Container System and Method for Freezing and Thawing a Liquid Product

Abstract

Container system and method for freezing (and subsequently thawing) a liquid such as a drug substance, such that all containers in a set have a uniform width, hence uniform freeze-path length, in the widthwise direction and perpendicular to major walls of the containers, irrespective of the particular length, height, and volumetric capacity of the various containers in the set. This leads to uniform freezing performance and thereby reduces cryoconcentration. The system also eliminates or reduces ice-bridging, and the potential for containers rupturing during freezing and thawing operations.

Description

FIELD OF THE INVENTION[0001]In general, the present disclosure relates to a system and method for processing liquid bulk drug substances and other pharmaceutical solutions. More particularly, the disclosure relates to a system, including a set of containers and other processing apparatuses, that is particularly well suited for freezing, transporting, and subsequently thawing such substances.BACKGROUND OF THE INVENTION[0002]In various contexts, there is a need to freeze and thaw a liquid product in a controlled manner, and to do so while maintaining quality of the liquid product. For example, it is common to produce a drug substance such as a vaccine, biologic, or pharmaceutical product, in bulk, liquid form; transfer the drug substance in liquid form into individual containers; and then freeze the drug substance in the containers. The frozen drug substance may then be shipped to a cold-storage facility, and subsequently shipped to a final-drug production site, where it is thawed and...

AI Technical Summary

Benefits of technology

This patent describes a system and method for freezing and thawing a liquid substance, such as a drug or other pharmaceutical solution, while preventing cryoconcentration and container ruptures. The system achieves consistent freezing and thawing across a range of container sizes by controlling the freezing process to maintain a constant freeze-path length from one container to another. The method includes insulating the headspace above the liquid with a shroud to limit heat transfer and prevent ice formation at the upper surface of the liquid. The frozen substance can then be thawed by flowing a heating medium through spaces between adjacent containers and agitating the liquid mechanically, while maintaining a generally uniform thawing process within each container.

Problems solved by technology

First, non-uniform freezing can lead to cryoconcentration, where freezing (e.g., of the water molecules in a given drug-substance solution) at different rates within a given container can lead to different levels of concentration of the drug substance throughout the container.

Second, if freezing is not uniform throughout the container, it is possible for the container to be breached or ruptured as the liquid drug substance freezes.

This is because uneven and / or non-uniform thawing within a given container or from container to container can lead to molecular aggregation; formation of precipitates; and / or other adverse consequences.

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