Fill and Finish System for Cell Processing
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Solution Overview
Problem
Conventional methods for processing biological fluids, such as blood, often result in cells being left behind in product bags and pose contamination risks due to inadequate sterilization protocols during transfer to syringes.
Innovation Solution
A filling system comprising a transfer set connectable to a source container, multiple filling stations, and a syringe pump, controlled by a controller to ensure a constant volume of fluid is transferred from the source container to flexible walled containers, minimizing cell loss and contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If conventional syringe transfer methods are used, then product can be transferred from bag to syringe, but cells are left in the product bag and contamination risk increases
Solution Approach 1:
The patent employs disposable single-use containers and transfer sets that are pre-sterilized and designed for one-time use. The source container is a disposable bag that can be fully emptied into the syringe, and the transfer set includes disposable tubing and connectors that eliminate the need for sterilization between uses, thereby preventing contamination while ensuring complete cell transfer.
Solution Approach 2:
The patent introduces a transfer set as an intermediary device between the source container and syringe. This transfer set includes a transfer hub and tubing that facilitates complete fluid transfer while maintaining sterility. The intermediary device allows for controlled transfer and ensures that all cells are moved from the source container to the syringe without direct contact between the syringe and the source bag, reducing contamination risk.
2Manufacturing precision
If manual transfer methods are used, then flexibility is maintained, but volume consistency and precision are poor
Solution Approach 1:
The patent incorporates a syringe pump that automatically controls the transfer of fluid from the source container to the syringe. The pump is configured to deliver precise volumes based on pre-programmed parameters, eliminating the need for manual operation while ensuring consistent and accurate volume transfer. The system self-regulates the flow rate and total volume delivered, providing manufacturing precision without increasing operational complexity for the user.
Solution Approach 2:
The patent includes a controller that monitors and adjusts the syringe pump operation in real-time. The controller receives feedback on the transfer progress and automatically adjusts parameters to ensure the target volume is achieved with high precision. This closed-loop control system maintains volume consistency while simplifying operation, as the system self-corrects any deviations from the desired transfer parameters.
Data Source
AI summary
A variety of fill options is provided for a cell processing system. Certain 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 may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system.