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FDA requirement for 0.5 and 5 micron particle monitoring


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Hi to everibody, A Manager comes to the facility where i work and has pointed out that there is a direct relationship between 1 micron particles and Bioburden in cleanroom and in Product, The reason we monitor 0.5 and 5 microns is because FDA states this are the indicator of the cleanliness in the areas and because the bacteria size is in that range, but if we had a direct relationship established on a reference make FDA ask to monitor just that size.

Do you know another reasons why FDA ask for monitor that rank of sizes and if really 1 microns is documented as the principal carrier of bioburden?

Thanks in advance

Sergio Avila
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