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Industrial Pharmaceutical Microbiology: Standards and Controls / Hodges, Norman & Hanlon, Geoff (Eds.)
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Industrial Pharmaceutical Microbiology: Standards and Controls
Hodges, Norman & Hanlon, Geoff (Eds.)
 
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List Price : US$ 199.94
Our Price : US$ 159.95
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 PRODUCT DETAILS
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  Book ID : 38122
 
 
  Place of Publication : Passfield, England
  Year of Publication : 2011
  Edition : (Indian Reprint)
  Language : English
  ix, 399p., 25 cm. ISSN: 1740-4975.
   
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 CONTENTS
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CONTENTS:-
1. The role of the Qualified Person in microbiological quality assurance.
2. Safety in microbiology.
3. Statistics and statistical process control in pharmaceutical microbiology.
4. Microbiology of water as an ingredient and product.
5. Rapid enumeration and identification methods.
6. Microbiological environmental monitoring.
7. Selection and use of cleaning and disinfection agents in pharmaceutical manufacturing.
8. Prevention and elimination of microbial biofilms in the manufacturing environment using Clean-in-Place.
9. Cleanroom design, operation and regulatory standards.
10. Isolator technology.
11. Validation of aseptic processing and media fills.
12. Endotoxins and depyrogenation.
13. Biological indicators.
14. New and emerging sterilization technologies.
15. Parametric release.
16. International disinfectant testing protocols.
17. Measurement of biocide effectiveness.
18. Microbiological quality and regulatory requirements for biotherapeutics and manufactured products.
19. The role of the microbiologist in HACCP.
20. Auditing the pharmaceutical microbiology department.
21. A compendium of microbiological standards and regulations.
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 DESCRIPTION
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A practical, annually updated international handbook for all those working in Industrial Pharmaceutical Microbiology.

In over 500 pages and 20 chapters, this book covers the entire spectrum of industrial microbiology from regulatory requirements to disinfectants, sterility testing, environmental monitoring and hazard analysis.

Most of the information in the book is of universal application and is written by experts with international experience. The authors provide expert insights into translating new advances in quality assurance, safety, validation and sterility into good laboratory practices and successful drugs.

Review in Microbiologist "The most valuable feature of this book is a comparison of regulatory approaches and legislation requirements in Europe, USA and the Far East ... such information will be extremely valuable in the industrial sector ... an exceptional and unique publication ... an extremely important and very practical collection of reference information. This book is value for money."

As many aspects of industrial microbiology are constantly changing, a new updated edition of the book will be published at 12-monthly intervals, commencing May 2011. Original subscribers will be offered this edition and future editions at half the normal price.

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