Freeze/Thaw Containment System for Biopharmaceutical Pouches
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Solution Overview
Problem
Current flexible pouches for biopharmaceutical fluids face challenges in freezing applications due to brittleness and ice expansion, leading to increased risk of breakage during shipping and storage, and existing protection systems are inefficient in maintaining uniform fluid distribution and compactness.
Innovation Solution
A freeze/thaw containment system comprising a flexible pouch sandwiched between two plates of a protecting body with a peripheral margin and a casing that extends planar in an empty state, featuring fastening elements and supporting members to secure the pouch, allowing for efficient protection and compact storage while preventing bulging and ice expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a flexible pouch is used to contain biopharmaceutical fluid, then the leakage risk is reduced and the pouch can be folded or stored flat, but the pouch is vulnerable to breakage during freezing due to brittleness and ice expansion
Solution Approach 1:
A protecting body comprising two rigid plates is positioned between the flexible pouch and external environment before freezing occurs. These plates absorb and distribute the mechanical stress generated by ice expansion, preventing the pouch material from fracturing due to brittleness at low temperatures.
Solution Approach 2:
The system combines the flexible pouch material with rigid protective plates to create a composite containment structure. The flexible pouch provides leak-proof containment while the rigid plates provide structural strength and resistance to freezing stresses, creating a synergistic protection system.
2Strength
If a rigid container is used to protect the flexible pouch, then the pouch is protected from mechanical stress, but the container has a large useless volume and the pouch can move within the container
Solution Approach 1:
Instead of using a rigid container with fixed walls, the invention uses thin rigid plates that directly contact and protect the pouch surfaces. This eliminates the need for large empty spaces between the pouch and container walls, significantly reducing the overall volume while maintaining protection.
Solution Approach 2:
The protecting body plates are designed to closely conform to the pouch dimensions, merging the protective function with the containment function. This eliminates the separation between pouch and container that creates useless volume, while the plates provide sufficient mechanical protection.
3Ease of operation
If the flexible pouch is not retained by positioning means, then the pouch can be easily accessed, but the pouch moves within the container during shipping increasing leakage risk
Solution Approach 1:
The protecting body is segmented into two separate plates rather than a single monolithic structure. This segmentation allows the plates to independently contact and stabilize the pouch from opposite sides, providing position stability during shipping while leaving the pouch accessible for removal when needed.
Solution Approach 2:
The thin plate structure provides stabilization through direct contact surfaces rather than through a complex rigid framework. This minimal contact approach prevents pouch movement during shipping while maintaining easy accessibility, as the plates can be quickly removed without obstructing pouch handling.
4Strength
If a protecting body with two plates is used to protect the flexible pouch, then the pouch is protected against freezing stresses, but the system complexity increases
Solution Approach 1:
The protecting body is divided into two separate plates rather than one complex piece. This segmentation simplifies manufacturing and assembly while providing effective protection, as each plate can be independently produced and then combined to sandwich the pouch.
Solution Approach 2:
Each plate serves multiple functions: it protects the pouch from mechanical stress, provides thermal mass for controlled freezing/thawing, and stabilizes the pouch position. This multi-functionality reduces the need for additional components, simplifying the overall system despite the two-plate structure.
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 system provides robust protection against freezing and thawing stresses, ensures uniform fluid distribution, and maintains compactness, facilitating quick analysis and reduced thawing time for biopharmaceutical compositions, especially for large volumes.
Implementation Method 1
ice volumetric expansion can cause significant mechanical stress leading to bag, port, tubing, or connector breakage
Implementation Method 2
The storage unit is for use in freezing, storing and thawing the biopharmaceutical composition contained in the flexible pouch
Implementation Method 3
The storage unit is for use in freezing, storing and thawing the biopharmaceutical composition contained in the flexible pouch
Data Source
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AI summary
A freeze/thaw containment system is provided, having a protecting body and a flexible pouch, of a first capacity, protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in a stationary frame and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch. One amongst the stationary frame and the protecting body includes fastening members for attachment of a casing configured for storing the bag, in order to have the bag fastened parallel to the protecting body. Two fasteners for cooperating with the fastening members are distributed around a bag containing part of a second capacity at least ten times inferior to the first capacity. Same biopharmaceutical composition is contained in the pouch and in the bag.