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.
1. Introduction - p. xxxi 2. Chapter 1. Sterility, sterilization, and the challenge from microorganisms - p. 1 3. Chapter 2. Pyrogenicity and bacterial endotoxin - p. 21 4. Chapter 3. Bioburden control - p. 37 5. Chapter 4. Regulatory requirements and good manufacturing practices (GMP) - p. 55 6. Chapter 5. Gamma radiation - p. 75 7. Chapter 6. Electron beam processing - p. 87 8. Chapter 7. Alternative method for sterilization: X-rays - p. 99 9. Chapter 8. Dry heat sterilization - p. 107 10. Chapter 9. Steam sterilization - p. 117 11. Chapter 10. Gaseous sterilization - p. 137 12. Chapter 11. Hydrogen peroxide vapor decontamination - p. 153 13. Chapter 12. Sterilization of liquids by filtration - p. 167 14. Chapter 13. Other applications of filtration: Gas filtration and nanofiltration - p. 181 15. Chapter 14. Other methods of sterilization - p. 191 16. Chapter 15. Ultraviolet-C radiation - p. 203 17. Chapter 16. Supercritical gases - p. 215 18. Chapter 17. Depyrogenation and endotoxin - p. 229 19. Chapter 18. Cleanrooms, isolators, and cleanroom technology - p. 243 20. Chapter 19. Aseptic processing and filling - p. 261 21. Chapter 20. Media simulation trials (aseptic process simulations) - p. 275 22. Chapter 21. Cleaning and disinfection of sterile processing facilities - p. 289 23. Chapter 22. Biological indicators - p. 305 24. Chapter 23. The sterility test - p. 321 25. Chapter 24. Investigating sterility test failures - p. 341 26. Chapter 25. Container–closure integrity - p. 353 27. Chapter 26. Good distribution practice - p. 363 28. Chapter 27. Auditing sterilization processes and facilities - p. 377 29. Chapter 28. Sterility assurance governance - p. 391 30. Conclusion - p. 405 31. Index - p. 413
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.
1. Introduction - p. xxxi 2. Chapter 1. Sterility, sterilization, and the challenge from microorganisms - p. 1 3. Chapter 2. Pyrogenicity and bacterial endotoxin - p. 21 4. Chapter 3. Bioburden control - p. 37 5. Chapter 4. Regulatory requirements and good manufacturing practices (GMP) - p. 55 6. Chapter 5. Gamma radiation - p. 75 7. Chapter 6. Electron beam processing - p. 87 8. Chapter 7. Alternative method for sterilization: X-rays - p. 99 9. Chapter 8. Dry heat sterilization - p. 107 10. Chapter 9. Steam sterilization - p. 117 11. Chapter 10. Gaseous sterilization - p. 137 12. Chapter 11. Hydrogen peroxide vapor decontamination - p. 153 13. Chapter 12. Sterilization of liquids by filtration - p. 167 14. Chapter 13. Other applications of filtration: Gas filtration and nanofiltration - p. 181 15. Chapter 14. Other methods of sterilization - p. 191 16. Chapter 15. Ultraviolet-C radiation - p. 203 17. Chapter 16. Supercritical gases - p. 215 18. Chapter 17. Depyrogenation and endotoxin - p. 229 19. Chapter 18. Cleanrooms, isolators, and cleanroom technology - p. 243 20. Chapter 19. Aseptic processing and filling - p. 261 21. Chapter 20. Media simulation trials (aseptic process simulations) - p. 275 22. Chapter 21. Cleaning and disinfection of sterile processing facilities - p. 289 23. Chapter 22. Biological indicators - p. 305 24. Chapter 23. The sterility test - p. 321 25. Chapter 24. Investigating sterility test failures - p. 341 26. Chapter 25. Container–closure integrity - p. 353 27. Chapter 26. Good distribution practice - p. 363 28. Chapter 27. Auditing sterilization processes and facilities - p. 377 29. Chapter 28. Sterility assurance governance - p. 391 30. Conclusion - p. 405 31. Index - p. 413
