Sterilization of Health care Products-ISO 11135:2014

Ethylene Oxide Sterilizer

Ethylene oxide (EtO), which was discovered during the late 1850s was first used as a sterilant during EtO sterilization a viable option for numerous moisture, heat, or radiation sensitive medical products.

the 1940s. Its popularity began to fade in the latter years because of the toxicity. Developments in EtO process technology along with improvement in residual limits have kept this sterilization process as the best sterilization choice for manufacturers. The compatibility of EtO with a broad range of material and its property of chemical molecule penetration in a less aggressive sterilization environment compared with alternative techniques make

Manufacturers and healthcare facilities have been provided with an outline for the establishment and validation of an EtO sterilization process for more than two decades by the ISO 11135 standard. In July 2014, ISO 11135:2014 was published to replace ISO 11135-1:2007 and ISO/TS 11135-2:2008 with a 36-month transition period.

Manufacturers need to have control of their sterilization processes; and thus they must take ownership by conducting a gap analysis between the previous version of the standard and the revised standard (2014), and evaluate the current sterilization program’s impact.

Medical device manufacturers interested in ethylene oxide sterilization can learn about the Changes to Ethylene Oxide sterilization in the new ISO 11135:2014 now at onlinecompliancepanel.