Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach

There is a concern that low atmospheric pressure typically encountered during shipment could result in plunger-stopper displacement in prefilled syringes impacting sterility and container closure integrity (CCI) of drug product.