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.
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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.