Guide to Microbiological Control in Pharmaceuticals - Couverture rigide

Couverture rigide

ISBN 10 : 0133728226 ISBN 13 : 9780133728224

Editeur : Taylor & Francis Ltd, 1990

Synopsis

This clear and comprehensive description of the micro-organism as a contaminant and as a potential growth medium reveals the problems of microbiological control in pharmaceutic product design and manufacture. It is a uniquely extensive and fundamental review of the problems of preserving complex formulation against the microbial stresses imposed during manufacture and afterwards, often with only a limited range of permissible preservatives and often at a stage close to licence application when formulation changes are strongly resisted. The authors, each invited for their particular expertise, underline the versatility of micro-organisms and the relative susceptibilities of product types and ingredients; the principles of factory hygiene, microbiological quality control and good manufacturing are considered as well as monitoring methods for microbiological quality. They establish the distinction between sterile and non-sterile products and the merits and demerits of available sterilization methods.

A propos du livre

Présentation de l'éditeur

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. 

Détails de l'édition

• Éditeur: Taylor & Francis Ltd
• Date d'édition: 1990
• Langue: anglais
• ISBN 10: 0133728226
• ISBN 13: 9780133728224
• Reliure: Relié
• Nombre de pages: 450
• Éditeur: Denyer Stephen P., Baird Rosamund M.
• Coordonnées du fabricant: non disponible
• Personne responsable: HACHETTE LIVRE SA; https://www.hachette.fr/; ; 1 AVENUE GUTENBERG; MAUREPAS CEDEX; 78319; France