Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
eBook - ePub

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Technology, Validation and Current Regulations

  1. 425 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Technology, Validation and Current Regulations

About this book

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. - Includes nine new chapters with many new case studies - Offers coverage on the most current standards and regulations - Provides full coverage of novel sterilization methods

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Information

Publisher
Woodhead Publishing
Year
2025
Edition
2
eBook ISBN
9780443364372
Topic
Medicine
Subtopic
Operations

Table of contents

  1. Title of Book
  2. Chapter 1. Sterility, sterilization, and the challenge from microorganisms
  3. Chapter 2. Pyrogenicity and bacterial endotoxin
  4. Chapter 3. Bioburden control
  5. Chapter 4. Regulatory requirements and good manufacturing practices (GMP)
  6. Chapter 5. Gamma radiation
  7. Chapter 6. Electron beam processing
  8. Chapter 7. Alternative method for sterilization: X-rays
  9. Chapter 8. Dry heat sterilization
  10. Chapter 9. Steam sterilization
  11. Chapter 10. Gaseous sterilization
  12. Chapter 11. Hydrogen peroxide vapor decontamination
  13. Chapter 12. Sterilization of liquids by filtration
  14. Chapter 13. Other applications of filtration: Gas filtration and nanofiltration
  15. Chapter 14. Other methods of sterilization
  16. Chapter 15. Ultraviolet-C radiation
  17. Chapter 16. Supercritical gases
  18. Chapter 17. Depyrogenation and endotoxin
  19. Chapter 18. Cleanrooms, isolators, and cleanroom technology
  20. Chapter 19. Aseptic processing and filling
  21. Chapter 20. Media simulation trials (aseptic process simulations)
  22. Chapter 21. Cleaning and disinfection of sterile processing facilities
  23. Chapter 22. Biological indicators
  24. Chapter 23. The sterility test
  25. Chapter 24. Investigating sterility test failures
  26. Chapter 25. Container–closure integrity
  27. Chapter 26. Good distribution practice
  28. Chapter 27. Auditing sterilization processes and facilities
  29. Chapter 28. Sterility assurance governance
  30. Conclusion
  31. Index

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Yes, you can access Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by Tim Sandle in PDF and/or ePUB format, as well as other popular books in Medicine & Operations. We have over 1.5 million books available in our catalogue for you to explore.