For high-risk medical device products, sterility verification is particularly important. It is used to verify that the sterilization process used (in special cases, the sterile production process is used) can ensure the sterility of all products that are finally marketed, and it is to ensure safe clinical use The key link. The key to aseptic process verification is to ensure that all products can be effectively sterilized, and that the inspection methods used under normal production conditions can detect abnormalities in the sterilization equipment in time.

Aseptic process verification must be carried out in the way of pre-verification, re-verification should be carried out regularly (generally at least once a year), and the key parameters of key sterilization equipment should be monitored during the production process. The verification method varies according to different sterilization equipment. For humid heat sterilization equipment, it is necessary to determine the process parameters such as the sterilization temperature and time, and verify that the sterilization cabinet is at different positions under different loading conditions such as full load, half load and no load. The product can get enough heat (for heat-resistant products, the F0 value should generally be ≥ 12 minutes); for the irradiation sterilization equipment, the process parameters such as time and dose should be determined to verify that sufficient heat can be obtained at different positions in the irradiation equipment. Radiation dose; for chemical sterilization equipment such as ethylene oxide, it is necessary to determine the concentration, time, temperature and other process parameters, and different positions in the sterilization equipment can be effectively sterilized under different loading methods. Sterilization verification should adopt physical testing methods and biological indicators. The microbial culture after sterilization should have a positive control and a negative control. The verification is generally repeated more than three times, and each time it is verified that all samples are sterile, it is considered qualified.

At present, ethylene oxide sterilization is the most widely used in medical device manufacturers. Among them, temperature and humidity have a greater impact on the sterilization effect of ethylene oxide. The relevant conditions should be monitored during verification and daily production. In addition, attention should be paid to epoxy Ethane is flammable, explosive and toxic to humans. It should be carried out in a closed device and fully analyzed after sterilization. Generally, the ethylene oxide process verification includes the detection of the residual ethylene oxide after analysis.

It should be noted that the sterilized products need to be properly handled to avoid bacterial contamination after the sterilization process. Aseptic products that have undergone the sterilization process need to be checked for sterility before they leave the factory.