ISO 14644 Class 8 Cleanroom Air Filter Requirements

prephil

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Can anyone confirm what grade of filter is required on a pneumatic filter regulator in order to ensure the air is of sufficient quality.
I am told it is 5 microns but I want to be 100% sure.
Looking here (ISO Class 8 Cleanroom Classification Guidelines) it appears that we would need a 0.5 micron filter?
ISO 14644 Class 8 Cleanroom Air Filter Requirements
 
Those are just the measured micron sizes. The number of particles at those sizes defines the clean room classification. There is a lot that goes into the clean room particle count, not just the filter.
Is this for a clean room or for compressed air? For compressed air, you may want to check out the ISO 8573 family of standards.
 

prephil

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Hi, thanks for your reply. Im a bit ignorant of clean room requirements. So we willbe building a machine for a pharma company that will be installed in a class 8 cleanroom. There will be pneumatic grippers used in the machine and therefore these will require a compressed air supply. Im wondering will a 5micron filter regulator be sufficient or will it need to be finer or does it not matter at all?
 
Typically, compressed air would not be class 8, but would be a lower class. I can't answer your question because there are too many factors to consider. I would discuss your issue with the manufacturer of the air compressor if that is possible (and if you are having the air compressor installed). You should set up your system to introduce as few particles as possible. Maybe someone else has additional insight.
 

AgnieszkaSz

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First, you should aim at oil-free compressor, because oil mist is not acceptable for pharma. Typical tests for clean compressed air system involve gas chromatography (they compare peaks with air standard), moisture content and particle count. I doubt whether gas chromatography would be actual requirement for class 8 rooms, but moisture and particle count can be, and at each supply point.
 
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