ETO Sterilizer Safety and Environmental Protection
Due to the explosive characteristics of ethylene oxide, the ethylene oxide sterilization device should meet the corresponding standards, and the management of the sterilization workshop should implement the detailed implementation rules for the production of single-use sterile device products (injection and infusion devices):
1. Formulate a complete and feasible sterilization process plan and ethylene oxide storage, sending and receiving system, and assign a person to work with a certificate, and operate in strict accordance with the operating procedures
2. The storage of ethylene oxide should be separated from the sterilization production, and there should be explosion-proof walls. The storage room should be cool, ventilated, and protected from the sun, with flammable, explosive, and toxic signs, and equipped with fire-fighting equipment.
3. There shall be no open flame operations, substation equipment and other equipment or operations that can produce sparks within 30-50 meters around the sterilization workshop
4. During the sterilization process, it is strictly forbidden to wear spiked shoes into the site, and it is strictly forbidden to smoke at the operation site to prevent an explosion accident
5. During operation, pay close attention to changes in pressure and temperature, and make adjustments at any time
6. When the sterilizer is turned on after the sterilization process, the doors and windows and ventilation equipment must be opened first. When the indoor smell of ethylene oxide is very strong, the electric light and flashlight shall not be turned on, except for explosion-proof lamps.
7. Residual ethylene oxide gas discharged after sterilization should be properly handled and comply with environmental protection requirements.
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