Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Validation Des Operations De Sterilisation Par La Chaleur En Industrie Pharmaceutique
Download Validation Des Operations De Sterilisation Par La Chaleur En Industrie Pharmaceutique full books in PDF, epub, and Kindle. Read online Validation Des Operations De Sterilisation Par La Chaleur En Industrie Pharmaceutique ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis Validation des opérations de stérilisation par la chaleur en industrie pharmaceutique by : Sonia Le Deist
Download or read book Validation des opérations de stérilisation par la chaleur en industrie pharmaceutique written by Sonia Le Deist and published by . This book was released on 2007 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: La stérilisation par la chaleur repose sur 2 procédés de traitement différents : le premier emploie de la chaleur humide et le second utilise de la chaleur sèche. La stérilisation par la chaleur humide, réalisée grâce aux autoclaves, permet d’éliminer les micro-organismes viables ou revivifiables des produits à stériliser en employant de la vapeur saturée sous pression. La stérilisation par la chaleur sèche, réalisée dans des tunnels de stérilisation, permet de stériliser et de dépyrogéner les produits en inactivant les substances pyrogènes présentes. Les étapes de stérilisation et de dépyrogénation sont les étapes critiques du processus de fabrication des médicaments injectables. Les équipements utilisés doivent alors être convenablement qualifiés et les procédés validés. Cette thèse permet de décrire, de manière détaillée et opérationnelle, les méthodes de qualification des opérations de stérilisation mises en place dans une industrie pharmaceutique et de les illustrer par 2 exemples.
Book Synopsis Développement et validation des procédés de stérilisation par la chaleur humide by : Fatima-Zahra Malha
Download or read book Développement et validation des procédés de stérilisation par la chaleur humide written by Fatima-Zahra Malha and published by . This book was released on 2017 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pour assurer la sécurité et la qualité des médicaments destinés à être stériles, la réglementation impose la vérification de la stérilité de ces produits, ainsi que la qualification et la validation de tous les moyens et les procédés utilisés pour leur stérilisation. Le choix du procédé de stérilisation doit être adapté à l'entité à stériliser de sorte à maintenir sa stabilité et son intégrité. Cela nécessite dans certains cas le développement et l'utilisation de différentes méthodes de stérilisation dans le cadre du même procédé de fabrication, ce qui entraîne une certaine complexité et des contraintes à gérer au niveau industriel. Selon les réglementations en vigueur, la stérilisation par la chaleur humide dans un autoclave est à utiliser en première intention, car ce procédé est d'une grande efficacité pour l'inactivation d'un large spectre de microorganismes. Cette thèse s'attache à décrire les notions théoriques nécessaires au développement et à la validation d'un procédé de stérilisation par la chaleur humide. La première partie de cette thèse sera dédiée à la présentation des méthodes de stérilisation les plus utilisées dans l'industrie pharmaceutique, à la description des notions théoriques nécessaires à la compréhension et au développement d'un procédé de stérilisation par la chaleur humide, ainsi qu'aux méthodes et moyens à mettre en œuvre pour évaluer l'efficacité du procédé lors des validations. La deuxième partie a pour objet l'explication du déroulement des grandes étapes de développement et de validation du procédé de stérilisation par la chaleur humide, en mettant en application les notions présentées dans la première partie de la thèse.
Book Synopsis Sterilization Validation and Routine Operation Handbook (2001) by : Anne F Booth
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Book Synopsis La stérilisation des médicaments administrés par voie parentérale dans l’industrie pharmaceutique ; application à l'harmonisation et la validation des cycles de stérilisation en autoclave by : Claire Bancel 1991-.....
Download or read book La stérilisation des médicaments administrés par voie parentérale dans l’industrie pharmaceutique ; application à l'harmonisation et la validation des cycles de stérilisation en autoclave written by Claire Bancel 1991-..... and published by . This book was released on 2015 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: La voie parentérale présente de nombreux avantages lors de l'administration des médicaments mais peut s'avérer fatale si la stérilité du produit administré n'est pas assurée. La stérilisation des médicaments injectables est donc un véritable enjeu pour l'industrie qui les fabrique, car il s'agit d'un procédé critique qui se doit d'être validé et contrôlé régulièrement. La partie bibliographique se propose, dans une première partie, de rappeler les notions essentielles sur la voie parentérale et les médicaments administrés par cette voie. Les différentes méthodes de stérilisation sont abordées dans une seconde partie, sous forme d'un état des lieux général des techniques applicables avant de s'attarder sur la stérilisation par la chaleur humide en autoclave. Il s'agit de la méthode recommandée par la Pharmacopée, elle est peu coûteuse et simple à mettre en œuvre. Après un bref rappel de microbiologie, les paramètres de la stérilisation, le contrôle de la stérilité, puis, le fonctionnement d'un autoclave seront décrits. La partie théorique s'achève par des notions de validation et de qualification. La partie pratique de ce travail met en œuvre en un projet d'harmonisation des cycles de stérilisation au sein d'un laboratoire pharmaceutique, s’appuyant sur la validation de procédé de stérilisation par la chaleur humide.
Book Synopsis VALIDATION D'APPAREILS DE STERILISATION DANS L'INDUSTRIE PHARMACEUTIQUE by : KARINE.. MONNERON
Download or read book VALIDATION D'APPAREILS DE STERILISATION DANS L'INDUSTRIE PHARMACEUTIQUE written by KARINE.. MONNERON and published by . This book was released on 1993 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Mise en place et validation d'une méthode de stérilisation par autoclave en industrie pharmaceutique by : Yonatan Bouchoucha
Download or read book Mise en place et validation d'une méthode de stérilisation par autoclave en industrie pharmaceutique written by Yonatan Bouchoucha and published by . This book was released on 2014 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Au vu de son efficacité et de son intérêt économique, la stérilisation par la vapeur d'eau en autoclave est aujourd'hui la méthode privilégiée par les industriels pharmaceutiques. Cette thèse se propose d'analyser les principes de bases sur lesquelles repose la stérilisation par autoclavage, ainsi que les besoins de qualification en industrie pharmaceutique. Les aspects techniques d'un système de stérilisation par autoclavage différent souvent, mais le déroulement d'une qualification d'autoclave au sein d'un site industriel suit toujours le même schéma. Cependant une qualification n'étant jamais totalement close tant que l'appareil est en cours d'exploitation, un programme de maintenance et de requalification périodique doivent être mis en place. Ce travail est composé de trois parties : la première partie est consacrée à l'approche théorique de la stérilisation, la deuxième partie expose les principes de qualification d'un autoclave au sein d'un site pharmaceutique, enfin la dernière partie met en application les parties précédentes à travers un exemple pratique en industrie pharmaceutique
Book Synopsis Stérilisation par la vapeur by : Nathalie Planes
Download or read book Stérilisation par la vapeur written by Nathalie Planes and published by . This book was released on 2006 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: La stérilisation par la vapeur éxige une extraction de l'air environnant afin de permettre la diffusion de la vapeur au niveau des éléments à stériliser et favoriser ainsi le transfert de chaleur. L'assurance de l'efficacité de l'opération passe par la validation du cycle de stérilisation associé à une charge à stériliser. C'est ce travail qui est entrepris dans cette étude : afin de juger de l'efficacité de la stérilisation de la charge, des capteurs thermiques ont été positionnés au cœur des éléments à stériliser permettant le suivi en temps réel de la température lors de l'opération, nous avons ainsi pu montrer qu'il est possible de valider le procédé dans des conditions représentatives de l'utilisation en routine.
Book Synopsis VALIDATION D'UN PROCEDE DE STERILISATION INDUSTRIELLE PAR LA CHALEUR SECHE ; APPLICATION A DEUX TYPES DE CONTENANTS POUR PREPARATIONS INJECTABLES by : DOMINIQUE.. DURDILLY
Download or read book VALIDATION D'UN PROCEDE DE STERILISATION INDUSTRIELLE PAR LA CHALEUR SECHE ; APPLICATION A DEUX TYPES DE CONTENANTS POUR PREPARATIONS INJECTABLES written by DOMINIQUE.. DURDILLY and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis LA VALIDATION DANS L'INDUSTRIE PHARMACEUTIQUE by : ALEXANDRE.. PIZON
Download or read book LA VALIDATION DANS L'INDUSTRIE PHARMACEUTIQUE written by ALEXANDRE.. PIZON and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Faecal Sludge Management by : Linda Strande
Download or read book Faecal Sludge Management written by Linda Strande and published by IWA Publishing. This book was released on 2014-08-15 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is estimated that literally billions of residents in urban and peri-urban areas of Africa, Asia, and Latin America are served by onsite sanitation systems (e.g. various types of latrines and septic tanks). Until recently, the management of faecal sludge from these onsite systems has been grossly neglected, partially as a result of them being considered temporary solutions until sewer-based systems could be implemented. However, the perception of onsite or decentralized sanitation technologies for urban areas is gradually changing, and is increasingly being considered as long-term, sustainable options in urban areas, especially in low- and middle-income countries that lack sewer infrastructures. This is the first book dedicated to faecal sludge management. It compiles the current state of knowledge of the rapidly evolving field of faecal sludge management, and presents an integrated approach that includes technology, management, and planning based on Sandecs 20 years of experience in the field. Faecal Sludge Management: Systems Approach for Implementation and Operation addresses the organization of the entire faecal sludge management service chain, from the collection and transport of sludge, and the current state of knowledge of treatment options, to the final end use or disposal of treated sludge. The book also presents important factors to consider when evaluating and upscaling new treatment technology options. The book is designed for undergraduate and graduate students, and engineers and practitioners in the field who have some basic knowledge of environmental and/or wastewater engineering.
Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl
Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian
Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Book Synopsis The Vaccine Book by : Barry R. Bloom
Download or read book The Vaccine Book written by Barry R. Bloom and published by Academic Press. This book was released on 2016-06-23 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child's risk. - Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines - Gives new ideas about future vaccines and concepts - Introduces new vaccines and concepts - Gives ideas about challenges facing public and private industrial investors in the vaccine area - Discusses the problem of declining immunization rates and vaccine hesitancy
Book Synopsis Cambridge Handbook of Engineering Education Research by : Aditya Johri
Download or read book Cambridge Handbook of Engineering Education Research written by Aditya Johri and published by Cambridge University Press. This book was released on 2014-02-10 with total page 1124 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Cambridge Handbook of Engineering Education Research is the critical reference source for the growing field of engineering education research, featuring the work of world luminaries writing to define and inform this emerging field. The Handbook draws extensively on contemporary research in the learning sciences, examining how technology affects learners and learning environments, and the role of social context in learning. Since a landmark issue of the Journal of Engineering Education (2005), in which senior scholars argued for a stronger theoretical and empirically driven agenda, engineering education has quickly emerged as a research-driven field increasing in both theoretical and empirical work drawing on many social science disciplines, disciplinary engineering knowledge, and computing. The Handbook is based on the research agenda from a series of interdisciplinary colloquia funded by the US National Science Foundation and published in the Journal of Engineering Education in October 2006.
Download or read book Engineering written by Unesco and published by UNESCO. This book was released on 2010-01-01 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report reviews engineering's importance to human, economic, social and cultural development and in addressing the UN Millennium Development Goals. Engineering tends to be viewed as a national issue, but engineering knowledge, companies, conferences and journals, all demonstrate that it is as international as science. The report reviews the role of engineering in development, and covers issues including poverty reduction, sustainable development, climate change mitigation and adaptation. It presents the various fields of engineering around the world and is intended to identify issues and challenges facing engineering, promote better understanding of engineering and its role, and highlight ways of making engineering more attractive to young people, especially women.--Publisher's description.
Book Synopsis Vaccine Analysis: Strategies, Principles, and Control by : Brian K. Nunnally
Download or read book Vaccine Analysis: Strategies, Principles, and Control written by Brian K. Nunnally and published by Springer. This book was released on 2014-11-27 with total page 669 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.
Author :International Centre for Engineering Education Publisher :UNESCO Publishing ISBN 13 :9231004379 Total Pages :183 pages Book Rating :4.2/5 (31 download)
Book Synopsis Engineering for Sustainable Development by : International Centre for Engineering Education
Download or read book Engineering for Sustainable Development written by International Centre for Engineering Education and published by UNESCO Publishing. This book was released on 2021-03-02 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: The report highlights the crucial role of engineering in achieving each of the 17 SDGs. It shows how equal opportunities for all is key to ensuring an inclusive and gender balanced profession that can better respond to the shortage of engineers for implementing the SDGs. It provides a snapshot of the engineering innovations that are shaping our world, especially emerging technologies such as big data and AI, which are crucial for addressing the pressing challenges facing humankind and the planet. It analyses the transformation of engineering education and capacity-building at the dawn of the Fourth Industrial Revolution that will enable engineers to tackle the challenges ahead. It highlights the global effort needed to address the specific regional disparities, while summarizing the trends of engineering across the different regions of the world.
