redundancy filtering?

If a redundant filtration system is used in production (please note: two-stage sterilization filters in series are not necessarily redundant filtration, please refer to the previous summary:redundant filtering is redundant filtering?), it is not necessary to test the integrity of both filters every time.

Recommended TestPrimary Filter, if the primary filter integrity test passes, the redundant filter does not need to be integrity tested.

ifprimary filter integrity test failed, yes.Redundancy Filterbe conducted and shall be successfully passed. In addition to recording and investigating the main filter that failed the test, it should also be carried out at this time.Risk Assessmentto ensure that the connections and components between the two filters are intact during the production of the batch, there is no risk of contamination, and the failure of the main filter does not increase the risk of contamination of the system. In this case,Redundant Filter Integrity Test Successfulis acceptable and can be used as the basis for product release.

If the product is not exported to the EU region, usuallyrecommended integrity testing, but in some cases, it can be passed.Risk Assessmentway to determine whether to carry out, and test which level of filter or two-stage filter should be tested, and determine whether to carry out before or after sterilization of the filter.after sterilization, consideration should be given to ensuring sterility between the two-stage filters.