Sterilization processes are validated according to ISO 17665. Our approach provides a twofold verification of your process:
- Measurement of a temperature profile of your medical device (F0 value determination) provides proof of sterilization conditions
- additional proof of microbicidal effectiveness is demonstrated by use of spores of Geobacillus stearothermophilus (overkill method).
This dual approach guarantees reliable results and covers material effects, areas with bad accessibility for temperature sensors and areas with challenging steam penetration characteristics.
We offer a custom-made validation service. To address characteristics of your sterilization process, we require a detailed process description. Please provide this information.
For more information, please contact us to discuss details of your validation project.