IMPLEMENTING A COLUMN PACKING METHOD FOR PROSEP-A~(TM) RESIN IN A 1200 mm ADJUSTABLE HEIGHT COLUMN

摘要

Implementation of packing procedures at industrial scale can be time consuming, inconsistent, and inflexible due to the constrains imposed by controlled documents. A reliable and reproducible packing procedure for industrial scale application can be developed using pilot scale columns of at least 400 mm. In this study, a packing method for PROSEP-A~(TM) was developed using a pilot scale 450 mm column. The method involved delivery of resin slurry through a slurry valve, a mixing step, and a constant flow packing step. Experiments in the pilot scale involved evaluation of the slurry percent, flow rates required, and volume of the packing buffer used during packing. The pilot scale method resulted in acceptable asymmetries and plate numbers. Based on these results, the method was implemented at industrial scale using an adjustable height column of 1200 mm in diameter. The bed integrity was assessed after packing and throughout the process runs using asymmetry, plate number, and data analysis of real-time chromatograms. This paper summarizes the method selected, implementation at scale, and process performance throughout 33 cycles.