The WFI syringe, which was developed in partnership with German contract manufacturing organisation (CMO) Vetter Pharma, is designed to eliminate interaction between lyophilised drug components and diluents.
The WFI product combines the FluroTec barrier film with Vetter’s tamper evident V-OVS technology in a pre-assembled single unit capable of holding 0.5 to 3.0ml volumes of pharmaceutical and diluent.
The FluroTec film, which was co-developed by West and Japan’s Daiyko Seiko, is designed to prevent any chemicals leaching from the outer packaging into the diluent and compromising its purity.
The V-OVS closure system consists of a tip cap designed by West, combined with Vetter’s Leur lock and a tamper evident seal that the firms claim will provide improved security and stability.
Vetter’s Oskar Gold explained that the firm will manufacture, fill and sterilise the WFI range at its facility in Langenargen, Germany from where it will ship them to pharma industry customers worldwide.
Gold also explained that the syringes meet with the regulatory requirements of key pharmaceutical markets including Japan, Europe and the US and went on to say that documentation will be supplied with each order.
Pre-filled syringe sector
In an increasingly global market, where drugs made in Asia can be sold in Europe and vice versa, an rising number of manufacturers are turning to lyophilisation to improve the stability of products during shipping.
However, since lyophilisation is dependant on a diluent for reconstitution, the need to prevent the two components mixing ahead of their use is critical. This need, coupled with growing market demand for pre-filled syringes, is the market West and Vetter are targeting.
In addition, a recent survey by Greystone Associates suggested the cost of biologics has intensified the interest in prefilled syringes to reduce cost and waste associated with the handling of vial-packaged drugs.