Sterility Testing for Medical Devices
Sterility testing is the regulatory gate between a sterilized lot and a released product. Boulder BioLabs executes sterility test protocols aligned with ISO 11737-2, operating under the Boulder BioMed ISO 13485 quality management system. Because we sit on the same campus as Boulder Sterilization, your devices move from sterilizer to incubator without leaving the property — no shipping, no transit contamination risk, no lost days. For BI-based release programs, we also offer 4-hour cycle release using rapid-readout biological indicators.
What Is Sterility Testing?
Sterility testing demonstrates that a sterilized medical device is free of viable microorganisms. The test is run by either direct inoculation or membrane filtration, depending on device geometry, and articles are incubated in fluid thioglycollate medium (FTM) and soybean-casein digest medium (SCDM) for 14 days.
Sterility testing is paired with a method suitability study — without it, the sterility test itself is not regulatorily defensible.
When You Need Sterility Testing
- EO sterilization validation — half-cycle, full-cycle, PCD studies aligned with ISO 11135.
- CD sterilization validation — sterility testing of post-sterilization samples.
- Routine release testing — periodic sterility verification of production lots.
- Method suitability pairing — bundled with every sterility program.
- Audit response and remediation.
4-Hour BI Release
For BI-based release programs: Boulder BioLabs offers 4-hour cycle release using rapid-readout biological indicators. Faster than the typical 6-day RMM offered by national labs, and traditional 7-day BI incubation.
Our Process
- Sample receipt and accessioning. Chain of custody documented in our LIMS.
- Cleanroom testing. Performed in ISO Class 5 environment.
- Incubation per ISO 11737-2.
- Result interpretation — positives sub-cultured to genus level.
- Reporting issued under our ISO 13485 QMS.