PDA Technical Report No. 17, (TR 17) Current Practices in the Validation of Aseptic Processing - 1992 (single user digital version)

Jan 1993
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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.

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Table of Contents

Table of Contents:

Release/Quarantine Practices
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