NEWARK– W. L. Gore & Associates has announced the commercial release of its new 0.5 mL silicone-free GORE® IMPROJECT® plunger, designed for use in ophthalmic pre-filled syringes. The launch expands Gore’s PharmBIO product line and addresses long-standing concerns over silicone-associated risks in injectable drug delivery.
This latest offering complements the previously launched 1 mL GORE IMPROJECT® plunger and is specifically engineered for intravitreal injections and other applications requiring precise, low-volume delivery. Unlike conventional syringe systems that rely on silicone for lubrication and sealing, Gore’s new plunger enables a completely silicone-free system when paired with compatible glass or advanced polymer syringe barrels.
“Pharmaceutical companies have been calling for syringe components that eliminate silicone-related risks, and our 0.5 mL plunger delivers exactly that,” said Emily Oliver, Gore’s Syringe Business Leader. “By removing silicone from the plunger and barrel, we can significantly reduce the potential for adverse effects in sensitive ophthalmic applications.”
Concerns about silicone in syringe systems have been documented in peer-reviewed studies, citing issues such as subvisible particulates, protein aggregation, immune responses, and increased intraocular pressure. Gore’s new plunger has been shown to meet stringent industry standards, achieving particulate levels below USP <789> thresholds, while also delivering reliable container closure integrity and consistent break loose and glide force performance.
The development of the new plunger involved collaboration with pharmaceutical manufacturers, contract manufacturing organizations, sterilization service providers, and syringe equipment suppliers. “We made sure to engage every stakeholder in the development process,” said Russ Hornung, Gore’s Business Development Manager. “This product isn’t just innovative—it’s been engineered to work seamlessly within existing commercial fill and finish environments.”
Gore’s 0.5 mL plunger is also capable of terminal sterilization, an essential requirement for many injectable therapies. It offers an alternative for growing markets such as ophthalmology, gene therapy, and pediatrics, where smaller dose volumes and heightened sensitivity to materials demand new approaches.
The launch underscores Gore’s broader commitment to improving patient safety and advancing the injectable therapeutics market through material science innovation.
