This chapter is taken from the book Thermal Validation in Moist Heat Sterilization
The manufacture of many pharmaceutical products includes
sterilization processes intended to eliminate microbial
contamination. This document will review the validation requirements
associated with moist heat sterilization processes that are destructive
of the microorganisms.
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ABOUT THE AUTHOR
James Agalloco is President of Agalloco & Associates, a technical service
firm to the pharmaceutical and biotechnology industry. Since the formation of
Agalloco & Associates in 1991, Jim has assisted more than 100 health care
firms in a wide range of validation, automation and compliance areas. Jim has
over 40 years of industry experience and has worked in organic synthesis,
pharmaceutical formulation, pharmaceutical production, project and process
engineering, validation and process automation during his career at Merck,
Pfizer, Squibb and Bristol-Myers Squibb. He received his B.S. in Chemical
Engineering from Pratt Institute in 1968 and his M.S., also in Chemical
Engineering from Polytechnic Institute of New York in 1979. He received his
M.B.A. in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He
is a past President of the Parenteral Drug Association and served as an Officer
or Director from 1982 to 1993. He is a member of USP’s Microbiology and
Sterility Assurance Expert Committee for 2005–2015. He is a member of the
editorial advisory boards of Pharmaceutical Technology and Pharmaceutical
Manufacturing. He serves on the scientific advisory boards of Laureate,
MEDInstill, VanRx and IPS.
He is a frequent author and lecturer on the subject of sterilization, aseptic
processing and process validation.