Ethylene oxide sterilization gas is currently the main method used for mask sterilization, but in the face of the flammable and explosive characteristics of ethylene oxide, do you know the national standard for the use of ethylene oxide? According to GB 18279.1-2015 and GB/T 18279.2-2015, the following summary was made.
I. Personnel
qualified personnel shall be responsible for equipment maintenance, EO sterilization confirmation and regular control and product release. The personnel responsible for the following work shall be acceptable and have the necessary qualifications:
① Microbiological tests
② Equipment installation and maintenance
③ Physical performance identification
daily sterilization operation
⑤ Calibration
⑥ Process design
⑦ Equipment specification
⑧ Other aspects applicable
II. Setting of Sterilization Process
when developing a sterilization process, all factors that affect the effectiveness of the sterilization process should be considered, including:
① Product design;
② Packaging;
③ Placement of sterilized articles;
④ Pretreatment requirements;
⑤ Treatment requirements;
the residual air content in the sterilization cabinet;
⑦ Addition of sterilizing agent
⑧ sterilization conditions (temperature, relative humidity, EO concentration, time)
⑨ Discharge conditions
⑩ Ventilation requirements
third, the applicability of the product
if the product needs to be sterilized by EO, the aspects to be considered in its design:
the product structure should not be changed;
the impact on material properties and possible biological hazards;
③ the EO residue level will affect the applicability of the product to sterilization;
④ the product may react with EO or dilution gas;
⑤ Product design should ensure that its effectiveness and safety are not affected by sterilization;
when the product needs to be sterilized again, its physical and chemical properties will not be affected;
the high humidity and pressure changes may affect the packaging sealing performance;
⑧ Determine the most difficult part of the sterilant according to the product design
IV. Sterilization Process
the sterilization process shall include pre-treatment and/or treatment, sterilization cycle and ventilation. The physical performance factors to be considered in the sterilization process are:
① The degree and speed of reaching vacuum;
② Leakage rate of the Cabinet (negative pressure and positive pressure);
③ The degree of pressure rise generated during steam injection during treatment;
④ the degree of pressure rise and the speed of reaching the specified pressure when the sterilant is added, as well as the correlation of the parameters used to detect the EO concentration;
⑤ Vacuum degree and speed to be achieved by removing sterilant;
⑥ The degree of pressure increase and the speed reached when air is added;
⑦ The number of repetitions above ⑤ ⑥ and any change in repetition
in addition to doing their own work according to the national standard, manufacturers should also pay attention to whether the gas suppliers have relevant filling and Operation qualifications when purchasing ethylene oxide sterilization gas.