HEPA Certification Under Grade A

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hello everyone,

Currently at my employer we do re-certification of HEPA filters (under grade A every 6 months). Our current process requires us to do a media fill right after the certification.
Reason being, if there’s a leak we do not want to impact all lots manufactured under grade A since last HEPA certification. If the media fill shows no contamination, we suppose that all aseptic lots manufactured were ok and risk of microbial contamination very low.

Until we get the result of the reading of the the media fill we do not manufacture any aseptic products just to not impact potentially new product.

This approach is very time consuming and probably not the more robust one from a GMP stand point.

I wanted to know what other folks do out there? Do you do continuous monitoring of your HEPAs?

Thank you so much for you insights
Oscar

2

When we do re-qualification of HEPA filters, we usually us PAO/DOP method to test the integrity of the filters. This test is not “destructive test”. So, when it passed the re-qualification, we can conduct the regular production right away.

But, if during the test, the leakage of the filter was detected, and you replace the filter, then it will initiate the media fill.