Ethylene Oxide (EO) Contract Sterilization
Small-lot EO processing in Colorado — six 3M Steri-Vac 8XL chambers, four-business-day turnaround, 99.9% emission abatement, and biological testing in the same building.
Ethylene oxide remains the workhorse of medical device sterilization because it is a low-temperature gas that penetrates complex assemblies, long lumens, and sealed packaging without the heat or radiation damage that limits other methods. Boulder Sterilization runs EO at small-lot scale — purpose-built for the device developer who needs a validated cycle on a handful of units, not a tractor-trailer load.
And because we also operate chlorine dioxide on the same campus, EO is a choice here — not the only tool we own. We will tell you honestly when EO is the right method for your device and when chlorine dioxide is the better fit.
Our EO Capability
A six-chamber fleet engineered for throughput on small and mid-size lots, with emissions and residuals controlled in-house.
Six 3M Steri-Vac 8XL chambers
Six chambers run in parallel so small lots move quickly instead of queuing behind one large vessel. More chambers means more independent cycles, tighter scheduling, and faster release.
99.9% emission abatement
A catalytic Abator destroys 99.9% of ethylene oxide before it leaves the building — a responsible, EPA-conscious EO operation, not an open-vent legacy site.
Small-chamber, small-lot strategy
Right-sized chambers mean you qualify a cycle on the units you actually have. Ideal for startups, clinical and design-verification builds, and low-volume commercial production.
Low-temperature processing
EO runs near 60°C, protecting heat- and moisture-sensitive plastics, electronics, adhesives, and combination products that steam or radiation would damage.
Material & packaging compatibility
We confirm device and ISO 11607 package compatibility during cycle development, so the validated process protects both sterility and your product.
In-house biological testing
BIs/PCDs, sterility, endotoxin, bioburden, and EO/ECH residuals are tested on site to ISO 10993-7 limits — no shipping samples between vendors, no inter-lab delay.
EO Turnaround
Engineering R&D runs and validated production cycles, in business days. Expedited and rush options available.
Typical timeline for a new EO validation to ISO 11135, including cycle development.
Single-lot release for products that need a documented sterility decision quickly.
Who small-lot EO is for
- Startups and design firms sterilizing design-verification and clinical builds
- Low-volume commercial devices that do not justify a warehouse-scale chamber
- Heat- and moisture-sensitive devices: electronics, optics, adhesives, combination products
- Complex geometries — long lumens, sealed assemblies, and intricate packaging EO penetrates well
- Programs that need biological testing and residual data without shipping samples to a third lab
Not sure EO is right? See how we choose between EO and CD or request a quote and we will recommend a path.
EO Sterilization FAQ
What is the turnaround time for EO sterilization?
Engineering R&D runs and validated production cycles complete in four business days, with expedited and rush options available. Because we run six 3M Steri-Vac 8XL chambers in parallel, small lots are not stuck waiting behind a single large vessel.
Is ethylene oxide good for small lots and small batches?
Yes. Our six-chamber Steri-Vac strategy is built around small-lot and small-batch EO processing. You are not forced to fill a warehouse-scale chamber to qualify for a run, which makes Boulder a strong fit for startups, clinical builds, and low-volume commercial production.
How does Boulder control EO emissions and residuals?
A catalytic Abator reduces ethylene oxide emissions by 99.9%. EO and ECH residuals are measured in our in-house lab to ISO 10993-7 limits, so devices are released against documented residual data without shipping samples to an outside vendor.
What materials is EO compatible with?
EO is a low-temperature gas (around 60°C) that is gentle on heat- and moisture-sensitive materials — many plastics, electronics, adhesives, and complex assemblies that cannot tolerate steam or radiation. We confirm material and packaging compatibility during cycle development.
Can I switch between EO and chlorine dioxide?
Yes — and that is what makes Boulder unique. We run both EO and chlorine dioxide on the same Colorado campus, so we can recommend the method that fits your device rather than the single one we happen to own. You are never forced to convert away from a working EO process.
Is your EO process validated to ISO 11135?
EO processing is performed under our ISO 13485 quality system and validated to ISO 11135, using overkill or bioburden-based (lethal-rate) approaches scoped to your device and risk profile.
Need a validated EO cycle on a small lot?
Tell us about your device, materials, and lot size. We will scope an EO cycle — or recommend chlorine dioxide if it fits better — within one business day.