Trying to benchmark 1) What type of documentation is created, and action taken, when a leak exceeding 0.01% during integrity testing (as with PAO) of a HEPA filter is detected? 2) If you do not respond to a >0.01% leak then at what % leak level do you start addressing documentation as investigation reports relating to the leak's impact on the product manufactured? Welcome all responses; however particularly interested in Pharmaceutical Manufacturing.
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Action for HEPA filter leaks >0.01%
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When you do cold DOP (aka integrity testing), it is wise to report leaks >0.01% and this is a general practice. IEST-RP-CC001, CC002, CC004 and CC006 give you details about installation and testing of HEPA filters, LAF stations and cleanrooms.
If I recall correctly, you can seal a maximum leak of size 5mmx12.5mm with a sealant. You should replace the filter if the leak size is bigger.
In all cases, you should re do the leak testing.
If I recall correctly, you can seal a maximum leak of size 5mmx12.5mm with a sealant. You should replace the filter if the leak size is bigger.
In all cases, you should re do the leak testing.
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