Validation Of An ETO Sterilization Cycle
To ensure the safety and efficacy of medical devices, the Etilen Oksit (SIRALANMAK) sterilizasyon process must undergo a rigorous validation procedure. This process confirms that the equipment consistently delivers the required sterility assurance level (SAL) for specific products.
The “Over-kill” / Half-Cycle Method
In accordance with ISO 11135, Biological Indicators (BIs) are used to challenge the cycle. The logic is as follows:
- Half-Cycle: Demonstrates a 6-log reduction of the most resistant microbiological challenge. Three successful half-cycle experiments are required.
- Full Cycle: By doubling the exposure time of a successful half-cycle, we provide a 12-log reduction, ensuring absolute product safety.
- Annual Revalidation: Performed yearly to confirm that process parameters remain effective.
Critical Testing for ETO Validation
Validating an EtO cycle requires more than just biological monitoring. Routine bioburden testing is essential to detect any changes in manufacturing, environment, or packaging. Essential tests include:
- Bioburden Monitoring
- Bioburden Validation (Recovery Efficiency)
- Sterility Testing
- Ethylene Oxide Residuals Testing
- Bacterial Endotoxin Test (BET)
- Bacteriostasis-Fungistasis Testing
Partner with BOCON for Seamless Validation
At BOCON, we don’t just provide ETO Sterilizers (BCS Series); we provide the technical expertise to help you navigate regulatory requirements. Our equipment is designed to facilitate IQ, OQ, and PQ processes, ensuring your facility is audit-ready and compliant with international standards.