What are the reasons of failure of a filter during imtegrity test?
If filter housing remain leakage or loose connection, connection with integrity tester machine remain loose It’s help to failure integrity test. If use WFI and try again i think it pass but It’s not allow SOP.
Please let us know the following information,
- What is this filter? and its purpose?
- Is it for filtration of a sterile product? or is it a vent filter fitted in the storage tank?
- Is this hydrophilic OR hydrophobic type?
- Have you received a Certificate of filter integrity from the manufacturer/supplier of this filter when newly purchased?
- Is those for single use or multiple uses?
-Did the integrity test fail before filtration OR after filtration of the solution/ product?
All information is most important before filter integrity test.
I’m Added. It’s important Know flow rate and pressurized. Some filter flow rate 2.70ml/sec or 7.50ml/sec and pressure 1040mbar or other required. So before start programme need sure about this filter required programme.