HEPA Filters Leak Test DOP Procedure

The purpose is to check the integrity for HEPA filters by leak test to assure that they are not damaged during installation or operation. 

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. 

This test should be performed by trained or certified personnel who introduce DOP aerosol upstream of the filter through a test port and search for leaks downstream with an aerosol photometer. Remove air diffusers and airflow laminators before performing the test (whatever is applicable) to get access to the filters. 

Introduce the challenge aerosol upstream from the HEPA filters, following the generator operating manual. 

A challenge aerosol concentration of 10 to 20 Xg/l of air is satisfactory. In upstream position (gain adjustment), adjust the concentration immediately upstream from the filter to read 100% on the photometer. If the upstream concentration of 100% cannot be reached, increase generator output. 

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