Studies following ANSI/AAMI/ISO 11135 can be executed utilizing the 3M GS8X 100% EO sterilizer, available in-house. Most commonly, an overkill half-cycle approach to validation is employed. Medical device or pharmaceutical article samples are seeded with appropriate biological indicators (more resistant than indigenous product bioburden) and exposed to a defined EO cycle. Biological indicators are then removed from the samples and tested for sterility. The minimum exposure time at which all biological indicators are negative for growth equates to one-half the cycle duration to be employed for routine use. The full cycle then provides for the minimum desired sterility assurance level. Alternatively, bioburden-based or bioburden based BI validation approaches can also be employed.
If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.