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

Environmental Impact on Media Fills

A two-week, hands-on Aseptic Processing Course has been offered annually since 1999 by PDA at their Training and Research Institute in Baltimore, Maryland. During the course, various curricula are provided where students perform specific tasks required in an aseptic pharmaceutical manufacturing environment, including the performance of process simulations or media fills with Tryptic Soy Broth (TSB) each week of the course.

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Table of Contents :

Summary
Course History - The Genesis
Course History - The Evolution
Facility Description
Materials and Methods
Case Studies
Discussion - Media Fills
Discussion - The Experimental Plan
Discussion - What the Data Does Not Demonstrate
Discussion - Recommendations
Conclusions
Acknowledgements

About the Author

John Lindsay is President and Senior Consultant at Aseptic Solutions, Inc. He has a Masters Degree in microbiology from Kansas University Medical School. John is a Registered Specialist Microbiologist by the American College of Microbiologists. A former Chair of the National Registry of Microbiologists, John has 27 years of experience in Industry in roles of Quality Control (Labs), Quality Assurance, and Manufacturing. He has been a consultant to the pharmaceutical industry for the past six years, specializing in aseptic processing, environmental control, sterility assurance and training. For the past four years, John has coordinated and led the PDA`s two-week Aseptic Processing course at the PDA Training and Research Institute in Baltimore. He is the recipient of the PDA Award for Excellence in Education for 2000. John is the author or co-author of numerous articles and book chapters.