Use of overkill half-cycle qualification data to support reduction of exposure time in validated ethylene oxide sterilization cycles

Abstract

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. The analysis presented provides an understanding of the extent of this conservative nature. Based on the analysis, exposure time can be reduced and rapidly implemented. The reduction in the exposure time may improve the product EO residuals and allow for additional time for the EO processing chamber to be utilized and/or for additional off-gassing for the product, if needed.