(407b) QbD Approaches for Continuous Manufacturing

In this talk, we discuss multiple examples of application of QbD ideas and principles to the design of continuous manufacturing systems. Examples include the use of DoE methods for the characterization of system subcomponents (feeders, blenders, feed frames, tablet press) and the identification of critical process variables, examination of the effect of process parameters (blend composition, shear, strain) on the material properties of intermediate and finished products (blend uniformity and flowability, tablet hardness and dissolution) and the analysis of the integrated system.