Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices
Contents: Part. I: The Impact of Microorganisms in Pharmaceutical and Medical Device Manufacture. 1. The Essentials of Pharmaceutical Microbiology/Tim Sandle and Madhu Raju Saghee. 2. Relevance of Microorganisms in Pharmaceutical Processing/Ossama M. El-Tayeb. 3. Microbial Contamination and Spoilage/David G. Allison. 4. Microbiological Considerations in Medical Device Industry/Martell Winters. Part. II: Aspects of Microbiological Quality Control. 5. Selection of Microbiological Culture Media and Testing Regimes/Tim Sandle. 6. Microbial Identification/Ziva Abraham. 7. Microbial Examination of Non-sterile Products/Jaymie Tomes and Florence Wu. 8. Practical Approaches to Sterility Testing/Tim Sandle. 9. Microbial Aspects in Cleaning Validation/Andrew Walsh. 10. Validation of Microbiological Methods/Sandy Rubio. 11. Selection and Validation of Disinfectants/Paul Viña, Sandy Rubio and Tim Sandle. 12. Auditing a QC Microbiology Laboratory/Andy Martin. 13. Quality Assurance in a Microbiology Laboratory/Christophe Barcella. Part. III: Measuring and Testing for Microorganisms. 14. Environmental Monitoring/Tim Sandle. 15. Microbial Content Testing of Pharmaceutical and Biotechnologically Derived Products/Dilip Ashtekar and Tim Sandle. 16. Bacterial Endotoxins Test/Masakazu Tsuchiya. 17. Antimicrobial Effectiveness Testing/Scott V. W. Sutton. 18. Monitoring of Microbiological Quality Attributes of Water for Pharmaceutical Use/Dilip Ashtekar. 19. Investigation of Microbiological Data Deviations/Mónica Lagomarsino. 20. Alternative Microbiological Methods and New Pharmaceutical Microbiology Curriculum/Claudio D. Denoya. 21. The Implementation of Rapid Microbiological Methods/Michael J. Miller. 22. Risk Management in Pharmaceutical Microbiology/Tim Sandle. Part. IV: Sterilization and Sterility Assurance. 23. Sterility/Edward C. Tidswell. 24. Process Selection for Sterile Products/James Agalloco. 25. Microbial Contamination Control in Pharmaceutical Manufacturing/Matts Ramstorp. 26. Aseptic Process Simulations/Media Fills/Marco Budini and Francesco Boschi. 27. Biological Indicators for Sterilization/Russ Nyberg. 28. Moist Heat Sterilization/Michael Sadowski. 29. Sterilization and Depyrogenation byDry Heat/Madhu Raju Saghee and Gary R. Mitchel. 30. Radiation Sterilization/Mark A. Seybold and John A. Williams. 31. Sterilization by Filtration/Maik W. Jornitz and Theodore H. Meltzer. 32. Sterilization by Ethylene Oxide/Gerry A. O’Dell. 33. Maintaining Sterility/Michelle A. Luebke and Bonnie J. Heredia. Index.
Injectable product manufacturing is booming because of the growth of new biopharmaceuticals and small molecule anticancer drugs. The requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and LAF-hoods in many production facilities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting.
This book is a useful reference guide for the SMB (Small and Medium Business) pharmaceutical sector which does not have the resources to have access to such top-quality information in this field. This book therefore represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. Perhaps even more outstanding is the fact that this book not only covers subject matter and technical content which is established as best and expected practice, but also includes content regarded as possible, future and emerging technology or processes.
