Guide to Microbiological Control in Pharmaceuticals and Medical Devices

Hardback

Main Details

Title Guide to Microbiological Control in Pharmaceuticals and Medical Devices
Authors and Contributors      Edited by Stephen P. Denyer
Edited by Rosamund M. Baird
Physical Properties
Format:Hardback
Pages:504
Dimensions(mm): Height 235,Width 156
Category/GenreMicrobiology (non-medical)
ISBN/Barcode 9780748406159
ClassificationsDewey:616.01
Audience
Undergraduate
Postgraduate, Research & Scholarly
Professional & Vocational
Edition 2nd New edition
Illustrations 49 Illustrations, black and white

Publishing Details

Publisher Taylor & Francis Ltd
Imprint Taylor & Francis Ltd
Publication Date 26 December 2006
Publication Country United Kingdom

Description

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.