As per Interpretation 4.7 under Section C.02.029 Sterile Products, the integrity of the sterilizing filter
must be verified before and after use. However, the pre-filtration integrity testing for that type of products
could lead to radioactive contamination as a result of the venting process of the filter assembly that must be
performed before the start of product filtration. This would pose an unacceptable health risk for the operators
and could result in disruption of production until the facility is decontaminated. It is therefore acceptable to
use two filters of a minimum filter rating of 0.22 micron and to verify the integrity of the sterilizing filters
after use only for these products. However, data should be available from the filter manufacturer that the
filters are supplied pre-assembled and individually integrity tested by the filter manufacturer.
