Silicone-oil migration in prefilled syringes induces smoke-like particulates in ultra-high viscosity formulations.

Abstract

Visible smoke-like particles are occasionally observed in ultra-high viscosity (UHV) formulations, such as ophthalmic viscosurgical devices (OVDs), stored in prefilled syringes (PFS), leading to reduced product yield. In this study, spatial distribution analysis revealed that smoke-like particles were significantly enriched near the silicone-coated plunger stopper, and the silicon content in the smoke-like samples was significantly higher than in normal samples. These results suggest that silico