Gore Introduces Silicone-Free Plunger for Ophthalmic Syringes

W. L. Gore & Associates Inc. (Gore) has launched the 0.5 mL silicone-free* GORE IMPROJECT Syringe Plunger, a new offering specially designed for prefilled syringes used in various applications, including ophthalmic intravitreal injections. The new product complements the GORE IMPROJECT 1 mLL plunger the company debuted in mid-2018.

Conventional pre-filled syringe systems use silicone to provide a seal and act as a lubricant between the barrel and plunger. 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 enables syringe systems to achieve particulate levels below the limits of the USP<789> subvisible particle standard in testing performed. The plunger can be 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 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,” Gore Syringe Business Leader Emily Oliver said.

To develop this new product, Gore worked closely not only with companies, but also contract manufacturing organizations, terminal sterilization companies, machine companies that design equipment for fill operations, and syringe barrel suppliers.

“We involved key partners to ensure the product meets the needs of stakeholders throughout the value chain including rigorous fill and finish requirements. This is a breakthrough solution for the industry and was designed with the goal of improving patients’ lives,” Gore Business Development Manager Russ Hornung stated.

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, according to the company. Designed for silicone sensitive applications, this innovation underscores Gore’s efforts to driv growth in the evolving injectable therapeutics market.

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.

W. L. Gore & Associates is a global materials science company employing approximately 13,000 workers. The team generates $5 billion in annual revenues.

* Silicone is not intentionally added as a raw material or in the manufacturing process.