Understanding Your Process Series
Sterilization: Establishing the Process
In the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and biotech manufacturers stay abreast, streamline processes and comply with regulators.
We have now collected bestsellers and added materials that have not published before in electronic book form covering three vital topics:
Cleaning and Cleanrooms
These easily accessible, reasonably priced, informative collections offer background and hands-on applications that will help with a myriad of activities for manufacturers.
The Sterilization: Establishing the Process discusses compliance, regulatory inspections, containment system sterility, test failure investigations and many other basics.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 1.24 MB)
Table of Contents:
Click here to download >>>Detailed Table of Contents
- Compliance Aspects of Sterility Testing
- Ensuring Sterility: Autoclaves, Wet Loads and Sterility Failures
- Preparing for Regulatory Inspections of Sterile Facilities: The Focal Points
- Biological Indicators for Steam Sterilization: Failure Investigations
- Containment System Sterility
- Sterility Test Failure Investigations
- 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.