Medical device sterilization efficacy testing
Medical device testing
Testing Services
Our laboratory provides comprehensive technical services for medical device sterilization validation. Whether your products utilize Gamma radiation (ISO 11137), Ethylene Oxide (ISO 11135), or Moist Heat sterilization (ISO 17665) validation frameworks, our critical microbiological testing strictly adheres to the ISO 11737 standard series.
To ensure regulatory compliance and the validity of test data, we perform rigorous product testing engineered to satisfy global regulatory submissions and audit requirements.
Microbiological Testing
- Bioburden Recovery test
- Bioburden test
- Bacteriostasis/Fungistasis test
- Sterility test
- Biological Indicator (BI) Inactivation & Culturing Test
- Sterilization Validation
- Dose Audit
Sterile Barrier System (SBS) Testing
- Accelerated Aging Testing
- Seal Strength Testing (Peel Test)
- Burst / Creep-to-Failure Testing
- Dye Penetration Integrity Testing
- Package Sterility Testing
- Microbial Barrier Testing