Monitoring Ethylene Oxide Off-Gassing

 Summary of Problem

  • Ethylene oxide (EtO) off-gassing of sterilized products is putting supply chain personnel at risk

    • EtO penetrates materials very well, passing through cardboard and dissolving in some plastics, and so takes a long time to come out again 

    • Off-gassing is approximate exponential decay with no sharp endpoint

    • Off-gassing rate depends on many factors including temperature, packaging, and ventilation and so is difficult to predict pallet to pallet and even similar pallets on different days

    • Even if rate is low, if the device is in a sealed container, the EtO can still reach a high concentration

    • EtO exposure hazards well known: carcinogenic, mutagenic, teratogen, etc, and OSHA has developed permissible exposure limits: 5 ppm and 1 ppm time weighted average over 15 minutes and 8 hours respectfully

 Standardized EtO Monitoring

  • The problem with a non-uniform approach

    • Inconsistent and Conflicting readings with EtO measurements

    • Most EtO sensors are VOC sensors and so respond to a wide range of chemicals (e.g. CO from truck exhaust)

  • Need reliable results

    • ChemDAQ EtO sensor employs (patented) chemical filter to increase accuracy by filtering common interferents

    • ChemDAQ Steri-Trac2 displays and tracks below OSHA Action Level

    • “Impending” Alerts warn before reaching unsafe exposure levels

    • Sensor Calibration / Exchange (SXP®) service program ensures quality, accuracy and integrity in the EtO monitoring system and avoids need for personnel to calibrate with EtO.

 The ChemDAQ Answer

SafeCide Portable Monitors

  • Testing trailers / Shipping containers before entry

  • Sampling pallets before and during break-down

  • Personal monitoring to measure individual’s exposure

Steri-Trac® Area Monitors

  • Continuously monitor pallet breakdown, staging and medical device storage areas

  • Automatically control ventilation to increase when needed