Ethylene Oxide Test Gas on the Resistance of Biological Indicators

On  Dec. 31, 2014, the United States Environmental Protection Agency Clean Air Act prohibited the sale and use of HCFC-based (hydrochlorofluorocarbon) products in the US, and that will include Oxyfume ethylene oxide (EtO) sterilant blends such as Oxyfume 2000, which consists of 8.6% EtO and 91.4% HCFC-124. (Oxyfume is a registered trademark owned by Honeywell International.) This requirement means that all BI manufacturers will have to move to 100% EtO as the test gas for determining the resistance performance of EtO BIs by the end of 2014. Currently, Oxyfume 2000 is often used by BI manufacturers for assessing BI EtO D-value label claims, so it is in the best interest of the BI community (manufacturers and end users) to assess the potential effects of this change.

To explore the implications of this change, Anthony M. Piotrkowski, Kellie A. Matzinger, Garrett Krushefski, Craig A. Wallace have written a review for Pharm. Tech. the article can be viewed here.


 Posted by Tim Sandle