Guide to Microbiological Control in Pharmaceuticals and Medical Devices

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 Reinmuller 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 Index

Review :
“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