How Silicone Oil on Syringe Plungers Impacts Particles in your Formulation

Particulate Burden in Plasma Crosslinked Silicone Lubrication vs. Standard Silicone Oil

During their pre-clinical trial studies, one pharmaceutical company found protein/silicone oil aggregates in their prefilled syringe.  TriboFilm was tasked with reducing the amount of extractable silicone oil to help mitigate the risk of aggregation.  The only caveat being that the customer did not want to significantly change their existing syringe processing line.  

TriboFilm used their downstream atmospheric plasma crosslinking process to modify the customer’s siliconized syringe and turn it into TriboLink-Si®.  The data in the Figure below shows a significant improvement in particulate generation, just by plasma treating their existing product.  With only minor modifications, TriboFilm was able to demonstrate a clear path toward reducing the particle burden in these syringes.  For more information on the testing protocols, click here to Request access to TriboFilm’s Agitation Protocol.

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Figure:  Particle counts for standard silicone oil vs. crosslinked silicone oil (TriboLink-Si®)