Method for Determining a Displacement of a Stopper of a Pre-Filled Medical Container During Thermal and/or Pressure Variations

Abstract

A method for determining a displacement of a stopper of a pre-filled medical container during thermal and/or pressure variations. The pre-filled medical container including a barrel containing a medical composition, the stopper slidably arranged at a proximal end of the barrel and an air bubble extending from a free surface of the medical composition. The method including calculating parameters for a thermomechanical model of the pre-filled medical container according to an analysis of the pre-filled medical container; based on the thermomechanical model of the pre-filled medical container, computing a thermal profile of the components; based on said computed thermal profiles of the components, computing the air pressure in the air bubble following a gas law and the displacement of the stopper over time during said thermal and/or pressure variations; based on said computed displacement, determining a risk of breaching the container closure integrity as a consequence of the cumulative proximal stopper displacement.

Dependencies are inferred from the claim text.