SBIR-STTR Award

The overarching goal of this project is to protect the nation's supply chain of critical medicaldevices that are sterilized using ethylene oxide (EtO). Despite the search for alternativeapproaches, numerous types of single-use devices are sterilized with EtO. These devices,including catheters, heart valves, and tracheostomy tubes, are critical to routine and life-savingprocedures and therapies. As regulation of EtO emissions and community and worker exposurelevels continues to become more stringent, there is a threat that supply chains for critical deviceswill be disrupted, in turn threatening the health and well-being of the nation. The specificobjectives of this project include the development of a novel photocatalytic method to mitigateEtO at levels that are hazardous but difficult to address with existing adsorptive and thermalcatalytic approaches. Specifically, the technology addresses concentrations in the range of 10 ppmand below. The technology can be used to mitigate EtO from existing sterilization plants as anadjunct to stack scrubbers, as well as deployed to address ambient levels of EtO in plants andwarehouses. Objectives include determining operating conditions at which low concentrations ofEtO (<10 ppm) are oxidized at 99% destruction and removal efficiency (DRE), identifyingoptimum photocatalyst and parameter space for achieving high DRE, developing a prototypephotoreactor operating at 20 cfm capable of 99% EtO DRE that is scalable to commercialrequirements, and evaluating the performance of the prototype for a target 99% EtO DRE at 20cfm. The specific aims are determining operating parameters at lab-scale, building a scalableprototype reactor capable of 20 cfm operation, and evaluating the performance of the prototypeat 20 cfm for a target of 99% EtO DRE. Study designs are centered around systematic catalystmodifications and exploration of gas flow / illumination geometries. Standard and cutting-edgedetection approaches that are capable of measuring EtO into the low ppb and ppt ranges will beused in the experimental program.

Public Health Relevance Statement:
Supply chains for more than 50% of medical devices are threatened by current and new ethylene oxide (EtO) regulations because of the limitations of current EtO control technologies. The proposed research will demonstrate an EtO abatement technology to minimize fugitive EtO emissions from sterilization facilities and warehouses beyond what is achievable with current approaches. The proposed technology addresses a void in current abatement strategies, creating the opportunity to dramatically reduce fugitive EtO emissions, ensure an uninterrupted supply chain of medical devices, and protect workers and communities from harmful EtO exposure.

Project Terms:

The overarching goal of this project is to protect the nation's supply chain of critical medicaldevices that are sterilized using ethylene oxide (EtO). Despite the search for alternativeapproaches, a large fraction of single-use devices is sterilized with EtO. These devices, includingcatheters, heart valves, and tracheostomy tubes, are critical to routine and life-saving proceduresand therapies. As regulations for EtO emissions become more stringent to protect workers andcommunities from harmful exposure, there is a significant risk that supply chains for criticaldevices will be disrupted, in turn threatening the health and well-being of the nation. The specificobjectives of this project include the development of a novel photocatalytic system to mitigate EtOat levels that are hazardous but difficult to address with existing adsorptive and thermal catalyticapproaches. Specifically, the technology addresses concentrations in the range of 5 ppm andbelow in sterilization facilities, transportation, and warehouses. These "fugitive emissions" are asignificant contributor to overall emissions and directly impact workers and community safety.Objectives include determining operating conditions at which low concentrations of EtO (<5 ppm)are oxidized at 99% destruction and removal efficiency (DRE) by identifying the optimumphotocatalyst and parameter space for achieving high DRE. The specific aims are: Aim 1)optimize a 100 CFM photoreactor fluid flow, optical power, and catalyst parameters for 99% EtODRE at fugitive EtO concentrations, Aim 2) develop a 100 CFM system based on the photoreactorfrom Aim 1 that can address EtO emissions in a real-world environment, Aim 3) evaluateperformance of the Aim 2 100 CFM system in a sterilization facility, and Aim 4) analyze the Aim2 system operational lifetime factors. Various computational fluid dynamics and non-sequentialoptical models will be leveraged by the experimental efforts. Standard and cutting-edge detectionapproaches that are capable of measuring EtO into the low ppb and ppt ranges will be used in theexperimental program.

Public Health Relevance Statement:
Narrative Supply chains for more than 50% of medical devices are threatened by current and new ethylene oxide (EtO) regulations because of the limitations of current EtO control technologies. The proposed research will demonstrate an EtO abatement technology to minimize fugitive EtO emissions from sterilization facilities and warehouses beyond what is achievable with current approaches. The proposed technology addresses a void in current abatement strategies, creating the opportunity to dramatically reduce fugitive EtO emissions, ensure an uninterrupted supply chain of medical devices, and protect workers and communities from harmful EtO exposure.

Project Terms: