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Parametric Product Release
The accuracy of BIs without the cost and delay
It's yours when you elect the parametric release option for your EO processing. Approved by the FDA and accepted by the AAMI, parametric release brings state-of-the-art speed, convenience and reliability to the EO process.
- Sterility is confirmed by establishing processing specifications for each of the key parameters (time, temperature, humidity and the concentration of gas steriliant), and then monitoring activity in the chamber load to verify that each condition has been met.
- As soon as all parameters have been met and documented, the product is ready for release.
- The result is earlier product release based on actual scientific data rather than empirical data, and long-awaited freedom from the costly delays associated with the use of biological indicators (BIs).
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