West Plastic Syringe With Prefixed Needle Targets Biologics

West (www.westpharma.com) has expanded its family of cyclic olefin polymer (COP) products with the introduction of the Daikyo Crystal Zenith (CZ) 1-mL long insert needle syringe system. The 1-mL long format has been favored for packaging of biologics in prefilled syringes. In manufacturing at West’s Scottsdale, AZ, facility, the needle is insert-molded into the plastic syringe.

dhesives and tungsten residues—potential contaminates in glass syringes with staked needles—are avoided, says Graham Reynolds, vice president, marketing and innovation, West.

Automated cleanroom manufacturing processes including automated vision inspection at several stages and x-ray analysis of the needles ensure the highest quality and safety, Reynolds says.

“We have worked with filling companies and machine vendors in developing a product ready-to-fill with the right packaging and validation and inspection in place. We need to make sure customers can use this product effectively in their current processes,”
Reynolds says.

“This is the first silicon-free plastic syringe on the market with a prefixed needle. The CZ 1-mL long insert needle system extends our family of CZ systems to an area of significant growth, where complex molecules’ more sophisticated devices need the benefits of a plastic material relative to glass,” Reynolds says.

The 1-mL long format is typically used for biologics where the drug is injected by hand or the prefilled syringe is incorporated into a disposable auto injector. West and Daikyo have offered Luer lock CZ syringes for some time, and many devices are marketed in this product, Reynolds says.

“The industry has a growing need for prefillable syringe systems that are break resistant, minimize interaction with the drug product, and provide options for use in self- administration devices such as auto injectors,” he says.

“The CZ 1-mL long insert needle syringe system is a timely solution in view of the recent significant jump in market recalls caused by glass breakage, delamination, and particles. (Apart from breakage in glass production) we are seeing recalls related to breakage or deployment failure in spring-based injectors operating with glass syringes.

“We believe there will be a transition to more plastic-based primary drug containment  systems, both vials and syringes,” Reynolds concludes.