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…mehr
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.
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).
Inhaltsangabe
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
