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Steam sterilizing units designed for total inactivation of microorganisms that are or may be present on medical devices that are not sensitive to high temperature, water, or steam using pressurized steam; the units are intended for simultaneous sterilization of large quantities (i.e., bulk) of medical devices. These units usually consist of a free-standing unit including a large treatment chamber with shelves on which the devices to be sterilized are placed, usually after being cleaned of gross debris and then packed; means to remove air prior to the sterilization (usually gravity and/or vacuum is used) and to introduce the steam (typically from an external boiler using a dedicated line) into the chamber; and controls to regulate the time and/or temperature of the procedure. Frequently the time and temperature of the sterilizing cycles are pre-established according the type of device to be sterilized; typical sterilization temperature range is 121 to 135 degrees Celsius (250 to 275 degrees Fahrenheit). After the sterilization cycle is complete, the steam is exhausted; partial vacuum is frequently used to facilitate the extraction. Bulk steam sterilizing units are used mainly in hospital central supply departments and/or in other healthcare facility areas that perform a great deal of sterilization.
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