Method for determining displacement of a stopper of a filled medical container during fluctuations in heat and / or pressure

Abstract

The present disclosure relates to a method for determining the displacement of a stopper of a filled medical container during thermal and / or pressure fluctuations. The filled medical container includes a barrel containing a medical composition, a stopper slidably disposed at the proximal end of the barrel, and a gas bubble extending from the free surface of the medical composition. The method comprises the following. That is, a step of calculating parameters for a thermal processing model of the filled medical container according to the analysis of the filled medical container. A step of calculating the thermal profile of the components based on the thermal processing model of the filled medical container. A step of calculating over time the air pressure in the gas bubble according to the gas law and the displacement of the stopper during the aforementioned thermal and / or pressure fluctuations based on the calculated thermal profile of the components. And a step of determining, based on the calculated displacement, the risk of violating the integrity of the container stopper as a result of the cumulative proximal displacement of the stopper.

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