Analysis of the Shear Stresses in a Filling Line of Parenteral Products: The Role of Peristaltic Pumping

Protein-based parenteral drug products processed in a filling line can be exposed to shear stress of varying magnitude depending on the operation. These shear stresses and other factors, such as interfacial stress, have been the focus of many studies in recent years on the cause of product degradation. Estimating shear stress in individual operating units represents the first step towards a more in-depth study of the shear-induced product instability. In this frame, the present manuscript shows an innovative workflow to obtain a computational model of a peristaltic pump and evaluate the exposure of the product to shear stresses. This was accomplished through Computational Fluid Dynamics simulations combined with Lagrangian Particle Tracking techniques. In this way, the shear stress history of each individual product particle passing through the peristaltic pump was taken into account. The results provide insight into shear stress dynamics within a peristaltic pump and show potential for future applications.