The only contract sterilizer where you choose EO or chlorine dioxide — under one Colorado roof.
Boulder Sterilization is the only place a medical device company can choose ethylene oxide or chlorine dioxide for the same project, on one Colorado campus, with cleanroom assembly, packaging, and in-house biological testing under the same roof.
Run by people who design devices and validate them by the dozen every year — EO veterans before chlorine dioxide, hundreds of products developed, dozens of sterilization validations annually.
Why Boulder Sterilization
A dual-method, co-located model no single competitor can copy without building the other half of our operation.
Choose EO or CD for the same project
No competitor reviewed can match this. ClorDiSys and Gulf are CD-only; Blue Line and Andersen are EO-only. We recommend the method that fits your device — not the one we happen to own.
Everything under one Colorado roof
Cleanroom assembly, packaging, EO and CD sterilization, and in-house biological testing on one campus — an unbroken chain of custody with no inter-vendor shipping.
Device designers first, then sterilizers
Boulder was a medical device design firm before it was a sterilizer, and ran EO before chlorine dioxide. We have sat in the device developer’s chair and know the design and regulatory path firsthand.
Validation at volume
Hundreds of products developed and dozens of sterilization validations every year, across both methods. The pure-play CD shops cannot say that.
EO or CD: which is right for your device?
We are the only provider offering both, so we can recommend the method that fits your device — not the one method we happen to own.
| Consideration | Ethylene Oxide (EO) | Chlorine Dioxide (CD) |
|---|---|---|
| Material sensitivity | Broad compatibility; low-temperature cycles for heat- and moisture-sensitive devices. | Low-temperature, low-humidity gas; excellent for electronics and combination devices. |
| Residuals | Requires aeration; EO/CD residual testing available in-house. | No carcinogenic residuals of concern; faster release. |
| Device size | Six small chambers run full for efficient small-lot processing. | World's largest contract CD chamber — two-pallet, handles 8-ft devices. |
| Turnaround | Production in 4 business days; rush in 1. | Standard CD cycle in ~5 business days. |
| Best for | Small-lot and small-batch EO, startups, validated production. | EtO alternatives, green programs, large or electronic devices. |
What We Do
Sterilization, validation, assembly, packaging, and biological testing — one campus, one quality system.
EO Sterilization
Six 3M Steri-Vac 8XL chambers run full for efficient small-lot ethylene oxide processing, with a catalytic Abator cutting emissions 99.9%.
Chlorine Dioxide (CD)
The world's largest contract CD chamber — a low-temperature, non-carcinogenic EtO alternative that handles devices up to eight feet.
Validation & Cycle Development
Validations in 8–10 weeks, single-lot release in 5–7 weeks, and an 80% timeline reduction at 75% cost savings.
Cleanroom Assembly & Packaging
ISO Class 7 cleanroom final assembly and packaging on the same campus as sterilization and biological testing.
In-House Biological Testing
BIs/PCDs, sterility, endotoxin, bioburden, and EO/CD residuals tested on site — no shipping samples between vendors.
Product Release
Overkill-method and lethal-rate (bioburden-based) product release pathways scoped to your device and risk profile.
Part of the Boulder iQ / Boulder BioMed Family
One campus, one quality system — design, sterilization, microbiology, packaging, and regulatory under one roof.
Frequently Asked Questions
Do you offer both EO and chlorine dioxide sterilization?
Yes. Boulder Sterilization is the only contract sterilizer that lets you choose ethylene oxide (EO) or chlorine dioxide (CD) for the same project, on one Colorado campus. Because we run both, we can recommend the method that best fits your device rather than the single method we happen to own.
How fast can you turn around a sterilization cycle?
Engineering R&D runs and validated production cycles run in four business days, with expedited and rush options available. CD standard cycles run in about five business days. New validations typically complete in 8 to 10 weeks and single-lot release in 5 to 7 weeks.
What size devices can your chlorine dioxide chamber handle?
We operate the world's largest contract chlorine dioxide chamber — a two-pallet chamber that handles devices up to eight feet, a scale the pure-play CD competitors cannot match.
Is Boulder Sterilization FDA registered and ISO 13485 certified?
Boulder Sterilization is FDA registered and operates under an ISO 13485 quality management system, with EO processing to ISO 11135, CD aligned to ISO 14937, and packaging to ISO 11607. Exact registration numbers and certificate wording are confirmed on request.
Why choose chlorine dioxide as an EtO alternative?
Chlorine dioxide is a low-temperature, low-humidity gas with no carcinogenic residuals of concern, making it a strong green alternative to ethylene oxide for electronics, combination devices, and sustainability-driven programs. Unlike CD-only providers, we can also run your product on EO, so you are never forced to convert away from a working EO process.
Can you assemble, package, sterilize, and test in one place?
Yes. Our 20,000 sq ft Boulder, Colorado facility includes an ISO Class 7 (Class 10,000) cleanroom for final assembly and packaging, EO and CD sterilization, and in-house biological testing — so a device can move from assembly through validated release without leaving the campus.
Request a Quote
Tell us about your device and method interest. Prefer to talk? Call 303-531-1238.