NEWARK, Del./USA (May 2025) — W. L. Gore & Associates, Inc. (“Gore”), a global materials science company, recently announced the commercial launch of the 0.5 mL silicone-free* GORE^® IMPROJECT^® Syringe Plunger within its PharmBIO business.  The new offering is specially designed for prefilled syringes used in various applications, including ophthalmic intravitreal injections, and complements the GORE IMPROJECT 1 mLL plunger which Gore launched in mid-2018.

Conventional pre-filled syringe systems use silicone to provide a seal and act as a lubricant between the barrel and the plunger.  However, peer reviewed literature highlights various problems with silicone including elevated subvisible particulate levels, silicone accumulation in the eye resulting in floaters, silicone-induced protein aggregation resulting in immunological responses, and ocular inflammation and increased intraocular pressure (IOP).  In addition, silicone-containing syringes have been associated with particle count increases and fatty acid creation over time.

The new plunger enabled syringe systems to achieve particulate levels below the limits of the USP<789> subvisible particle standard in testing performed.  The plunger is capable of being terminally sterilized and has been shown to provide suitable break loose and glide force (BL/GF) and CCI performance when used in combination with appropriate syringe components and commercial fill and finish processes. “Gore’s 0.5mL 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,” emphasized Gore Syringe Business Leader, Emily Oliver.

To develop this new product Gore worked closely not only with pharma companies, but also CMOs, terminal sterilization companies, machine companies that design equipment for fill operations, and leading syringe barrel suppliers to bring forth the 0.5 mL silicone-free GORE IMPROJECT Plunger for pre-filled syringes.  “We involved key partners to ensure the product meets the needs of stakeholders throughout the value chain including rigorous fill & finish requirements.  This is a breakthrough solution for the industry and was designed with the goal of improving patients’ lives”, highlights Russ Hornung, Gore Business Development Manager.

The GORE IMPROJECT Plunger may enable today’s more challenging ophthalmic injections without the need to introduce silicone oil, cross-linked silicone or resin enhanced silicone.  With increasing needs for precise, low-volume injections in ophthalmology, gene therapy, and pediatric care, Gore’s 0.5 mL prefilled syringe plunger offers a new alternative.  Designed for silicone sensitive applications, this innovation underscores Gore’s commitment to enhancing patient outcomes and to driving growth in the evolving injectable therapeutics market.

PharmBIO enables life improving therapies of our customers through our leading products and commercial capability. In a highly regulated industry marked by economic pressures and drug development and processing challenges, Gore provides technology-driven products and process components designed for safety, efficiency, reliability and productivity. Gore PharmBIO is focused on satisfying the evolving product, regulatory and quality needs of medical device manufacturers, pharmaceutical and biopharmaceutical customers. The products in the Gore PharmBIO portfolio are tested and manufactured under our stringent quality system.
https://www.gore.com/pharmbio

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion.
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W. L. Gore & Associates
Nicole Miller, Gore Communications & External Affairs
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W. L. Gore & Associates
Ernesto Sosa, Gore PharmBIO Global Marketing Leader
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Referenced peer-reviewed literature available upon request.
*silicone not intentionally added as a raw material or in the manufacturing process