils sont montés. La maîtrise, a priori, du champ vibratoire (et donc acoustique) de l'assemblage, suppose la prédiction des efforts vibratoires à l'interface équipement/structure d'accueil. Le formalisme utilisé pour décrire le couplage entre sous-systèmes permet d'établir que la recherche, dans des situations pratiques, des efforts appliqués à l'accueil est un problème inverse. Une méthode prédictive des efforts est construite et validée par une mise en œuvre expérimentale. Pour que les efforts vibratoires transmis respectent un gabarit imposé a priori, un problème d'optimisation numérique de l'interface est proposé et résolu. Il sera montré que pour l'interface ainsi optimisée, la dispersion de la norme des efforts transmis est systématiquement plus faible que pour l'interface nominale.
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"Mathematical-based Approaches for the Semiconductor Capital Equipment Installation and Qualification Scheduling Problem." Doctoral diss., 2015. http://hdl.handle.net/2286/R.I.29822.

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abstract: Ramping up a semiconductor wafer fabrication facility is a challenging endeavor. One of the key components of this process is to schedule a large number of activities in installing and qualifying (Install/Qual) the capital intensive and sophisticated manufacturing equipment. Activities in the Install/Qual process share multiple types of expensive and scare resources and each activity might potentially have multiple processing options. In this dissertation, the semiconductor capital equipment Install/Qual scheduling problem is modeled as a multi-mode resource-constrained project scheduling problem (MRCPSP) with multiple special extensions. Three phases of research are carried out: the first phase studies the special problem characteristics of the Install/Qual process, including multiple activity processing options, time-varying resource availability levels, resource vacations, and activity splitting that does not allow preemption. A modified precedence tree-based branch-and-bound algorithm is proposed to solve small size academic problem instances to optimality. Heuristic-based methodologies are the main focus of phase 2. Modified priority rule-based simple heuristics and a modified random key-based genetic algorithm (RKGA) are proposed to search for Install/Qual schedules with short makespans but subject to resource constraints. Methodologies are tested on both small and large random academic problem instances and instances that are similar to the actual Install/Qual process of a major semiconductor manufacturer. In phase 3, a decision making framework is proposed to strategically plan the Install/Qual capacity ramp. Product market demand, product market price, resource consumption cost, as well as the payment of capital equipment, are considered. A modified simulated annealing (SA) algorithm-based optimization module is integrated with a Monte Carlo simulation-based simulation module to search for good capacity ramping strategies under uncertain market information. The decision making framework can be used during the Install/Qual schedule planning phase as well as the Install/Qual schedule execution phase when there is a portion of equipment that has already been installed or qualified. Computational experiments demonstrate the effectiveness of the decision making framework.
Dissertation/Thesis
Doctoral Dissertation Industrial Engineering 2015
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Loureiro, Diogo José Cardoso. "Qualificação na Indústria Farmacêutica." Master's thesis, 2017. http://hdl.handle.net/10316/82939.

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Dissertação de Mestrado Integrado em Engenharia Mecânica apresentada à Faculdade de Ciências e Tecnologia
A indústria farmacêutica enfrenta o grande desafio de garantir a conformidade de todos os seus processos ao longo do ciclo de vida de um produto, desde a aquisição das matérias-primas até a expedição do produto acabado. Tendo em conta que, a atividade de uma indústria farmacêutica compreende os processos relativos ao fabrico e embalamento dos seus produtos, cumprindo sempres os requisitos e regulamentos necessários ao controlo de qualidade, é necessário efetuar a validação das instalações, dos processos e ainda dos equipamentos implicativos na qualidade do produto final.A empresa ao garantir a conformidade de todas as etapas envolvidas neste ciclo, demonstra perante as autoridades regulamentares e clientes, o cumprimento dos requisitos mínimos necessários que asseguram a qualidade, segurança e eficácia dos seus produtos. Suportada por evidências documentais bem definidas, permitirá a obtenção da Autorização de Introdução do Mercado (AIM), que consentirá a comercialização dos produtos.A presente dissertação insere-se nos ramos da manutenção e da garantia da qualidade da empresa Farmalabor, uma vez que, todas as conformidades são asseguradas por um trabalho conjunto entre estes dois departamentos. É feita uma introdução ao tema de qualificação de equipamentos nesta indústria e descrito de seguida o processo de qualificação de um sistema de aquecimento, ventilação e ar condicionado (AVAC). Foi uma experiência enriquecedora e desafiante na medida que permitiu ao autor sair da sua zona de conforto, inserindo-se num ambiente industrial, possibilitando a integração numa nova realidade. Durante o estágio de duração de seis meses surgiu a oportunidade de contactar com diversos setores de atividade, dos quais o autor tentou tirar o máximo proveito.
Nowadays the organizations inserted on the pharmaceutical industry faces the great challenge of assurance the conformity of its processes over the life cycle of products, since acquisition of the raw material until the expedition of the finished product.The industry activities englobe every process linked to the manufacturing and packaging of its products, complying with quality control requisites and regulations. For this reason, it is necessary to validate installations, processes and equipment that affect the quality of the manufactured product.Therefore, the company by ensuring the compliance of each step of the process can prove to regulatory authorities and clients that the minimum criteria are met to assure the product quality and its efficiency. Documental evidence allows obtaining the Market Introduction Authorization, authorizing the selling permission of the products.The present dissertation is inserted in the Farmalabor’s maintenance and quality departments, that working together can ensure the conformity of every installation, equipment and system. It is made in this thesis an introduction to the qualification theme of equipment and later a description to the process of qualification a heating, ventilation and air conditioned (HVAC) system.It was an enriching and challenging experience for the author that made him to get off his comfort zone, by entering an industrial environment and getting in touch with a different reality. There were several opportunities through the internship period to know different activity sectors of which he tried to take maximum advantage.
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Huang, Ching-ting, and 黃敬婷. "THE QUALIFICATIONS OF THE MEDICAL EQUIPMENTS IN CHINESE MEDICINE --THE APPLICATION OF ANALYTICAL HIERARCHY PROCESS (AHP)." Thesis, 2008. http://ndltd.ncl.edu.tw/handle/63883441447685147182.

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碩士
大同大學
事業經營學系(所)
96
There are technology and knowledge-intensive properties in the medical equipment industry. Its output grows up double in recent years. Output of medical equipment industry in Taiwan in 2004 is NT$50.4 billion and export value is NT$ 27.6 billion. We expected the output of medical equipment in Taiwan to achieve NT $200 billion by 2011. In order to advance the quality of medical services, the Department of Health, Executive Yuan issued "specific medical technology inspects of administration of medical equipment or uses management approach ", but it has not enough relevant regulations of medical equipment in Chinese medicine. The application of Chinese medicine uses a lot of equipments for diagnosis or treatment due to technological development in recent years, but certification of relevant medical equipment has not definite clearly standard of selling and operators’ qualifications. This study focuses on the research of domestic and foreign literatures and government agency system, and questionnaires of domestic dealer and physician. And this study used Analytic Hierarchy Process (AHP) to find a complete set of the operation qualifications of the medical equipments in Chinese medicine. It can make medical and research in Chinese medicine scientific in the future.
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Ferreira, Óscar Gaël Mendes. "Controlo de qualidade na indústria farmacêutica." Master's thesis, 2019. http://hdl.handle.net/10284/8755.

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Cabe ao controlo de qualidade numa indústria farmacêutica a avaliação da qualidade do medicamento ao longo do processo de produção de forma a garantir a sua segurança e eficácia. Este controlo abrange todas as matérias-primas, o fabrico e o produto acabado. O controlo de qualidade é uma área essencial na indústria farmacêutica que deverá ter laboratórios próprios, independentes dos da produção e com pessoal especializado na condução de todos os testes a que o produto farmacêutico terá que ser sujeito. Este trabalho tem como objetivo perceber o estado da arte relativamente ao controlo de qualidade na indústria farmacêutica. Para tal, procedeu-se a uma extensa pesquisa bibliográfica, recorrendo a artigos científicos, normas internacionais, regulamentações europeias e farmacopeias. O presente trabalho faz uma perspetiva histórica sobre a necessidade de estabelecimento do controlo de qualidade na produção de medicamentos. Para que o medicamento tenha ou mantenha a sua qualidade superior, o seu fabrico e distribuição deverão obedecer às Boas Práticas de Fabrico, às Boas Práticas de Laboratório e às Boas Práticas de Distribuição, definidas pelas diretrizes europeias e mundiais. Até à sua comercialização, um medicamento é submetido a testes experimentais durante e após o fabrico, ensaios pré-clínicos e ensaios clínicos. Os ensaios de laboratório avaliam principalmente as propriedades físico-químicas do medicamento e são efetuados durante o desenvolvimento e fabrico do medicamento. O controlo em processo é uma monitorização e adaptação de processos de fabrico para que o produto esteja em conformidade com as especificações. Os materiais em processo deverão ser testados em termos de identidade, robustez, qualidade e pureza. A qualidade do medicamento comprovada pela sua eficácia e segurança garante a sua manutenção no mercado, a escolha por parte dos profissionais de saúde e por vontade do doente.
Quality control in a pharmaceutical industry is responsible for evaluating the quality of the medicinal product throughout the production process to ensure its safety and efficacy. This control covers all raw materials, the manufacture and the finished product. Quality control is therefore an essential area of the pharmaceutical industry that should have its own laboratories, independent of those of medicinal products manufacture with specialized staff in the conduction of these tests. The goal of this thesis is to understand the state of the art of quality control in the pharmaceutical industry. Thus, an extensive bibliographic search has been performed, using scientific articles, international standards, European regulations and pharmacopoeias. The present thesis starts with a historical perspective about the need to establish quality control during medicinal products manufacture. In order to maintain the superior quality of the medicinal product, its manufacture and distribution must be in accordance with Good Laboratory Practice, Good Manufacturing Practice and Good Distribution Practice implemented by European and worldwide guidelines. A medicinal product is often subjected to experimental tests, such as appropriate analytical laboratory techniques during manufacture, preclinical and clinical trials before its release to the market. Laboratory tests evaluate the medicinal product physicochemical properties and they are performed during its development and manufacture. In-process control is a monitoring and adaptation of manufacturing processes so that the product is in compliance with its specifications. In-process materials should be tested in terms of identity, robustness, quality and purity. The quality of a medicinal product proven by its efficacy and safety guarantees its maintenance in the market, the choice by health professionals and the will of use by the patient.
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Books on the topic "Equipment qualification"

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Cloud, Phillip A. Pharmaceutical equipment validation: The ultimate qualification handbook. Buffalo Grove, Ill: Interpharm Press, 1998.

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Institute, American National Standards. Qualification of active mechanical equipment used in nuclear power plants. New York: American Society of Mechanical Engineers, 2007.

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Subudhi, M. Seismic and dynamic qualification of safety related electrical and mechanical equipment. Washington, D.C: Division of Engineering, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, 1986.

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Weidenhamer, G. H. Program plan for environmental qualification of mechanical and dynamic (including seismic) qualification of mechanical and electrical equipment program (EDQP). Washington, D.C: Division of Engineering Technology, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 1986.

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Weidenhamer, G. H. Program plan for environmental qualification of mechanical and dynamic (including seismic) qualification of mechanical and electrical equipment program (EDQP). Washington, D.C: Division of Engineering Technology, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 1986.

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Cook, M. Qualification of improved joint heaters: Final test report. Brigham City, UT: Thiokol Corp., Space Operations, 1989.

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Chang, T. Y. Regulatory analysis for resolution of unresolved safety issue A-46, seismic qualification of equipment in operating plants. Washington, DC: Division of Safety Review and Oversight, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, 1987.

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Corbell, Randall D. Shock qualification of combat systems equipment using tuned mounting fixtures on the U.S. Navy Mediumweight Shock Machine. Monterey, Calif: Naval Postgraduate School, 1992.

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Chang, T. Y. Seismic qualification of equipment in operating nuclear power plants: Unresolved safety issue A-46 : draft report for comment. Washington, D.C: Division of Safety Technology, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, 1985.

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Regulation, U. S. Nuclear Regulatory Commission Office of Nuclear Reactor. Regulatory analysis for proposed resolution of unresolved safety issue A-46: Seismic qualification of equipment in operating plants. Washington, D.C: Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commissoin, 1985.

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Book chapters on the topic "Equipment qualification"

1

Rudd, David. "Qualification of Analytical Equipment." In Method Validation in Pharmaceutical Analysis, 227–41. Weinheim, FRG: Wiley-VCH Verlag GmbH & Co. KGaA, 2005. http://dx.doi.org/10.1002/3527604685.ch4.

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Jones, Ian, and Chris Smalley. "Equipment Qualification, Process and Cleaning Validation." In Pharmaceutical Blending and Mixing, 369–99. Chichester, UK: John Wiley & Sons, Ltd, 2015. http://dx.doi.org/10.1002/9781118682692.ch14.

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Huber, Ludwig. "Equipment Qualification and Computer System Validation." In Analytical Method Validation and Instrument Performance Verification, 255–76. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2004. http://dx.doi.org/10.1002/0471463728.ch17.

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Block, Carsten, Thomas Bauer, and Fritz-Otto Henkel. "Seismic Qualification of Equipment in Industrial Facilties." In Seismic Design of Industrial Facilities, 271–80. Wiesbaden: Springer Fachmedien Wiesbaden, 2013. http://dx.doi.org/10.1007/978-3-658-02810-7_22.

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Winters, Martell, and Richard Lomas. "The Principles of Process Validation and Equipment Qualification." In Tissue and Cell Processing, 124–47. Oxford, UK: Blackwell Publishing Ltd., 2012. http://dx.doi.org/10.1002/9781118316467.ch7.

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Keller, Michael W., and Ibrahim A. Alnaser. "Coupon-Based Qualification of Bonded Composite Repairs for Pressure Equipment." In Composite, Hybrid, and Multifunctional Materials, Volume 4, 39–45. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-06992-0_5.

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Alnaser, Ibrahim A., and Michael W. Keller. "Coupon-Based Qualification for the Fatigue of Composite Repairs of Pressure Equipment." In Conference Proceedings of the Society for Experimental Mechanics Series, 405–9. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-21762-8_47.

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Gatscher, Jeffrey. "Performance Based Seismic Qualification of Large-Class Building Equipment: An Implementation Perspective." In Role of Seismic Testing Facilities in Performance-Based Earthquake Engineering, 305–21. Dordrecht: Springer Netherlands, 2011. http://dx.doi.org/10.1007/978-94-007-1977-4_16.

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Baseman, Harold S., and Michael Bogan. "Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, 129–77. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch7.

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Fan, Jin, Liang Li, Yong-Bin Sun, and Hua-Ming Zou. "Equipment Qualification and Methods Application for Class 1E Digital Instrumentation and Control System." In Lecture Notes in Electrical Engineering, 219–25. Singapore: Springer Singapore, 2019. http://dx.doi.org/10.1007/978-981-13-3113-8_25.

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Conference papers on the topic "Equipment qualification"

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Glennie, Neil. "CBTC Equipment EMC Qualification Testing." In 2014 Joint Rail Conference. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/jrc2014-3711.

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Many railroads are installing new Communications Based Train Control (CBTC) systems and replacing their relay based signaling equipment with solid state equivalents. When installing new signaling and train control equipment on a property, laboratory Electromagnetic Compatibility (EMC) testing is an important part of the qualification process. Much of the new train control equipment is designed and manufactured overseas and Commercial Off The Shelf (COTS) equipment is frequently incorporated into subsystem designs. It is, therefore, important that the railroads and system providers understand the railroad EMC requirements, and that the equipment being installed is tested to the appropriate standards in the laboratory in order to ensure that it will operate as intended in the field. The two main equipment level laboratory qualification testing standards referenced in railway signaling contract specifications are the Military Standard MIL STD-461F and the CENELEC (European Committee For Electrotechnical Standardization) Standard EN 50121 (IEC equivalent IEC 62236). Although the two standards are similar, there are some key differences that can lead to costly delays if not properly understood and addressed. This paper will provide a comparison of these two standards, including the different test methodologies, specific test procedures, and test limits.
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Thomas, James E., and Samuel C. Steiman. "Benefits of Digital Equipment Generic Qualification Activities." In 10th International Conference on Nuclear Engineering. ASMEDC, 2002. http://dx.doi.org/10.1115/icone10-22380.

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As a result of nuclear power plant instrumentation and control obsolescence issues, there have been numerous activities during recent years relating to the qualification of digital equipment. Some of these activities have been “generic” in nature in that the qualification was not limited to plant specific applications, but was intended to cover a broad base of potential applications of the digital equipment. These generic qualifications have been funded by equipment manufacturers and by utility groups and organizations. The generic activities sponsored by the Electric Power Research Institute (EPRI) have been pilot projects for an overall generic qualification approach. The primary benefit resulting from the generic qualification work to date is that a number of digital platforms and digital devices are now available for use in various nuclear safety-related applications. Many of the tests and evaluations necessary to support plant specific applications have been completed. The amount of data and documentation that each utility must develop on a case by case basis has been significantly reduced. There are also a number of additional benefits resulting from these industry efforts. The challenges and difficulties in qualifying digital equipment for safety-related applications are now more clearly understood. EPRI has published a lessons learned document (EPRI Report 1001452, Generic Qualification of Commercial Grade Digital Devices: Lessons Learned from Initial Pilots, which covers several different qualification areas, including device selection, project planning, vendor surveys and design reviews, and electromagnetic compatibility (EMC) qualification. Application of the experience and lessons learned from the EPRI pilot activities should help reduce the effort and cost required for future qualification work. Most generic qualification activities for commercial equipment have been conducted using the approach of EPRI TR-106439, Guideline on Evaluation and Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Applications, and the supplemental guidance of EPRI TR-107339, Evaluating Commercial Digital Equipment for High Integrity Applications. The U. S. Nuclear Regulatory Commission (NRC) has reviewed some of the qualification activities and reports and issued a number of Safety Evaluation Reports (SERs). Although some additional work may be required to support specific applications, the generic qualification activities and NRC reviews have provided significant clarification and further stabilized the regulatory environment for use of digital equipment in safety-related applications.
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Harris, David, John Frick, Bryan Lane, and Brian Schwind. "Completion Optimization: Equipment & Material Qualification." In SPE High Pressure/High Temperature Sour Well Design Applied Technology Workshop. Society of Petroleum Engineers, 2005. http://dx.doi.org/10.2118/97598-ms.

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Selvam, R. Panneer, and Yamini Gupta. "Seismic Qualification of High Voltage Substation Equipment." In 2019 International Conference on High Voltage Engineering and Technology (ICHVET). IEEE, 2019. http://dx.doi.org/10.1109/ichvet.2019.8724274.

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Parise, Giuseppe, Luigi Martirano, Luigi Parise, Maurizio De Angelis, Salvatore Perno, and Anna Reggio. "Seismic Qualification Categories (EQC) of electrical equipment." In 2013 IEEE Industry Applications Society Annual Meeting. IEEE, 2013. http://dx.doi.org/10.1109/ias.2013.6682595.

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Veneruso, A. F., S. Hiron, R. Bhavsar, and L. Bernard. "Reliability Qualification Testing for Permanently Installed Wellbore Equipment." In SPE Annual Technical Conference and Exhibition. Society of Petroleum Engineers, 2000. http://dx.doi.org/10.2118/62955-ms.

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Parise, Giuseppe, Luigi Martirano, Luigi Parise, Maurizio De Angelis, Anna Reggio, and Joe Weber. "Seismic qualification of electrical equipment in critical facilities." In 2013 IEEE/IAS 49th Industrial & Commercial Power Systems Technical Conference (I&CPS). IEEE, 2013. http://dx.doi.org/10.1109/icps.2013.6547338.

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Borguet, B., A. Boueé, A. Deep, L. Maresi, M. Taccola, Y. Stockman, C. Michel, et al. "Development of a calibration equipment for spectrometer qualification." In International Conference on Space Optics 2016, edited by Nikos Karafolas, Bruno Cugny, and Zoran Sodnik. SPIE, 2017. http://dx.doi.org/10.1117/12.2296101.

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Peypoudat, Vincent, and Raymond Roumeas. "A Stepwise Approach for Inflatable Space Equipment Qualification." In 44th AIAA/ASME/ASCE/AHS/ASC Structures, Structural Dynamics, and Materials Conference. Reston, Virigina: American Institute of Aeronautics and Astronautics, 2003. http://dx.doi.org/10.2514/6.2003-1909.

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Chatterjee, Payel, and Abhinav Gupta. "Seismic Qualification of Equipment: A PRA-Consistent Framework." In 2016 24th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/icone24-60674.

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The seismic probabilistic risk assessment (SPRA) for a nuclear power plant involves the estimation of fragility curves for plant equipment. The seismic qualification of an equipment based on testing requires the equipment to continue to function when subjected to a specific test response spectrum (TRS). Broad banded ground motions have been found to cause more damage to equipment than the filtered narrow banded excitations. As a result, the definition of acceleration capacity used in the fragility models use clipped response spectra for both test response spectrum (TRS) and required response spectrum (RRS). The main purpose of the clipping factors is to convert a narrow banded response spectrum to a broad banded spectrum. The broadband correction factor and the modal interaction correction factors together contribute to the definition of clipping factor. The current study involves reconciliation with previous research by generating the mean response factor for different waveforms and subsequently the root-mean-square (RMS) severity ratio as a function of bandwidth. This ratio can be estimated for real earthquakes from their peak-to-rms values and the peak spectral values. In addition it can be shown that in case of real narrow banded earthquakes, this ratio is even lower and therefore the clipping would be greater. The modal interaction correction factor which considers the effect of interaction between different modes in case of broad banded time histories has also been investigated. The primary objective of this work is to study the existing Conservative Deterministic Failure Margin (CDFM) and Probabilistic approaches for estimating these factors as per the guidelines of EPRI [2] and apply the same to real life ground motions. It has been observed that the recommended practices are based on studying the behavior of random ground motions generated artificially for different bandwidths and center frequencies. The present study aims towards a more realistic fragility estimation of equipment by studying the spectral response of equipment based on actual ground motions. The purpose is to evaluate clipping factors that are consistent with Seismic Probabilistic Risk Assessment.
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Reports on the topic "Equipment qualification"

1

Decker, Q., L. Fackrell, L. Fitch, and O. Meeky. Equipment Qualification Data Base user manual. Office of Scientific and Technical Information (OSTI), September 1985. http://dx.doi.org/10.2172/6189712.

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Kellogg, Brian Richard, and Joseph Peter Brenkosh. Technical network equipment qualification : cubicle-class switches. Office of Scientific and Technical Information (OSTI), December 2003. http://dx.doi.org/10.2172/918233.

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Bonzon, L. L., F. J. Wyant, L. D. Bustard, and K. T. Gillen. Equipment qualification issues research and resolution: Status report. Office of Scientific and Technical Information (OSTI), November 1986. http://dx.doi.org/10.2172/6753795.

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Kiebel, G. R. ,. Westinghouse Hanford. Light duty utility arm equipment qualification test procedure. Office of Scientific and Technical Information (OSTI), July 1996. http://dx.doi.org/10.2172/664384.

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Dupont, Pierre E. Design and Analysis Methods for Equipment Emulation in the Shock Qualification of Deck Structures. Fort Belvoir, VA: Defense Technical Information Center, December 2000. http://dx.doi.org/10.21236/ada389562.

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Steele, R. Jr, D. L. Bramwell, J. C. Watkins, and K. G. DeWall. Summary of work completed under the Environmental and Dynamic Equipment Qualification research program (EDQP). Office of Scientific and Technical Information (OSTI), February 1994. http://dx.doi.org/10.2172/10126095.

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Korsah, K. Application of Microprocessor-Based Equipment in Nuclear Power Plants - Technical Basis for a Qualification Methodology. Office of Scientific and Technical Information (OSTI), August 2001. http://dx.doi.org/10.2172/788507.

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Korsah, K., R. T. Wood, M. Hassan, and T. J. Tanaka. Technical basis for environmental qualification of microprocessor-based safety-related equipment in nuclear power plants. Office of Scientific and Technical Information (OSTI), January 1998. http://dx.doi.org/10.2172/573313.

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D. Blanchard and R. Youngblood. Risk Informed Safety Margin Characterization Case Study: Selection of Electrical Equipment To Be Subjected to Environmental Qualification. Office of Scientific and Technical Information (OSTI), April 2012. http://dx.doi.org/10.2172/1047195.

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R. Youngblood and D. Blanchard. Risk Informed Safety Margin Characterization Case Study: Selection of Electrical Equipment To Be Subjected to Environmental Qualification. Office of Scientific and Technical Information (OSTI), September 2011. http://dx.doi.org/10.2172/1033912.

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