Vital Components for Biologics: A Checklist to Mitigate Risk and Assure Performance in Delivery Systems

[Article Title]

As demand for complex biologics grows, choosing the right primary packaging for high-value injectables has never mattered more. Elastomer components like plungers, stoppers, needle shields and seals can make or break the performance of pre-filled syringes, cartridges, pens, autoinjectors and on-body devices. This checklist from Datwyler covers the five areas that matter most: formulation compatibility, functional performance, device and operational compatibility, sterilization, and validation and regulatory compliance. You’ll get practical guidance on reducing extractables, handling high-viscosity formulations, getting through Annex 1 “double sterilization,” and speeding up supplier qualification. Download it to lower risk and protect drug performance from development through commercial scale-up.

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