The new offering, designed specifically for prefilled syringes used in various applications, complements its 1 mL ImProject plunger. According to Gore, its uses extend to areas such as ophthalmic intravitreal injections.
Newark, Delaware-based Gore says conventional prefilled syringe systems use silicone to provide a seal and act as a lubricant between barrel and plunger. However, the company cites 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). Additionally, some silicone-containing syringes have been associated with particle count increases and fatty acid creation over time, according to a news release.
Gore’s new plunger enabled syringe systems to achieve particulate levels below the limits of the USP<789> subvisible particle standard. The plunger offers terminal sterilization and provides suitable break loose and glide force and CCI performance.
The plunger may enable today’s more challenging ophthalmic injections without the need to introduce silicone oil, cross-linked silicone or resin-enhanced silicone. It offers a new alternative for those in need of precise, low-volume injections.
“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,” said Gore Syringe Business Leader Emily Oliver.
