Guide to Microbiological Control in Pharmaceuticals

Denyer, S P; Baird, R M [eds.]

ISBN 10: 0133728226 / ISBN 13: 9780133728224

Edité par Ellis Horwood Ltd, Chichester, 1990

A propos de cet article

VG: in very good condition without dust jacket as issued. Cover rubbed and marked. 250mm x 170mm (10" x 7"). 389pp. Ellis Horwood series in pharmaceutical technology. Illustrated hardback laminated board cover.

N° de réf. du vendeur h0601b

Détails bibliographiques

• Titre: Guide to Microbiological Control in Pharmaceuticals
• Éditeur: Ellis Horwood Ltd, Chichester
• Date de parution: 1990
• Langue: anglais
• ISBN à 10 chiffres: 0133728226
• ISBN à 13 chiffres: 9780133728224
• Reliure: Couverture rigide
• Édition: First Edition.
• État de l'article: Very Good

A propos de ce titre

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.

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.