Download or read book Moyens de maitrise de l environnement aseptique et de d tection des contaminations written by Baptiste Lissarague and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La production des médicaments est régie par un cadre réglementaire strict afin d'offrir aux patients l'accès à des produits de santé conformes et sûrs. En France, la production aseptique de médicaments stériles ne déroge pas à cette règle. Bien au contraire, le cadre réglementaire dicté par les BPF et notamment son annexe 1 est l'un des plus restrictifs rencontré dans l'industrie pharmaceutique. Dans l'optique de maintenir un environnement de production aseptique conforme aux exigences tout au long du procédé de fabrication, les industriels ont à leur disposition de nombreux moyens de maitrise de l'asepsie permettant de réduire les risques de contamination de l'environnement et des produits fabriqués. De plus, en association des moyens de maitrise de l'asepsie implémentés, la réglementation impose qu'un suivi environnemental des ZAC soit mené afin de détecter les potentielles contaminations et de démontrer que les moyens de maitrise de l'asepsie en place sont pertinents. Malgré l'adéquation des pratiques des industriels aux exigences réglementaires, malgré la pertinence des moyens de maitrise de l'environnement implémentés, malgré le travail consciencieux et les compétences du personnel de production, le risque zéro de contamination n'existe pas. En cas de perte de maitrise de l'asepsie d'une ZAC et de détection d'une contamination microbiologique, une anomalie relative au suivi environnemental est déclarée et doit être traitée selon un processus défini. L'objectif de ce dernier est d'identifier la cause racine de la perte de maitrise de l'asepsie et de permettre la mise en place, si nécessaire, de nouvelles mesures de prévention afin d'en éviter la récurrence.
Download or read book Maitrise de la contamination dans un secteur de remplissage aseptique written by Clémence Cappelle and published by . This book was released on 2017 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: La fabrication des médicaments injectables impose des exigences particulières en vue de minimiser les risques de contamination microbienne et particulaire. L'objectif de cette thèse est de présenter une démarche pour l'investigation et l'analyse d'une non-conformité d'un Test de Remplissage Aseptique (TRA). Celle-ci correspond à la recherche de cause racine, au recueil d'éléments décisionnels et à la mise en place de plan d'actions dans une démarche d'amélioration continue. Pour cela, le principe de la répartition aseptique des préparations injectables ainsi qu'un état des lieux des moyens de maîtrise de la contamination en zone conventionnelle sont présentés. Cette étude a été réalisée au sein d'un département de remplissage aseptique d'une usine de production de solution dt enoxaparine. Elle met en évidence l'importance de la surveillance tant de l'environnement particulaire et microbiologique que des contrôles en cours de production pour la fabrication des médicaments injectables. Afin de maîtriser le niveau de contamination, des éléments tels que des locaux adéquats, des équipements de production appropriés, conçus pour être facilement nettoyés et stérilisés sont requis. Le principal risque de contamination lors des procédés aseptiques étant l'intervention humaine directe, le savoir-faire, la formation et le comportement du personnel impliqué doivent être soutenus par un système formalisé soigneusement élaboré et par une méthodologie validée à toutes les étapes de la production.
Download or read book Ma trise de la contamination dans un isolateur de r partition aseptique exp rience men e lors de la qualification initiale d un nouvel quipement ajout au sein d un isolateur de r partition written by Mylène Frongia and published by . This book was released on 2013 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: La maîtrise des procédés de fabrication de médicaments stériles doit inclure la parfaite maîtrise de l'environnement de production. Ce dernier doit permettre de réduire au maximum la contamination particulaire et microbiologique que l'on retrouve aussi bien dans l'air extérieur mais aussi et surtout sur l'Homme. Afin de maîtriser au mieux cet environnement, des isolateurs de répartition peuvent être employés. Ces enceintes closes et décontaminables permettent de répartir le produit considéré avec un niveau de sécurité très élevé. Mais ceci à condition de mettre en place des moyens de maîtrise de l'environnement adaptés et un monitoring efficace. Ce sujet a fait l'objet d'un retour d'expérience menée lors d'un stage industriel dans le service chargé des validations. Il permet de mettre en avant l'importance que peut avoir l'environnement lors de la répartition aseptique d'un produit injectable. Ceci par le biais d'une modification apportée au sein d'un isolateur utilisé pour remplir et boucher de manière aseptique des seringues.
Download or read book Le bionettoyage written by Clément Razé and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La répartition des préparations stériles nécessite une maitrise de la contamination qui permet de garantir une libération d'un médicament sûr et efficace. La répartition aseptique de solutions stériles se réalise dans des zones à atmosphère contrôlée. Ces dernières permettent de maitriser l'environnement au cours de la production. Cependant, différents éléments peuvent venir mettre en péril la maitrise de cette contamination. Dans cette thèse, la partie 1 aborde les trois sources de contamination : microbiologique, particulaire, et chimique. Une analyse 5M permet de mettre en évidence la principale source de contamination : le personnel. En effet, c'est ce dernier, qui par des interventions inappropriées, peut venir contaminer l'environnement de production. Cette première étape d'analyse permet de définir les moyens de prévention à mettre en place. Bien que différents moyens permettent de prévenir une contamination, l'humain reste au centre des stratégies. En effet, plus que des moyens, c'est une rigueur tout au long du cycle de production qui permet d'assurer la qualité des préparations stériles. Plutôt que de chercher à éliminer les contaminants des zones de productions, il est préférable d'éviter qu'ils n'y pénètrent ou y soient transférées. Le bionettoyage est l'un des moyens de prévention de la contamination. La partie 2 de cette thèse traite du bionettoyage, et de sa mise en place sur les lignes de productions. Le bionettoyage est composé de 4 étapes à réaliser dans un ordre défini afin d'avoir des surfaces propres et dépourvus de microorganismes. Souvent laissé de côté, il est une étape clé d'un cycle de production. Maitrisé, il permet de garantir l'état de surface des locaux. Une description détaillée du bionettoyage permet d'assurer la reproductibilité des activités des techniciens de production. Lors de sa mise en place d'un bionettoyage, la participation des techniciens à l'élaboration des protocoles permet d'avoir de procédures adaptées aux locaux et aux différentes contraintes techniques et pratiques. Cela permet également de faciliter la prise en main et l'adhésion des opérateurs, et de favoriser un déploiement pérenne.
Download or read book Ma trise de la contamination particulaire et microbiologique dans l environnement des Zones Atmosph re Contr l e appliqu e la production aseptique des m dicaments written by Camille Bignossi and published by . This book was released on 2015 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book African Small Ruminant Research and Development written by R. T. Wilson and published by ILRI (aka ILCA and ILRAD). This book was released on 1989-01-01 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume contains 44 papers and 2 abstracts from a international conference on African small ruminants research and development. eleven papers and 1 abstract deal with the importance of small ruminant production systems and economics. Another 11 describe and analyse feed resources and feeding systems and there are 6 papers on reproductive problems and their solutions. Seven papers and 1 abstract review the prevalent health problems under various management systems and present the solutions to these production constraints. The last 9 papers deal with breeds, breeding systems and breed improvement.
Download or read book Bananas and Food Security written by Claudine Picq and published by Bioversity International. This book was released on 1999 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: Importance de la banane sur les plans economique et alimentaire; Diversite et dynamique des filieres; Organisation des marches et commercialisation; Systemes de productions/production systems.
Download or read book Advanced Intelligent Systems for Sustainable Development AI2SD 2020 written by Janusz Kacprzyk and published by Springer Nature. This book was released on 2022-02-10 with total page 1298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book publishes the best papers accepted and presented at the 3rd edition of the International Conference on Advanced Intelligent Systems for Sustainable Development Applied to Agriculture, Energy, Health, Environment, Industry, Education, Economy, and Security (AI2SD’2020). This conference is one of the biggest amalgamations of eminent researchers, students, and delegates from both academia and industry where the collaborators have an interactive access to emerging technology and approaches globally. In this book, readers find the latest ideas addressing technological issues relevant to all areas of the social and human sciences for sustainable development. Due to the nature of the conference with its focus on innovative ideas and developments, the book provides the ideal scientific and brings together very high-quality chapters written by eminent researchers from different disciplines, to discover the most recent developments in scientific research.
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 368 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.
Download or read book Pharmaceutical Isolators written by Brian Midcalf and published by Pharmaceutical Press. This book was released on 2004 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work considers the basic concepts, definitions, and standards necessary in the design, construction, commissioning, maintenance, and use of pharmaceutical isolators.
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.
Download or read book Advanced Intelligent Systems for Sustainable Development AI2SD 2019 written by Mostafa Ezziyyani and published by Springer. This book was released on 2020-01-04 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains the latest researches on advanced intelligent systems applied in the field of education presented during the second edition of the International Conference on Advanced Intelligent Systems for Sustainable Development (AI2SD’2019) held on July 08–11, 2019, in Marrakech, Morocco. The book proposes new approaches and innovative strategies for the manipulation of data and big data collected from the educational environment, exploiting the analysis tools, algorithms of artificial intelligence, and machine learning techniques, in order to extract results, which allow improving the performance and effectiveness of the education field, which is a strategic lever for sustainable development. The book deals with concepts, strategies, and approaches developed on various current axes of scientific research in the field of education, such as smart e-learning, smart education (smart classroom, smart assessment and smart teaching and learning technologies), massive open online courses (MOOC), courseware design, and development for smart learning, cloud learning, and mobile learning. The book is intended for all actors in the educational sector, namely students, professors, academic researchers, and stakeholders. It constitutes a large-scale forum for the exchange of ideas, approaches, and innovative techniques between these actors on the development and innovation of the field of education with the revolution 4.0. The authors of each chapter report the state of the art of the various topics addressed and present results of their own research, laboratory experiments, and successful applications. The purpose of this session is to share the idea of advanced intelligent systems with appropriate tools and techniques for modeling, management, and decision support in the field of education.
Download or read book Clean Hands Save Lives written by Thierry Crouzet and published by Thaulk. This book was released on 2014-04-28 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: You may not know it, but an innovation has made our world a better place. The use of alcohol-based handrubs protects us from infectious diseases and saves millions of lives each year through safer health care. Here is the story of this revolutionary formulation, made available without patent and offered as a gift to humanity by Professor Didier Pittet and his team at Hôpitaux Universitaires de Genève (HUG). From bush doctors to giant pharmaceutical corporations, everyone can now produce effective handrubs, cheaply and easily. Didier Pittet’s medical odyssey has taken him to the four corners of the Earth. It also reveals a new path open to human society, one that pro- mises a radical shift from a predatory economic system to an economy of peace. Thierry Crouzet — blogger, essay writer, and novelist — is fascinated by contemporary issues located at the nexus of technology, politics, and lite- rature. A former journalist, his published works in French include Le Peuple des connecteurs [The Connected People], a reflection on our networked society; J’ai débranché [How I Unplugged], a tale of digital burnout; and La Quatrième Théorie [The Fourth Theory], a political techno-thriller.
Download or read book Advanced Intelligent Systems for Sustainable Development AI2SD 2019 written by Mostafa Ezziyyani and published by Springer. This book was released on 2020-02-06 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights the latest research in the fields of health care and agriculture, presented at the second installment of the International Conference on Advanced Intelligent Systems for Sustainable Development (AI2SD-2019), held on July 08–11, 2019 in Marrakech, Morocco. Gathering contributions by respected researchers in the field of agriculture, the book is intended to stimulate debate in this field, and proposes new solutions, tools and effective techniques concerning various current topics in the field of agriculture, such as ICT, IoT and big data analytics for agriculture, smart systems for plant productivity, and data analytics of socio-economic dimensions for sustainable agriculture and aquaculture. With regard to the field of health, the book addresses several areas of research, including E-health services in smart environments (smart homes, smart medical institutions, smart cities), E-health and big data analysis, IoT for health, network interoperability in E-health ecosystems, current and emerging web norms and communication technologies for E-health, heterogeneity of E-health environments and platforms (sensors and actuators, heterogeneous access technologies, security), human–computer interaction, RFID and localization techniques, E-health virtual communities, and business intelligence in health care. This book is intended for academic and professional researchers, decision-makers and all stakeholders in the fields of health and agriculture whose work involves the development and improvement of this field with modern I4.0 technologies and approaches. The authors of each chapter report on the state of the art and present the outcomes of their own research, laboratory experiments, and successful applications. The purpose of the book is to combine the idea of advanced intelligent systems with appropriate tools and techniques for modeling, management, and decision support in the fields of health and agriculture.
Download or read book Alley Farming written by B. T. Kang and published by IITA. This book was released on 1999 with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Tropical Agriculturalist is a series of practical field guides and textbooks for: producers, farmers and farm managers, agricultural extension officers agricultural diploma, degree and vocational students, teachers and lecturers, senior secondary students, as reference books, adult education, rural and community development programmes.
Download or read book Color Atlas of Equine Pathology written by Claus D. Buergelt and published by John Wiley & Sons. This book was released on 2014-01-28 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt: Color Atlas of Equine Pathology offers a practical guide to identifying equine diseases, presenting a single resource with more than 1000 images showing predominantly gross pathology. Organized by body systems, the book allows for picture matching during or after an equine necropsy. In this user-friendly atlas, each chapter takes a common format, presenting the disease process as well as congenital, degenerative, inflammatory, and neoplastic sequences, with text boxes offering quick reference to key information. The book begins with an introductory chapter summarizing the principles of the equine field necropsy, and subsequent organ-based chapters depict gross features of disease, focusing on macroscopic digital images supplemented by histology and immunohistochemistry when necessary. Some clinical information for correlation with pathology is included. Color Atlas of Equine Pathology is an essential resource for diagnostic veterinary pathologists and pathology residents, as well as for equine practitioners performing necropsies in the field.
Download or read book Historical Dictionary of Iran written by John Henry Lorentz and published by Historical Dictionaries of Asia, Oceania, and the Middle East. This book was released on 2007 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides an overview of specific events, movements, people, political and social groups, places, trends, and chronology. Allows for considerable exploration of a number of historical and contemporary topics and issues. The modern period, defined as 1800-present, is covered extensively.
