Flow imaging microscopy (FIM)

Flow imaging microscopy (FIM) is a powerful microscopy-based tool for counting, quantifying (in multiple ways), characterizing, and identifying subvisible particles that occur in water-based liquids. Our FlowCam 8010 instrument is capable of handling particles between 2 and 300 micrometers in greatest dimension.

FIM is an orthogonal method to light obscuration methods meaning it can be used to evaluate light obscuration results. The power of FIM is the ability to capture actual digital microscope images of each particle. Visualization provides the ability to characterize particles and classify them as distinct types, if not outright identify them.

This ability to identify the particles visually makes FIM especially valuable for biological therapies that may contain biological components, such as cellular matrices, which are easily distinguished from foreign materials, based on many possible characterization methods, but importantly confirmed by examination of the images.

At McCrone Associates, FIM is a screening tool that results in a visualization of populations of contaminants in client samples. It is a presumptive test (non-cGMP compliant and not yet added to our ISO 17025 scope of accreditation) that can provide valuable insight into cleaning validations, rinse studies, and other contaminant investigations.

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