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Introducing the FlowCam + LO
Perform Light Obscuration analysis for USP Compliance AND verify with images – all with ONE run & ONE instrument
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Does your lab use Light Obscuration to comply with USP 788 guidelines?
LO data shows particle size distribution, but gives you no insight into what kinds of particles are in your sample.
Given that LO converts all particles to a sphere (equivalent spherical diameter or ESD), it's possible that extrinsic particles would have the same ESD as your proteins, and would pass the LO test. The image above shows the variety of particles you might see with a similar ESD (shown here: proteins, agglomerates, silicone droplets, air bubbles and other contaminants - silica, glass shards).
A sample like this might pass USP size limits, but still fail at the trial stage. The FDA recalled Peginesatide/Omontys in 2013 due to severe adverse post marketing events that could have been avoided with visual analysis.
Now, for the first time, you can obtain LO data to meet regulatory guidelines, and also verify your data with real images, all with a single instrument, and one sample run.
The new FlowCam + LO combines the FlowCam's patented flow imaging microscopy (FIM) technology with an embedded light obscuration (LO) module - so you visually confirm the particle makeup of your formulation.
Benefits of the FlowCam + LO
Collect and process data for FIM and LO sequentially
Test for USP 788 compliance and confirm your results with digital images
Reconcile data between two runs of the same sample
Minimize required sample volume
Reduce bench time by combining two particle analysis techniques in a single instrument
Learn more on our website
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Yokogawa Fluid Imaging Technologies, Inc., 200 Enterprise Drive, Scarborough, Maine 04074, USA, +1 207-289-3200
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