Medical Devices
The EtO Transition Is Happening Now
Ethylene oxide sterilization faces regulatory restriction, community opposition, and mounting safety concerns. VHP is the established alternative — and PuroGen has been developing it since 1996.
Industry Transition
The Ethylene Oxide Crisis
Approximately 50% of all medical devices requiring sterilization use ethylene oxide. That dependency is becoming untenable.
90%
EPA-mandated reduction in EtO emissions from sterilization facilities
50%
Share of sterile medical devices currently processed with ethylene oxide
$5B+
Estimated annual market for medical device sterilization services
Regulatory Pressure
The EPA has finalized rules requiring 90% reduction in ethylene oxide emissions from commercial sterilization facilities. Compliance timelines are accelerating, and facility expansions using EtO face growing regulatory barriers.
Community Opposition
Communities near EtO sterilization facilities have organized against continued operations. Cancer risk data and air quality monitoring have intensified public pressure, leading to facility closures and operational restrictions.
Safety Concerns
EtO is classified as a known human carcinogen. Worker exposure limits are tightening, and the 12–72 hour aeration period required to remove toxic residues from sterilized devices adds cost, complexity, and risk to every cycle.
FDA Acknowledgment
The FDA has publicly acknowledged the need for viable EtO alternatives and has taken concrete steps — including reclassifying VHP to Category A — to facilitate industry transition to non-toxic sterilization methods.
Established Alternative
VHP Is Not Experimental — It Is Recognized
On January 8, 2024, the FDA reclassified vaporized hydrogen peroxide from Category B (novel) to Category A (established) — placing VHP alongside steam and EtO as a recognized sterilization modality.
FDA reclassifies VHP to Category A
VHP moves from novel (Category B) to established sterilization method — recognized alongside steam and EtO
ISO 22441 published
International standard for sterilization of health care products using vaporized hydrogen peroxide
EPA EtO emission mandates
90% reduction in ethylene oxide emissions required — driving industry-wide search for alternatives
The PuroGen Approach
Not One-Size-Fits-All
Medical device sterilization is not a generic problem. Every device portfolio presents unique material constraints, geometric challenges, and regulatory requirements. A sterilization transition demands a platform that can be validated for your specific needs — not a fixed-cycle system that forces design compromises.
SteriFlex™ provides complete parametric customization — adjustable dwell times, reagent dosing control, flexible vacuum settings, and high-humidity capability. This means the sterilization process can be engineered around your device, not the other way around.
And you're not working with a distributor or a product-line manager. You're working with the team that invented the technology — deep VHP expertise applied directly to your sterilization challenge.
Material Compatibility
Broad Compatibility, Zero Residue
VHP sterilization operates at room temperature and decomposes to water and oxygen. No heat damage. No toxic residue. No aeration time.
Polymers
PEEK, PTFE, polyethylene, polypropylene, silicone, PVC
Metals
Stainless steel, titanium, cobalt-chrome, aluminum alloys
Electronics
Sensors, circuit boards, battery-powered devices
HEPA Filters
Filter media integrity preserved through low-temperature processing
Optics
Lenses, fiber optics, camera systems for endoscopic devices
Composites
Multi-material assemblies, coated surfaces, adhesive bonds
25–50°C
Operating temperature — no thermal damage to heat-sensitive components
H₂O + O₂
Decomposition products — zero toxic residue on sterilized devices
0 hrs
Aeration time required — immediate post-cycle availability
Partnership
VHP Expertise from the Inventor, Applied to Your Challenge
We work with device manufacturers and contract sterilization organizations to validate VHP for specific device portfolios. Whether you're exploring a transition from EtO or expanding your sterilization capabilities, you're working with the organization that invented and validated the technology.
The engagement model is flexible. License the SteriFlex platform for in-house sterilization. Partner on a private-label basis for your branded sterilization service. Or explore a deeper strategic collaboration that leverages PuroGen's complete technology portfolio.
Device Manufacturers
Validate VHP for your specific device portfolio with PuroGen's engineering support and regulatory expertise.
Contract Sterilizers
Add VHP capability to your service offering with a proven, customizable platform — expand your portfolio beyond EtO.
Strategic Partners
Co-develop VHP solutions for emerging device categories or explore licensing arrangements for your market.
Begin the Transition
The regulatory trajectory is clear. The technology is validated. The question is not whether the industry transitions away from EtO — but how your organization gets there.