Guide to Microbiological Control in Pharmaceuticals and Medical Devices: 2nd Edition (Hardback) book cover

Guide to Microbiological Control in Pharmaceuticals and Medical Devices

2nd Edition

Edited by Stephen P. Denyer, Rosamund M. Baird

CRC Press

504 pages | 49 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9780748406159
pub: 2006-12-26

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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.


“Considering the diversity of topics covered in the book and the diversity of the contributors, the style of writing is surprisingly consistent. Each chapter uses clear, easy-to-understand English… this book should appeal to a wide range of employees within the pharmaceutical and medical device industries, from Chief Executive Officers to managers, quality assurance/regulatory affairs assistants and laboratory staff.”

—David Pickard, Senior Technical Specialist and Microbiologist, London, UK, in Journal of Medical Device Regulation

Table of Contents

Introduction to microbiology; Rosamund M. Baird and Stephen P. Denyer

Microbial contamination: spoilage and hazard; Sally F. Bloomfield

Microbial ecology of the production process; David N. Payne

The design of controlled environments; Alan G.Cosslett

Microbiological considerations for biotechnological products; Adekunle O. Onadipe

Microbiological considerations in the production of medical devices; Haroon A.R.D. Atchia

Good manufacturing practice in the control of contamination; Paul Hargreaves

Dispersion of airborne contaminants and contamination risks in clean rooms; Bengt Ljungvist and Berit Reinműller

Monitoring microbiological quality: conventional testing methods; Rosamund M. Baird

Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals; Stephen P. Denyer

Principles of sterilization; Eamoun V. Hoxey, Nicola Thomas, and David J.G. Davies

Sterilization methods; Eric L. Dewhurst and Eamoun V. Hoxey

Assurance of sterility by process validation; Klaus Haberer

Principles of preservation; Donald S. Orth

Antimicrobial preservatives and their properties; Stephen P. Denyer

Preservative stability and efficacy: formulation influences; Hans van Doorne

Package integrity testing; Lee Kirsch

Official methods of preservative evaluation and testing; Michael J. Akers, Veda K Walcott, and C. Julia Taylor

Preservative evaluation and testing: the linear regression method; Donald S. Orth

Preservatives, antimicrobial agents and antioxidants: registration and regulatory affairs; R. Keith Greenwood

Microbial standards for pharmaceuticals; Marie L. Rabouhans

Risk management and microbiological auditing; Robert A. Pietrowski


Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Life Sciences / Biology / Microbiology