NovaPure® Syringe Plungers eBook: Chapter 4: Drug Product Compatibility

Maintaining the sterility and stability of injectable drug products is a critical challenge, especially as regulatory standards like EU GMP Annex 1 intensify. Throughout a syringe system’s lifecycle, environmental factors and component interactions constantly threaten drug integrity. For sensitive biologic molecules and viral vectors, the risk extends beyond simple contamination; contact with incompatible packaging materials can lead to protein adsorption, reduced dosage accuracy, and impaired long-term stability.

To mitigate these risks, advanced barrier technologies—such as ETFE-based films—are employed on plunger drug-contact surfaces. These films lower surface energy, creating a chemically inert boundary that prevents the migration of compounds from the elastomer into the formulation. Comparative analysis via headspace gas chromatography confirms that these barriers effectively separate the drug from the plunger, ensuring product efficacy and patient safety. Understanding these material interactions is essential for navigating modern containment challenges.