The particle distribution produced in high shear wet granulation is a critical process parameter in ensuring consistency of granule flowability, tabletability, and product bioavailability. Optimization and control of particles during all stages of pharmaceutical processing help ensure Quality by Design (QbD) in solid dosage formulation. FBRM® and PVM® are probe-based Process Analytical Technologies (PAT) that are used to promote faster formulation development, improve process confidence, and control batch to batch consistency in manufacturing.
Formulators and engineers can optimize granulation development and scale-up by directly monitoring the granule distribution in real time. For high shear granulation, in process FBRM® and PVM® provide immediate feedback for batch control and repeatability, without the need for offline sampling and analysis.
Process Analytical Technology (PAT) tools in granulation promote faster and more thorough mapping of the experimental design space, enable consistent scale-up and tech transfer, and allow control of the process to a desired endpoint that assures downstream critical endpoint product quality and process efficiency.