The Association for the Advancement of Medical Instrumentation’s (AAMI) Recommended
Practice ST79 requires environmental monitoring for sterile processing and decontamination
areas and sterile product storage for specific ranges of temperature and humidity
to ensure that sterile barriers remain sterile barriers.
The EBI 20-TH Datalogger System
Monitor Work and Storage Areas
Ensure Packaging Integrity
• Continuous, automatic recording and readout of temperature and humidity throughout
• Read, record, and store the data with a PC only once a quarter!
• Min/Max values and alarm displayed
• No network connection required
• Conforms to 21 CFR Part 11 for data integrity
• Provides compliance with AAMI ST79 requirements to monitor decontamination, assembly,
sterilization, conditioning and storage areas
e•vent [i-vent] (n): a failure of the sterile barrier around the sterilization load.
It’s Sterile. Now what?
Event-Related Sterility Assurance is based upon ensuring that sterility failure events
do not take place, not time since sterilization.
Events can be:
-tears in the packaging,
any of which can cause the packaging to not act as a sterile barrier.