Environmental Impact on Media Fills (single user digital version)
- Published
- Dec 2005
- ISBN
- 193372210X
- Pages
- 36
- PDA Item Number
- 17914
- Format
- PDF Single user
- Member Price
- $55.00
- Nonmember Price
- $69.00
- Government Price
- $30.00
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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.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 19.0
MB)
Paper version is not available.
Table of Contents
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 Authors
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.