Objective: To compare the results of two MFI instruments（MFI 5100 and MFI 5200） and demonstrate possible difference after analyzing five polystyrene particle standards and six monoclonal antibodies（mAbs） for sizing,counting and imaging quality. Methods: 5 μm,10 μm,15 μm,25 μm and 50 μm polystyrene particle standards were analyzed by MFI 5100 and MFI 5200 equipped with automated sample injector. Resultswere compared with the data measured by light obscuration as well as certified values. Six different mAbs were also analyzed by MFI 5100,MFI 5200 and HIAC,and the results were also compared. Results: Both MFI instruments have good sizing and counting precision for polystyrene particle standards. The measured particle sizes are comparable with certified values while the counting results are lower than the certified or light obscuration data. MFI 5200 has better image quality,however,MFI 5200 counting results are lower than those of MFI 5100. These differences may due to the differences in instrument design,data process and analysis algorithms. For mAbs, the counting results showed more variation. The two instruments may read higher or lower counts than each other depending on the sample and the sizing range. The counting results by light obscuration were lower than those by micro-flow digital imaging. Conclusion: MFI instruments have good precision and sizing accuracy for polystyrene standard particles. However,instrument differences exist. When used in quality control beyond Chinese Pharmacopeia methods of test for particulate matter in injection for particulate control,instrument variation should be considered and appropriate system suitability standard and data interpretation should be set up based on sample characteristics and the purpose of the method.
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