Cell Washing Protocol Control With User Authorization Levels
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Solution Overview
Problem
Current biological fluid processing systems lack effective control over process parameters, leading to potential misuse and variability in results due to lack of authorization and flexibility in processing protocols.
Innovation Solution
A cell washing system incorporating a disposable fluid circuit and reusable processing machine with a touch screen interface and controller that manages process parameters based on user authorization, allowing controlled operation of wash procedures and separation of red blood cells from waste solutions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the processing machine is designed to permit operation to be varied in hundreds of different ways to maintain maximum flexibility, then adaptability is improved, but reliability deteriorates due to lack of control over process parameters
Solution Approach 1:
The system segments control authority by dividing users into different authorization levels (e.g., operator, supervisor, administrator). Each level has specific permissions to modify process parameters, creating a hierarchical control structure that maintains flexibility while ensuring reliability through controlled access to critical parameters.
Solution Approach 2:
The system applies local quality by allowing process parameter modification rights to be distributed selectively to different users based on their roles and responsibilities. Not all parameters are editable by all users - instead, editability is assigned locally to specific parameters based on user authorization levels, enabling flexibility where needed while maintaining control where critical.
2Adaptability or versatility
If process parameters can be freely modified to accommodate local variations in processing, then adaptability is improved, but manufacturing precision deteriorates due to unauthorized modifications
Solution Approach 1:
The system performs preliminary action by pre-configuring process parameters with appropriate authorization levels before processing begins. Critical parameters are locked by default and can only be modified by authorized users through formal processes, ensuring that reproducibility is maintained while still allowing necessary local variations to be made by competent personnel.
Solution Approach 2:
The system implements feedback mechanisms that track and record all modifications to process parameters, including who made the modification, when it was made, and what the original and new values were. This creates an audit trail that maintains manufacturing precision by enabling verification and reproduction of processes while accommodating authorized local variations.
3Reliability
If the system implements hierarchical authorization control over process parameters, then reliability is improved, but device complexity increases
Solution Approach 1:
The system applies universality by implementing a multi-functional authorization framework that handles multiple control objectives through a single integrated system. The hierarchical authorization structure simultaneously manages user access control, parameter editability, audit trail generation, and protocol management, reducing overall complexity compared to implementing separate systems for each function.
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 reproducible results by controlling process parameters based on user authorization, reducing the risk of unauthorized modifications and enhancing the portability of procedures while accommodating local variations in biological fluid processing.
Implementation Method 1
the separator device is configured to separate red blood cells from a waste solution including free hemoglobin
Implementation Method 2
a pump configured to pump the combination of biological cell suspension and wash solution through the fluid circuit
Data Source
AI summary
A cell washing system includes a fluid circuit, a source container, a source of wash solution, a pump, and a separator device. The system also includes a touch screen configured to receive user input and to display data to a user, and a controller coupled to the touch screen and configured to control the separator device and pump to operate a wash procedure, wherein the controller is configured to receive from the touch screen user input data for at least one protocol, the at least one protocol including values for a set of process parameters for a wash procedure, to store the at least one protocol in a memory, to receive an identifier associated with a user, to apply the at least one protocol based at least in part on the identifier, and to operate the wash procedure using the applied protocol.