(745e) A DEM-Based Approach for Prediction of Pellet Mixing in a Full-Scale Conical Blender

Blending operations are prevalent in the manufacture of drug products within the pharmaceutical industry, but most often involve powders in diffusion/tumble blenders. In this work, the development of blending process for millimeter-scale pellets in a large-scale, conical screw mixer is discussed. A model-based approach using the discrete element method was used to guide process development. The DEM-based approach was used (1) predict the mixing time required for the full-scale process in a 6000 L conical mixer and (2) guide appropriate selection of blend uniformity acceptance criteria for pellet samples. An experimental mixing study at scale confirmed the mixing conditions and mixing time required to achieve a well-mixed batch.

WK, DM, MD, and BR are employees of AbbVie and may own AbbVie stock. DA is a former employee of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.