Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations, Second Edition is a comprehensive guide that navigates the complex world of pharmaceutical sterilisation. This new edition is updated to reflect the latest standards and regulations, ensuring the book remains aligned with current approaches. The book also explores emerging sterilisation methods, providing readers with the most up-to-date techniques in the field. Additionally, the inclusion of new case studies offers practical examples that aid in the understanding and application of these sterilisation methods. The failure to control any microbial challenge within a process or product can lead to a contaminated marketed product, potentially causing harm to patients. Hence, sterilisation is of critical importance to healthcare and the manufacturing of medical devices and pharmaceuticals. This edition covers a wide range of topics including sterility, sterilisation and microorganisms, pyrogenicity and bacterial endotoxins, regulatory requirements and good manufacturing practices, and different sterilisation methods such as gamma radiation, e-beam, dry heat, steam, gas, vapour, filtration, and new sterilisation techniques. It provides a thorough examination of sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, container and packaging design, and cleanroom environments. The new edition also introduces substantial additions such as X-ray sterilization, liquid-phase sterilization, ultraviolet light, supercritical gases, and sterilisation assurance governance. Each chapter has been updated to reflect the latest changes in the field. "Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations" is an indispensable resource for those involved in the manufacturing of sterile products. Its comprehensive coverage of sterilisation methods, combined with practical case studies, provides readers with a robust understanding of sterilisation technology and its application. The book will be of great value to those in pharmaceuticals, healthcare, and medical device manufacturing, providing them with the knowledge to ensure their products are safe and compliant with current standards and regulations.
Table of Contents
1. Sterility, sterilization and microorganisms2. 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
Authors
Tim Sandle Head of Microbiology, Bio Products Laboratory, Elstree, UKVisiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UKCommittee Member of the Pharmaceutical Microbiology Interest Group (Pharmig), UK. 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).
