Table of Contents:

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1. Compliance Aspects of Sterility Testing
2. Ensuring Sterility: Autoclaves, Wet Loads and Sterility Failures
3. Preparing for Regulatory Inspections of Sterile Facilities: The Focal Points
4. Biological Indicators for Steam Sterilization: Failure Investigations
5. Containment System Sterility
6. Sterility Test Failure Investigations
7. Variations in the Resistance of Biological Indicators used to Assess Sterilization

Dr. Tim Sandle is the Head of Microbiology at the UK Bio Products Laboratory. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. Tim has over 20 years experience of work in the scientific and pharmaceutical fields. He serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards), and has acted as a spokesperson for several microbiological societies. He is a committee member of the UK and Irish Microbiology Society Pharmig and editor of the organization's newsletter. Tim has written over 200 book chapters, peer reviewed papers and technical articles relating to microbiology. In addition, Tim runs an online microbiology website (www.pharmamicro.com) as well as two LinkedIn groups relating to microbiology and sterility assurance.