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Multiphysics Simulation of Needle Clogging in Pre-Filled Syringes.

Joseph M Barakat¹, Matthew Hancock²

¹Veryst Engineering, LLC jbarakat@veryst.com.

PDA Journal of Pharmaceutical Science and Technology

|May 14, 2025

Summary

Computer simulations reveal key factors causing needle clogging in prefilled syringes. Understanding these mechanisms helps design better drug delivery devices and improve product quality.

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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.

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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.