(648b) Control of a Membrane Separation Process by UV / Vis P.a.T

This project demonstrated the benefits of controlling an Ultrafiltration/Diafiltration (UF/DF) membrane separation process by UV/Vis photometry. API freebase concentrations in the retentate (product) and permeate (waste) streams were monitored continuously. The ExP unit performed robustly and provided useful data in an engineering run, three ensuing validation runs, and a fifth manufacturing run. The UV/Vis PAT could streamline operation of the membrane process, potentially eliminating four in-process analytical samples and an additional 36 permeate grab samples taken to verify membrane integrity and detect product losses. The features of the UV/Vis photometer will be described, as will the design of the in situ sample loops, including full color photographs of the field installation and data collected.