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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.