Cell Processing Controller with Pre-Process Safety Evaluation
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Solution Overview
Problem
Existing biological fluid processing systems rely on empirical assumptions that may not accurately reflect the actual conditions, leading to potential operational issues and suboptimal results due to lack of precise data or operator experience.
Innovation Solution
A blood processing system with reusable hardware and disposable fluid circuits, equipped with a controller that performs pre-process calculations and checks, providing real-time feedback and warnings to ensure accurate processing parameters and conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pre-process calculations and checks are implemented, then processing accuracy and safety are improved, but device complexity increases
Solution Approach 1:
The system performs pre-process calculations and checks before the actual blood processing begins. The controller calculates expected process parameters (run time, fluid volumes, centrifugal forces) and compares them against safety thresholds in advance, preventing unsafe operations before they occur.
Solution Approach 2:
The system continuously monitors actual process parameters and compares them against the pre-calculated expected values. When deviations are detected, the controller provides feedback to the operator through warnings or errors, enabling real-time correction of process deviations.
2Manufacturing precision
If real-time monitoring and feedback are provided, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
The controller receives real-time data from sensors monitoring actual process parameters, compares these against pre-calculated expected values, and provides immediate feedback through the display unit. This enables precise control of blood processing parameters such as flow rates, centrifugal forces, and fluid volumes.
Solution Approach 2:
The system replaces manual operator estimation and adjustment with automated electronic calculations and monitoring. The controller performs complex mathematical models to predict process outcomes and automatically compares actual measurements against these predictions, eliminating the need for operator experience-based assumptions.
3Ease of manufacture
If disposable fluid circuits are used, then ease of manufacture is improved, but loss of substance increases
Solution Approach 1:
The system performs pre-process calculations to determine the exact volume of blood and fluids required for the separation process. By calculating expected fluid volumes before operation, the system can identify potential losses and alert operators to adjust parameters or compensate for expected fluid consumption.
Solution Approach 2:
The controller monitors actual fluid consumption during the process and compares it against the pre-calculated expected volumes. When deviations indicating excessive fluid loss occur, the system provides feedback to alert the operator, enabling real-time investigation and correction of the issue.
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
Ensures uniform and safe processing by preventing damage to materials, maintaining safe operating conditions, and producing products that meet specifications, while alerting operators to deviations during operation.
Implementation Method 1
a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter
Data Source
AI summary
A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition.