PAT and Process Monitoring in Crystallization Development and Manufacturing

Crystallization is an industrially important unit operation for purification and formulation of a wide range of chemical products, including pharmaceuticals and fine chemicals. Developing a crystallization process can be challenging, often complicated by multiple components and requirements that the solids are consistently isolated in the desired polymorphic forms, compounds, or solvates. Control of particle size distribution may be needed to avoid difficult filtrations or high impurity content. This session is focused on providing examples where Process Analytical Technologies (PAT) or other means of process monitoring have been used in the development or manufacturing of crystallization processes. PAT applications may include various spectroscopy (FTIR, NIR, Raman), particle size and counting techniques (FBRM, video imaging), and other on-line or in-line monitoring or sensing techniques. Novel approaches and methodologies to drive crystallization development or control manufacturing crystallization processes are of particular interest.