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.

Available to download
Format: PDF (1 file - 1.86 MB)

Click here for the digital downloading instruction and Terms of Usage.

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

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