One Colorado Campus, Under One Roof
A 20,000 sq ft Boulder facility with an ISO Class 7 cleanroom, EO and chlorine dioxide sterilization, and in-house biological testing — an unbroken chain of custody with no inter-vendor shipping.
Most sterilization programs are stitched together across vendors: assemble in one place, ship to a sterilizer, ship samples to a test lab, wait for results, ship again. Every handoff adds time, cost, and risk to the chain of custody. Boulder collapses all of it onto a single 20,000 sq ft campus in Boulder, Colorado.
A device can be assembled in our cleanroom, packaged, sterilized by EO or chlorine dioxide, and tested in our own microbiology lab — then released — without ever leaving the building. That co-location is the engine behind our 80% timeline reduction and 75% cost savings versus a multi-vendor path.
On the campus
ISO Class 7 cleanroom
Class 10,000 controlled environment for final device assembly and ISO 11607 packaging.
Six 3M Steri-Vac 8XL EO chambers
Parallel small-lot ethylene oxide capacity with a catalytic Abator cutting emissions 99.9%.
World's largest contract CD chamber
A two-pallet chlorine dioxide chamber handling devices up to roughly eight feet.
In-house microbiology lab
BIs/PCDs, sterility, endotoxin, bioburden, and EO/CD residual testing on site.
Packaging & labeling
ISO 11607 packaging and labeling integrated with assembly and sterilization.
One ISO 13485 quality system
A single quality system spans assembly, sterilization, testing, and release.
Facility FAQ
Where is Boulder Sterilization located?
Our facility is at 5421 Western Ave., Boulder, CO 80301. Assembly, packaging, sterilization, and biological testing are all on this single Colorado campus.
What cleanroom classification do you operate?
We operate an ISO Class 7 (Class 10,000) cleanroom for final assembly and ISO 11607 packaging, co-located with our sterilization and testing operations.
Can a device be assembled, packaged, sterilized, and tested in one place?
Yes. Our 20,000 sq ft facility lets a device move from cleanroom assembly through packaging, EO or CD sterilization, and in-house biological testing to validated release without ever leaving the campus — an unbroken chain of custody with no inter-vendor shipping.
Want everything under one roof?
Tell us about your device and program. We will show you how assembly, sterilization, and testing come together on one Colorado campus.