Cell Processing Pre-Process Evaluation for Safer Separation
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Solution Overview
Problem
Existing biological fluid processing systems rely on empirical assumptions that may not accurately reflect the conditions of the actual processing, leading to potential inefficiencies and risks due to operator experience or lack of data.
Innovation Solution
A blood processing system with reusable hardware and a disposable fluid circuit, equipped with a controller that performs pre-process calculations and checks, providing estimates and warnings to ensure accurate operation and prevent errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pre-process calculations and evaluations are performed, then measurement precision and reliability of process parameters are improved, but device complexity and processing time increase
Solution Approach 1:
The system performs pre-process calculations and evaluations before actual blood processing operations. The controller calculates expected process parameters, potential waste volumes, and safety conditions in advance based on input data, providing estimates and warnings prior to operation initiation.
Solution Approach 2:
A controller serves as an intermediary between input data and processing operations. It receives process parameters, performs calculations, compares against control values, and provides evaluated outputs or warnings, mediating the complexity between raw inputs and actual processing.
2Reliability
If pre-process evaluations and real-time monitoring are implemented, then reliability and manufacturing precision are improved, but loss of time increases
Solution Approach 1:
The system performs evaluations and safety checks before processing begins, calculating expected outcomes and identifying potential issues in advance. This preliminary action ensures reliability without requiring continuous time-consuming monitoring during the actual processing operation.
Solution Approach 2:
The controller provides feedback in the form of evaluated outputs and warnings based on calculated process parameters. This feedback mechanism ensures safety and quality by comparing expected versus actual conditions, allowing for timely corrections without requiring constant real-time monitoring throughout the entire process.
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 uniform estimates and prevents unsafe operations, damage to materials, and produces products meeting specifications by using pre-process evaluations and real-time monitoring.
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.