Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices
Subtitle: The results of 45 years of scientific and technological development are laid down in these 33 chapters. These chapters, all written by international experts, give a vivid picture of todays pharmaceutical microbiology. The high standard of the chapters makes it an essential reference guide that should be on the shelf of everyone who is involved or interested in this field.
Publisher: Business Horizons
Published: February 2011
Place of publication: New Dehli, New York, London
Format: Hardcover
Number of pages: 996
ISBN-13: 9788190646741
Description: The most comprehensive text for microbiologists, regulatory and quality personnel to cover the subject of pharmaceutical microbiology and sterility assurance. The book was designed to provide an introductory text for students and those new to the industry and to provide a useful aid for the more experienced practitioner with which to compare their own approaches or policies, and to act as a useful reference aid.
Table of contents: title: 1. The Essentials of Pharmaceutical Microbiology by Tim Sandle and Madhu Raju Saghee; title: 2. Relevance of Microorganisms in Pharmaceutical Processing by Ossama M. El-Tayeb; title: 3. Microbial Contamination and Spoilage by David G. Allison; title: 4. Microbiological Considerations in Medical Device Industry by Martell Winters; title: 5. Selection of Microbiological Culture Media and Testing Regimes by Tim Sandle; title: 6. Microbial Identification by Ziva Abraham; title: 7. Microbial Examination of Non-sterile Products by Jaymie Tomes and Florence Wu; title: 8. Practical Approaches to Sterility Testing by Tim Sandle; title: 9. Microbial Aspects in Cleaning Validation by Andrew Walsh; title: 10. Validation of Microbiological Methods by Sandy Rubio; title: 11. Selection and Validation of Disinfectants by Paul Vina, Sandy Rubio and Tim Sandle; title: 12. Auditing a QC Microbiology Laboratory by Andy Martin; title: 13. Quality Assurance in a Microbiology Laboratory by Christophe Barcella; title: 14. Environmental Monitoring by Tim Sandle; title: 15. Microbial Content Testing of Pharmaceutical and Biotechnologically Derived Products by Dilip Ashtekar and Tim Sandle; title: 16. Bacterial Endotoxins Test by Masakazu Tsuchiya; title: 17. Antimicrobial Effectiveness Testing by Scott V. W. Sutton; title: 18. Monitoring of Microbiological Quality Attributes of Water for Pharmaceutical Use by Dilip Ashtekar; title: 19. Investigation of Microbiological Data Deviations by Monica Lagomarsino; title: 20. Alternative Microbiological Methods and New Pharmaceutical Microbiology Curriculum by Claudio D. Denoya; title: 21. The Implementation of Rapid Microbiological Methods by Michael J. Miller