ISO 14644-1:2015_Sample location

Microbiology
1

Hello there,

As per 14644:2015, we do not have to carry out sample location calculation because there’s a table already. Suppose that we have a 52m^2 room and we need to take 10 samples.

  1. Which location need to be selected? I mean the floor, or the wall, or other? (I just want to take microbial samples)
  2. To sample location selection, is there any difference between ‘at rest’ and ‘in operation’?

Thank you for spending time reading my topic.

Nguyen,

2

Hi:

The added table with the quantity of meausring points in the ISO 14644 just concern to points for non-viable particles counting. In the same document you can find an explanation related to location’s definition. In the case of microbial sampling points you must to conduct a Risk assessment to select locations. You should conseder operations in each room, “dead zones” in non-laminar air flow rooms, equipments, entrance zone, air locks connecting with rooms with lower cleanliness classification, etc
Greats

2 Likes
3

Yes madam what u said that is correct, but for intial HVAC area qualification purpose we should adopt the locations as per ISO 16444:2015 with proper justification. After getting EMP results we may reduce or keep the locations for routine monitoring. What am said is correct are any corrections.?

4

During routine you can reduce sampling points, you should to select them considering elements I had mentioned before, selection you do must be explained in some document. In addition is a good seen practice to conduct a different EMP sometimes, for example every a determined quantity of batches. In those programs you can to change monitoring points or frequencies to look for changes in the clean room’s behaviour

5

guideline says with respect to area… if area of room is 12X12, and if there is a equipment in room of area 6X4 than the how many locations for NVPC…??