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Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition, by Lucia Clontz
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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 changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.
Includes New and Updated Material
Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.
Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.
- Sales Rank: #1866629 in Books
- Brand: Brand: CRC Press
- Published on: 2008-10-14
- Original language: English
- Number of items: 1
- Dimensions: 9.30" h x .90" w x 6.10" l, 1.35 pounds
- Binding: Hardcover
- 280 pages
- Used Book in Good Condition
About the Author
Diosynth Biotechnology, a part of Schering-Plough, Morrisville, North Carolina, USA
Most helpful customer reviews
1 of 1 people found the following review helpful.
Comprehensive coverage of material
By Robert Murphy
Comprenhensive subject matter covered throughly. Lacks recommended limits for specific application justification as to why specific limit would be appropriate in defined circulstances.
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