Mechanism for storage of refrigerated calibration and quality control material
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Solution Overview
Problem
In vitro diagnostics (IVD) systems face challenges in storing calibrators and controls for extended periods while maintaining their stability and preventing evaporation, especially in automated systems where frequent access and refrigeration are required.
Innovation Solution
A refrigerated storage assembly integrated into clinical analyzers, featuring an insulated housing with thermoelectric coolers, thermal sensors, and evaporation covers, accessible by a robot arm to maintain a controlled environment for calibrator and control fluids, ensuring multi-day storage with minimal evaporation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If calibrators and controls are stored in a traditional laboratory refrigerator, then they can be maintained for extended periods, but they require manual access and are not easily accessible to automated systems
Solution Approach 1:
The patent combines the refrigerated storage function with the automated sample handling system by integrating a refrigerated storage module directly into the analyzer. The robot arm, which is part of the automated sample handling system, is configured to access and retrieve calibrator and control tubes from this integrated refrigerated storage, eliminating the need for separate manual refrigerator access.
2Stability of the object's composition
If calibrators and controls are stored for extended periods in refrigeration, then stability is maintained, but evaporation can occur during storage
Solution Approach 1:
The patent applies local quality by providing individual evaporation covers for each storage tube within the refrigerated storage module. These covers are specifically designed to seal the tube openings and prevent evaporation at the local level where it occurs, while the refrigerated environment maintains overall fluid stability.
Solution Approach 2:
The evaporation covers are placed on the tubes before any significant evaporation can occur during long-term storage. This preliminary protective action prevents the harmful evaporation process from starting, preserving the fluid volume and composition throughout the extended storage period.
3Extent of automation
If a refrigerated storage system is integrated into the clinical analyzer, then automated access is enabled, but the system complexity increases
Solution Approach 1:
The refrigerated storage module is designed as a multi-functional integrated component that serves both as a refrigerated storage unit and as part of the automated sample handling system. The robot arm uses the same motion control and positioning mechanisms for accessing both patient samples and calibrator/control tubes, reducing overall system complexity despite the added automation capability.
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 solution provides stable storage for calibrators and controls, maintaining their effectiveness for up to 30-60 days with less than 1% evaporation, ensuring accurate calibration and quality control in IVD systems.
Implementation Method 1
one or more thermoelectric coolers, and a refrigerated base assembly contained within the insulated housing
Implementation Method 2
an insulated housing, an insulated door assembly comprising one or more doors
Implementation Method 3
Individual evaporation covers for each tube are provided to mitigate evaporation from long-term storage
Data Source
AI summary
Systems and methods for refrigerated storage of controls and calibrators utilize a refrigerant storage assembly having an insulated housing and door assembly, thermoelectric coolers, and the refrigerated base assembly having a metal plate thermally coupled to coolers, one or more sensors, and a plurality of receptacles to receive fluid tubes. Refrigerated storage provides a refrigerated environment suitable for multi-day storage of control and calibrator fluids.