A project team at Glaxosmithkline is using the FlowCAM particle imaging and analysis system from Fluid Imaging Technologies to learn more about particles found in samples of a parenteral formulation.
According to Fluid Imaging Technologies, the FlowCAM automatically detects particles in a sample, takes a high-resolution digital image of each particle detected and saves them for analysis with the count, size, shape, ESD and other corresponding measurements, all in real time.
Light obscuration, by contrast, is said to encounter difficulty determining the actual number of particles present since it may exclude transparent and translucent particles and cannot differentiate one type of particle from another, such as an air bubble or a foreign fibre from an aggregated protein.
The FlowCAM's ability to detect opaque, translucent and transparent particles and to automatically discern one from the other with its proprietary pattern recognition software provided advantages versus light obscuration and visual inspection as well as from other particle analysis methods.
The FlowCAM provided the team with the ability to see what particles were present, determine why they were present and understand whether the particles detected were related to the formulation or to the sampling technique.
Since installation in February 2010, the FlowCAM has been in continuous operation to automatically uncover trends in the number and/or type of visible particles present in the samples.
The FlowCAM data is also being used to verify the accuracy of the data generated by visual inspection.
