This suggested validation-testing program follows the guidelines contained in the ANSI/AAMI/ISO 11135:1994 standard. This international recognized document contains requirements and offers guidance for the validation of ethylene oxide sterilization processes that rely on a microbiological challenge to monitor the sterilizing cycle. Part of these requirements include determining the initial population level of the product (bioburden), verifying the adequacy of the microbial challenge (spore strip verification), and determining the minimum time of exposure by performing successive reproducible studies (sub-lethal & half-cycle and full cycle tests). Residual levels are also tested to assure compliance with established international and FDA guidelines.
These suggested validation-testing programs follow the guidelines contained in the ANSI/AAMI/ISO 11137:1994 standard and AAMI TIR 27:2001. This internationally recognized documents contain requirements and offer guidance for the validation and control of Radiation Sterilization processes. Part of these requirements include determining the overall average bioburden for the product, establishing a Device Verification Dose level and a routine Sterility Assurance Level dose. Specifications also call for routine quarterly monitoring of the DVD program by performing bioburden and sterility testing.