Effect of Silicone Oil Viscosity on Observed Particle Counts in Parenteral Container Closure Systems

In this study we looked at various grades and viscosities of silicone fluid both neat and as an emulsion to understand their effect on the subvisual particle load on the closures on which they were applied.

This information gives parenteral developers a science and risk based strategy to qualify primary parenteral packaging and enables them to make informed decisions based on quantitative data from this study.

Silicone oils provide the advantage of reducing friction, they also have drawbacks which can include transfer to filling line surfaces. Moreover, interactions with proteins and other drugs, causing haze on reconstitution of lyophilized drugs can occur as well as formation of subvisible and visible particles that frequently are counted as part of the overall particle burden in finished parenterals.

Jeff Smythe, Commercial Development Manager, Datwyler Pharma Packaging