Filter device test apparatus, filter integrity testing method and computer program product

1. A test apparatus ( 1 ) for automatically carrying out an integrity test on a filter device ( 3 ) having a filter housing ( 5 ) with a filter material ( 13 ) in an interior of the filter housing ( 5 ), a fluid inlet ( 7 ), a fluid outlet ( 9 ) and a venting port ( 11 ) at a location on the filter housing ( 5 ) spaced from the fluid inlet ( 7 ) and the fluid outlet ( 9 ), the venting port ( 11 ) being at a location on the filter housing ( 5 ) to prevent fluid in the filter housing from flowing through the venting port ( 11 ) while providing gas flow into or out of the filter device ( 3 ), the test apparatus ( 1 ) comprising:

an external filter integrity testing device ( 15 ) having a measurement gas supply pipe ( 57 ) communicating with a pressure sensor ( 17 ) and/or a flowmeter ( 63 ), a measurement gas connector ( 83 ) at an externally accessible position on the external filter integrity testing device ( 15 ) and communicating with the measurement gas supply pipe ( 57 ), the external filter integrity testing device ( 15 ) further having an electrical connector ( 79 ) at an externally accessible position on the external filter integrity testing device ( 15 ); and

a valve unit ( 77 ) provided separately from the external filter integrity testing device ( 15 ) and being configured to be fluidly connected to the filter device ( 3 ), the valve unit ( 77 ) further having a complementary measurement gas connector ( 85 ) at an externally accessible position thereon and configured to be connected to the measurement gas connector ( 83 ), and a complementary electrical connector ( 81 ) at an externally accessible position thereon and configured to be connected to the electrical connector ( 79 ) of the external filter integrity testing device ( 15 ), wherein the valve unit ( 77 ) comprises:

an inlet connector ( 19 ) fluidly connectable to the fluid inlet ( 7 ),

a wetting liquid supply valve (V 4 ) fluidly connecting the inlet connector ( 19 ) to a wetting liquid supply;

a drainage valve (V 3 ) fluidly connecting the inlet connector ( 19 ) to a first drain ( 45 );

an outlet connector ( 21 ) fluidly connectable to the fluid outlet ( 9 )

an outlet valve (V 2 ) fluidly connecting the outlet connector ( 21 ) to a second drain ( 49 );

a venting port connector ( 23 ) fluidly connectable to the venting port ( 11 );

a measurement gas valve (V 5 ) fluidly connecting the venting port connector ( 23 ) to the complementary measurement gas connector ( 85 ) that is connected fluidly to the pressure sensor ( 17 ) and/or the flowmeter ( 63 ) of the filter integrity testing device ( 15 ) and a measurement gas source ( 59 );

a venting valve (V 6 ) fluidly connecting the venting port connector ( 23 ) to a venting pipe ( 53 ) for providing gas flow into or out of the filter device ( 3 ) at a location spaced from the fluid inlet ( 7 ) and the fluid outlet ( 9 );

a dry gas valve (V 7 ) connected to the venting port connector ( 23 ) and connectable to a dry gas source; and

communication means ( 71 b - 71 f ) for communicatively connecting the valves (V 2 , V 3 , V 4 , V 5 , V 6 ) with the filter integrity testing device ( 15 ) and controlling the valves (V 2 , V 3 , V 4 , V 5 , V 6 ) by means of the filter integrity testing device ( 15 ).

2. The test apparatus ( 1 ) of claim 1 , wherein the wetting liquid supply comprises a wetting liquid supply connector ( 29 ) and wherein a wetting liquid storage container ( 27 ) is fluidly connectable to the wetting liquid supply connector ( 29 ).

3. The test apparatus ( 1 ) of claim 2 , further comprising wetting liquid pumping means.

4. The test apparatus ( 1 ) of claim 3 , wherein the wetting liquid pumping means are pneumatic pumping means.

5. The test apparatus ( 1 ) of claim 1 ,

wherein the connection between the filter integrity testing device ( 15 ) and the valve unit ( 77 ) is established by moving the filter integrity testing device ( 15 ) along a direction (R) relative to the valve unit ( 77 ).

6. A microprocessor controlled method for carrying out an integrity test by the test apparatus ( 1 ) of claim 1 on the filter device ( 3 ) having the fluid inlet ( 7 ), the fluid outlet ( 9 ) and the venting port ( 11 ), wherein a hydrophilic or hydrophobic filter material ( 13 ) is arranged between the fluid inlet ( 7 ) and the fluid outlet ( 9 ), the inlet connector ( 19 ) of the test apparatus ( 1 ) being connected to the fluid inlet ( 7 ), the outlet connector ( 21 ) of the test apparatus ( 1 ) being connected to the fluid outlet ( 9 ), and the venting port ( 23 ) of the test apparatus ( 1 ) being connected to the venting port ( 11 ), the method comprising the steps:

providing a wetting liquid ( 25 ) from said wetting liquid supply that is fluidly connectable to the fluid inlet ( 7 );

connecting the electrical connector ( 79 ) of the filter integrity testing device ( 15 ) to the complementary electrical connector of the valve unit ( 77 );

instructing the filter integrity testing device ( 15 ) of the test apparatus ( 1 ) to carry out and control an integrity test procedure that comprises the steps:

opening the venting valve (V 6 ) and closing the measurement gas valve (V 5 ) and the dry gas valve (V 7 )

wetting the hydrophilic or hydrophobic filter material ( 13 ) in the filter device ( 3 ) with the wetting liquid ( 25 ) by filling the filter device ( 3 ) at least partially with wetting liquid ( 25 ) until the filter material is substantially saturated with the wetting liquid ( 25 ) while permitting gas in the filter housing to vent through the venting valve (V 6 );

draining wetting liquid from the filter device ( 3 ) keeping the filter material ( 13 ) substantially saturated;

closing the venting valve (V 6 ) and opening the measurement gas valve (V 5 ) to dry the filter material ( 13 );

providing a pressurised measurement gas to the venting port ( 11 ) in order to apply a pneumatic pressure to the saturated filter material ( 13 );

recording the applied pneumatic pressure with a pressure sensor ( 17 ) and/or recording the applied measurement gas volume with a flowmeter ( 63 );

determining the integrity status of the filter device ( 3 ) based on the recorded pneumatic pressure and/or measurement gas volume; and

closing the measurement gas valve (V 5 ) and opening the dry gas valve (V 7 ) for drying the filter material ( 13 ); and

performing the integrity test procedure.

7. A microprocessor controlled method for carrying out an integrity test by the test apparatus ( 1 ) of claim 1 on a filter device ( 3 ) having the fluid inlet ( 7 ), the fluid outlet ( 9 ) and the venting port ( 11 ), wherein a hydrophobic filter material ( 13 ) is arranged between the fluid inlet ( 7 ) and the fluid outlet ( 9 ), the inlet connector ( 19 ) of the test apparatus ( 1 ) being connected to the fluid inlet ( 7 ), the outlet connector ( 21 ) of the test apparatus ( 1 ) being connected to the fluid outlet ( 9 ), and the venting port connector ( 23 ) of the test apparatus ( 1 ) being connected to the venting port ( 11 ), the method comprising the steps:

providing a testing liquid ( 25 ) from said wetting liquid supply that is fluidly connectable to the fluid inlet ( 7 );

connecting the measurement gas connector ( 83 ) of the complementary gas connector ( 85 ) and connecting the electrical connector ( 79 ) of the filter integrity testing device ( 15 ) to the complementary electrical connector of the valve unit ( 77 );

instructing the filter integrity testing device ( 15 ) of the test apparatus ( 1 ) to carry out and control an integrity test procedure, wherein the integrity test procedure comprises the steps:

opening the venting valve (V 6 ) and closing the measurement gas valve (V 5 ) and the dry gas valve (V 7 );

covering the hydrophobic filter material ( 13 ) in the filter device ( 3 ) with the testing liquid ( 25 ) by filling the filter device ( 3 ) at least partially with testing liquid ( 25 ) until the filter material is substantially completely covered with the testing liquid ( 25 ) while permitting gas in the filter housing to vent through the venting valve (V 6 );

closing the venting valve (V 6 ) and opening the measurement gas valve (V 5 ) to dry the filter material ( 13 );

providing a pressurised measurement gas to the venting port ( 11 ) in order to apply a hydraulic pressure to the liquid covered filter material ( 13 );

recording the applied pressure of the measurement gas with a pressure sensor ( 17 ) and/or recording the applied measurement gas volume with a flowmeter ( 63 );

determining the integrity status of the filter device ( 3 ) based on the recorded applied pressure and/or applied volume of the measurement gas; and

closing the measurement gas valve (V 5 ) and opening the dry gas valve (V 7 ) for drying the filter material ( 13 ); and

performing the integrity test procedure.

8. The method of claim 7 , wherein the integrity test procedure comprises the step:

sterilizing the filter material ( 13 ) in the filter device ( 3 ).

9. A non-transitory computer readable medium containing computer executable instructions to perform a method, the method comprising:

executing the method of claim 7 for carrying out the integrity test on the filter device.