PDA Technical Report No. 17, (TR 17) Current Practices in the Validation of Aseptic Processing - 1992 (single user digital version)
- Published
- Jan 1993
- Pages
- 25
- PDA Item Number
- 43223
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- Format
- PDF Single user
- Member Price
- $50.00
- Nonmember Price
- $100.00
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.
This Technical Report was prepared by Dr. James Agalloco and Dr. James Akers.
It contains the results of a 1992 PDA survey about current practices in validating aseptic processing. The survey questionnaire was sent to PDA members representing about 450 sites, worldwide. A total of 77 responses were received and tabulated.
Major areas covered by the survey include media fill release/quarantine practices, frequency, methods, growth promotion studies, incubation practices, personnel and environmental monitoring, use of placebos, and microbial levels for controlled areas.
Available to download
Format: PDF (1 file - 1.97 MB)
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Table of Contents
Table of Contents:
Introduction
Release/Quarantine
Practices
Frequency
Methods
Growth Promotion Studies
Incubation of
Media Fill Samples
Personnel Monitoring
Environmental
Monitoring
Microbial Levels for Controlled Areas
Terminal Sterilization
and Aseptic Processing
Aseptic Processing Technology
FDA Aseptic
Processing Guideline
Other
Issues
Conclusion
Acknowledgements