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Micro-Flow Imaging (MFI) - officially called flow imaging microscopy (FIM) is a well-established and frequently-used technique for sizing, quantifying, visualizing and, in certain cases, identifying (sub-) visible particles. In MFI , bright-field images are captured in successive frames as a continuous sample stream passes through a flow-cell positioned in the field of view of a microscopic system. The digital images of the particles present in the sample are processed by image morphology analysis software that allows their quantification in size and count.

 

MFI has become an established technique for subvisible particle analysis, though no monograph/specifications in the pharmacopoeias exist so far. The instructional chapter USP<1787> mentions MFI as a possible orthogonal technique for subvisible particle analysis in addition to light obscuration. Even though MFI is also a light-based technique, it is typically superior to light obscuration in the detection of particles with a refractive index close to that of the surrounding formulation.