HEPA validation

Good morning,
Dear All,
Can any body tell me about HEPA Validation and,
What test should bo performed as per US FDA Guide lines ?


HEPA filters per se, are not validated, the room conditions that they give, are.

So what is the filter there for – to filter air – and most importantly - all the air coming into your controlled area.

So there are three things to do:-
While injecting aerosol bubbles up stream of the filter; check around filter seal and ensure there are zero leaks.

While injecting aerosol bubbles up stream of the filter; line scan filter face with detector and ensure that all areas of flow contain only aerosols of a size or intensity that are within the allowable range for the specification of the filter under test.

All filters have a rated flow, at which (when new) they will give a specific pressure drop. If a new filter is fitted and the flow is not ‘Standard’ then this pressure drop will not be the same. Therefore the dirty pressure drop will be different. A correction must be calculated and applied.

Usually it is impossible to line scan outlet filters (the outlet faces are usually hidden in ductwork), so it is acceptable to check the mass flow, through the ductwork for aerosol compliance.

Alex Kennedy
Validation Online