Do I need a Cleanroom to manufacture Medical Devices?

B

bing1997

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#1
#1
Hello, everyone
I am engaged in IVD production. Now I want to build an IVD factory. I would like to ask whether the factory needs a clean room.
 
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chris1price

chris1price

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#3
#3
Without knowing the processes, the product and every else related to the IVD, its impossible to say if you need a clean room. It is up to you to assess the risks to product quality from contamination and plan accordingly. Take a look at ISO13485, 6.4.
 
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