An ETO ethylene oxide integrator is a Class 5 chemical indicator strip used to monitor the effectiveness of an ethylene oxide (EtO) sterilization process, ensuring critical parameters like time, temperature, and gas concentration are met. It changes from an initial color (e.g., purple/brown) to a final color (e.g., green) when the cycle successfully achieves the kill time for a theoretical spore population, indicating a "safe" condition.
Function and Use
- Purpose: To verify that an EtO sterilization cycle has met all critical process variables and is capable of sterilizing a load.
- Placement: Placed inside the most difficult-to-sterilize part of a package or load before running the cycle.
- Procedure: After the cycle is complete and the load has been ventilated, the integrator is removed to check the color change.
- Interpretation:
- Level 1 (Exposure Indicator): Starts red and turns yellow after exposure to the process. This only indicates exposure, not a successful sterilization.
- Level 2 (Integration Indicator): Starts purple/brown and turns green when the cycle has successfully reached the required integration condition, meaning a theoretical spore population has been killed.