Uniform-Width Freezing Containers to Reduce Cryoconcentration
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Solution Overview
Problem
The challenge lies in freezing and thawing liquid drug substances uniformly to prevent cryoconcentration and container rupture, which can lead to degradation and contamination, especially when freezing and thawing processes are non-uniform across containers of varying sizes.
Innovation Solution
The system employs containers with a consistent width, ensuring a uniform freeze-path length across all containers, and uses a cooling/heating medium flow between containers to control the freezing/thawing process, along with an insulating shroud to limit headspace heat transfer, and mechanical agitation during thawing to maintain uniformity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If containers of different volumes are used for freezing liquid drug substances, then storage capacity and productivity are improved, but freezing uniformity deteriorates leading to cryoconcentration and container rupture
Solution Approach 1:
The patent applies local quality by making the width (freeze-path dimension) uniform across containers of different volumes, while allowing length and height to vary. This localized geometric constraint ensures that the critical freeze-path length remains constant, providing uniform freezing characteristics despite differences in overall container size and volume.
Solution Approach 2:
The patent changes the geometric parameters of containers by maintaining a constant width parameter while allowing volume to vary through changes in length and height. This parameter control approach ensures that the freeze-path length (width) remains consistent, resolving the contradiction between storage capacity and freezing uniformity.
2Loss of time
If freezing rate varies within a container, then faster freezing reduces processing time, but non-uniform freezing causes cryoconcentration and container breach
Solution Approach 1:
The patent controls the freezing process by maintaining a constant width parameter across all containers, which standardizes the freeze-path length. This parameter control allows for optimized freezing rates while ensuring uniformity, preventing both excessive processing time and container breach risks.
Solution Approach 2:
The patent creates equipotential conditions for freezing by ensuring that all containers have the same width dimension, which equalizes the thermal path length during freezing. This allows uniform heat transfer characteristics across all containers, enabling synchronized and controlled freezing rates that maintain container integrity.
3Productivity
If non-uniform thawing occurs in containers, then faster thawing increases productivity, but uneven thawing causes molecular aggregation and precipitate formation
Solution Approach 1:
The patent applies local quality by maintaining uniform width across all containers, which standardizes the thawing path length. This localized geometric consistency ensures that heat distribution during thawing is uniform across all containers and within each container, preventing molecular aggregation while maintaining efficient thawing speed.
Solution Approach 2:
The patent creates equipotential conditions for thawing by ensuring constant width dimensions, which equalizes the thermal path during the thawing process. This results in uniform heat distribution and consistent thawing rates across all containers, maintaining product composition stability while achieving high productivity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach ensures consistent freezing and thawing performance across containers of different sizes, reducing cryoconcentration and container rupture, thereby maintaining product quality and preventing contamination.
Implementation Method 1
causing the liquid substance contained within the liquid-containing containers to freeze, with generally uniform progression of the freeze front or freeze fronts within each of containers, by flowing a cooling medium through spaces between adjacent containers
Implementation Method 2
causing the frozen liquid substance contained within the containers to thaw, with generally uniform progression of the thawing within each of containers, by flowing a heating medium through spaces between adjacent containers
Implementation Method 3
an insulating shroud to limit headspace heat transfer
Data Source
AI summary
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.