New book: 'Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation And Current Regulations'.
A new book covering a the entire range of different sterilization methods, as well as exploring the related areas of sterility assurance and the concept of sterility, has been published. The book has been written by Tim Sandle.
The key features of the book are:
- The main sterilization methods of physical removal, physical alteration and inactivation
- Discussions of medical devices, aseptically filled products and terminally sterilized products
- An examination of the bacterial, pyrogenic, and endotoxin risks to devices and products.
The chapter list is:
- Sterility, sterilization and microorganisms
- Pyrogenicity and bacterial endotoxin
- Regulatory requirements and Good Manufacturing Practices (GMP)
- Gamma radiation
- Electron beam processing
- Dry heat sterilization
- Steam sterilization
- Gaseous sterilization
- Hydrogen peroxide vapor sterilization
- Sterilization by filtration
- Other methods of sterilization
- Depyrogenation and endotoxin
- Cleanrooms, isolators and cleanroom technology
- Aseptic processing and filling
- Media simulation trials
- Cleaning and disinfection of sterile processing facilities
- Biological indicators
- The Sterility Test
- Investigating sterility test failures
- Auditing sterilization processes and facilities.
Further details of the hardback version and the order page can be found here.
Details of the e-book version and an opportunity to order can be found here.
The book is also available via Amazon and other bookstores.
Harcopy and e-copy
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources