Microbial Limit and Bioburden Tests
Validation Approaches and Global Requirements,Second Edition
Seiten
2008
|
2nd edition
Crc Press Inc (Verlag)
978-1-4200-5348-7 (ISBN)
Crc Press Inc (Verlag)
978-1-4200-5348-7 (ISBN)
Assists readers in understanding the issues associated with pharmaceutical microbiology and provides them with tools to create microbial contamination control and microbial testing programs for the areas under their responsibility. This work is suitable for those responsible for the microbial quality of products and manufacturing facilities.
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.
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.
Diosynth Biotechnology, a part of Schering-Plough, Morrisville, North Carolina, USA
Microbial Life and Ecology. Microbial Contamination and Control. The USP Microbial Limit Tests. Pharmaceutical Waters. Environmental Monitoring. Bioburden Considerations In Equipment-Cleaning Validation.
Method Validation and Media. Suitability Testing. Microbial Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials. Rapid Testing and Alternative Methods in Microbiology.
Biofilms. Handling Aberrant and Out-of-Specification Microbial Data. Index.
| Erscheint lt. Verlag | 20.10.2008 |
|---|---|
| Zusatzinfo | 43 Tables, black and white; 97 Illustrations, black and white |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 156 x 234 mm |
| Gewicht | 612 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Mikrobiologie / Infektologie / Reisemedizin |
| Naturwissenschaften ► Biologie ► Mikrobiologie / Immunologie | |
| Technik | |
| ISBN-10 | 1-4200-5348-5 / 1420053485 |
| ISBN-13 | 978-1-4200-5348-7 / 9781420053487 |
| Zustand | Neuware |
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