(145d) Real-Time Particle Size and Shape Characterization Using in-Process Video Imaging Process Analytical Technology (Pat) in Dynamic Processes

The Mettler-Toledo Lasentec in-line Particle Vision and Measurement (PVM) in-process imaging system have been successfully implemented in the pharmaceutical world to monitor and characterize particle growth at the mesoscale and the particle size distribution at the macroscale. The PVM is a unique in-process imaging system capable of providing high-resolution images at most solids concentrations. With resolution below 3 microns and the ability to be inserted directly in a process line or reactor, the in-process video microscope provides an unsurpassed qualitative understanding of the change to particles and particle structures during dynamic processes. The PVM allows the user to characterize or visually confirm surface morphology and/or microstructures. As a quantitative tool, advanced image analysis techniques are implemented, in which particle properties and characteristics specific to the process (i.e., crystallization, granulation, polymorphic shift, etc.) are reported (e.g., length, width, aspect ratio, particle projected area and perimeter). Several examples, including droplets in crude oil emulsions and a polymorphic shift in carbamazepine, are provided to demonstrate the application of in-process video imaging and image analysis to characterize particle shape and size, as well as dynamic process changes.