Full sterilization validation of medical devices requires reliable sterility testing — an inherently challenging process. Devices come in myriad shapes and sizes, often with individual areas that are difficult to render sterile. And in many labs, badly designed procedures or failure to follow correct protocols lead to inadvertent contamination. The resulting high false positive rates necessitate expensive retesting and long-delayed product releases.
Microtest’s leadership in sterility testing that validates United States Pharmacopoeia USP 71 requirements is proven by our extremely low false positive rate. For the past 5 years, that number has averaged only [CLIENT: INSERT NUMBER], including for such challenging devices as:
Implantable electronic devices
- Hip implants
- Cranial access kits
- Foam products
- Blood reservoirs
- Large catheter systems
Microtest advantages begin with the industry’s best-trained, most credentialed professional workforce. We conduct our testing in two fully-equipped, ISO Class 5 sterility suites. And our in-house environmental monitoring (EM) department provides weekly monitoring to eliminate contamination risks.
You get the industry’s lowest false positive rates, for fewer out-of-specification (OOS) occurrences, less time to ship — and reduced time to revenue.
Our sterility testing services include