Multiphysics Simulation of Needle Clogging in Pre-Filled Syringes

Area of Science:

• Biopharmaceutical Engineering
• Materials Science
• Computational Fluid Dynamics

Background:

• Needle clogging in prefilled syringes is a significant challenge, impacting drug delivery efficacy and product quality.
• Current understanding of clogging mechanisms is limited, hindering effective design strategies.
• Computer simulations offer a powerful approach to investigate and predict clogging phenomena.

Purpose of the Study:

• To investigate the mechanisms of needle clogging in prefilled syringes using multiphysics simulations.
• To evaluate the impact of various parameters on the onset and probability of clogging.
• To leverage simulation insights for the rational design of prefilled syringes with minimized clogging.

Main Methods:

• Multiphysics simulations of monoclonal antibody solutions in prefilled syringes.
• Evaluation of two primary clogging mechanisms: fluid evaporation and shear-induced jamming.
• Systematic study of parameters including solution properties, needle diameter, barrel hub shape, and plunger speed.

Main Results:

• Identified critical material, geometric, and operational parameters influencing needle clogging.
• Demonstrated the role of protein concentration on solution viscosity and its effect on clogging.
• Quantified the impact of plunger speed and needle geometry on shear-induced jamming.

Conclusions:

• Computer simulations provide valuable insights into prefilled syringe clogging mechanisms.
• Simulation-driven analysis enables systematic evaluation and optimization of drug product formulations and device designs.
• This approach facilitates the development of prefilled syringes with reduced clogging probability for improved drug delivery.