Sterilization: Practical Approaches (single user digital version)

Apr 2017
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Pharmaceutical Manufacturing: Understanding Your Process Series
Sterilization: Practical Approaches

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
  • Sterilization
  • Environmental Monitoring

    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: Practical Approaches offers practical approaches to sterility testing, Gamma Irradiation for single use disposables, sterilization using EtO and dry heat, ophthalmic preparations and contamination control.

    Available to download. Prior to purchase please view the download instructions and Terms of Usage.
    Format: PDF (1 file 564 KB)

  • Table of Contents

    Table of Contents:

    Click here to download >>>Detailed Table of Contents

    1. Practical Approaches to Sterility Testing
    2. Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector
    3. Gaseous Sterilization
    4. Dry Heat Sterilization
    5. Sterile Ophthalmic Preparations and Contamination Control

    About the Authors

    About the Author

    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 ( as well as two LinkedIn groups relating to microbiology and sterility assurance.