Medical device Sterilization Validation Studies are performed for all processes, including radiation sterilization by either gamma radiation or electron beam, ethylene oxide gas sterilization, hydrogen peroxide sterilization and thermal sterilization (both moist and dry heat).
At NAMSA, we’re known for our ability to design custom protocols that not only meet your testing budget, but are backed by a complete documentation package that fulfills all necessary regulatory requirements.
Sterilization Validation Assignments
Testing includes:
- Bioburden
- Dose Verification Experiments
- Biological Indicator Sterility Tests
- Half-Cycle Studies
- Pharmacopoeia Sterility Tests
- Fractional Cycle Studies
- Bacteriostasis/Fungistasis
- EO Cycle Development
- Growth Promotion
- EO Residual Testing
- Monitor/Notification of Quarterly
- Dose Audits