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Today is 2021-10-19 Tuesday,Welcome to this site 

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In what environment should non-standard blades be cleaned?

Word:[Big][Middle][Small] QR Code 2018-1-11     Viewed:    


  Many friends do not know, non-standard blade washing or have requirements, not just to wash, but also in the appropriate environment to carry out non-standard blade cleaning, then non-standard blade to wash in what environment? So let's learn with loose machinery next, in the production workshop of non-standard blade in what environment to clean.
  1、 Since the regulations do not make clear provisions for non-standard blades, there is a common practice to this issue. In fact, it should be said that it is not a custom. Because IVD quality management system of the regulation and provisions are used in many of the previous drug standards.   In the implementation guide of gmp2010, non-standard blade cleaning in production area is specified to be cleaned in accordance with the production environment.
  2、 Let's look at the regulations of other equipment products: in the sterile appendix to the quality management specification for equipment production (Announcement No. 101, 2015), it is stipulated that the air cleanliness level of the non-standard blade washing: the air cleanliness level of the area of the drying room, the cleaning room and the final cleaning treatment of the special station appliance can be lower than that of the production area, but not lower than 300000. The storage after finishing sterile non-standard blades shall be in the 10000 class clean room (area). Is this rule applicable as an IVD product? Some people think this provision is not applicable for IVD specific products, because: Although the non-standard blades are cleaned under the production level, there is no particle left on the non-standard blades after washing, and these clean clothes are in contact with the products, so, Under such a premise, cleaning of non-standard blades can not guarantee the safety of the products. So to carry out the washing of non-standard blades according to requirements, so is the machine non-standard blade!
  Therefore, for IVD products, the non-standard blades in the production area should be washed in the same conditions as the production environment.   This is also a major standard for non-standard blades in workshop work. If we need to wash non-standard blades, we should follow the standards!

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