Epoxy ethane is flammable and explosive gas, especially warned!
Ethylene oxide is a kind of flammable and explosive toxic hazardous chemicals, the concentration of more than 3% in the air encounter fire is burning and explosive . Therefore the use and operation of ethylene oxide sterilizer must strictly abide by the safety operation procedures, without training do not operate!
1. The sterilizer should be placed in an independent room.
2. EO sterilization site should be far away from crowd. Open fire work and other circumstances involving open fire should be prohibited in 50 m range.
3. Isolation measures should be taken in the room where EO sterilizer is placed, i.e. sterilizer cabinet, control cabinet, control frame, EO gas cylinder should be separately placed in different rooms or should be isolated according to the installation sketch map provided by us.
4. The illumination and electric switches in EO sterilization workshop should be explosion-proof. Any electrical appliances, which may cause electric spark, as well as open fire should be prohibited.
5. Epoxy ethane sterilizer placed workshop to have good ventilation, poor ventilation conditions should be forced ventilation, such as the installation of the axial flow fan, ventilation equipment installation shall be explosion proof type.
6. After the sterilization, ethylene oxide residual need special processing system after treatment to reach the national standards, then can be discharged.
7. Ethylene oxide sterilization workshop and sterilization area should be obvious fireproofing, non-smoking marker. Sterilization workshop is a key fire prevention area, there must be enough fire prevention, fire fighting facilities.
8. The staff can not wear nail shoes and electrostatic clothes, to prevent all possible spark.
9. Please note that the lightning protection, anti-static, anti leakage, pay attention to the personal and equipment safety.
10. Epoxy ethane gas should be stored in a separate room, room should have ventilation, explosionproof, fire fighting facilities.
11. Epoxy ethane gas cylinders should be stored in a cool, away from the heat source, storage environment temperature not higher than 30 ℃ area, a fire operation shall not be within 50 meters of storage area.
12. Epoxy ethane gas cylinders should be fixed in bracket, may not strongly impact and collision.
13. For the use of epoxy ethane mixed gas users, must add flow control valve in ethylene oxide gas pipe line.
14. The use of internal circulation system must be guaranteed in the sterilization process of epoxy ethane in non explosion range, otherwise, the absolute prohibition of the use.
Documents will be provided
1. Company profile, qualification certificate
2. Product list
3. Producing-in-process inspection record
4. Safety notification, safety operation manual, Daily maintenance.
5. ETO sterilizer operation instruction. (operation instruction, mechanical drawing , electrical drawing, common troubleshooting table)
6. Auxiliary information, qualification certificates
7. Sensor validity certificate, qualification certificate (if need the third party test certificate, please notify)
8. Provide software validation reports, functional validation
9. Provide IQ/OQ test report
Drawing or diagram: layout, schematic diagram , general assembly diagram.
Special or customized items
To meet the compliance standards of 21 CFR Part 11, it is recommended to add the following configuration:
-Auxiliary industrial computer ( Auxiliary IPC)
-Online EO sensor
In addition, it is recommended to increase the use of ethylene oxide monitoring devices in the workshop environment. The sterilization workshop can set up 8 monitoring sampling points to improve workshop safety.
Or other projects that the client wants to customize.
Jun 17, 2025
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eto sterilizer instructions 1. Ordinary masks: three cubic sterilizers are used for 50000 masks per day, and five or six cubic sterilizers are used for 100000 masks per day. N95 mask: 50000 with 6 cubic meters, 100000 with 10 cubic sterilizers. 2. Di...
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