NEWARK, DE — W. L. Gore & Associates, Inc. (“Gore”) has officially launched the 0.5 mL silicone-free GORE® IMPROJECT® Syringe Plunger, designed to address a range of challenges associated with silicone in prefilled syringe systems. This innovative product, under Gore’s PharmBIO business, expands upon the company’s earlier release of the 1 mL GORE IMPROJECT Plunger in 2018.
Prefilled syringes traditionally rely on silicone to create a seal and provide lubrication between the barrel and plunger. However, studies have documented issues such as increased particulate levels, protein aggregation, ocular floaters, inflammation, and elevated intraocular pressure. Gore’s new silicone-free plunger offers a safer, high-performance alternative, particularly for applications like ophthalmic intravitreal injections.
Testing demonstrated that systems incorporating the 0.5 mL GORE IMPROJECT Plunger meet stringent USP<789> subvisible particle standards. The plunger also supports terminal sterilization and delivers reliable break loose and glide force (BL/GF) and container closure integrity (CCI) when paired with compatible syringe barrels and commercial filling systems.
“Gore’s 0.5 mL plunger, in combination with a silicone-free glass or advanced polymer syringe barrel, enables pharmaceutical companies to achieve what they’ve been asking for—to reduce risk associated with silicone by enabling its removal from the syringe plunger and barrel,” said Emily Oliver, Syringe Business Leader at Gore.
The development of this groundbreaking product involved close collaboration with pharmaceutical firms, contract manufacturing organizations (CMOs), sterilization experts, filling equipment providers, and syringe barrel suppliers to ensure its compatibility across the value chain.
“We involved key partners to ensure the product meets the needs of stakeholders throughout the value chain, including rigorous fill-and-finish requirements,” noted Russ Hornung, Business Development Manager at Gore. “This is a breakthrough solution for the industry and was designed with the goal of improving patients’ lives.”
With its silicone-free, patient-centric design, the 0.5 mL GORE IMPROJECT Syringe Plunger marks a significant advancement in prefilled syringe safety and functionality, underscoring Gore’s commitment to innovation and collaboration in addressing critical industry challenges.
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