Calibration Free Supersaturation Assessment and Control for the Development and Optimization of Crystallization Processes

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In the free webinar, Calibration Free Supersaturation Assessment and Control for the Development and Optimization of Crystallization Processes, a method will be presented which facilitates the calibration free use of in situ ATR-FTIR spectra for the production and control of qualitative supersaturation trajectories.

Crystallization scale-up

The quantitative use of in situ ATR-FTIR for real time supersaturation assessment has been well defined within literature. However, these now well structured and understood methodologies have yet to be incorporated into the standard pharmaceutical crystallization development due to time and calibration/statistical analysis experience. In the Calibration Free Supersaturation Assessment and Control for the Development and Optimization of Crystallization Processes webinar on November 4, a method to facilitate the calibration free use of in situ ATR-FTIR spectra for the production and control of qualitative supersaturation trajectories will be presented.

Development and scale-up experiments are performed in a 100ml and 1L scale automated laboratory reactors. These laboratory reactor platforms, used in conjunction with Process Analytical Technologies, are used to develop and optimize the crystallization of both an Active Pharmaceutical Ingredient (API) and benzoic acid. The use of this methodology for assessing and solving laboratory based tech transfers and scale-up issues is also demonstrated.

The use of a commercially available software package is shown to implement an open loop feedback control strategy, used in conjunction with ATR-FTIR peak height values. The presented strategy demonstrates how qualitative supersaturation trajectories can be controlled to a specific set point and in turn ensure particle dimension and quality are not jeopardized in the tech transfer and scale-up of these processes.

The knowledge gained when coupled with in situ particle dimension information significantly increase process understanding and as a result minimal experimentation is required to output a desirable crystallization process.

The webinar presenter, Mark Barrett, received his Ph.D. from University College Dublin (UCD) in Ireland, where he also studied Chemical Engineering. His thesis work focused on crystallization development and scale-up. Previously, Mark worked for Schering-Plough as a Process Development Engineer. Mark is now a Senior Research and Development Engineer at the Solid State Pharmaceutical Cluster (SSPC), based in Ireland. Mark Barrett also presented the Optimization and Scale-up of Anti-Solvent Addition Crystallizations From Lab to Pilot Plant Webinar Series.

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Patricia Hicks
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