West syringe to minimise leachables

By Nick Taylor

- Last updated on GMT

Related tags Syringe West

West has launched the first silicone-oil-free, prefillable syringe,
which minimises the quantity of leachables in the pharmaceutical

The Daikyo Crystal Zenith RU uses Flurotec as a thin barrier film, providing lubrication without the risk of contaminating the medicine. Silicon, which is traditionally used, can leach into the drug, causing proteins to aggregate and immunogenic reactions in particularly sensitive patients. West has high hopes for the product, with Fran DeGrazio, vice president, marketing and strategic business development, saying: "Our first offering is a 1mL luer lock system that is ideally suited for packaging and administering large-molecule biopharmaceuticals and vaccines​." Flurotec is used to coat the surfaces which are in contact with the medicine, providing a barrier against organic and inorganic extractables while lubricating the moving parts. It is a fluorocarbon film, which is made from a modified ethylene-tetrafluoroethylene (ETFE) copolymer. West claims the system also offers consistent piston release, reduces absorption and improves drainage. Consequently the system should not suffer from the age related variability present in other syringes. In addition, as the syringe barrel is manufactured from a cyclic olefin polymer the risks posed by broken glass are negated. These risks extend beyond potential cuts to loss of product during filling, shipping, storage and administration. The barrel is manufactured by Daikyo, using its proprietary Crystal Zenith technology that can be autoclaved at 121 ºC and can also withstand freeze-drying and exposure to liquid nitrogen. This transfer of technology is part of the long-standing agreement between West and Daikyo. As part of this agreement West and Daikyo have also developed a packaging system that facilitates the introduction of pistons and barrels directly into aseptic and barrier isolator filling lines. Development of products incorporating Crystal Zenith technology was attributed to a $1.8m increase in research and development spending in the first quarter of 2008. West has put considerable resources into both Flurotec and Crystal Zenith product development and will be hoping the investments drive the company through 2008 after a challenging 2007. The recovery already appears to be underway with West's first quarter results for 2008 rising by 5 per cent year-on-year.

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