Download or read book La m thode de calcul des Limites R siduelles Acceptables un pilier de l optimisation de la strat gie de la validation de nettoyage dans l industrie pharmaceutique written by Fanny Dupuy and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans l'industrie pharmaceutique, le nettoyage représente un pilier fondamental dans la lutte contre les contaminations des produits fabriqués. Afin d'évaluer l'efficacité de cette opération la stratégie de validation de nettoyage est particulièrement importante. Cela passe notamment par le choix de seuils d'acceptation adaptés et pertinents (prise en compte de la Permitted Daily Exposure (PDE), de la surface réelle des équipements...). Ce travail expose donc dans un premier temps, les différents modes de contamination et les différents moyens mis en œuvre pour les éviter. Puis, il détaille les pré requis à la validation de nettoyage ainsi que ses diverses étapes. Pour finir, il présente un exemple concret d'optimisation de stratégie de validation de nettoyage via le calcul de nouvelles Limites Résiduelles Acceptables (LRA) et le choix de nouveaux critères d'acceptation.
Download or read book Handbook of Hygiene Control in the Food Industry written by H. L. M. Lelieveld and published by Taylor & Francis US. This book was released on 2005-10-30 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Complementing the highly successful Hygiene in food processing, this book reviews recent research on improving hygiene in food processing. Part 1 considers recent research on contamination risks such as biofilms and how they can be assessed. Part 2 reviews ways of improving hygienic design of both buildings and equipment, including clean room technology. The final part of the book discusses ways of improving hygiene practice and management.
Download or read book Industrial pharmaco technology written by and published by . This book was released on 1999 with total page 521 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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 Some Antiviral and Antineoplastic Drugs and Other Pharmaceutical Agents written by IARC Working Group on the Evaluation of Carcinogenic Risks to Humans and published by World Health Organization. This book was released on 2000 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evaluates the carcinogenic risks to humans posed by the use of four antiretroviral agents four DNA topoisomerase II inhibitors used in the treatment of cancer and an additional three pharmaceutical agents (hydroxyures phenolphthalein and vitamin K substances). The volume marks the first IARC evaluation of nucleoside analogs that act as antiviral agents. The evaluation responds in part to recent findings that zidovudine (AZT) an effective antiretroviral agent now being given to pregnant HIV-infected women to prevent maternal-to-fetal transmission of the virus is a transplacental carcinogen in mice. The opening monograph evaluates the carcinogenicity to humans of the antiretroviral nucleoside analogs zidovudine (AZT) zalcitabine (ddC) and didanosine (ddI) and the antiherpesvirus drug aciclovir. Of these aciclovir and didanosine could not be classified on the basis of available data. For zidovudine transplacental administration to mice resulted in an increased incidence and multiplicity of lung and liver tumours and in an increased incidence of female reproductive tract tumours in one study but not in another involving treatment at a lower dose. Despite observation of toxic effects in some studies of humans human carcinogenicity data were judged to provide inadequate evidence of carcinogenicity in humans. Zidovudine was classified as possibly carcinogenic to humans. Similar weaknesses in human carcinogenicity data for zalcitabine which consistently induces thymic lymphomas in mice resulted in its classification as possibly carcinogenic to humans. The second monograph evaluates four DNA topoisomerase II inhibitors: etoposide teniposide mitoxantrone and amsacrine. Of these etoposide - one of the most widely used and effective cytotoxic drugs in combination therapy - was classified as probably carcinogenic to humans and etoposide in combination with cisplatin and bleomycin was judged to be carcinogenic to humans. Teniposide was classified as probably carcinogenic to humans and mitoxantrone and amsacrine were classified as possibly carcinogenic to humans. Of the three pharmaceutical agents evaluated in the final monograph hydroxyurea which is widely used in cancer treatment and increasingly in combination with didanosine in HIV infection could not be classified. Phenolphthalein a widely used laxative now being withdrawn from the market in many countries because of toxicological concerns was classified as possibly carcinogenic. Vitamin K substances could not be classified on the basis of available evidence.
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.
Download or read book Analysis of Food Constituents written by J.-L. Multon and published by John Wiley & Sons. This book was released on 1997-03-28 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ob Analyse eines Nahrungsmittelbestandteils, Interpretation von Meßwerten oder Risikoabschätzung - dieses vierbändige Nachschlagewerk für die Praxis, dessen letzter Band jetzt vorliegt, läßt keine wichtige Frage offen. Mit umfassender Bibliographie.
Download or read book Preparative Layer Chromatography written by Teresa Kowalska and published by CRC Press. This book was released on 2006-02-03 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preparative Layer Chromatography explains how this method is used for separating large quantities of mixtures containing a wide variety of important compounds. It offers a broad review of preparative layer chromatography (PLC) applications and adaptable working procedures for microseparations involving organic, inorganic, and organometallic compoun
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 Cleaning Validation written by Destin A. LeBlanc and published by CRC Press. This book was released on 2022-12-23 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Download or read book Cleaning in Place written by Adnan Y. Tamime and published by Wiley-Blackwell. This book was released on 2008-05-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the third edition of the Society of Dairy Technology's highly successful volume on Cleaning-in-Place (CIP). Already a well-established practice in dairy technology, CIP has become increasingly relevant in the processed food industry during the last 10-15 years, and the beverage industry has seen increased demands from customers regarding CIP verification and validation to provide improvements in plant hygiene and related efficiency. The book addresses the principles of cleaning operations, water supply issues and the science of detergents and disinfectants. Aspects of equipment design relevant to ease of cleaning are covered in a special chapter, as is the assessment of cleaning efficiency and the management of cleaning operations. This third edition features for the first time a chapter on membrane cleaning - a relatively new area requiring very specialised cleaning products and procedures. Useful data on fluid flow dynamics and laboratory test methods are also included in separate chapters. Authors have been selected from within industry, allied suppliers and academia to provide a balanced, leading edge assessment of the subject matter. Cleaning-in-Place is directed at dairy scientists and technologists in industry and academia, general food scientists and food technologists, food microbiologists and equipment manufacturers.
Download or read book The Functional Art written by Alberto Cairo and published by New Riders. This book was released on 2012-08-22 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unlike any time before in our lives, we have access to vast amounts of free information. With the right tools, we can start to make sense of all this data to see patterns and trends that would otherwise be invisible to us. By transforming numbers into graphical shapes, we allow readers to understand the stories those numbers hide. In this practical introduction to understanding and using information graphics, you’ll learn how to use data visualizations as tools to see beyond lists of numbers and variables and achieve new insights into the complex world around us. Regardless of the kind of data you’re working with–business, science, politics, sports, or even your own personal finances–this book will show you how to use statistical charts, maps, and explanation diagrams to spot the stories in the data and learn new things from it. You’ll also get to peek into the creative process of some of the world’s most talented designers and visual journalists, including Condé Nast Traveler’s John Grimwade , National Geographic Magazine’s Fernando Baptista, The New York Times’ Steve Duenes, The Washington Post’s Hannah Fairfield, Hans Rosling of the Gapminder Foundation, Stanford’s Geoff McGhee, and European superstars Moritz Stefaner, Jan Willem Tulp, Stefanie Posavec, and Gregor Aisch. The book also includes a DVD-ROM containing over 90 minutes of video lessons that expand on core concepts explained within the book and includes even more inspirational information graphics from the world’s leading designers. The first book to offer a broad, hands-on introduction to information graphics and visualization, The Functional Art reveals: • Why data visualization should be thought of as “functional art” rather than fine art • How to use color, type, and other graphic tools to make your information graphics more effective, not just better looking • The science of how our brains perceive and remember information ¿ • Best practices for creating interactive information graphics • A comprehensive look at the creative process behind successful information graphics ¿ • An extensive gallery of inspirational work from the world’s top designers and visual artists On the DVD-ROM: In this introductory video course on information graphics, Alberto Cairo goes into greater detail with even more visual examples of how to create effective information graphics that function as practical tools for aiding perception. You’ll learn how to: incorporate basic design principles in your visualizations, create simple interfaces for interactive graphics, and choose the appropriate type of graphic forms for your data. Cairo also deconstructs successful information graphics from The New York Times and National Geographic magazine with sketches and images not shown in the book. All of Peachpit's eBooks contain the same content as the print edition. You will find a link in the last few pages of your eBook that directs you to the media files. Helpful tips: If you are able to search the book, search for "Where are the lesson files?" Go to the very last page of the book and scroll backwards. You will need a web-enabled device or computer in order to access the media files that accompany this ebook. Entering the URL supplied into a computer with web access will allow you to get to the files. Depending on your device, it is possible that your display settings will cut off part of the URL. To make sure this is not the case, try reducing your font size and turning your device to a landscape view. This should cause the full URL to appear.
Download or read book Biotechnology and Sustainable Development written by Ismail Serageldin and published by CABI. This book was released on 2003 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on the first scientific conference convened at the Library of Alexandria, 'Biotechnology and Sustainable Development: Voices of the South and North', which was held in Alexandria, Egypt, in March 2002, this book contains overviews of agriculture, health, ethics and the environment. It discusses how dramatic improvements in food security, health, and lifestyle could accrue to the poor people of developing countries through the applications of new technologies.
Download or read book Global Burden of Disease and Risk Factors written by Alan D. Lopez and published by World Bank Publications. This book was released on 2006-04-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.
Download or read book Cleaning Validation Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2010-05-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-
Download or read book Per and polyfluorinated substances in the Nordic Countries written by Stefan Posner and published by Nordic Council of Ministers. This book was released on 2013-06-19 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Tema Nord report presents a study based on open information and custom market research to review the most common perfluorinated substances (PFC) with less focus on PFOS and PFOA. The study includes three major parts:1) Identification of relevant per-and polyfluorinated substances and their use in various industrial sectors in the Nordic market by interviews with major players and database information; 2) Emissions to and occurence in the Nordic environment of the substances described in 1); 3) A summary of knowledge of the toxic effects on humans and the environment of substances prioritized in 2); There is a lack of physical chemical data, analystical reference substances, human and environmental occurrence and toxicology data, as well as market information regarding PFCs other than PFOA and PFOS and the current legislation cannot enforce disclosure of specific PFC substance information.
