Saturday 5 September 2015

Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

PDA has issued an important new Technical Report “Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities.”

PDA Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to ensuring 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.

The table of contents is:

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
15.Conducting Investigations Related to Cleaning and Disinfection
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
26.Suggested Reading

For further details, see PDA.

Posted by Tim Sandle

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