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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

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SteriCert
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INFECTION CONTROL

CLEANING AND REPROCESSING

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 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.

 

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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.

EBI 20-TH Temperature Humidity Datalogger