Device Designers First, Then Sterilizers
We sat in the device developer's chair before we ran a single cycle — and we ran EO before chlorine dioxide. That order is why we recommend the method your device needs, not the one we happen to own.
Our story
Boulder was a medical device design firm before it was a contract sterilizer. We developed products, ran the regulatory gauntlet, and lived the timeline pressure that every device company knows — long before we operated a sterilization chamber.
When we did move into sterilization, we ran ethylene oxide first. Chlorine dioxide came later, as the technology matured — and we ultimately built the world's largest contract CD chamber. That sequence matters: we adopted CD as experienced EO operators and device designers, evaluating it on the merits rather than betting a company on a single method.
So when a chlorine-dioxide-only competitor claims to have “created the market,” our answer is grounded in operating reality: we run both methods, across hundreds of products developed and dozens of sterilization validations every year. We have nothing to defend except your device's best outcome.
What sets us apart
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.
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.
Device designers first
We have sat in the developer’s chair and know the design and regulatory path firsthand, not just the chamber.
Validation at volume
Hundreds of products developed and dozens of validations every year, across both methods. The pure-play shops cannot say that.
Quality & compliance
Boulder Sterilization is FDA registered and operates under an ISO 13485 quality management system. EO processing is validated to ISO 11135, chlorine dioxide is aligned to ISO 14937, and packaging follows ISO 11607.
Exact registration numbers and certificate wording are confirmed on request.
Part of the Boulder iQ / Boulder BioMed Family
One campus, one quality system — design, sterilization, microbiology, packaging, and regulatory under one roof.
Work with sterilizers who think like device developers
Tell us about your device and timeline. We will recommend the method and path that fit — not the one we are selling — within one business day.