Medical Device Manufacturing

Ethylene Oxide (EtO) is used throughout the medical device manufacturing process to sterilize devices prior to shipping them to hospitals and distribution centers around the world. While effective, EtO is a toxic gas, and products may continue to off-gas for some time following sterilization. With ChemDAQ's portfolio of products, workers can monitor their environment and check for hazardous conditions to ensure their health and safety.

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Gas Applications

According to the Federal Drug Administration (FDA), over 50% of all medical devices used in the United States are sterilized with EtO, equaling around 20 billion items per year. Pallets filled with thousands of medical devices are mass sterilized using EtO gas to permeate the instruments and kill any harmful bacteria. The sterilized medical devices are then loaded onto a truck or shipped to their final destination. Because of the high concentrations used throughout the sterilization operation, EtO poses a significant risk to workers both at the sterilization facility and throughout the distribution process, as EtO may continue to off-gas from the medical devices for weeks following sterilization. 

Permissible Exposure Limits

Because of the exposure risks associated with EtO, occupational exposure limits and safety guidelines have been developed and are closely monitored by governing bodies.

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Monitoring Solutions

ChemDAQ has been a leader in EtO monitoring solutions in the U.S. for more than 20 years. We offer patented EtO detection technology that provides unmatched accuracy and specificity at occupational safety levels. Our suite of products offers an array of solutions to keep workers safe-from sterilization to distribution facilities around the world. 

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Steri-Trac® Sensor

EtO detection sensors are notorious for being sensitive to other gasses. ChemDAQ’s Steri-Trac Sensor features patented filter technology that prevents cross interference from other factors, such as​ alcohols and carbon monoxide, to ensure accurate readings of ​​EtO vapor. It can also be used in intrinsically safe applications and is available for Oxygen (O₂) and Lower Explosive Limit (LEL) applications.

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Steri-Trac® Series

ChemDAQ’s Steri-Trac 2 area monitor continuously and simultaneously measures EtO vapor levels in the air. This fixed monitoring system can be installed at multiple points throughout the facility to keep workers safe around-the-clock and alert you if and when hazardous vapor levels occur.

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Sensor Communication Interface (SCI™)

The SCI is a multi-configurable monitoring solution to accurately and reliably detect vapors throughout your facility and communicate readings to a compatible data system for enhanced connectivity.

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Hospitals rely on  H₂O₂ PAA  and  EtO  to sterilize medical instruments needed in patient care. This essential task requires workers to employ high concentrations in Sterile Processing Departments, placing them at risk of exposure.

Food & Beverage Packaging

H₂O₂  and  PAA  are used in high concentrations and in large quantities through aseptic packaging operations to ensure the safe production and extended shelf life of common food and beverage products.

​Protein Processing

PAA  is used in poultry and meat processing.  PAA  is distributed to various areas of the processing plant to kill harmful bacteria on meat and surfaces to meet USDA food safety guidelines.

Supply Chain Logistics

Medical devices that are sterilized with  EtO  and then shipped to their final destination may continue to off-gas for days. During transport,  EtO  accumulates in trucks and continues to off-gas once held in storage facilities, accumulating emissions that can often exceed OSHA's permissible exposure limit. 

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