Monday, 18 November 2013

New book: Sterility, Sterilisation and Sterility Assurance



A new book of interest has been published. The book is titled ‘Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations’ and it has been written by Tim Sandle. The book has been published by Woodhead Biomedicine, an imprint of Elsevier.

The book addresses the following concerns:
  • The main sterilisation methods of physical removal, physical alteration and inactivation.
  •  Discussions relating to medical devices, aseptically filled products and terminally sterilised products.
  • Bacterial, pyrogenic, and endotoxin risks to devices and products.
  • The latest technology in the field.
  • Current thinking behind risk assessment and good manufacturing practices. 
Throughout 18 chapters, the book outlines and discusses sterilization technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging and addresses the cleanroom environments in which products are prepared.

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 book is available directly from the publisher or via Amazon and other good booksellers (such as Waterstones and Powells).

The Amazon links are:

Amazon U.S.

Amazon U.K.

Amazon Canada

Amazon China

Amazon France

Amazon Germany

Amazon Austria

Amazon Italy

Amazon Spain

Amazon India

Amazon Japan

An e-book version is available from the publisher.

Tim Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK

Reference:

Sandle, T. (2013). Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations, Woodhead Publishing, Oxford

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