Ethylene Oxide Gas Die Sterilization

Ethylene oxide gas is a gaseous process, usually conducted at 55oC, 60% RH with an EO concentration in the range of 600 mg/l. This is a process that can be utilized with dies constructed of temperature sensitive materials. As this is a gaseous process, the packaging selected must be breathable (e.g. the sterilization wrap or pouch.) A non-breathable package (e.g. a sealed plastic bag) is not compatible with this type of sterilization.

Our FDA-registered, ISO 13485 certified laboratories will validate the selected sterilization process to the current FDA and industry recognized standards:

AAMI/ANSI/ISO 11135 -1:2007, “Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.”

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