Analysis of the shear stresses in a filling line of parenteral products: The role of sterilizing filters

Abstract

This study investigates the impact of shear stress on protein-based parenteral drug products, particularly during the filling process, with a focus on the filtration unit. A 3D computational replica of a real sterilizing filter was developed using a stochastic geometry generation methodology, able to replicate realistic values of permeability, porosity, and pore size distribution. Computational Fluid Dynamics simulations were employed to analyze fluid dynamics within the filtration unit. The evolution of shear stress for massless tracers was examined to assess average shear stress in the sterilizing filtration unit. The results provide insights into shear stress dynamics and suggest potential scale-down strategies for industrial applications. The presented analysis is novel compared to most estimations of shear stress in sterilizing filtration units, which generally rely on mathematical calculations.