PDA Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities (single user digital version)

Jul 2015
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PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified environments. Focusing on controlled and non-controlled environments, microbial contamination control and corrective actions for loss of control for viable excursions contamination, this technical report provides comprehensive information and suggested best practices as well as appropriate references to support such guidance.

This document is not intended to fully address product-contact surface cleaning from a clean in place or clean out of place system, which is specifically addressed in PDA Technical Report No. 29: Points to Consider for Cleaning Validation and PDA Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Sanitizer, Disinfectant, and Sporicide Claims and Classifications
  4. Regulatory Expectations
  5. Qualification of New Suppliers and Agents
  6. In-Use Expiration Dating
  7. Control of the Environment
  8. In-Situ Field Studies
  9. Cleaning and Disinfection
  10. Frequency for Cleaning and Disinfection
  11. Resistance and Rotation
  12. Return from a Shutdown
  13. Hold Times for Cleaned Areas, Non-Product-Contact Equipment, and Utensils
  14. Training
  15. Conducting Investigations Related to Cleaning and Disinfection
  16. Conclusion
  17. Appendix I: History of Disinfection
  18. Appendix II: Registration of Sanitizers, Disinfectants and Sporicides
  19. Appendix III: Overview of the U.S. Environmental Protection Agency
  20. Appendix IV: Overview of the EU Biocidal Regulations
  21. Appendix V: EPA-Related Safety Labeling Information
  22. Appendix VI: AOAC Protocol Testing For Disinfectant Registration
  23. Appendix VII: EN Tests for Disinfection Efficacy
  24. Appendix VIII: Large-Scale Gassing or Fogging of Clean Rooms
  25. References
  26. Suggested Reading

Figures and Tables Index