West Adds Cleanroom Manufacturing Environments In Scottsdale, Arizona
With biopharmaceutical companies seeking safe packaging and delivery solutions for high-value drug products, West Pharmaceutical Services, Inc. is preparing to increase its capacity for manufacturing the Daikyo Crystal Zenith 1mL syringe system. Ideally suited for biopharmaceutical drug packaging and delivery, the Crystal Zenith syringe system overcomes problems inherent in glass-based systems, such as breakage and glass delamination.
By creating additional clean room manufacturing environments within its Scottsdale, Ariz., facility, West will have room for production cells capable of producing up to 20 million units 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.
“We found a high level of interest in the Crystal Zenith insert needle syringe system during its formal launch at a customer open house in Scottsdale last October,” said Donald E. Morel, Jr., Ph.D., Chairman and CEO. “The renovation project will give us the space for additional sophisticated injection molding technologies required for manufacturing Crystal Zenith syringes. These will be needed to support numerous customer stability trials and anticipated scale-up as customers realize the significant benefits of this system.”
West is converting 32,000 square feet of existing space to include ISO 7 (Class 10,000) clean rooms for automated manufacturing, microbiological and functional testing laboratories, and additional climate controlled and monitored warehouse space. Completion is scheduled for the fourth quarter of 2011.
“In the past few months, several drug products have been recalled because of glass delamination, which creates glass flakes in drug solutions stored over time,” said Dr. Morel. “Recalls are expensive, cause serious interruptions to the drug supply chain and are potentially harmful to patients. Crystal Zenith containment solutions can overcome these and other problems inherent with glass.”
Daikyo Crystal Zenith, a cyclic olefin polymer developed by West’s Japanese partner Daikyo Seiko, Ltd., provides a proven solution to glass syringe problems.
West’s innovative system, device and component solutions help improve the safety and administration of injectable drugs. West’s proprietary materials science, formulation research and manufacturing technologies advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics and vaccines. West supports its customers from facilities in North and South America, Europe, Asia and Australia. For more information, visit www.westpharma.com. Follow West on Twitter: www.twitter.com/WestPharma