What are the ethylene oxide sterilization (EO sterilization) processes?
①
Ethylene oxide sterilization procedures need to include preheating, pre-wetting, vacuuming, introducing vaporized ethylene oxide to reach a predetermined concentration, maintaining the sterilization time, clearing the ethylene oxide gas in the sterilizer, and analyzing to remove Residues of ethylene oxide in sterilized items.
②100% pure ethylene oxide or mixed gas of ethylene oxide and carbon dioxide can be used for ethylene oxide sterilization. The use of Freon is prohibited.
③Analysis can be continued in an
ethylene oxide sterilizer, or it can be placed in a special fume hood. Natural ventilation should not be used. The repeatedly input air should be filtered with high efficiency, which can filter out more than 99.6% of particles ≥0.3um.
④Ethylene oxide residue mainly refers to the ethylene oxide remaining in articles and packaging materials after ethylene oxide sterilization and its two by-products, chloroethanol ethane and ethylene glycol ethane; exposure to excessive ethylene oxide Alkane residues can cause burns and irritation to patients. The amount of ethylene oxide residue is related to the materials of the sterilized articles, the parameters of the sterilization, the packaging materials and the size of the packaging, the loading capacity, and the analysis parameters. When the polyvinyl chloride catheter is at 60℃, it is analyzed for 8h; at 50℃, it is analyzed for 12h. Some materials can shorten the resolution time, such as metal and glass can be used immediately, and some materials need to extend the resolution time, such as a built-in pacemaker.
The ethylene oxide tail gas treatment device is finally discharged after real-time concentration monitoring reaches the relevant national emission standards.
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