Monitoring Of ETO-Sterilisator
Effective monitoring of the Ethylenoxid (AUSRICHTEN) Sterilisation process is essential to guarantee the safety of medical devices. Ein robustes Qualitätskontrollsystem integriert physische, chemisch, und biologische Indikatoren, um sicherzustellen, dass jede Charge den internationalen Standards zur Sterilitätssicherung entspricht.
1. Physical Monitoring
- Continuous recording of Temperature (37-55℃).
- Pressure and Humidity (40%-60%RH) Überwachung.
- Exposure time (1-3h) and aeration/exhaust time (up to 12h) tracking.
- Compliance with equipment operation manuals.
2. Chemical Monitoring
- External indicators on every package to confirm process exposure.
- Internal indicator cards placed in the “most-difficult-to-sterilize” locations.
- Verification of color change (typically from Brown to Green).
3. Biological Monitoring
- Performed for every sterilization batch.
- Utilizes Bacillus stearothermophilus spore variants.
- Indicators are cultured immediately post-cycle.
- The gold standard for determining absolute sterilization efficacy.
4. Post-sterilization Treatment
Once the cycle is complete, strict handling protocols must be followed to maintain sterility:
1
Integrity Check: Inspect every package for damage or seal failure. Any compromised packaging is considered a sterilization failure.
2
Indicator Verification: Confirm that both external labels and internal cards have reached the required color endpoint.
3
Dokumentation: Print, save, and archive all sterilization records for regulatory traceability.
4
Aseptic Storage: Store items on specialized shelves in sterile areas. Release items only after all monitoring results are qualified.
5
Secure Transport: Use clean, sealed containers during distribution to prevent environmental re-contamination.
