PDA Letter Article

Putting the Pieces Together

by Wendy Saffell-Clemmer, Baxter Healthcare

Are the Components in Your Prefilled Syringes Compatible?

Prefilled syringes offer potential cost savings for high-value, complex, biologic products because minimal overfill volume is needed in the primary container as compared to vials (1). While a prefilled syringe offers many advantages for biologic products, manufacturers must carefully evaluate the potential impact of a prefilled syringe on product quality by conducting laboratory studies prior to selecting the final components. In particular, assessing the impact of silicone oil and tungsten residues is crucial.