Hi everyone.

I am elaborating a PQ protocol for Clean Room. My client wants to get a US approval and this protocol should be compliant with US FDA. So I have looked at USP 36(2013) which you gave me and Guidance for industry(Sterile Drug products produced by aseptic processing, 2004). It makes me more confuse because these guides have different acceptance criteria for airborne, settle plates, surface microbial which are totally different compared to EU Annex 1. In case that client wants for US FDA, what should I apply to compliance with US FDA? The client wants to perform microbial test(airborne, settle plates, surface) but the guides of US does not provide exact ACs for each microbial. In USP 36, it recommend only under aseptic gowning zone as recovery rates. Please advise.


Dear Benny,
There are many documents you could consult - PIC/S GMP Guide has the particulates and microbial counts acceptable for each area.
ISO 14644 is also applicable, but it really depends on what the Clean Room is being used for. Any Auditor regardless whether US FDA or MHRA etc would not really be too bothered about which system you use so long as it is appropriate for the room’s use. For example you would not be allowed to do aseptic filling within an unclassified area.

I would suggest that you use the EU Annex 1 as it is essentially the same as PIC/S GMP Guides (the PIC/S guides are freely available on the internet) and also since Jan 2013 the US FDA have joined PIC/S.

The particulate and microbial limits for each area, at rest and in use conditions, are clearly listed in these documents. So long as your clients clean room has been design and built correctly and operates within its design criteria there should be no problem with the US FDA (although they may want results in cubic feet)

Hope this helps.

thanks you for ur valuable inputs