Safety Requirements for Using Ethylene Oxide in sterilization

when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities.
Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames.
The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric sparks should be avoided. Open flames are strictly prohibited.
Before sterilizing each type of item, the parameters must be confirmed according to the national standard GB18279-2000.
The control section of the sterilizer should be installed separately from the main unit (see diagram D.1).
After the displacement (flushing) phase is completed, the sterilized items should not remain in the sealed sterilization chamber for more than 15 minutes. Otherwise, the displacement phase must be repeated before opening the door.
After Ethylene Oxide in sterilization is complete, the displacement air must be processed according to the relevant sterilization operation regulations. Before opening the door to remove the items, the axial fan should be turned on to ensure ventilation. Do not immediately take out the items after opening the door to avoid exposure to harmful residual gases in the sterilization chamber.
Medication Alert: Based on the amount of medication to be administered, set the pressure or weight. When the required dosage is reached, an audible alert will sound. At this point, the operator must immediately close the medication bottle switch and the main unit’s dosing valve.
Users of ethylene oxide mixed gases must install a pressure regulator (user-installed) at the outlet of the medication bottle to reduce the bottle outlet pressure to below 0.4 MPa, preventing high pressure from causing leaks in the dosing pipeline.
Before disconnecting or opening any part of the sterilant supply system, it is necessary to clean the system (except for the gas tank supply system).
If the air pressure of the door seal gasket in the sterilization chamber falls below 0.45 MPa during the sterilization process, the air supply to the rubber seal should be shut off, and a backup pressure source should be connected to ensure the rubber seal has a pressure greater than 0.45 MPa. At the same time, the ethylene oxide leak handling procedure should be activated to evacuate and clean the sterilization chamber. Then, measures should be taken to restore the original air source.
If the workplace ventilation system fails, the equipment should be shut down and not restarted. If the failure occurs while the sterilizing agent has already entered the chamber, the operator should only enter the chamber to contact the sterilized items after the sterilant removal and flushing procedures have been fully completed.
After each work cycle, the ethylene oxide pipeline system should be cleaned. Cleaning media can include water, compressed air, or steam. The user should install local exhaust systems in areas where sterilizing gas may accumulate, such as near the sterilizer door, the storage area for sterilized items, and the sterilant storage area. The exhaust system should not discharge any substances that could cause danger.

注意： Regardless of whether the equipment is in normal operation, malfunction, or maintenance state, if personnel need to enter the sterilizer chamber, the door must be lowered to the ground or supported. It should be confirmed that the door is locked and cannot be closed. Personnel should take or safely store the key before entering the chamber.