INNOVATION
New mobile systems target fugitive ethylene oxide emissions, offering sterilization plants sharper compliance and ESG gains
11 Feb 2026

Ethylene oxide has long been central to the sterilisation of medical devices. It is now facing closer examination as European regulators and investors tighten expectations around environmental performance.
Sterilisation facilities across the region are under pressure to show how they manage emissions, particularly those that do not pass through traditional exhaust stacks. Attention has shifted to so-called fugitive emissions, low-level releases that can occur in product handling areas, aeration rooms and storage zones.
Sonata Scientific has introduced a mobile control system, the Helios MP500, designed to capture ethylene oxide at these points of escape. Unlike fixed exhaust treatment systems attached to sterilisation chambers, portable units can be positioned near areas where diffuse emissions are most likely.
The focus on such emissions reflects broader regulatory trends. While much of the recent public debate has taken place in the US, European oversight is also evolving. MDCG 2024-13 guidance has clarified how ethylene oxide sterilisation fits within the Medical Device Regulation, MDR, and In Vitro Diagnostic Regulation, IVDR, reinforcing compliance requirements for operators.
The Helios MP500 is built as a modular, self-contained unit that does not require major construction or new ductwork. Facilities can deploy it without halting production, the company says, and it reports removal rates above 99 per cent, reducing airborne concentrations to very low levels.
Industry analysts view the technology as part of a broader shift in emissions control. Rather than relying solely on centralised abatement systems, operators are adding localised controls that can be deployed quickly and generate measurable performance data.
For multinational device manufacturers, environmental metrics increasingly influence supplier selection and contract negotiations. Sterilisation partners that can demonstrate tighter emissions management may strengthen their position in both procurement processes and ESG reporting.
Portable systems are unlikely to replace established infrastructure entirely. Questions over long-term maintenance, operating costs and integration with existing controls will shape their uptake.
Still, as demand for low-temperature sterilisation continues to grow, emissions management is moving from a technical afterthought to a strategic concern for Europe’s sterilisation sector.
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