Article: Quantifying Sterilizing Membrane Retention Performance

In aseptic processing, performance of sterilizing filtration is of critical importance. A filter device must provide high confidence of retaining organisms under production conditions as well as in worst-case validation scenarios. To achieve this performance, it is necessary to understand and quantify retention capabilities of sterilizing grade membranes. Such understanding needs to begin during design of the membrane used in a filtration device. To date, manufacturers have provided this information descriptively or semiquantitatively. The level of confidence or assurance is left to a user's interpretation. Here, I provide a framework for quantifying membrane retention performance when sterile filtrate is required.

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