Practical Aspects of Thermal Validation for Moist Heat Sterilization (single user digital version)
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This chapter is taken from the book Thermal Validation in Moist Heat Sterilization
This document describes the practical application of thermal science and engineering aspects that are essential for the development and validation of a moist heat sterilization process. The primary "tools of the trade" for the development and validation of moist heat sterilization processes are temperature sensors and dataloggers which gather data that is used to evaluate the efficiency and efficacy of the sterilization process. The main types of temperature sensors will be summarized and various use applications will be presented.
About the Authors
About the Authors
Angela Coon is currently a Senior Manager of Research within the Technology Resources Sterility Assurance organization of Baxter Healthcare Corporation. Her current responsibilities include management of the sterilization product and process development group, which focuses on validation of sterilization methods for new or modified products and processes. She has been with the Sterility Assurance Group since 2001, and holds a B.S. degree in Chemical Engineering from North Carolina State University. Prior to joining Baxter, she worked in the paper and converting industries gaining experience in radiation technologies and certification as a Six Sigma Black Belt.
Mike Sadowski is currently the Director, Sterile Product Manufacturing Support at Baxter Healthcare Corporation in Round Lake, Illinois with international sterility assurance responsibilities for pharmaceutical products and medical devices. Mike has more than 20 years of experience with drug and device sterilization with a variety of sterilization methods including moist heat, ethylene oxide, radiation, and aseptic processing. In addition to participation on the Task Force to revise Parenteral Drug Association (PDA) Technical Report No. 1 on Moist Heat Sterilization, he is currently active with AAMI (Association for the Advancement of Medical Instrumentation), is the Chairman of the Task Force for the revision of the PDA Technical Report No. 30 on Parametric Release, and serves on the PDA Board of Directors. Mike is a published author and has given presentations and training sessions on moist heat sterilization and parametric release to industry and regulatory sterilization professionals across the globe. Mike received his B.S. Degree in Microbiology from Purdue University in West Lafayette, Indiana.