Sunday, 12 January 2014

Sterility, Sterilization and Sterility Assurance for Pharmaceuticals (new book)



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.
In terms of the book's importance for pharmaceuticals, medical devices and healthcare:

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.

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.
The book has been published by Woodhead Publishing / Elsevier and is available as a hardback and as an e-book.

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