Steam Sterilization Process Validation (single user digital version)

Jul 2011
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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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Format: Digital PDF ( file - 526 KB)

About the Authors


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.