(335h) An Assessment of Batch Powder Bin Blending Performance Via Process Analytical Technology (PAT) and Discrete Element Method (DEM) Simulation to Predict Blend Homogeneity

In recent years, continuous mixing of powders has been a topic of great interest in the pharmaceutical industry. Despite these advances, many solid oral dosage manufacturing processes still rely on batch powder blending to mix incoming raw ingredients. In this work, we describe a comprehensive assessment of bin blending performance/blend homogeneity via calibrated DEM simulations and experiments with an acetaminophen formulation. A range of process conditions are examined including bin scale, rotation speed, and powder fill level. Various blend performance assessment techniques are utilized including on-line NIR and off-line NIR of powder thief samples. Each of these are compared with corresponding virtual powder samples from DEM simulations as well as a DEM system-wide mixing index. Several key points related to the impact of process parameters and sampling/analysis methods on the observed blending performance are described.