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Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.
Schott and W.L. Gore & Associates collaborated to introduce a prefillable, silicone-free glass syringe (PFS) system that eliminates the need for silicone, which has the potential for harmful interactions with drugs, but has long been necessary for prefillable syringes to help reduce injection force, Schott said in a Nov. 5, 2019 press release.
The new system combines Gore ImproJect Plungers with Schott’s syriQ BioPure silicone-free syringes. The companies say it is the only commercial option for a silicone-free PFS to protect sensitive biologics from potential interactions with silicone, which Schott says is a growing need.
“Biologics stored in prefillable glass syringes can come into contact with up to seven components that have the potential to leach and interact,” said Dr. Nicolas Eon, senior global product manager at Schott, in the press release. “This product allows a new class of drugs to be manufactured and stored in prefillable syringes.”
Schott’s syriQ BioPure silicone-free syringes use no silicone inside the syringe barrel. Careful attention to geometry and dimensions aids the ability to maintain a consistent gliding force and injection duration over the shelf-life of the product and maintains container closure integrity. The new syringes are made of FIOLAX CHR glass tubing that is 100% inspected with the help of a big data process named perfeXion, which ensures tight dimensions and a high cosmetic quality of each barrel. In addition, the syringes have ultra-low tungsten residuals as well as low cannula adhesive residuals to lower the extractible profile and reduce risk of container/drug interactions.
The barrels will now be offered with Gore ImproJect silicone-free plungers to further eliminate the risk of container interaction with sensitive biologics. Designed for use in bare-glass (non-siliconized) barrels, these plungers can help to protect complex or sensitive biologics from silicone-induced aggregation and particulation while maintaining consistent injection performance over time.
“Pharmaceutical manufacturers seeking to avoid silicone induced aggregation and sub-visible particles have had to choose vials even when they wanted to offer other delivery options,” said Christiane Gumera, product specialist at Gore, in the press release.
The new product won an award for excellence in pharmaceutical packaging at the 16thannual CPhI Pharma Awards.