PDA DHI Technical Books

Environmental Monitoring for Sterilization Process Development (print version)

by: Anne Booth

This booklet was excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 2, edited by Jeanne Moldenhauer.

Environmental Monitoring for Sterilization Process Development

Manufacturing of pharmaceutical products and sterile medical devices requires an environment in which the number of viable particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of such particles. An understanding of the viable microorganisms on a finished device is necessary and required to support a sterilization validation process.

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Table of Contents :

Standards and Guidance
Understanding the Sterilization Process
Sterility Assurance Levels (SAL)
Product Microbial Levels
First Step - Establish a Bioburden Testing Program
Second Step - Understand and Control Environmental Factors that affect Product Bioburden
Third Step - Sterilization Process Development
Ethylene Oxide
Case Studies
Importance of Understanding Bioburden
Affect of Environment

About the Author

Anne Booth
is a quality GMP and Sterilization specialist with over 22 years of experience in the field of medical device and manufacturing. She has worked for three medical device manufacturers as Microbiology and Sterilization Services Manager/Director and a contract sterilizer as Director of Validation. In each of these positions, she provided technical support in the development, validation, and management of GMP compliant sterilization programs. Ms. Booth holds an MS degree in Cellular Zoology/Biochemistry from the University of Michigan and a BA degree in Biology from Wilson College. She is a member of the American Society of Quality, RAPS, PDA. ISPE, and AAMI, where she is a member of the EtO Sterilization, EtO Residual, Packaging, Radiation, Microbiological Methods and Reuse standards working groups.

Date of Publication: December 2005
ISBN Number: 1-933722-11-8
Number of Pages: 26
Binding: Softcover