What Particle Limit Should I Follow During the Particle Count Test?

GOOD MANUFACTURING PRACTICE (cGMP)
1

HI

i am going to install new air lock between class B and class C room , the air lock type is cascade.
could you please tell me what the particle limit should I follow during the particle count test , should I follow class B or C limits ??

thanks for all

1 Like
2

Hi, Sanhari
Of course particle count for class B limits.
Best Regards.

3

Use the more strict requirement. Especially if the area is cascade, the whole area should meet B requirements. (If it was a sink, then you might get some air from the C area in the airlock.

Also, the surfaces of the C side of the airlock might have higher microbial counts. Especially the floors if there are dedicated shoes on the B side, or else other bootie covering which is occurring at the transition. If this is the case, you should discuss what surface limits should be on the C side.

Airborn limits should meet the B level requirements, because you cannot keep airborn contaminants from passing from the C to the B. But you can in some ways keep surface contaminants on one side of a demarcation line (again due to gowning, shoe covers, gloving practices, etc.)

4

thank you for your useful answer