Cell Processing Parameter Access Control for Reproducible Results
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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 only authorized users to modify process parameters within specified limits, ensuring reproducible results and facilitating the transfer of procedures across systems while maintaining flexibility.
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 user access into different authorization levels (administrator vs. standard user). The administrator level retains full flexibility to modify any process parameter, while standard users operate within predefined controlled parameters. This segmentation resolves the contradiction by allowing flexibility where needed (administrator mode) while maintaining control where required (standard user mode).
Solution Approach 2:
The system applies different levels of parameter modifiability to different users based on their authorization level. Rather than uniformly restricting or allowing all parameter changes, the system locally applies control restrictions only to standard users while leaving administrator users with full access. This local quality approach maintains overall system flexibility while implementing control where necessary.
2Adaptability or versatility
If process parameters can be freely modified to accommodate different processes, then versatility is improved, but manufacturing precision deteriorates
Solution Approach 1:
The system performs preliminary action by pre-defining controlled parameter ranges and authorization levels before actual processing begins. Administrators pre-configure the acceptable parameter ranges that standard users must adhere to, ensuring that reproducibility is maintained from the outset while still allowing versatility within those predefined boundaries.
Solution Approach 2:
The system manages parameter changes by allowing full parameter modification capability for administrators while restricting standard users to predefined parameter ranges. This selective parameter change approach maintains versatility for process development (administrator level) while ensuring manufacturing precision and reproducibility for routine operations (standard user level).
Data Source
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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.