Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements

Clontz, Lucia

ISBN 10: 1574910620 / ISBN 13: 9781574910629

Published by Interpharm Press, 1998

About this Item

Light wear to boards. Content is clean with light age tone. DJ with some edge wear and fading.

Seller Inventory # 9999-99993585556

Bibliographic Details

• Title: Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements
• Publisher: Interpharm Press
• Publication Date: 1998
• Language: English
• ISBN 10: 1574910620
• ISBN 13: 9781574910629
• Binding: Hardcover
• Condition: Good

About this title

Synopsis

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

About the Author

Diosynth Biotechnology, a part of Schering-Plough, Morrisville, North Carolina, USA