West is adding the capacity to its headquarters facility in Scottsdale, AZ. The contract molder / manufacturer and its customer Daikyo have worked together on this syringe system for the past few years and market it as a slightly less costly in the short term, but immeasurably less expensive long-tern replacement for glass syringe systems. The slightly higher short-term costs are countered by the reduction of risk (of breakage or delamination) that pharmaceutical and biopharmaceutical companies assume when they opts for glass syringes.
Auto-injector systems traditionally use 1-ml long glass prefilled syringes. These systems are the established standard but have limitations, including the potential for breakage and the potential for silicone oil and tungsten residues to induce protein aggregation in prefilled syringes. Silicone oil is used to increase lubricity in glass syringe systems. West argues that this oil can be distributed unevenly, leaving surface areas with insufficient lubrication. This will greatly increase the force required to operate the auto-injector and may lead to delivery of a partial dose to the patient.
The Crystal Zenith prefillable syringe system includes a piston and nozzle cap with Daikyo Flurotec barrier film on the drug contact surfaces. Flurotec film provides a barrier against organic and inorganic extractables and it imparts lubricity, so there is no need to apply free silicone oil to the syringe barrel or piston. The syringe barrel is injection molded from Daikyo's proprietary cyclic olefin polymer (COP). The material can be autoclaved at 121 ºC.
West says the additional clean rooms to be erected within its Scottsdale facility will give it room for injection molding cells sufficient to produce up to 20 million syringe systems annually. The facility will also handle the warehousing and release of other ready-to-use Crystal Zenith systems such as vials and bulk drug containers.
West is converting 32,000 square feet of existing space to include ISO 7 (Class 10,000) clean rooms for automated injection molding and assembly, microbiological and functional testing laboratories, and additional climate controlled and monitored warehouse space. Completion is scheduled for the fourth quarter of 2011.