Autoclaving Die Sterilization

Sterilization by autoclave is the most widely used method. Autoclaving is saturated steam under pressure (moist heat). This heat can kill microorganisms by causing coagulation of essential proteins. Autoclaving is the most effective and efficient means of die sterilization. Typically performed at 121.1 oC., 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 17665:2006, “Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices.”

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