Premounted Fluid Conveyance Assembly for Cell Expansion
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Solution Overview
Problem
Cell expansion systems face challenges in maintaining sterility and efficiency during equipment disassembly and reassembly, leading to prolonged downtime between cell expansion cycles, which hinders the rapid preparation of equipment for subsequent expansions.
Innovation Solution
A premounted fluid conveyance assembly is designed to be detachably attached to a cell expansion machine, allowing for quick exchange of used assemblies without the need for sanitization, featuring a tubing-organizer and integrated fluid conveyance system that includes a gas transfer module and bioreactor, enabling rapid setup for subsequent cell expansion cycles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If equipment is disassembled and reassembled between cell expansion cycles, then equipment can be prepared for subsequent expansions, but sterility cannot be maintained and downtime increases
Solution Approach 1:
The fluid conveyance system is divided into separate modular components (bioreactor, gas transfer module, tubing-organizer, fluid containers) that can be independently sterilized and reconfigured. This segmentation allows the machine itself to remain sterile while consumable components are replaced, eliminating the need to disassemble the entire system between cycles.
Solution Approach 2:
Components are pre-sterilized and pre-assembled in a controlled environment before being installed on the cell expansion machine. The tubing-organizer and fluid conveyance components are prepared in advance with all connections pre-formed, so that during cell expansion cycles only simple attachment/detachment operations are needed without complex assembly or sterilization procedures.
2Reliability
If complete equipment sanitization is performed between cell expansion cycles, then sterility is maintained, but downtime between cycles increases
Solution Approach 1:
The tubing-organizer, fluid conveyance components, and associated tubing are designed as disposable or limited-life items that are replaced rather than sanitized between cycles. These components are pre-sterilized in their packaging and discarded after single use, eliminating time-consuming sanitization procedures while maintaining sterility through proper disposal and replacement.
Solution Approach 2:
The consumable fluid conveyance components are extracted from the permanent machine structure. The machine retains only the durable, sterilizable core components (bioreactor vessel, pumps, sensors), while all temporary fluid pathways and tubing are removed and replaced, allowing rapid cycle-to-cycle transitions without machine sanitization.
3Ease of operation
If complex fluid conveyance system is assembled during each cell expansion cycle, then system functionality is achieved, but setup time and labor requirements increase
Solution Approach 1:
The entire fluid conveyance system including all tubing connections, valve configurations, and fluid container attachments is assembled and pre-tested in advance during manufacturing. The tubing-organizer is pre-configured with all fluid pathways established, so that during cell expansion operations the system is simply activated rather than assembled, dramatically reducing setup time and labor requirements.
Solution Approach 2:
Multiple separate components (bioreactor, gas transfer module, tubing-organizer, fluid containers) are merged into an integrated pre-assembled unit that functions as a single replaceable module. This consolidation eliminates the need to assemble and connect multiple separate components during each cycle, reducing both setup time and operational complexity while maintaining full system functionality.
Data Source
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AI summary
A premounted fluid conveyance assembly for use with a cell expansion machine comprises a tubing-organizer and a fluid conveyance system. The fluid conveyance system is at least partially attached to the tubing-organizer, and the fluid conveyance system comprises an oxygenator or gas transfer module, a length of tubing and a bioreactor all fluidly interconnected. The premounted fluid conveyance assembly is adapted to be detachably-attached to the cell expansion machine. Accordingly, after a premounted fluid conveyance assembly is used, it is removed from the cell expansion machine by disengaging it from the cell expansion machine. Thereafter, another premounted fluid conveyance assembly can be attached in place of the previously used premounted fluid conveyance assembly.