The EU approach to moist heat sterilization is complex and is based on a variety of standards and guidance. A course is offered that will provide the context and understanding needed to comply with EU regulations for Moist Heat Sterilization. The class will be offered at locations throughout the U.S. and will cover topics including:
- History and regulatory background
- Cycle design criteria
- Equilibriation times and other measures
- Bowie Dick/DART tests
- Steam quality and steam quality testing
- Leak rate tests and test specifications
- Test frequencies
- Load configurations for validation/revalidations
- Choice of biological indicators
- Long hold times
- Air detectors
Carltex, Inc., P.O. Box 770, Nyack, NY 10960
