GlaxoSmithKline Embraces Imaging Particle Analysis to Automatically Reveal and Identify Foreign Matter in Parenterals
Automated FlowCAM® Termed Superior To Manual, Subjective Testing Methods
Yarmouth, ME, USA: To find out exactly what particles and how many might be hiding in samples of a parenteral formulation in development at GlaxoSmithKline, King of Prussia, Pa., a project team concerned with the accuracy of their subjective, manual particle counting methods such as visual inspection and light obscuration turned to the FlowCAM® particle imaging and analysis system from Fluid Imaging Technologies, Yarmouth, Maine. The FlowCAM automatically detects particles in a sample, takes a hi-resolution, digital image of each particle detected and saves them for analysis with the count, size, shape, ESD and dozens of other corresponding measurements, all in real time and with unprecedented speed and accuracy. Light obscuration, by contrast, according to Gregory Morrone, Associate Scientist, Biophysics, Biopharmaceutical Analytical Sciences for GlaxoSmithKline, encounters 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 foreign fiber from an aggregated protein.
The FlowCAM's ability to detect opaque, translucent and transparent particles and automatically discern one from the other with its proprietary pattern recognition software provided dramatic advantages versus light obscuration and visual inspection, as well as from other particle analysis methods. The FlowCAM provided 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, in contrast to the several other types of instrumentation that were also tested. 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.
For more information, contact Lew Brown, Fluid Imaging Technologies, Inc.; 65 Forest Falls Drive, Yarmouth, ME 04096 USA; 207.846.6100.; Fax 207.846.6110; fluidimaging.com; lew@fluidimaging.com. or Paul Entin at 908.479.4231; paul@eprmarketing.com
