Guide To Microbiological Control In Pharmaceuticals

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Guide To Microbiological Control In Pharmaceuticals

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Author : S. P. Denyer
language : en
Publisher: Taylor & Francis Group
Release Date : 1990

Guide To Microbiological Control In Pharmaceuticals written by S. P. Denyer and has been published by Taylor & Francis Group this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990 with Business & Economics categories.

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.

Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition

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Author : Stephen P. Denyer
language : en
Publisher: CRC Press
Release Date : 2006-12-26

Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition written by Stephen P. Denyer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12-26 with Science categories.

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.

Pharmaceutical Microbiological Quality Assurance And Control

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Author : David Roesti
language : en
Publisher: John Wiley & Sons
Release Date : 2020-01-02

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 2020-01-02 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 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

Guide To Microbiological Control In Pharmaceuticals And Medical Devices

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Author : S. P. Denyer
language : en
Publisher:
Release Date : 2007

Guide To Microbiological Control In Pharmaceuticals And Medical Devices written by S. P. Denyer and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with MEDICAL categories.

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.

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

Microbiological Assay For Pharmaceutical Analysis

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Author : William Hewitt
language : en
Publisher: CRC Press
Release Date : 2003-12-15

Microbiological Assay For Pharmaceutical Analysis written by William Hewitt and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-12-15 with Medical categories.

A user-friendly guide for the evaluation of microbiological assays, this book provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. The author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist. The book expands on the guidance given in pharmacopoeias and helps readers choose the assay design most appropriate for the purpose of their assay.

Guide To Inspections Of Microbiological Pharmaceutical Quality Control Laboratories

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Author : United States Food and Drug Administration Division of Field Investigations
language : en
Publisher:
Release Date : 1993

Guide To Inspections Of Microbiological Pharmaceutical Quality Control Laboratories written by United States Food and Drug Administration Division of Field Investigations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with categories.

Microbiological Contamination Control In Pharmaceutical Clean Rooms

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Author : Nigel Halls
language : en
Publisher: CRC Press
Release Date : 2004-06-25

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 2004-06-25 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 multidisciplinary approach, Microbiological Contamination Control for Pharmaceutical Clean Rooms neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms. The book helps you satisfy domestic and international regulations and prevent your organization from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This valuable guide brings you up to date on the types of techniques available, the scientific principles that underpin them, and the practicalities and limitations of each.

Microbial Contamination Control In Parenteral Manufacturing

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Author : Kevin Williams
language : en
Publisher: CRC Press
Release Date : 2004-05-20

Microbial Contamination Control In Parenteral Manufacturing written by Kevin Williams and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-05-20 with Medical categories.

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce

Hugo And Russell S Pharmaceutical Microbiology

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Author : Stephen P. Denyer
language : en
Publisher: John Wiley & Sons
Release Date : 2008-04-15

Hugo And Russell S Pharmaceutical Microbiology written by Stephen P. Denyer 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 2008-04-15 with Medical categories.

Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes