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In 2011, the US FDA issued an advisory regarding the potential formation of glass lamellae in vials containing injectable drugs. This was in response to several drug recalls in 2010-11. The number of glass-related drug recalls has since declined greatly. This no doubt is due to key actions taken by pharmaceutical manufacturers before the drug goes to market, even during the development phases.
These actions are better risk assessments and more comprehensive/proactive evaluations of drug formulation interactions with container closure systems. Such actions are especially encouraged as the glass delamination phenomenon may take months, or even years, to occur. Evaluating only during manufacturing is ineffective, and risks not only recalls, but patient safety.
At West, we highly recommend this proactive approach. And to enable customers in using it, we have gathered our expertise in container and delivery systems into comprehensive, customizable Integrated Solutions proposal packages. These comprise relevant testing for any phase of the drug development process, and across all systems, whether based on glass or polymer (e.g., Daikyo Crystal Zenith® cyclic olefin polymer).
With the growing need to store at cryogenic temperatures (gene and cell therapies), and use silicon-free components, polymer components are often preferred to those of glass. The Integrated Solutions approach enables customers to make the right choices. For more, please contact a West Technical Customer Service (TCS) representative or visit our Daikyo Crystal Zenith cyclic olefin polymer vials page and the Integrated Solutions page.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.