Sterilization for Medical Protective Mask verification process:
1) Initial contaminating bacteria of measured products.
2) Put in biological indicator and measure sterilization cycle by half cycle method
During validation, the biological indicator should be placed in the most difficult part of the whole load, and should reach a certain amount to fully reflect the sterilization effect of each position in the sterilization cabinet room. The half cycle method determined the shortest time of exposure of biological indicator to ethylene oxide. After sterilization, the biological indicator is taken out of the load and Bi test is carried out within 2 hours after replacement. If the result of Bi test is aseptic growth, the sterilization time is twice of that of half cycle method.
3) Determine the sterilization temperature and humidity of the product
4) Double the measured sterilization time is the daily sterilization time
Routine control of EO sterilization for Medical Protective Mask
1.Sterilization cabinet supplier information (business license, production license, medical device registration certificate, product quality assurance ability, etc.)
2.Equipment data (certificate of conformity, operation manual, operation manual, drawings related to maintenance plan, troubleshooting instructions for Longjian, delivery inspection report, installation location map, etc.)
3.Qualification certificate of dosage instruments (hygrometer, pressure gauge, flowmeter, hygrometer) configured by the equipment within the effective time
4. Training of operation and maintenance personnel. Post certificate after assessment
5.Equipment pressure, temperature, humidity, production sterilization batch number and monitoring record of sterilization products
6.Record of dosing amount of each cabinet and equipment maintenance (inspection) record.
7.Sterilization test and inspection record (report)
8.EO purchase (tracking) record
9.Sterilization status identification and site management
10.Relevant safety requirements
We are a professional manufacturer of Eo Sterilizer Chamber
Our company's ethylene oxide sterilizer is the best choice for mask manufacturers. Ethylene oxide sterilizer is the most professional tool for sterilizing and disinfecting medical masks and disposable civilian masks.
Today, for medical masks, the disinfection and sterilization of disposable civilian masks use ethylene oxide sterilizers. The ethylene oxide sterilizer not only has good sterilization and disinfection effects, but also has a short disinfection and sterilization time. The patented technology of our company's ethylene oxide sterilizer has greatly reduced the sterilization time.