What should be noted in the medical device clean area
1、 In the production of sterile medical devices, production techniques that reduce contamination to a lower limit should be adopted to ensure that medical devices are not contaminated or can effectively eliminate contamination.
2、 Aseptic medical devices or single packaging accessories that are implanted and inserted into blood vessels, as well as those that require subsequent processing (such as filling and sealing) in some Class 100 clean areas below Class 10000, and their (uncleaned) components are processed by the factory; The final cleaning, assembly, initial packaging, and sealing production areas should have a cleanliness level of no less than 10000.
3、 The processing, final cleaning, assembly, initial packaging, and sealing of non cleaned components of reactive bridge therapy devices or single package factory accessories that are implanted into the human body and directly or indirectly immersed in blood or non natural cavities should have a cleanliness level of no less than 100000 in the production area
4、 The processing, final cleaning, assembly, initial packaging, and sealing of sterile medical devices or single packaged (uncleaned) components that come into contact with human skin and mucous membranes should be carried out in a cleanroom of no less than 300000 levels
5、 The cleanliness level of the production environment for initial packaging materials that come into direct contact with the surface of sterile medical devices and are used without cleaning should be set to be the same as the cleanliness level of the product production environment, so that the quality of the initial packaging materials meets the requirements of the packaged sterile medical devices. If the initial packaging materials do not come into direct contact with the surface of sterile medical devices, they should be produced in a clean room of no less than 300000
6、 Aseptic medical devices (including medical materials) that require or use aseptic operation skills for processing should be produced in some Class 100 cleanrooms below Class 10000
7、 The air cleanliness level in the area for cleaning, drying, and wearing clean work clothes, as well as the final cleaning and disinfection of specialized workstation equipment, can be one level lower than that in the production area. The organization of sterile work clothes and storage after sterilization should be carried out in a clean area with a cleanliness level of 10000.
Article source: Hunan Purification Engineering http://www.0571pet.cn/
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