Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations

Failure to adequately control any microbial challenge by sterilization will result in a contaminated marketed product, with potential harm to the patient. Sterilization is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals.

The author, Tim Sandle, examines different means of rendering a product sterile by providing an overview of sterilization methods including heat, radiation and filtration. Throughout 18 chapters, he 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.


Product Details

   Series: Woodhead Publishing Series in Biomedicine
   Hardcover: 370 pages
   Publisher: Woodhead Publishing; 1 edition (October 14, 2013)
   Language: English
   ISBN-10: 1907568387
   ISBN-13: 978-1907568381

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