Cell Processing System with Segmented Syringe Filling
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Solution Overview
Problem
Conventional biological fluid processing systems often leave cells in product bags and risk contamination during transfer to syringes, due to inefficient separation and sterilization protocols.
Innovation Solution
A cell processing system with a separator that divides biological fluid into two streams, allowing for efficient transfer of one stream to syringes, and a filling system that uses a pump to transfer the product to containers, including syringe assemblies or flexible bags, ensuring complete product utilization and minimizing contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If conventional syringe transfer method is used, then product can be transferred from bag to syringe, but cells are left in product bag and contamination risk increases
Solution Approach 1:
The system segments the product container into multiple smaller syringe containers, with each syringe receiving a specific portion of the product. This segmentation ensures complete product utilization and eliminates residual cells in the original bag.
Solution Approach 2:
A sterile filling system acts as an intermediary between the product bag and syringes, enabling complete product transfer while maintaining sterility. The filling system includes sterile connectors and filling mechanisms that prevent contamination during the transfer process.
2Ease of operation
If manual syringe filling is used, then product transfer is possible, but sterilization protocols are compromised and contamination risk increases
Solution Approach 1:
The filling system merges multiple functions including sterile connection, automated filling, and sealing into an integrated system. This combination maintains sterility while simplifying the overall operation through automation.
Solution Approach 2:
The system performs self-sterilization through sterile barriers and disposable components that maintain sterility without requiring external sterilization protocols. The sterile filling system automatically maintains sterility throughout the filling process.
3Loss of substance
If complete product transfer to multiple syringes is implemented, then cell retention in bag is reduced, but system complexity increases
Solution Approach 1:
The filling system is designed with universal components that can handle multiple syringes simultaneously or sequentially. The same sterile filling mechanism serves multiple functions: connecting to the product bag, filling individual syringes, and sealing them, thereby managing complexity through component reuse.
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 effectively separates and transfers biological fluid components, reducing cell retention in product bags and enhancing sterility, thereby improving the efficiency and safety of biological fluid processing and filling operations.
Implementation Method 1
Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation
Implementation Method 2
Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation
Implementation Method 3
a pump configured to transfer a product from the cell processing system to the at least one filling station
Data Source
AI summary
A variety of fill options is provided for a cell processing system. Certain options relate to a syringe assembly that receives a product directly from a separator. Other options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container, that receive product from a product container associated with the cell processing system.