FEP Cryopreservation Bag Structure for Leak Containment
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Solution Overview
Problem
Commercially available containers for cryopreservation are prone to fracture during preservation and thawing processes, leading to potential leakage and contamination of biomaterials and the surrounding environment, lacking a sterile, closed environment for safe storage and handling.
Innovation Solution
A container system comprising an inner bag with a sterile environment and an overwrap bag, both made from fluoroethylenepropylene (FEP) materials, which provides a closed and sterile environment for biomaterials, with access ports for fluid access and leak containment, ensuring the material remains sterile and secure throughout cryopreservation and thawing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional container materials are used for cryopreservation, then the container can be manufactured with standard materials, but the container is prone to fracture during preservation and thawing processes
Solution Approach 1:
The patent employs composite material construction by combining FEP inner bag material with outer container materials, creating a multi-material system that leverages the fracture resistance and flexibility of FEP at cryogenic temperatures while maintaining manufacturability through established composite packaging techniques
Solution Approach 2:
The patent changes the material parameter from conventional plastics to FEP (fluoroethylenepropylene), which has fundamentally different physical properties including superior flexibility and fracture resistance at -196°C, directly addressing the brittleness issue while remaining compatible with standard manufacturing processes
2Reliability
If conventional container systems are used, then the structure can be simple, but leakage and contamination of biomaterials and surrounding environment can occur
Solution Approach 1:
The patent implements a nested bag structure where an inner FEP bag is placed within an outer container bag, creating multiple containment layers. This nested configuration provides redundant leak prevention - if the inner bag fails, the outer bag contains the biomaterial, preventing environmental contamination while maintaining a relatively simple overall structure
Solution Approach 2:
The patent uses flexible FEP thin film material for the inner bag, which provides superior leak resistance through its flexibility and conformability, preventing punctures and fractures that occur with rigid conventional containers while maintaining structural simplicity
3Stability of the object's composition
If conventional plastics are used for container construction, then the container can be made with standard materials, but the material becomes brittle and fractures at cryogenic temperatures
Solution Approach 1:
The patent fundamentally changes the material parameter from conventional plastics to FEP, which exhibits opposite thermal behavior - remaining flexible and ductile at -196°C rather than becoming brittle. This parameter change maintains compatibility with standard manufacturing while achieving the required cryogenic stability
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 container system effectively prevents leakage and contamination, maintaining the sterility of biomaterials during cryopreservation and thawing, with FEP materials providing flexibility and resistance to fracture down to -196°C, ensuring the integrity and safety of the stored materials.
Implementation Method 1
FEP materials providing flexibility and resistance to fracture down to -196°C
Data Source
AI summary
A container includes an inner bag, where the interior of the inner bag includes a sterile environment for storing a material, at least one access port configured to provide fluid access to the interior of the inner bag, an overwrap bag, where the interior of the overwrap bag includes a sterile environment for storing the material and where the inner bag is enclosed within the interior of the overwrap bag, and an overwrap access port configured to provide fluid access to the interior of the overwrap bag. The material can include a biomaterial. Each of the inner bag, the overwrap bag, the at least one access port, and the overwrap access port can include a fluoropolymer such as fluoroethylenepropylene (FEP).