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October 10, 2003

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Aseptic Filler Validation

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Table of Contents
  1. Aseptic Filler Validation
  2. Title 21 CFR 113
  3. Need for Validation
  4. Intent of System Validation
  5. Validation Steps
  6. 1. Develop a Hazard Analysis/HACCP Plan
  7. Pre-Purchase Review of Equipment
  8. Pre-Purchase Review of Equipment
  9. Pre-Purchase Review of Equipment (cont'd)
  10. Define the Sterile Zone
  11. Integrity of Sterile Zone
  12. Integrity of Sterile Zone (cont'd)
  13. Sample Aseptic Filler
  14. Does the transport enter and then exit the sterile zone?
  15. Identify the Critical Factors/Limits
  16. What is a Critical Factor?
  17. Information Needed About Critical Factors
  18. Traditional Thermal Process Bioburden (Canning)
  19. Aseptic Process Bioburden
  20. 2. Conduct Challenge Study
  21. Establish the Necessary Indicator Organism Log Reductions
  22. Log Reduction
  23. Test Organisms for Aseptic Systems*
  24. Log Reduction
  1. Log Reduction
  2. Log Reduction (cont'd)
  3. Concept of PNSU
  4. Concept of PNSU (cont'd)
  5. Measure Indicator Organism Thermal/Chemical Resistance
  6. A. Sterilization of sterile zone
  7. Sterilization of Sterile Zone
  8. Sterilization of Sterile Zone (cont'd)
  9. Sterilization of Sterile Zone (cont'd)
  10. Sterilization of Sterile Zone
  11. Sterilization of Sterile Zone (cont'd)
  12. B. Sterilization of package material
  13. Sterilization of Package
  14. Sterilization of Package (cont'd)
  15. Statistical Evaluation of the Biological Validation of a Continuous Aseptic Process
  16. Impact of Statistical Assumptions for Inoculated Pack Studies
  17. Underlying Assumptions
  18. How do You Know When an Inculcated Pack Procedure can be used for the Inoculation Study?
  19. Log Count Reduction (LCR) as a Property of the Challenge Level*
  20. LCR at different challenge levels...
  21. Sterilization of Package (cont'd)
  22. 3. Document the Results
  23. Records
  24. Records (cont'd)
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Acidified and Low-Acid Canned Foods
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Hypertext updated by dav/dms November 21, 2005