PDA Technical Report No. 36, (TR 36) Current Practices in the Validation of Aseptic Processing - 2001 (single user digital version)

May 2002
PDA Item Number

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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.

The validation of aseptic processing continues to be a major area of interest within the pharmaceutical industry. Five years have passed since the last PDA survey on this subject. While there have been no new broadly applicable regulations or regulatory guidance since that time, there has been continued controversy over the details of aseptic processing and process simulation practice.

Industry practices largely adhere to current regulations and guidelines on aseptic processing by the:

  • European Union (1),
  • ISO (2),
  • and FDA (3).

The impact of PDA`s TR No. 22 on Process Simulation Testing for Aseptically Filled Products (4) is also apparent. The Pharmaceutical Manufacturers Association (now PhRMA) in 1979 (5) and PDA in 1986 (6), 1992 (7), and 1996 (8) conducted surveys on this subject that have provided a clearer understanding of contemporary industry practice. This survey addresses the continuing need to track industry practices in the validation of aseptic processing as it evolves.

The survey was prepared, distributed, and compiled by Dr. James Agalloco, Dr. James Akers and Mr. Russell Madsen.

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Table of Contents

Table of Contents:

  1. Introduction
  2. PDA 2001 Aseptic Processing Survey
  3. Release/Quarantine Practices
  4. Frequency
  5. Methods
  6. Growth Promotion Studies
  7. Incubation of Process Simulation Samples
  8. Personnel Monitoring
  9. Environmental Monitoring, Aseptic Processing
  10. Environmental Monitoring, Media Fills
  11. Suspension Products
  12. Sterile Semi-Solid Products
  13. Freeze Dried Products
  14. Sterile Dry Powder Products
  15. Research & Development (Clinical Trial Material)
  16. Isolation/Barrier Technology
  17. Microbial Levels for Controlled Areas
  18. Terminal Sterilization and Aseptic Processing
  19. Aseptic Processing Technology
  20. Other Issues
  21. Conclusion
  22. Acknowledgements
  23. References