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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations, Second Edition is an in-depth guide to the world of pharmaceutical sterilization. This new edition has been updated to reflect the latest standards and regulations, ensuring alignment with current practices. It explores emerging methods and techniques, complemented by new case studies that provide practical examples. Readers will gain comprehensive knowledge about sterilization’s critical role in healthcare and pharmaceutical manufacturing, highlighting the importance of controlling microbial challenges to ensure product safety and patient well-being.
The book discusses sterility, sterilization methods such as gamma radiation, e-beam, dry heat, steam, gas, vapor, filtration, and new techniques like X-ray sterilization, liquid-phase sterilization, ultraviolet light, supercritical gases, and sterilization assurance governance. It covers biopharmaceutical manufacturing processes, including aseptic filling, container and packaging design, and cleanroom environments. This edition is essential for professionals in pharmaceuticals, healthcare, and medical device manufacturing, providing the knowledge needed to comply with current standards and regulations.
Sommario
1. Sterility, sterilization and microorganisms
2. Pyrogenicity bacterial endotoxin
3. Bioburden control
4. Regulatory requirements and Good Manufacturing Practices (GMP)
5. Gamma radiation
6. Electron beam processing
7. X-ray sterilization
8. Dry heat sterilisation
9. Steam sterilisation
10. Gaseous sterilisation
11. Hydrogen peroxide vapour biodecontamination
12. Liquid-phase sterilization
13. Sterilisation by filtration
14. Other methods of sterilisation
15. Ultraviolet light
16. Supercritical gases
17. Depyrogenation and endotoxin
18. Cleanrooms, isolators and cleanroom technology
19. Aseptic processing filling
20. Aseptic process simulations (media simulation trials)
21. Cleaning disinfection of sterile processing facilities
22. Biological indicators
23. The Sterility Test
24. Investigating sterility test failures
25. Container closure integrity
26. Good distribution practices
27. Auditing sterilization processes facilities
28. Sterility assurance governance
Info autore
Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.
He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.
Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).
