<b>EXPLORING REGIME MAPPING IN TOROIDAL FLUID BED GRANULATION: TOWARDS OPTIMIZED PROCESS CONTROL</b>
Creators: name: Koleilat, Line
Publisher: name: Purdue University Graduate School
Year: 2024
Subjects: classificationCode: 321405
subject: Pharmaceutical sciences
classificationCode: 400406
subject: Powder and particle technology
classificationCode: 401699
subject: Materials engineering not elsewhere classified
classificationCode: 409903
subject: Granular mechanics

description: Flow patterns in a toroidal-fluidized bed granulator were analyzed using the effects of wall friction on the bed pressure drop. Toroidal flows were generated by directionally inclined jets from a radially-slotted distributor plate. The relatively small open area of the slotted distributor provides significant jet velocities, inducing toroidal flow even at relatively low superficial airflows. In this aspect, the process is of interest to fluidized bed granulation wherein the toroidal flow can assist spray flux without excessive elutriation. The current dissertation explores the effect of toroidal multiphase flow on wall friction and pressure drop. Relevant process parameters include particle size, airflow, temperature, and bed inventory. Particle size growth is especially important in fluidized bed granulation; airflow and temperature parameters must balance with the binder spray enthalpy; and the bed inventory is relevant to capacity and throughput analyses. An empirical process model was developed to guide fluidized bed granulation with a consistent pressure-drop balance across the distributor plate and product bed during the granulation process.Fluidized bed granulation integrates several process transformations into a single unit operation. Transformations include powder fluidization, atomization of binder solution and wetting of the fluidized powder, growth and consolidation of granules, drying, and discharge of the fluidized product. The balance of the binder addition and drying rates is used in combination with fluidization (i.e., flow field) parameters to control the process. Balanced control of fluidization can be challenging in the context of micronized powders, prone to elutriation, for example as required in some pharmaceutical formulations. This manuscript explores the effects of thermodynamic and flow field parameters on the size and shape distributions of a challenging pharmaceutical formulation. Pre-wetting the powder mixture prior to fluidization effectively reduces elutriation, stabilizes the fluidization process, and results in narrower granule size distributions. Optimizing blowback pressure can further stabilize the process. These strategies contribute to improved control of fluidized bed granulation, particularly for challenging pharmaceutical formulations, enhancing both product quality and process efficiency.A regime map for a challenging pharmaceutical formulation was developed to link operational parameters to granule characteristics, establishing a stable processing space that connects moisture gain with particle size and shape distributions and uniformity. This comprehensive framework supports scale-up and reliable application of fluid bed granulation in pharmaceutical and related industries, contributing to improved process efficiency and product quality. The findings presented here advance the scientific understanding of toroidal fluid bed granulation and offer practical and actionable strategies for controlling this process.