3. Qualifying the performance of sterilizing filters

by Corinne DANAN and Alain RACHON

Sterilizing filtration belongs to the field of microfiltration. It is defined as a process which, when properly validated, is capable of physically retaining all micro-organisms from a fluid (gas or liquid), producing a sterile effluent downstream of the filter . Viruses are not considered in this document. This sterilization technique avoids heat treatment and is particularly well suited to heat-sensitive products. In particular, it can be applied to products which are subsequently distributed in their final container under aseptic conditions....