Cover image for Microbial limit and bioburden tests : validation approaches and global requirements
Title:
Microbial limit and bioburden tests : validation approaches and global requirements
Author:
Clontz, Lucia., author.
ISBN:
9781420053494
Edition:
Second edition.
Physical Description:
1 online resource (280 pages)
General Note:
Rev. ed. of: Microbial limit and bioburden tests for the pharmaceutical industry.
Contents:
chapter 1 Microbial Life and Ecology -- chapter 2 Microbial Contamination and Control -- chapter 3 The USP Microbial Limit Tests -- chapter 4 Pharmaceutical Waters -- chapter 5 Environmental Monitoring -- chapter 6 Bioburden Considerations in Equipment-Cleaning Validation -- chapter 7 Method Validation and Media Suitability Testing -- chapter 8 Microbiological Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials -- chapter 9 Rapid Testing and Alternative Methods in Microbiology -- chapter 10 Biolms -- chapter 11 Handling Aberrant and Out-of-Specication Microbial Data.
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E-Book 546031-1001 RS199 .M53 C57 2009
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