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

Abstract

Fill-finish of parenteral formulations represents a crucial step in the pharmaceutical industry that necessitates careful monitoring of product stability down the line. Shear stress and interfacial stress are two elements that threaten product stability, the respective contributions of which are still up for debate. This article focuses on the analysis of shear stress in the sampling phase of the filling line. Specifically, Computational Fluid Dynamics (CFD) simulations were employed to determine the shear stress distribution experienced by a protein-based parenteral drug as it passes through sampling fittings of various shapes under laminar and turbulent regime conditions. Rather than seeking the specific mechanism triggering the destabilization of a product, an attempt was made to analyze the fluid dynamics within these fittings and offer further understanding of the resulting shear stress. In addition, information was collected on the product path within the fittings, which allowed the identification of equations suitable for describing the shear stress distribution. The proposed approaches made it possible to consider the actual flowrate subjected to a given shear stress at a given time. Finally, a comparison was drawn with respect to the fluid dynamics within classical straight tubing to outline differences. This study revealed that the shear stress experienced within the fittings was higher than that in the tubing. Moreover, significant differences were reported in the T-fitting case under turbulent conditions.