- 4:30 PM

High Throughput Product / Process Monitoring and Control Using Automated Td-NMR Technology

Supriyo Ghosh, minispec Division, Bruker Optics Inc., 2700 N Crescent Ridge Dr, The Woodlands, TX 77381

The manufacturing processes in chemical/pharmaceutical industries involve application of various unit operations on raw materials. These processing steps induce multiple physico-chemical changes leading to the desirable properties in the final product. During the process development as well as the industrial-scale implementation of the same, monitoring of the effects of each processing step need to be fast, accurate and precise. TD-NMR (time domain nuclear magnetic resonance) is a PAT (process analytical technology) which can be utilized to look into the physicochemical processes at a molecular level and precisely quantify them, using a small bench-top instrument. It obtains the signal from the atomic nucleus in a material. Mathematical analysis of the TD-NMR signal reveals the changes occurring in molecular level in a material. Measurements can be done in a matter of a few seconds to obtain quantitative characterization of materials undergoing physico-chemical changes. The entire measurement procedure can be done in a continuous fashion using either an on-line system or an automated robotic system. In this presentation, the basic principle of TD-NMR technology will be introduced. Various high throughput automated TD-NMR characterizations relevant to process development for pharmaceutical/biotech industries will be elaborated including but not limited to: tablet hardness/density, contactless weighing of medicine, moisture in powder/tablet, moisture in lyophilized materials, solvent/oil content, crosslink density, crystallization, copolymer ratio, hydration, impurity quantification, drying kinetics, fat-moisture-protein content, emulsion stability, droplet size distribution in emulsions, lean-fat analysis of live animals and tissue, porous media microstructure and transport. Probable new areas of pharmaceutical/biotech industry where this TD-NMR technology can be exploited in the future will also be discussed.