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Services
| | Sterilization Validation
Validation of sterilization is one of the most important processes for medical
device sterilization. C.G. Labs has been validating the sterilization of medical
devices for over 13 years with over 15 years of medical device testing
experience. Sterile medical devices require extensive microbiological testing to
ensure the sterility of the device and comply with FDA regulations. Trained
degree-holding microbiologists will be handling your device under a laminar flow
hood to ensure that your device is being tested by the best personnel and in the
best environment. C.G. Labs can perform all the microbiological testing required
no matter the sterilization method used (gamma radiation, ethylene oxide, etc.).
We can also provide consulting to help you comply with FDA requirements for
sterilization and what sterilization method would be best suited for your
device.
- AAMI Method 1 gamma radiation validation
- AAMI quarterly dose audits
- Sterility testing of biological indicators
- Accelerated aging studies
- Package integrity testing
- Bioburden testing
- Microbial identification
- Endotoxin testing (LAL gel clot)
- Ethylene oxide residual testing
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