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Pharmaceuticals/Class A with background class C


Dear Dr Michael Anisfeld

for class A with background C ( LAF in compounding area for products to be sterilized ) & ( LAF in dispensing with class D background )   at end samples swaps fail to meet class A limits in viable counts , is it possible to make Risk assessment and raise the Limits
or is there any other limits for such cases , as it is impossible to meet class A limits while the background is not class B and the gowns are for class C

Thanks a lot
Mohamed Eissa

Your question is interesting, but as written is confusing. I assume by stating areas as Classes A, C and D, you are referring to EU GMPs which you are trying to meet.

If the failing sample swabs were taken in the Class A area (working) with either C or D (background), then you have serious problems, as Class A has tight microbial limits.

If the failing sample swabs were taken in the Class C or D (background) areas, then you also have concerns but lesser than if they were found in the Class A (working) area.

Your proposal to change the limits is not legal if you are exporting product to the EU; and is not good practice or acceptable even if you are not exporting to EU countries. What you need to do is perform a thorough root cause analysis, find the problem and resolve it.

I hope this helps.


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Michael Anisfeld


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