West says Crystal Zenith syringe is solution to pharmas' glass delamination problem
The Pennsylvania, US-based medical device manufacturer said it will create additional clean room manufacturing environments at its facility in Scottsdale, Arizona, which, when complete, will be capable of producing up to 20 million units annually.
“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 Morel, chairman and CEO of West.
“The renovation project will give us the space for additional sophisticated injection moulding technologies required for manufacturing Crystal Zenith syringes. These will be needed to support numerous customer stability trials and anticipated scale-up as customers realise the significant benefits of this system,” he added.
Ideal solution
West uses a cyclic olefin polymer - manufactured by Japanese affiliate Daikyo Seiko - in its Crystal Zenith syringes, which it says helps overcome many of the problems inherent in glass-based systems such as breakage and glass delamination.
Morel explained that by adopting a polymer-based delivery system, clients could ensure patient safety, as well as avoid the risk of product recalls.
“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,” explained 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.”
Automated manufacturing
Work at the Scottsdale manufacturing facility is expected to begin immediately, with the company planning to convert 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.
The facility will also handle the release of other Crystal Zenith systems such as vials and bulk drug containers. Renovations are scheduled for completion in the fourth quarter 2011.
