Application Note: Separation Process Evaluation And Validation Using MFI

Integrity testing of sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry. FDA guidelines also require integrity testing of filters used in the processing of sterile solutions such as large volume parenterals (LVPs) and small volume parenterals (SVPs). MFI analysis of filter influent and effluent provides an effective means of evaluating alternative filtration/separation processes and of validating the performance of selected techniques. Strengths of the technology in performing these tasks include high detection sensitivity, capability of measuring large and small concentrations and the additional insight provided by captured particle images.