Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements - Rilegato

Clontz, Lucia

Rilegato

ISBN 10: 1574910620 ISBN 13: 9781574910629

Casa editrice: CRC Press, 1997

Riassunto

This invaluable book guides readers through the microbial limit testing methodologies of the major world markets, including the US Pharmacopeia, the European Pharmacopoeia, British Pharmacopoeia, and Japanese Pharmacopoeia. It compares and contrasts various methods and provides easy-to-follow approaches to validation of these test methodologies. Packed with practical guidance on all aspects of bioburden evaluation both for product and for support mechanisms, the book covers microbial ecology, preservation of pharmaceuticals, water, equipment/surfaces and environment, Rapid Test methods, and handling of aberrant data in the lab.

Features

Su questo libro

Contenuti

o Contamination & Control
o Microbial Life & Ecology
o USP Microbial Limit Test
o Validation of USP Microbial Limit Test (Preparatory Testing)
o JP Test
o BP & EP Test
o Biocontamination Control & Bioburden Analysis in Cleaning
Validation Studies
o Microbiological Attributes/Testing Requirements: Pharmaceutical Articles
o Rapid Testing & Automated Methods
o Handling Aberrant & Failing Data in the Lab

Product Description

Book by Clontz Lucia

Dettagli dell?edizione

• Editore: CRC Press
• Data di pubblicazione: 1997
• ISBN 10: 1574910620
• ISBN 13: 9781574910629
• Rilegatura: Copertina rigida
• Lingua: Inglese
• Numero edizione: 1
• Numero di pagine: 240
• Contatto del produttore: non disponibile