Guide to Microbiological Control in Pharmaceuticals and Medical Devices

ISBN-13: 9780748406159 / Angielski / Twarda / 2006 / 504 str.

S. Denyer; Denyer Denyer; Stephen P. Denyer

Opis

In both the pharmaceutical and medical device industry, increasing demands on the company microbiologist have required not only a detailed understanding of traditional techniques and methods of culture, but also an appreciation of the developing role of rapid methods and the accompanying regulatory requirements. This book provides a comprehensive distillation of this information and specifically concentrates on the practical issues facing the industrial microbiologist of today.

Recenzje

“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

Spis treści

Introduction to microbiology. Microbial contamination: spoilage and hazard. Microbial ecology of the production process. The design of controlled environments.  Microbiological considerations for biotechnological products. Microbiological considerations in the production of medical devices. Good manufacturing practice in the control of contamination. Dispersion of airborne contaminants and contamination risks in clean rooms. Monitoring microbiological quality: conventional testing methods. Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals. Principles of sterilization. Sterilization methods. Assurance of sterility by process validation. Principles of preservation. Antimicrobial preservatives and their properties.
Preservative stability and efficacy: formulation influences. Package integrity testing. Official methods of preservative evaluation and testing. Preservative evaluation and testing : the linear regression method. Preservatives, antimicrobial agents and antioxidants: registration and regulatory affairs. Microbial standards for pharmaceuticals. Risk management and microbiological auditing.

O autorze

Stephen P. Denyer, Rosamund M. Baird