Cell Washing Protocol Access Control 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 and variability in processing outcomes, as users without proper authorization can modify settings, compromising reproducibility and portability of procedures.
Innovation Solution
A cell washing system incorporating a disposable fluid circuit and reusable processing machine with a touch screen interface and controller that uses user identifiers and authorization levels to control and limit modifications to process parameters, ensuring only authorized users can modify settings within predetermined ranges.
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 patent segments the user community into different authorization levels (administrators and regular users) and segments the control capabilities accordingly. Administrators have full access to modify process parameters, while regular users are restricted to predefined protocols. This segmentation resolves the contradiction by providing flexibility to administrators while ensuring control and consistency for regular users.
Solution Approach 2:
The patent applies local quality by providing different levels of access control to different user groups. Rather than uniformly restricting or allowing all users to modify all parameters, the system tailors the level of control and flexibility to each user's authorization level, allowing administrators full flexibility while maintaining control for standard users.
2Ease of operation
If users without proper authorization can modify settings, then ease of operation is improved, but manufacturing precision deteriorates
Solution Approach 1:
The patent implements dynamic control where the system adapts its behavior based on user authorization levels. Regular users interact with a simplified, restricted interface that maintains reproducibility, while administrators access a more flexible interface that allows parameter modification. This dynamic adaptation resolves the contradiction by providing ease of operation appropriate to each user's needs while preserving procedural precision.
Solution Approach 2:
The controller acts as an intermediary between users and the processing system. It mediates user inputs by checking authorization levels and either allowing or blocking parameter modifications accordingly. This intermediary function enables regular users to operate the system easily with predefined protocols while preventing unauthorized changes that would compromise reproducibility.
3Adaptability or versatility
If the system allows widespread modification of process parameters, then adaptability is improved, but loss of information deteriorates
Solution Approach 1:
The patent applies preliminary action by pre-configuring standardized protocols with optimized process parameters that ensure procedural consistency. Regular users can select from these pre-defined protocols without modifying parameters, thereby preserving procedural consistency. Administrators retain the ability to create and modify custom protocols when adaptability is needed, thus resolving the contradiction between customization and consistency.
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
This solution enhances reproducibility and portability of biological fluid processing by restricting unauthorized changes to process parameters, maintaining consistency and adaptability while allowing authorized administrators to modify settings as needed.
Implementation Method 1
Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation
Implementation Method 2
The reusable hardware may include at least one drive to spin the spinning membrane, at least one scale to weigh the at least container and contents thereof, and at least one pump
Data Source
AI summary
A method of processing blood includes receiving from a touch screen user input data for a protocol for a wash procedure. The user input data includes a numeric value. The method includes storing the protocol in a memory, receiving an identifier from a user, determining if the identifier permits the user to modify the protocol and receiving a modification of the protocol from the user. The method includes providing a plurality of authorizations, a second authorization being a default and an administrator authorization permitting the user to change a setting. The method includes comparing a password to a password stored in memory and, if there is a match, determining that the password is associated with an administrator. If a command to change the setting is received, the command is applied to change the setting. The blood is processed employing a wash procedure using the modified protocol and the changed setting.