Microbial Limit And Bioburden Tests
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Microbial Limit And Bioburden Tests
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Author : Lucia Clontz
language : en
Publisher: CRC Press
Release Date : 1997-10-31
Microbial Limit And Bioburden Tests written by Lucia Clontz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-10-31 with Medical categories.
This invaluable book guides readers through the microbial limit testing methodologies of the major world markets, including the US Pharmacopeia, the European Pharmacopoeia, British Pharmacopoeia, and Japanese Pharmacopoeia. It compares and contrasts various methods and provides easy-to-follow approaches to validation of these test methodologies. Packed with practical guidance on all aspects of bioburden evaluation both for product and for support mechanisms, the book covers microbial ecology, preservation of pharmaceuticals, water, equipment/surfaces and environment, Rapid Test methods, and handling of aberrant data in the lab. Features
Microbial Limit And Bioburden Tests
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Author : Lucia Clontz
language : en
Publisher: CRC Press
Release Date : 2008-10-14
Microbial Limit And Bioburden Tests written by Lucia Clontz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-10-14 with Medical categories.
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
Pharmaceutical Microbiological Quality Assurance And Control
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Author : David Roesti
language : en
Publisher: John Wiley & Sons
Release Date : 2019-11-12
Pharmaceutical Microbiological Quality Assurance And Control written by David Roesti and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-12 with Technology & Engineering categories.
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Rapid Microbiological Methods In The Pharmaceutical Industry
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Author : Martin C. Easter
language : en
Publisher: CRC Press
Release Date : 2003-03-19
Rapid Microbiological Methods In The Pharmaceutical Industry written by Martin C. Easter and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-19 with Medical categories.
In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond?
Microbiological Contamination Control In Pharmaceutical Clean Rooms
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Author : Nigel Halls
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Microbiological Contamination Control In Pharmaceutical Clean Rooms written by Nigel Halls and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc
Handbook Of Microbiological Quality Control In Pharmaceuticals And Medical Devices
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Author : Rosamund M. Baird
language : en
Publisher: CRC Press
Release Date : 2000-08-17
Handbook Of Microbiological Quality Control In Pharmaceuticals And Medical Devices written by Rosamund M. Baird and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-08-17 with Medical categories.
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
Handbook Of Modern Pharmaceutical Analysis
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Author : Satinder Ahuja
language : en
Publisher: Academic Press
Release Date : 2001
Handbook Of Modern Pharmaceutical Analysis written by Satinder Ahuja and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Medical categories.
This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
Pharmaceutical Microbiology
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Author : Tim Sandle
language : en
Publisher: Woodhead Publishing
Release Date : 2015-10-09
Pharmaceutical Microbiology written by Tim Sandle and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-10-09 with Science categories.
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. - Contains the applications of pharmaceutical microbiology in sterile and non-sterile products - Presents the practical aspects of pharmaceutical microbiology testing - Provides contamination control risks and remediation strategies, along with rapid microbiological methods - Includes bioburden, endotoxin, and specific microbial risks - Highlights relevant case studies and risk assessment scenarios
Sterile Filtration
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Author : Maik W. Jornitz
language : en
Publisher: CRC Press
Release Date : 2020-04-15
Sterile Filtration written by Maik W. Jornitz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-15 with Business & Economics categories.
This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!
Encyclopedia Of Pharmaceutical Technology
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Author : James Swarbrick
language : en
Publisher: CRC Press
Release Date : 2000-12-05
Encyclopedia Of Pharmaceutical Technology written by James Swarbrick and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-12-05 with Medical categories.
The Encyclopedia of Pharmaceutical Technology presents authoritative and contemporary articles on all aspects of drug development, dosage forms, manufacturing, and regulation-enabling the specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and a solid investment for years to come--maintaining currency through its supplements [Volume 18/Supplement 1: Published November, 1998] The Encyclopedia contains interdisciplinary contributions in a wide array of subjects, including Drugs decomposition metabolism pharmaceutical incompatibilities pharmacokinetics physicochemical properties preformulation stability Drug Delivery Systems and Devices-Development and Manufacture analysis and controls bioavailability use of computerization formulation and processing alternatives national and international registration packaging patents process validation scale-up safety and efficacy stability standards Post-Production and Practical Considerations governmental/industrial/professional organizations legal aspects national and international agencies patent life of drugs patient compliance ...and much, much more!