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Imaging Particle Analysis - Pharmaceutical & Biopharmaceutical Applications - Exceptional QC from R&D to Production
- FlowCAM® can play a valuable role in drug research and development - helping to bring timely drugs to market faster. In the testing phase, FlowCAM® can provide a feedback loop to determine the exact size and shape of biological material and compounds, making it an important tool for stability studies.
- In manufacturing, FlowCAM® can be used to provide continuous monitoring, for process control, and to test batch samples for quality control.
The FlowCAM is being used by several leading pharmaceutical companies to characterize particles - such as protein aggregates (image on right), air bubbles and silicone (Si) oil droplets - in therapeutic protein formulations and vaccines. Imaging particle analysis provides a much more detailed look at the particulates than does classical light obscuration technologies used to comply with USP method 788. Not only does FlowCAM provide information on particle size, concentration and appearance, but it also requires much less sample than light obscuration techiques (typically less than 1ml). Further, FlowCAM can characterize agglomerates which are transparent and therefore not detected by light obscuration devices.
Particle concerns can be addressed by three FlowCAM configurations, two that are optimized for specific particle size ranges, and one for general purposes:
- Small particle analysis - Uses up to 3 magnifications for characterizing particles sizing from 1 µm to 300 µm (3 µm and up for particle identification and differentiation)
- Large particle analysis - Uses one magnification for characterizing particles sizing from 20 µm to 1,000 µm (50 µm and up for particle identification and differentiation)
- General - Uses up to four magnifications for characterizing particles sizing from 1 µm to 800 µm (3 µm and up for particle identification and differentiation)
The FlowCAM is also used to characterize dry products that have been suspended in fluid media. Anything from suspended API's to column packing material to sand can be characterized by FlowCAM. It is the FlowCAM's versatility that allows it to be applied to a wide variety of fields.
FlowCAM's VisualSpreadsheet© software provides sophisticated pattern recognition capabilities which can automatically characterize different particle types in a heterogeneous solution. Additionally, with FlowCAM's color imaging capability and high quality images, even subtle determinations such as the difference between an air droplet and a silicon droplet can be determined.
Silicon droplet (left) and
air droplet (right) as imaged
by FlowCAM.
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