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22nd January 2014  Content supplied by: 

New Book on Sterility Assurance and Sterilization Technology

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.

Further details of the hardback version and the order page can be found here. Alternatively, the book is available from Amazon and other book sellers.



Date Published: 22nd January 2014