Q:Is sterility test required for mask?
A:Not necessarily. According to the international practice, that is to say, the European Union or the United States generally do not need to carry out sterility test of products. As long as the sterilization is confirmed according to the requirements of iso11135, the daily sterilization can also be released according to the standard. However, at present, the release of sterile products in China should not only consider the requirements of iso11135, but also meet the requirements of product registration standard. Product registration standard is the standard established by the enterprise when applying for product registration certificate by the drug administration, and it is the commitment of an enterprise. Many enterprises do not fully consider the issue of product sterile release when establishing product registration standard, but follow the old formula The sterility test is needed for the batch by batch inspection. Since the enterprise has stipulated that the products should be aseptic in batch inspection, it has to be done.
Ethylene oxide, also known as ethylene oxide, is a colorless liquid at low temperature, with aromatic ether flavor, boiling point of 10.8 ℃, olfactory threshold of 760 mg / m-1064mg / m, density of 1.52; ethylene oxide is a minimum combustion concentration of 3%. Ethylene oxide gas has strong penetration. Ethylene oxide has strong sterilizing power and wide sterilizing spectrum. It can kill all kinds of microorganisms, including bacterial spores. It is a sterilizing agent.
Q:Is EO / ECH residue test required for daily sterilized products?
A:Not necessarily. According to international practice, that is to say, EU or US practice, EO / ECH residue test of products is generally not required. As long as the residue release is confirmed according to the requirements of iso10993-7, the daily sterilization can also be analyzed according to the standard. However, at present, the release of sterile products in China should not only consider the requirements of iso10993-7, but also meet the requirements of product registration standards. Product registration standards are the standards established by enterprises when applying for product registration certificate by the drug administration. They are the commitment of an enterprise. Many enterprises do not fully consider the issue of residual release when establishing product registration standards, but follow the old rules EO / ECH residues of products are required for batch by batch inspection. Since the enterprise has stipulated that the products should be inspected batch by batch to make EO / ECH residues, it has to be done.
Observe the sterilization effect of ethylene oxide sterilizer on the equipment of disinfection supply center under the condition of pure ethylene oxide
In the process of sterilization, the sterilization effect was monitored, using 3M ethylene oxide sterilizer and pure ethylene oxide gas (100g), using temperature of 55 degrees, acting for 1 hour, each sterilization treatment of 3 packages, a total of 450 packages. Results: the qualified rate was 100%. The automatic process monitoring of sterilization has 8 times of automatic interruption of sterilization program, including 3 times of too dense loading and placing, 2 times of compressor failure, 3 times of Midway power failure. After correction, continue to re sterilize the program, and the sterilization is qualified. Conclusion: the sterilization effect of 3M ethylene oxide sterilizer in USA is reliable, and the failure of sterilization process can be detected automatically.
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