Cell Washing Parameter Authorization for Reproducible Processing
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Solution Overview
Problem
Current biological fluid processing systems lack effective control over process parameters, leading to potential misuse or unintended modifications by users, which can result in inconsistent results and reduced portability of procedures across different systems.
Innovation Solution
A cell processing system with a controller that receives an identifier to determine authorization levels, allowing administrators to modify process parameters within specified limits, while preventing unauthorized changes, and utilizing a network of systems with a non-transitory memory storage device to transmit and apply process parameter controls.
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 control over process parameters deteriorates
Solution Approach 1:
The system segments control authority by dividing users into different authorization levels (administrators vs. other users). Administrators have full control to modify process parameters, while other users are restricted to predefined parameters. This segmentation resolves the contradiction by allowing flexibility for administrators while ensuring control and consistency for routine operations.
Solution Approach 2:
The system changes the state of process parameters based on user authorization. For authorized administrators, parameters are modifiable to enable process adaptation. For other users, parameters are locked to predefined values to ensure consistency and control. This dynamic parameter management resolves the contradiction between flexibility and control.
2Adaptability or versatility
If process parameters can be freely modified to accommodate different processes, then adaptability is improved, but manufacturing precision deteriorates
Solution Approach 1:
The system performs preliminary action by pre-defining process parameters for routine operations. These predefined parameters are established in advance and locked for regular users, ensuring procedure consistency without requiring modification during execution. This allows adaptability when needed (by administrators) while maintaining precision for standard procedures.
Solution Approach 2:
The system applies different levels of parameter modifiability to different user groups. Administrators receive full parameter modification capability when needed, while regular users receive locked predefined parameters for their operations. This local differentiation resolves the contradiction by providing precision where needed while maintaining adaptability where required.
3Ease of operation
If the system allows extensive parameter modification capability, then ease of operation is improved, but reliability deteriorates due to potential misuse
Solution Approach 1:
The system introduces an intermediary mechanism (authorization verification) between the user and the parameter modification capability. The controller verifies user authorization status before allowing parameter changes. This intermediary ensures that only authorized administrators can modify parameters, preventing misuse while maintaining ease of operation for authorized users and result consistency through restricted access.
Data Source
AI summary
A cell processing system includes a processor to receive a biological fluid to be processed, a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter, and at least one input coupled to the controller, the at least one input configured to receive an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied. The controller is configured to determine if the identifier is associated with an administrator authorization and to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.