Use of Overkill Half-Cycle Qualification Data to Support Reduction of Exposure Time in Validated Ethylene Oxide Sterilization Cycles.

This article details the evaluation conducted for the potential to reduce ethylene oxide (EO) exposure times using data from currently validated EO sterilization cycles. The candidate cycles used the overkill half-cycle approach detailed in Annex B of ANSI/AAMI/ISO 11135:2014. The overkill half-cycle approach is conservative and has been the method of choice with medical device manufacturers because of its ease of understanding.