Container system and method for freezing and thawing a liquid product
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Solution Overview
Problem
Existing methods for freezing and thawing liquid drug substances in containers often result in non-uniform freezing and thawing, leading to cryoconcentration and container rupture, which can cause degradation and contamination of the product.
Innovation Solution
A system of containers with a consistent width and varying volumes, designed to maintain a uniform freeze-path length, along with a container-support platform for uniform heat transfer, and a method involving cooling and heating media flow to control the freezing and thawing processes, ensuring consistent performance across different container sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If containers of different volumes are used for freezing liquid drug substances, then the storage capacity and productivity are improved, but the freezing uniformity deteriorates leading to cryoconcentration and container rupture
Solution Approach 1:
The patent applies local quality by making the width dimension uniform across containers of different volumes, while allowing length and height to vary. This localized standardization of the width parameter ensures that the freeze-path length remains consistent, achieving uniform freezing throughout the container regardless of its total volume, thereby resolving the contradiction between storage capacity and freezing uniformity
Solution Approach 2:
The patent changes the geometric parameters of containers by maintaining a constant width dimension while varying length and height to achieve different volumes. This parameter change strategy ensures that the freeze-path length (width) remains constant across all container sizes, enabling uniform freezing performance while accommodating different storage capacities
2Productivity
If freezing rate is increased to reduce processing time, then productivity is improved, but the risk of container rupture and cryoconcentration increases
Solution Approach 1:
The patent changes the container geometry parameter (width) to optimize the freeze-path length, enabling faster and more uniform freezing. By adjusting this geometric parameter, the system achieves improved freezing speed while maintaining container integrity, as the uniform width ensures even heat distribution and prevents localized stress concentrations that could cause rupture
3Adaptability or versatility
If non-uniform freezing occurs to accommodate different container sizes, then adaptability is improved, but product quality deteriorates due to cryoconcentration
Solution Approach 1:
The patent applies local quality by standardizing the width dimension while allowing other dimensions to vary for different volumes. This localized constraint ensures that the freeze-path length remains constant, achieving uniform freezing and preventing cryoconcentration even in containers of different sizes, thus maintaining drug substance concentration uniformity while preserving adaptability
Solution Approach 2:
The patent creates equipotential conditions for heat transfer by maintaining a constant width dimension across all containers. This ensures that the thermal path length is uniform, allowing freezing to proceed evenly throughout the liquid regardless of container volume, thereby preventing cryoconcentration and maintaining composition stability while accommodating size variations
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 uniform freezing and thawing, reducing cryoconcentration and container rupture, thereby maintaining product quality and preventing contamination.
Implementation Method 1
a cooling or heating medium is passed through spaces between adjacent containers
Implementation Method 2
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 the containers
Implementation Method 3
a heating medium is passed through spaces between adjacent containers... causing the frozen substance contained within the containers to thaw, with generally uniform progression of the thaw front or thaw fronts within each of the containers
Data Source
Figure 1
Figure 2
Figure 3A~3B
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.