Storage unit for use in freezing, storing and thawing of biopharmaceutical materials and method of assembling a freeze/thaw containment system with such storage unit
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Solution Overview
Problem
Current flexible pouches for biopharmaceutical fluids face challenges in freezing and thawing due to brittleness and ice expansion, leading to increased leakage risk and uneven fluid distribution, with existing solutions either being complex or inefficient in preventing liquid concentration in the middle area.
Innovation Solution
A storage unit comprising a protecting body with two plates and a holding device that constrains the flexible pouch, allowing for controlled expansion and shrinkage, with positioning members to prevent excessive inward movement and maintain uniform fluid distribution by limiting shrink strokes at intermediate parts more than end parts, thus preventing bulging and enhancing handling and freezing efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid container with positioning means is used to protect the flexible pouch, then the pouch is protected from movement during shipping, but the container has a large useless volume and increases leakage risk if positioning means are not adequate
Solution Approach 1:
The patent employs flexible shells and thin films by using a protecting body made of flexible material that can adapt to the pouch's shape. This flexible protecting body provides adequate support and positioning during shipping while conforming closely to the pouch, thereby minimizing unnecessary volume. The flexibility allows it to move with the pouch rather than creating rigid empty spaces.
2Quantity of substance
If the flexible pouch is allowed to expand freely during filling, then the pouch can accommodate the fluid volume, but a significant bulge forms in the middle, making freezing time longer and fluid distribution uneven
Solution Approach 1:
The patent applies dynamics by making the protecting body partially displaceable within the holding and retaining device. This dynamic arrangement allows the protecting body to move and adapt as the pouch expands during filling, providing controlled constraint that prevents excessive bulging while still accommodating the fluid volume. The dynamic system balances between allowing necessary expansion and preventing harmful bulge formation.
3Strength
If the protecting body is made rigid to protect the pouch, then the pouch is protected from external forces, but the protecting body cannot adapt to pouch expansion and shrinkage
Solution Approach 1:
The patent applies parameter changes by using a protecting body made of flexible material whose physical properties allow it to change its degree of rigidity. The protecting body maintains sufficient rigidity to protect against external forces while simultaneously being flexible enough to adapt to the pouch's expansion and shrinkage. This is achieved through selecting materials and designing structures that exhibit appropriate mechanical properties across different states.
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
The solution provides a robust freeze/thaw containment system that maintains flexibility, reduces leakage risk, and ensures uniform fluid distribution, making it easier to freeze and handle frozen pouches without modifying the pouch design, thereby increasing confidence in handling and storage.
Implementation Method 1
the positioning members being distributed longitudinally and limiting shrink stroke of the longitudinal sides of the protecting body by a retaining effect due to engagement of the positioning members with the two opposite margin portions
Implementation Method 2
The two plates are able to sandwich the flexible pouch for constraining the flexible pouch
Implementation Method 3
In addition, ice volumetric expansion can cause significant mechanical stress leading to bag, port, tubing, or connector breakage
Data Source
Figure 1
Figure 2~3
Figure 4~5
AI summary
A flexible pouch is placed in a stack provided with two plates forming a protecting body (12) to sandwich and constrain the pouch. At two opposite margin portions, the protecting body has slots (51, 52, 53) or interlocking members for cooperating with positioning members of an outer holding device (HR). Between lower and upper parts of the holding device, the two plates can move during filling of the pouch and the margin portions shrink inwardly in a protecting body plane. Some of the positioning members act as stoppers (41') to have lower clearance range for shrink strokes of the protecting body in a middle part thereof, as compared to a higher clearance range (X2) at respective longitudinal end parts of the margin portions. A higher constraining effect can be obtained in a center of the pouch, to limit maximum thickness of its content, which is of interest for managing freeze/thaw operations of biopharmaceutical content of the pouch.