“Our first offering is a 1mL luer lock system that is ideally suited for packaging and administering large-molecule biopharmaceuticals and vaccines,” said Ms. DeGrazio.
West introduced the Crystal Zenith RU prefillable syringe system to the European market at Interpack 2008.
The syringe barrel is manufactured from Crystal Zenith, a proprietary cyclic olefin polymer developed by Daikyo Seiko, Ltd., that is market-proven in Europe, Japan and the United States. Crystal Zenith is break resistant, which helps reduce product loss during filling, shipping, storage and administration. The material is highly transparent and drainable, can be autoclaved at 121 ºC and has excellent low-temperature characteristics, including tolerance of freeze drying and liquid-nitrogen exposures..
The Crystal Zenith prefillable syringe system includes a piston and nozzle cap with Daikyo Flurotec® barrier film on the drug contact surfaces.Flurotec imparts lubricity, so there is no need to apply free silicone oil to the syringe barrel or piston to enhance functionality. As a result, manufacturers can eliminate the presence of silicone oil from the syringe barrel and piston transferring to the drug product, a cause of protein aggregation and a possible source of immunogenicity risk and product returns. More importantly, the absence of silicone oil dramatically reduces the age-related variability of the Crystal Zenith syringe system’s functional properties compared to systems currently in the market.
To decrease the risk of incompatibility between the components and the drug, Flurotec film provides an effective barrier against organic and inorganic extractables. The fluorocarbon film reduces sorption of the drug product and improves drainability.
The combination of a Daikyo Crystal Zenith syringe barrel or cartridge and a fully laminated Flurotec piston creates a unique silicone-oil-free system that provides consistency in the critical functional properties of piston release and travel force, making the system the ideal choice for auto-injector applications.
Daikyo Seiko manufactures the Crystal Zenith syringe system at its facility in Japan using automated, world-class processes in a clean room environment. The components are vision inspected for a virtually defect-free product. Daikyo and West worked together to develop a packaging system that is appropriate for introducing the pistons and syringe barrels directly into aseptic and barrier isolator filling lines.
About West
West is the world’s premier manufacturer of components and systems for improving the safety and effectiveness of therapeutic and diagnostic health care deliver systems. This includes ready-to-sterilize and ready-to-use stoppers and seals for vials, plungers and other prefillable syringe components and an assortment of safety, reconstitution and delivery system capabilities and services. The Company also provides products with application to the personal care, food and beverage markets. West’s customers include the world’s leading pharmaceutical, biotechnology, generic drug and medical device producers. Headquartered in Lionville, Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Asia and Australia. For more information, visit West at westpharma.com.
Daikyo Crystal Zenith® and Daikyo Flurotec® are trademarks of Daikyo Seiko, Ltd., in Japan.