Action for HEPA filter leaks >0.01%
Action for HEPA filter leaks >0.01%
(OP)
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.





RE: Action for HEPA filter leaks >0.01%
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.