Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition

Author : Stephen P. Denyer,Rosamund M. Baird
Publisher : CRC Press
Page : 500 pages
File Size : 49,6 Mb
Release : 2006-12-26
Category : Science
ISBN : 9781420021622

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Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition by Stephen P. Denyer,Rosamund M. Baird Pdf

Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

Author : S. P. Denyer,Rosamund M. Baird
Publisher : Unknown
Page : 482 pages
File Size : 44,5 Mb
Release : 2007
Category : MEDICAL
ISBN : 0367800926

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Guide to Microbiological Control in Pharmaceuticals and Medical Devices by S. P. Denyer,Rosamund M. Baird Pdf

Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license applica.

Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Page : 274 pages
File Size : 43,8 Mb
Release : 2000-08-17
Category : Medical
ISBN : 9780203305195

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Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices by Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer Pdf

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

Author : S. P. Denyer,Rosamund M. Baird
Publisher : Taylor & Francis Group
Page : 400 pages
File Size : 54,6 Mb
Release : 1990
Category : Drugs
ISBN : UOM:39015021504090

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Guide to Microbiological Control in Pharmaceuticals by S. P. Denyer,Rosamund M. Baird Pdf

A handbook to the micro-organism as a contaminant and as a potential growth medium, focusing on the problems of microbiological control in pharmaceutical product design and manufacture. Topics include the relative susceptibilities of product types and ingredients and factory hygiene.

Author : United States Food and Drug Administration
Publisher : Createspace Independent Publishing Platform
Page : 92 pages
File Size : 53,8 Mb
Release : 2017-09-21
Category : Electronic
ISBN : 1976578671

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Pharmaceutical Microbiology Manual by United States Food and Drug Administration Pdf

Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

Author : Tim Sandle
Publisher : Elsevier
Page : 370 pages
File Size : 46,8 Mb
Release : 2013-10-31
Category : Medical
ISBN : 9781908818638

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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by Tim Sandle Pdf

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Author : Lucia Clontz
Publisher : CRC Press
Page : 0 pages
File Size : 51,5 Mb
Release : 2008-10-14
Category : Science
ISBN : 1420053485

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Microbial Limit and Bioburden Tests by Lucia Clontz Pdf

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 changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies. Includes New and Updated Material Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation. Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

Author : Anonim
Publisher : Unknown
Page : 964 pages
File Size : 49,6 Mb
Release : 2011
Category : Pharmaceutical microbiology
ISBN : 8190646745

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Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices by Anonim Pdf

Author : Jan Egebjerg,Arne Schousboe,Povl Krogsgaard-Larsen
Publisher : CRC Press
Page : 456 pages
File Size : 40,8 Mb
Release : 2001-10-04
Category : Science
ISBN : 0748408819

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Glutamate and GABA Receptors and Transporters by Jan Egebjerg,Arne Schousboe,Povl Krogsgaard-Larsen Pdf

The ubiquitous presence of glutamate and GABA receptors in the nervous system makes these receptor systems pivotal to our understanding of neurotransmission. Cloning of the molecular components of these receptor systems has provided insights to the selectivity of many drugs and detailed characterisation at the molecular level is emerging. Moreover, continuous development of novel and selective drugs has revealed detailed information on the mechanism of receptor activation and regulation. However, the rapid development of different aspects of glutamate and GABA receptor research makes it increasingly difficult to establish a general view of the field. Studies of the receptors are a multi-disciplinary task employing many specialised techniques. This book conveys recent discoveries in a framework of the basic concepts in the field of glutamate and GABA receptor research. Glutamate and GABA Receptors and Transporters: Structure, Function and Pharmacology is suitable for postgraduate students studying ligand gated channels but also beneficial for industrial and academic research scientists in both the glutamate and GABA field. Universities offering programs in neuroscience, molecular pharmacology or medicinal chemistry will find this a valuable reference.

Author : Michael J. Akers
Publisher : CRC Press
Page : 517 pages
File Size : 49,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020564

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Sterile Drug Products by Michael J. Akers Pdf

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 52,8 Mb
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 9781119356073

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Pharmaceutical Microbiological Quality Assurance and Control by David Roesti,Marcel Goverde Pdf

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 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

Author : Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publisher : Academic Press
Page : 266 pages
File Size : 53,8 Mb
Release : 2019-06-15
Category : Technology & Engineering
ISBN : 9780128050828

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Assurance of Sterility for Sensitive Combination Products and Materials by Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans Pdf

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Author : Mustafa Edik
Publisher : CRC Press
Page : 474 pages
File Size : 41,5 Mb
Release : 2024-06-28
Category : Medical
ISBN : 9781003814047

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GMP Audits in Pharmaceutical and Biotechnology Industries by Mustafa Edik Pdf

The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.

Author : Adam P. Fraise,Jean-Yves Maillard,Syed Sattar
Publisher : John Wiley & Sons
Page : 626 pages
File Size : 49,7 Mb
Release : 2013-02-18
Category : Medical
ISBN : 9781444333251

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Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization by Adam P. Fraise,Jean-Yves Maillard,Syed Sattar Pdf

The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.

Author : Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman,Brendan F. Gilmore
Publisher : John Wiley & Sons
Page : 534 pages
File Size : 53,5 Mb
Release : 2011-11-22
Category : Medical
ISBN : 9781118293829

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Hugo and Russell's Pharmaceutical Microbiology by Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman,Brendan F. Gilmore Pdf

Pharmaceutical microbiology has a bearing on all aspects of pharmacy, from the manufacture and quality control of pharmaceutical products through to an understanding of the mode of action of antibiotics. Fully revised and restructured, drawing on the contributions of subject experts, and including material relevant to the European curricula in pharmacy, the eighth edition covers: biology of micro-organisms pathogens and host response prescribing therapeutics contamination and infection control pharmaceutical production current trends and new directions Hugo and Russell’s Pharmaceutical Microbiology, a standard text for Schools of Pharmacy for seven editions, continues to be a user-friendly and authoritative guide for both students and practitioners of pharmacy and pharmaceutical microbiology. 'Highly Commended' in the Pharmacology section of the 2012 BMA Book Awards