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Sterilization can also be achieved using ethylene oxide (ETO) gas. This process was created in the 1950s by the US military [4] and is used on items that cannot withstand the high temperatures of steam sterilization. ETO sterilization takes far longer than steam sterilization and is hazardous to workers, so alternative methods were created in ...
Ethylene oxide treatment is the most common chemical sterilization method, used for approximately 70% of total sterilizations, and for over 50% of all disposable medical devices. [ 26 ] [ 27 ] Ethylene oxide treatment is generally carried out between 30 and 60 °C (86 and 140 °F) with relative humidity above 30% and a gas concentration between ...
For example, medical device manufacturers design their sterilization processes for an extremely low SAL, such as 10 −6, which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilization process. A very effective sterilization process has a very low SAL.
ISO 11135:2014 Sterilization of health-care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices; ISO 11137 Sterilization of health care products – Radiation; ISO 11138 Sterilization of health care products - Biological indicators
The odor threshold for these gases is above the PELs and for ethylene oxide it is 500 ppm, approaching that of the IDLH. [1] Odor is thus inadequate as a monitoring technique. Continuous gas monitors are used as part of an overall safety program to provide a prompt alert to nearby workers in the event that there is a leak of the sterilant gas ...
Ethylene oxide scrubber: After the gaseous stream from the main reactor, containing ethylene oxide (1–2%) and CO 2 (5%), is cooled, it is then passed to the ethylene oxide scrubber. Here, water is used as the scrubbing media which scrubs away majority of ethylene oxide along with some amounts of CO 2 , N 2 , CH 2 =CH 2 , CH 4 and aldehydes ...
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