Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

Front Cover
CRC Press, Oct 14, 2008 - Medical - 280 pages
0 Reviews
Reviews aren't verified, but Google checks for and removes fake content when it's identified
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
 

What people are saying - Write a review

We haven't found any reviews in the usual places.

Contents

Chapter 1 Microbial Life and Ecology
1
Chapter 2 Microbial Contamination and Control
35
Chapter 3 The USP Microbial Limit Tests
63
Chapter 4 Pharmaceutical Waters
93
Chapter 5 Environmental Monitoring
113
Chapter 6 Bioburden Considerations in EquipmentCleaning Validation
139
Chapter 7 Method Validation and Media Suitability Testing
159
Chapter 8 Microbiological Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials
203
Chapter 9 Rapid Testing and Alternative Methods in Microbiology
223
Chapter 10 Biofilms
263
Chapter 11 Handling Aberrant and OutofSpecification Microbial Data
299
Index
311
Back cover
327
Copyright

Other editions - View all

Common terms and phrases

Bibliographic information