Hepa Filter Gasket Leak Test

GOOD MANUFACTURING PRACTICE (cGMP)
1

Apart from DOP METHOD, is there any other method to check the gasket leakage of hepa filter after installation in the module.
please specify the mathod or name of the method

2

I don´t know any method for gasket leakeage, but… between the different stages of filtration, your equipment have gauges (magnehelic). In general the equipment have values of desing for differencial pressure for the different stages of filtration, you can check this values and see if the filter is already saturated or have a leakage. Regards.

3

Dear Navas,

How r you

This is satya

i dont know about the other tests for the gasket leak test other than DOP/PAO airosol test.

any way as per ISO 14644-1, you need to qualify the filter integrity test after installation (installed filter leak test purpose is to check the leakes from gaskets and grilles also) by using 0.3 micron airosols. Then no need to check again the gasket leak test.

and presure drop across the Hepa filter can be checked.

Satya
Manager -Quality assurance
pava_satya@rediffmail.com

4

Kind Attn Mr:Satya

we do agree with your reply

Regards

A.Aziz

5

Dear Mr. Satya

I agreed with your answer. It’s a right answer. No other test is required to check the grill and filter lekage.

6

[quote=Al-Pharao Air Data]Kind Attn Mr:Satya

we do agree with your reply

Regards

A.Aziz[/quote]

Kind Attn Mr:Satya

we do agree with your reply

Regards

A.Aziz

7

Ok
But please some one tell me how to check the integrity of filter prior to installation.
like checking the filter with high voltage luminous light,(that I heared some people do)
Or smoke(what kind?) produced and detected using this light.
Please update is this method is valid and if yes how to do it.
Thanks

8

There is no quantitative test method to check the Hepa filter integrity on site prior to installation except visual inspection (qualitative). We have to believe on certification given by filter manufacturer. Hepa filter manufacturer do have big testing rig to perform filter integrity test at their site based on which lotwise certificates are released.
Luminous light based test can not be considered as valid as it is not fullproof & quantitative test. Anyhow as we have to perform filter integrity test (DOP) after every installation/replacement of filter, there is no need to look for a test prior to installation. Visually we can assure the filter free from any damage before installation.

9

Dear all
From PIC/S Guide (PI 009-3), The Filter Installation leak test should follow BS EN 1822