EN 17141:2020 Recommended limits for microbiological contamination

Nuno_

Starting to get Involved
#1
Greetings all.
I am currently studying EN 17141 at the suggestion of my auditor, and there is a table that I cannot understand.
In table B1 on page 26 the standard has four cleanroom categories: 1, 2, 3 and 4. However, I don't think this classification has anything to do with the ISO 14644-1 cleanroom categories. On the one hand because of the context, on the other hand because in the table B3 that follows they explicitly classify cleanrooms in categories 5, 6, 7 and 8 according to ISO 14644-1.
So if anyone has studied this standard, could you help me understand table B1?
Thank you in advance.
 
Elsmar Forum Sponsor
#2
EN 17141 is about biocontamination control. This means bacteria, viruses, endotox, etc. ISO 14644-1 is about air particles of every type.

Sorry, I don't have this standard. Could it be that Table B1 is listing device risk classifications?
 

Nuno_

Starting to get Involved
#3
EN 17141 is about biocontamination control. This means bacteria, viruses, endotox, etc. ISO 14644-1 is about air particles of every type.

Sorry, I don't have this standard. Could it be that Table B1 is listing device risk classifications?
Thanks for the answer. I'm familiar with ISO 14644-1, 17141 is new to me, although I'm really enjoying it and I'm thinking of changing a lot both the risk analysis and the monitoring system (we have a clean room where we manufacture class III).

Below I copied the table where my doubts arise. As you can see in the first column, the table mentions 4 categories, but I don't know what these categories correspond to (I think these categories do not correspond to the 14644-1 cleanroom classification categories). I was hoping that someone who had studied the standard would know. But thanks anyway.

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chris1price

Trusted Information Resource
#4
The information in Table B1 is identical to that of Eurdalex Vol 4 Annex 1 for The Manufacture of Sterile Medicinal Products. However this uses grades A to D rather than Categories 1 to 4. For comparison, these are extracts from Annex 1.

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Nuno_

Starting to get Involved
#5
Thank you very much for the message chris1price. I happened to have a monitoring system based on Eurdalex and I didn't even make the association... I think 17141 should be clearer in the cleanroom classification, it should keep the rating from A to D. Furthermore, the table B3 that follows (see below) classifies cleanrooms according to ISO 14644-1, which only confuses things more.
In any case, our room is classified as class C, so there will be no changes in the limits of microbiological contamination.
I think I can now interpret the table, again thank you very much.

1647594042827.png
 
#7
Hello all,
In relation to this section of Anexx B, I want to understand the impact of EN 17141 on the number of monitoring locations. We manufacture class 2 & 3 devices and we follow ISO 14644. As per 14644, we have 24 sampling points. Then as per EN 17141, do I need additional monitoring locations on top of the existing 24 points or the same sampling points can be used for both EN 17141 and ISO 14644?
 
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