We provide an extensive range of services pertaining to ETO Sterilization Validation by our panel of expert professionals available with us. Our service range includes:
- Heat Distribution test through one cycle Full Load Full Time and No Load Cycle
- Heat Penetration Test through 3 cycles Full loaf Half Time and 3 cycles Full Load Full Time.
ETO Sterilization Validation includes two parte, Physical Part and Microbiological Part, since Microbiological Part is Conducted by distribution Biological Indicators (Inside the Product) during Penetration Study.
1- Heat Distribution
Temperature distribution studies should be done to locate cold or slow heating zones in preparation for heat-penetration studies; in the case of new installations; and for any changes to an installation which may influence the temperature distribution in the product zone.
Examples are: changes to steam spreaders, decreased steam pressure in lines, changes to the product loading patterns
Because of the concerns about the chamber seals, remote battery powered loggers are generally preferred for ETO sterilization validation over thermocouple and transducers cabled to an exterior data acquisition device.
The purpose of a heat-penetration study is to determine the heating and cooling behavior of a product/package combination in a specific retort system for the establishment of safe thermal processes and evaluating process deviations. The study must be designed to adequately and accurately examine all critical factors associated with the product, package and process which affect heating rates.
This study is conducted using thermal loggers which planted inside the product/pouch.
1- Biological Indicator Result
Biological Indicators are distributed in the ETO chamber to ensure the sterilization of the product and provide an evidence for a good heat penetration result.