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BoulderBioLabs

Sterilize. Test. Release. All on One Campus.

The Boulder BioMed integrated pipeline cuts weeks off medical device validation — without sacrificing data integrity or audit defensibility.

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The Problem

For most medical device manufacturers, the validation timeline looks like this. Devices are manufactured in one city, packaged in another, sent to a contract sterilizer in a third, and then shipped — often across the country — to a contract microbiology lab in a fourth. Each transition adds days of transit, paperwork, and chain-of-custody risk. New device introductions that should take a quarter end up taking three.

This is the problem Boulder BioMed was built to solve.

Sterilization-to-test transfer on the Boulder BioMed campus

The Boulder BioMed Solution — Co-Location

1

Sterilize

Boulder Sterilization — EO or chlorine dioxide cycles, ISO 13485 certified.

2

Test (you are here)

Boulder BioLabs — sterility, bioburden, residuals, BET.

3

Release

Boulder RA/QA — documentation, audit support, 510(k).

Three steps. Three companies. One campus. One quality system.

The Integration Advantage

No shipping. Sterilized devices walk from the sterilizer to the lab. No FedEx, no transit risk.
No chain-of-custody gap. Internal custody transfer documented in a single LIMS.
Faster cycle iteration. Validation iterations that used to take two-week round trips finish in days.
Single QMS. One ISO 13485 system across Boulder Sterilization, Boulder BioLabs, and Boulder RA/QA.
Single point of contact. One project manager runs the full workflow.

What Customers Say

[Draft testimonials — customer attribution to be added.]

Boulder BioLabs was a laboratory customer first — they know our pain points and they've fixed them. The team gets what it's like on the manufacturer side because they've lived it.— [QA Director, Class III Implantable Device Manufacturer]
We've used five of the big national labs over the years. They are impersonal and they don't give the service Boulder BioLabs does. The difference isn't subtle — it's the difference between a lab you call and a lab that calls you.— [VP Operations, Cardiovascular Device Manufacturer]
We're a Boulder Sterilization client and having the co-located microbiology lab saves us more in shipping than the actual cost of the residuals testing. Net cost of EO residuals testing here is negative for us, before we even count the time savings.— [Director of Sterilization Operations, Orthopedic Implant Company]

See if the Integrated Pipeline Fits Your Program.

One person in charge of the full workflow across whichever Boulder BioMed spokes you need.

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