Cryopreservation Container System with Sterile Filter Assembly
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Solution Overview
Problem
Current cryopreservation and resuspension systems for body fluids face challenges in maintaining sterility and extending the shelf life of thawed products, particularly in settings without validated aseptic handling environments, leading to potential contamination and limited storage duration.
Innovation Solution
A closed and sterile container system comprising a cryopreservation container, a resuspension container, and a connection tube with a shut-off element, allowing for the addition of a resuspension solution to the cryopreserved body fluid without mixing during freezing, maintaining sterility and extending the shelf life beyond 4 hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional resuspension operations breach the storage container, then the product can be accessed for administration, but the product is subject to potential contamination and has a limited 4-6 hour expiry time
Solution Approach 1:
A sterile filter assembly acts as an intermediary component between the cryopreservation container and resuspension container, allowing fluid transfer while maintaining the closed sterile system. The filter assembly includes a filter holder with a membrane filter that permits passage of resuspension solution into the cryopreserved product without breaching container sterility, thereby extending product stability beyond the conventional 4-6 hour window
Solution Approach 2:
The sterile filter assembly is pre-attached to the cryopreservation container before freezing, extracting the filtration function from the resuspension step. This allows the system to maintain a closed sterile configuration during storage and thawing, with the filter already in position to receive resuspension solution without requiring container breach
2Reliability
If conventional systems require validated aseptic handling environments for resuspension, then product sterility is maintained, but the systems are not suitable for remote or austere settings without trained personnel and controlled facilities
Solution Approach 1:
The system performs self-sterilization through the closed container design with pre-attached sterile filter assemblies that remain sterile throughout freezing and thawing. The sterile barrier is maintained without requiring external aseptic handling facilities or trained personnel, enabling use in remote hospitals, rural health care settings, and austere environments while maintaining product sterility
Solution Approach 2:
The sterile filter assembly is pre-attached to the cryopreservation container before freezing in a controlled manufacturing environment. This preliminary sterile connection eliminates the need for aseptic handling during subsequent thawing and resuspension operations, allowing the system to be used in environments without validated facilities or trained personnel
3Reliability
If the container system maintains a closed sterile configuration during freezing, then product contamination is prevented, but resuspension requires complex aseptic processing procedures
Solution Approach 1:
The cryopreservation container, sterile filter assembly, and resuspension container are merged into a single integrated closed system with pre-established sterile connections. The filter holder is permanently attached to the cryopreservation container, and the resuspension container connects through sterile tubing, eliminating the need for separate aseptic handling steps and complex processing procedures
4Ease of operation
If resuspension solution is added to cryopreserved body fluid after thawing, then the product is prepared for administration, but the product must be administered within 4-6 hours limiting shelf life
Solution Approach 1:
The sterile filter assembly serves as a mediator that enables resuspension solution addition while maintaining the closed sterile system. This allows the resuspended product to remain stable for extended periods (up to 14 days for platelets, 3 months for other fluids) without the 4-6 hour expiry limitation, as the sterile barrier prevents contamination during the extended storage period
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 ensures the sterility and stability of the resuspended body fluid for an extended period, allowing for transportation and administration in remote settings, reducing waste and logistical challenges, with a shelf life of up to 14 days for platelets and 3 months for other fluids.
Implementation Method 1
When the container system is frozen, the shut-off element is closed such that the body fluid in the cryopreservation liquid and the resuspension solution cannot mix
Data Source
AI summary
The disclosure provides for a container system and method for the cryopreservation and resuspension of a body fluid. The container system may include a cryopreservation container comprising the body fluid in a cryopreservation liquid, a resuspension container comprising a resuspension solution, a connection tube sterilely connecting the cryopreservation container and the resuspension container, and at least one shut-off element actively associated with the connection tube.