PDA Technical Report No. 24, (TR 24) Current Practices in the Validation of Aseptic Processing - 1996 (single user digital version)

Mar 1997
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.

This Technical Report was prepared by Dr. James Agalloco and Dr. James Akers.

This survey updates PDA 1992 aseptic processing survey published in Technical Report No. 17. The survey consists of 136 questions encompassing many different aspects of aseptic processing and includes separate sections on manual, semi-automated, conventional, and advanced conventional filling, plus sections on blow-fill-seal and closed isolator filling.

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There was an update survey published in 2002 - PDA Technical Report 36.

Table of Contents

Table of Contents:

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