Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

ISBN-13: 9780748406142 / Angielski / Twarda / 2000 / 280 str.

Stephen Denyer; Rosamund M. Baird; Norman E. Hodges

Opis

A practical guide to techniques used in microbial quality assurance in the pharmaceutical industry. The text aims to fill the gap in the literature between food and medical microbiology technique books. The techniques presented represent the best of the standard tests employed by industry including both traditional and rapid analysis methods. The emphasis is on what the user, rather than the supplier, must do. Microbial quality control follows guidelines presented in the appropriate pharmacopoeia. However, these descriptions provide brief outlines only and this has led to subtle differences in testing between laboratories. This book provides laboratories with detailed protocols for all established tests with the aim of improving standardization. This book should become known as the industry standard for microbial testing.

Spis treści

Safety in Microbiology. Culture Media. Sampling. Enumeration of Micro-organisms. Identification of Micro-organisms. Specified Organisms. Rapid Methods. Sterility Assurance. Endotoxin Testing. Preservative Efficacy Testing. Microbiological Assay. Disinfection and Cleansing. Microbiological Audit. Case Studies and Calculations.

O autorze

Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyer