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Not using gloves in Clean Room Class 8 (ISO 14644)

T

thnksnow247

#21
#21
I also wanted to point out that there are a lot processes where gloves are import to limit transfer of hand oils and what ever people put on there hands. Lots of coating and adhesive processes fall into this category.
 
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alimary15

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#22
#22
Hi,

here are my two cents from medical device perspective.

A human being can lose just from his hands up to 1x10^3 cfu/cm^2. More in general, we are losing on average 10 g of skin per day.

From a medical device perspecive, this means that you might have a certain quantity of viable micro-organisms on your product, which could affect your initial bioburden.

From a regulatory perspective, depending on risk management and product intended use, you might want to reduce as far as possible the risk of infection.

Hope this helps
 
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