Contact SteriCert Co. an H&W Technology Company at: 585-218-0385 or email us at info@stericert.com
PO Box 20281, Rochester, NY 14602-0281 USA
| e•vent [i-vent] (n): a failure of the sterile barrier around the sterilization load.
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| 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, -too-moist conditions, -too-dry conditions, any of which can cause the packaging to not act as a sterile barrier. |
Event-related... How do you know if you've had any events? 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. |
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Documented Proof. The EBI 20-TH Datalogger System Monitor Work and Storage Areas Ensure Packaging Integrity |
• Continuous, automatic recording and readout of temperature and humidity throughout the day
• Read, record, and store the data with a PC only once every two weeks! • Min/Max values displayed • Conforms to FDA 21 CFR Part 11 for software data integrity • Data export to Microsoft Excel® for simple reporting • Provides compliance with AAMI ST79 requirements to monitor decontam, assembly, sterilization, conditioning and storage areas |
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