Are You Changing Your Silicone Lubricant?
Dow Corning are revising their syringe lubricant formulation. There is a surfactant change and the removal of parabens with the replacement of DC365 by DC366 (at least in Europe). Will your injection system need revalidating?
MET can offer a reduced injection forces programme combined with stability testing to help demonstrate that there has been no change in syringe performance. This might be combined with a dose accuracy study. On the chemical side, a verification of the absence of particulates (particularly for protein based biosimilars) and the leaching properties of the syringe or cartridge may be prudent.
MET’s syringe validation and batch release testing services are conducted under ISO 17025 and GMP.