System for scale-down the processes of freezing and thawing aqueous solutions of thermo-sensitive pharmaceuticals
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Solution Overview
Problem
Current methods for scaling down freezing and thawing processes of thermo-sensitive substances fail to replicate the equivalent thermal stresses experienced in large-scale manufacturing, particularly in small-volume containers, leading to inconsistencies in processing parameters and potential damage to biological and pharmaceutical products.
Innovation Solution
A scale-down system where at least 50% of the lateral walls of the container are insulated to match the equivalent radius and heat transfer resistance of large containers, ensuring equivalent freezing and thawing processes when both are under the same external thermal conditions, using an insulating shell adaptable to various containers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the same external conditions are applied to both large and small containers, then the experimental setup is simple, but the freezing and thawing rates differ significantly due to dimensional disparity
Solution Approach 1:
The patent applies insulation selectively to specific portions of the small container's external surface, rather than uniformly to the entire surface. By insulating only the regions corresponding to heat transfer areas in the large container, the method creates localized thermal equivalence while maintaining experimental simplicity.
Solution Approach 2:
The patent modifies the thermal parameters of the small container by adding insulation layers with specific thermal conductivities and thicknesses. This changes the effective heat transfer coefficient of the small container to match that of the large container, enabling equivalent thermal profiles despite dimensional differences.
2Duration of action of moving object
If external temperature is manipulated to achieve equivalent freezing or thawing time, then the total processing time can be matched, but the spatial distribution of thermal histories becomes significantly different
Solution Approach 1:
Instead of uniformly manipulating the external temperature of the small container, the patent applies localized insulation to specific regions. This creates non-uniform thermal resistance distribution that replicates the spatial thermal history patterns of the large container, maintaining both timing and spatial equivalence.
Solution Approach 2:
The patent creates a thermal copy of the large container's heat transfer characteristics by insulating the small container to reproduce the same heat transfer resistance pattern. This allows the small container to experience equivalent thermal histories without requiring identical dimensions or uniform temperature manipulation.
3Reliability
If insulation is added to the small container to reduce heat transfer, then the thermal profiles can be improved, but the device complexity increases
Solution Approach 1:
The patent reduces device complexity by applying insulation only to specific local regions of the container rather than covering the entire surface. This selective insulation approach achieves the required thermal equivalence while minimizing the added structural complexity.
Solution Approach 2:
The patent applies insulation to only the necessary portions of the container surface that correspond to heat transfer areas in the large container. This partial action approach provides sufficient thermal equivalence without the excessive complexity of complete surface insulation.
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 allows for consistent and representative small-volume freeze-thaw processes that mimic large-scale conditions, reducing product damage and improving quality control by maintaining identical thermal profiles and heat transfer coefficients.
Implementation Method 1
at least 50% of the lateral walls of the container are insulated to match the equivalent radius and heat transfer resistance of large containers
Implementation Method 2
when both are under the same external thermal conditions, using an insulating shell adaptable to various containers
Data Source
Figure 1a~1b
Figure 2
Figure 3a~3b
AI summary
This disclosure relates to a scale-down system (10) for freezing and thawing aqueous liquid mixtures of thermo sensitive substances comprising a small first container (100), and a holder for holding the first container and an insulator (300), wherein the holder is outwardly surrounded by the insulator such that the insulator insulates at least 50% of the holder and such that the heat transfer between the first container and a second, larger container (20) is equivalent. The active heat transfer surface of the scale-down container can be attached to a heat exchanger having a precise heat transfer coefficient. The first container may have a square cross-section, a triangular or a trapezoidal cross-section.