Date: September 22, 2022
Commercial Sterilization and Regulatory Drivers
Fenceline and community monitoring of Ethylene Oxide (EtO or EO) has become a significant focus since the US EPA derived a new Integrated Risk Information System (IRIS) value for EtO in 2016. The revised unit risk factor (URF) increased lifetime inhalation risk by a factor approximately 60 times the previous value, resulting in many challenges to the EPA assessments by industry groups. On August 3, 2022 the EPA announced it will soon publish a long-anticipated rule impacting commercial sterilization facilities regarding EtO air emissions with additional rulemakings covering other industry sectors through 2024. Following the recently launch community engagement efforts by the EPA last month, medical device sterilizers across the nation are expected to receive greater public scrutiny and calls for action.
Monitoring Technologies and Concerned Stakeholders
Whether it’s the companies using EtO, regulating agencies, or community members, stakeholders alike are increasingly interested in the cumulative impacts of EtO emissions on the public. Monitoring campaigns implemented by these groups have shown that passive sampling techniques fail to produce consistent and reliable data while other continuous methodologies such as PTR-MS, TILDAS, and GC-MS require specialized expertise. Industrial sites such as sterilization facilities and chemical plants continue pursuing monitoring alternatives that will generate defensible fenceline monitoring data and lend further understanding of background concentrations. Existing data used to communicate cancer risks associated with EtO exposure in the ambient air are based on data with high levels of uncertainty. A fundamental gap exists with community engagement since existing data and modeled risk values may not reflect the background or fenceline concentrations found in many areas today.
The sterilization industry serves a critical market need across the world with over 50% of all medical devices sterilized with EtO. These products range from life-saving devices to sensitive medical components with integrated electronics. Many facilities are operating at maximum capacity while trying to sustain a sensitive supply chain. Risk communication is one of the greatest impacts on a facility’s operations from concerned employees and surrounding communities.
Picarro is addressing the growing need for precise, real-time EtO monitoring systems that exhibit the reliability, time resolution, responsiveness, and hands-off functionality necessary for continuous and repeatable data generation.
Picarro EtO Monitoring Solutions
The Picarro G2910 and G2920 are an innovative family of extractive gas analyzers than can measure EtO in real-time with ultra-precise, continuous measurements. Over the past two years, these analyzers have supported comprehensive solutions for monitoring stacks, aeration processes, indoor air, fencelines, and communities. Recently, Picarro announced a new solution for detecting ambient levels of EtO at community monitoring stations and industrial fencelines. The new Ambient Air Monitoring System provides continuous, real-time monitoring of EtO at extremely low concentrations and operates automatically for months without the need for sample pre-treatment, chromatographic separation, or complex peripherals.(Figure 1).
Figure 1: Picarro Ambient Air Monitoring System for EtO
The system leverages Picarro’s G2920 analyzer and Zero Reference Module (ZRM). The ZRM provides a zero reference in which EtO is removed, but compounds like CO2 and CH4 remain with any offset of EtO in the background being accounted for. During the span of 24 hours, CO2 and CH4 levels in the atmosphere can change by several parts-per-million (ppm) from biogenic and anthropogenic sources. This often impacts the reliability of fenceline data generated by other technologies when detecting EtO at such low levels. By effectively removing drift and improving the averaging value, Picarro provides the lowest detection limits for fenceline and community monitoring systems and unmatched data confidence.
As mentioned earlier, public risk communications may not account for the uncertainties in existing data nor the many other sources contributing to background EtO concentrations. Picarro’s comprehensive Ambient Air Monitoring System can provide sterilization facilities and surrounding communities with the information necessary to evaluate cumulative EtO exposure and assess the effectiveness of emissions control programs.
Put Picarro Monitoring Systems to Work for Your Organization
For nearly 25 years, Picarro has been deploying advanced measurement solutions that deliver continuous, high precision measurements for long-term monitoring applications in over 95 countries. Picarro EtO monitoring systems are based on a versatile technology platform that can be applied across many applications, including Continuous Emissions Monitoring Systems (CEMS), process, indoor air quality, and fenceline monitoring. Please visit the EtO product information page or contact us to learn more.
About the Author
Dave Miller supports Picarro as Business Development Manager within the Environmental function with a strong focus on growing the application of our hazardous air pollutant analyzers. He has a diverse background with various regulatory and project management roles including the installation and operation of emissions controls, process, continuous, and fence-line monitoring. His previous experience also includes managing environmental regulatory and ISO 14001 programs, public water and wastewater infrastructure project management, and legislative affairs work.