Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Technology, Validation and Current Regulations

Inbunden, Engelska, 2025

Av Tim Sandle, UK) Sandle, Tim (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)

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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.

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

Produktinformation

Utgivningsdatum2025-08-14
Mått191 x 235 x 28 mm
Vikt1 000 g
FormatInbunden
SpråkEngelska
SerieWoodhead Publishing Series in Biomedicine
Antal sidor456
Upplaga2
FörlagElsevier Science
ISBN9780443364365

Tillhör följande kategorier

Projektledning inom Ekonomi och ledarskap
Farmakologi inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik
Apotek och farmaceuter inom Medicin

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).

1. Sterility, sterilization and microorganisms2. Pyrogenicity bacterial endotoxin3. Bioburden control4. Regulatory requirements and Good Manufacturing Practices (GMP)5. Gamma radiation6. Electron beam processing7. X-ray sterilization8. Dry heat sterilisation9. Steam sterilisation10. Gaseous sterilisation11. Hydrogen peroxide vapour biodecontamination12. Liquid-phase sterilization13. Sterilisation by filtration14. Other methods of sterilisation15. Ultraviolet light16. Supercritical gases17. Depyrogenation and endotoxin18. Cleanrooms, isolators and cleanroom technology19. Aseptic processing filling20. Aseptic process simulations (media simulation trials)21. Cleaning disinfection of sterile processing facilities22. Biological indicators23. The Sterility Test24. Investigating sterility test failures25. Container closure integrity26. Good distribution practices27. Auditing sterilization processes facilities28. Sterility assurance governance