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2. Integrity testing
The filters should be confirmed structural integrity before and after use, three methods: bubble point test, diffusion test and water invasion test can be employed according to the GMP. The wetting liquids are standard reagents(water, alcohol, etc) or process liquid.
1.Principle: The integrity test value is detected by statistical method, according to the differences of surface tension or other physical parameters of the different fluids.
2.Detected filter types:
Membrane filters(micron<1 um)
Bacterial removal membrane filters
Virus removal membrane filters
Hydrophobic air filters
3.Test items: bubble point, diffusion, pressure holding or water invasion test;
Cartridge filter test:
Plate filter test:
5.Integrity testing procedures
a. Wet the filter cartridge or membrane with the appropriate fluid
b. Connect the integrity tester with air source and power source, then link with the filter housing.
c.Start the integrity tester, input test procedure and data;
d. Install the wetted filter cartridge or membrane in the housing, auto detect and decide the results.
6. Notes of Integrity Tester
a. Power:100-240 V, 50/60Hz, 1.6A;
b. Air source requirements: clear, room temperature, dry, oil free compressed air or N2,
c. Air pressure: ＜7000mbar, normally 6000mbar;
d.Operating temperature: 5-40℃;
e.Relative humidity: 20~80%
a. Move carefully;
b.Stable the power voltage;
c. Ensure the quality of air and pressure stability;
d. Keep the instrument clean;
e. Avoid the liquid into the internal instrument;
f. Calibrate the pressure sensor periodically, Consult the instrument supplier;
g. When not use for a long time, place the filter integrity tester in boxes, and store in a dry place.