Eliminate silicone in both barrel and plunger to protect sensitive biologics in glass pre-filled syringes (PFS)
GORE® IMPROJECT® Plungers eliminate the need for silicone as a lubricant in pre-filled syringes. Used with bare-glass (non-siliconized) barrels, these silicone-free plungers provide consistent delivery performance over time, and can protect complex or sensitive biologics from silicone-induced aggregation and particulation.
Today’s complex biologics, such as monoclonal antibodies and conjugate vaccines, can be vulnerable to silicone-induced protein aggregation, particle formation and drug product precipitation. In addition, over time, silicone migration can impact consistency of delivery, as it may change break loose/glide force (BLGF) and injection time. As a result, many biopharmaceutical manufacturers are actively seeking ways to address issues related to silicone sensitivity.
New GORE IMPROJECT Plungers for pre-filled syringes protect complex and sensitive biologics from silicone-induced protein aggregation and particulation. They do so by completely eliminating the need for silicone in both the syringe plunger and the glass barrel.
The syringe plunger material is completely silicone-free: Silicone is not a raw material and is not used in the manufacture of the plungers.
Designed for use in bare-glass (non-siliconized) barrels, these syringe plungers provide excellent container closure integrity (CCI) and maintain consistent drug delivery time in two-year and accelerated aging tests.