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.
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
“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