Single-Use Sensor Calibration Line for Closed Bioprocess Flow Paths
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Solution Overview
Problem
The challenge of calibrating single-use sensors integrated in a single-use process configuration without the need for disassembly, which contradicts the closed system and disposable approach required by current good manufacturing practices.
Innovation Solution
A device assembly with integrated calibration lines and switching means allows for calibration of single-use sensors within the flow line, using reference means like reference sensors or standard solutions, enabling calibration before, during, or after the biopharmaceutical process without disassembly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the sensor is calibrated outside the flow line or in a bypass arrangement, then the sensor can be calibrated with access to reference standards, but the system complexity increases and the closed single-use approach is compromised
Solution Approach 1:
The patent combines the calibration function directly into the single-use flow line by integrating a calibration port and reference standard into the same disposable assembly as the sensor. This merging eliminates the need for separate bypass arrangements or external calibration setups, thereby reducing system complexity while maintaining calibration accuracy.
Solution Approach 2:
The patent introduces a calibration port as an intermediary component that allows reference standards to be introduced directly into the flow line without requiring disassembly or external connections. This mediator enables in-line calibration while preserving the closed single-use system architecture.
2Measurement precision
If the sensor is disassembled for calibration, then the sensor can be calibrated externally, but the closed system approach and disposable concept are violated
Solution Approach 1:
The patent incorporates a calibration port and reference standard into the single-use assembly before the sensor is installed in the flow line. This preliminary integration allows calibration to be performed in-line without requiring subsequent disassembly, thereby maintaining the closed single-use system while enabling calibration capability.
Solution Approach 2:
The single-use assembly is designed to be self-sufficient with integrated calibration functionality. The calibration port and reference standard are included as part of the disposable assembly, allowing the system to calibrate its own sensor without external intervention or disassembly, thus preserving the single-use concept.
3Productivity
If a bypass arrangement is used for calibration, then the process can continue during calibration, but the system complexity and device footprint increase
Solution Approach 1:
The patent merges the calibration function into the main flow line by providing a calibration port that allows calibration media to be introduced directly into the flow path. This eliminates the need for separate bypass arrangements, reducing flow path complexity while enabling calibration without process interruption.
Data Source
AI summary
A device assembly for calibrating a single-use sensor before, during or after a biopharmaceutical manufacturing process step including a single-use process equipment assembly for performing at least a part of the process step. The single-use process equipment assembly includes a flow line through which a medium flows in a defined direction during the process step and an integrated single-use sensor for measuring or detecting a property at a measurement location in the flow line. The device assembly includes a calibration line and a switch inserted into the flow line upstream of the measurement location. The switch includes a flow line inlet, a flow line outlet, and a calibration line inlet connected to the calibration line. The switch selectively switches between a first (main) flow path and a second (calibration) flow path. The device assembly includes a dedicated reference sensor, reference source, or reference standard solution in the calibration line.