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:
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
Posted by Tim Sandle
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