PDA Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations (single user digital version)

Jun 2015
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PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. It encompasses pharmaceutical and biopharmaceutical manufacturing processes, but does not include the final aseptic and terminal sterilization fill-finish operations.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Overview of Bioburden and Biofilms
  4. Design, Control, and Prevention Considerations
  5. Bioburden and Biofilm Detection and Characterization
  6. Investigation and Remediation
  7. Contamination Scenarios
  8. Appendix I: Bioprocess Unit Operations and Typical Process Controls and Detection
  9. Appendix II: Typical Bacterial Response Limits for Bioprocessing
  10. References

Figures and Tables Index