What the New EPA Ruling on EO Emissions Means for You – and What to Do

March 20, 2024

Last week, the U.S. Environmental Protection Agency (EPA) announced a rule that will put in place the strongest measures to date for ethylene oxide commercial sterilization facilities – a rule that has medical device manufacturers worrying about their future sterilization options.

According to the EPA, new emissions standards for medical device sterilizers should reduce ethylene oxide (EO) emissions by 21 tons per year – all with the intent to significantly reduce health risks for people who live and work near sterilization facilities. While sterilization companies have a few years to come into compliance, the ruling represents a real challenge for the industry since EO is used to sterilize billions of medical devices every year.

Safe EO option with Boulder Sterilization
Yet there is no need to panic. The EPA is not eliminating EO sterilization, but rather working to reduce any exposure to EO. Safe EO sterilization does exist – right now, in fact – and Boulder Sterilization is one of those providers.

We’re already a step ahead. Working with small chambers, we can more easily manage the safe use of EO. Our small canisters provide simple, safe loading and unloading – eliminating risks in dealing with large quantities of potentially dangerous-to-handle EO gas. Plus, we’ve equipped our small-chamber sterilizers with abators (catalytic converters) that reduce emissions by more than 99.9%.

In addition, our quick-turn EO service can take care of your sterilization needs quickly and cost-effectively, reducing validation timelines by 80% in most cases – at a 75% cost savings.

The environmentally friendly alternative: CD
There’s more good news in that med device developers have a viable sterilization alternative with chlorine dioxide (CD). An effective, efficient, clean method of sterilization, CD is an environmentally friendly option appropriate for a majority of medical devices.

  • Non-carcinogenic, nonflammable
  • Compatible with wide range of materials
  • Works at room temperature
  • Low-impact
  • No exposure to excessive heat, moisture or radiation
  • Ability to kill bacteria and spores quickly
  • Complete distribution
  • Fast aeration
  • Real-time monitoring and measurement ease
  • No post-treatment residuals
  • Water-soluble


Here at Boulder Sterilization, we have a large CD chamber that can accommodate up to two pallets. In fact, our large chamber is the world’s largest contract CD sterilizer. We offer our quick-turn sterilization with CD as well as EO.

Don’t wait until the EPA deadlines close in to research your sterilization options. We’re here and we’re ready for you. Contact us now to learn how we can save you time and money in sterilizing your device.