Embedded Sensor Tubing for Contamination Control

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Solution Overview

Problem

Conventional fluid monitoring systems in pharmaceutical and biologic manufacturing processes face contamination risks and high replacement costs due to direct sensor contact with reactants or products, and the complexity of sterilizing numerous components in cumbersome systems.

Innovation Solution

A fluid monitoring assembly featuring a segment of silicone tubing with sensors embedded within the wall, housed in a two-part assembly that allows for easy replacement and minimizes direct contact with the fluid, using UV-cured or thermally cured silicone and a reusable housing to reduce contamination and maintenance costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If sensors are placed directly in contact with the fluid stream to monitor process variables, then measurement capability is improved, but contamination risk increases

Engineering Contradiction:
Improveprocess variable monitoringVSAvoidcontamination risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses the tubing wall itself as an intermediary medium. Sensors are embedded within the tubing wall rather than being in direct contact with the fluid stream. The tubing material (such as silicone or other biocompatible materials) acts as a mediator that transmits mechanical deformations caused by fluid pressure, flow, or other parameters to the embedded sensors, enabling measurement while preventing contamination.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs flexible tubing with embedded sensors where the tubing wall serves as both the containment structure and the sensing interface. The flexible nature of the tubing allows it to deform in response to fluid dynamics while maintaining a barrier between the sensor and the fluid, thus enabling measurement through the flexible shell without direct contact.

Inventive Principle:
Principle #30Flexible shells and thin films

2Measurement precision

If conventional sensors are replaced when malfunctioning or for different products, then measurement accuracy is maintained, but time and cost increase

Engineering Contradiction:
Improvesensor accuracyVSAvoidreplacement time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines the sensor with the tubing into a single integrated assembly. The sensor is embedded within the tubing wall during manufacturing, creating a unified component that cannot be contaminated by the fluid stream. This integration means the entire tubing-sensor assembly can be replaced as one unit, and the reusable housing allows rapid exchange without complex disassembly, reducing both time and cost compared to replacing separate sensor components.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent employs a disposable tubing-sensor assembly that can be easily replaced. While the housing is reusable, the tubing with embedded sensor is designed as a single-use component that is discarded after use, eliminating the need for complex sterilization and sensor replacement procedures. This approach reduces overall system cost and replacement time.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Adaptability or versatility

If multiple conduits, valves, and sensors are used in manufacturing systems, then process monitoring capability is improved, but system complexity increases

Engineering Contradiction:
Improveprocess monitoring capabilityVSAvoidsystem complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent creates a universal tubing-sensor assembly that can be used across different process applications. The standardized housing and tubing design allow the same basic assembly to monitor various process variables (pressure, flow, temperature) in different locations within the manufacturing system, reducing the need for multiple specialized components and simplifying the overall system architecture.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Object-affected harmful factors

If the entire tubing and sensor assembly is thrown away after use, then contamination risk is reduced, but manufacturing cost increases

Engineering Contradiction:
Improvecross-contamination riskVSAvoidmanufacturing cost
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The patent divides the monitoring system into two segments: a reusable housing and a disposable tubing-sensor assembly. The housing can be sterilized and reused across multiple batches, while only the tubing with embedded sensor is discarded after single use. This segmentation reduces overall cost by preserving the expensive housing component while maintaining the safety benefits of single-use sensing elements.

Inventive Principle:
Principle #1Segmentation

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 a cost-effective, contamination-minimized, and easily replaceable fluid monitoring system that reduces the complexity of sterilization procedures and minimizes the risk of cross-contamination in pharmaceutical and biologic manufacturing processes.

Implementation Method 1

The sensor is at least partially embedded within a wall of the tubing... fluid pressure within the lumen is transmitted through the wall to the pressure sensing end

Methodology Applied
Scientific EffectPressure transmission through material: Conduction (thermal)

Implementation Method 2

The tubing is silicone. For example, the tubing may include UV-cured silicone or in other embodiments, thermally cured silicone

Methodology Applied
Scientific EffectUV curing: Photopolymerisation

Implementation Method 3

The tubing may include UV-cured silicone or in other embodiments, thermally cured silicone

Methodology Applied
Scientific EffectThermal curing: Heat Treatment

Data Source

PatentEP3063506B1Fluid monitoring device with disposable inner liner with sensor integration
Publication Date: 2024.03.06 REPLIGEN CORP
  • EP3063506B1 patent drawingFigure 1A~1D
  • EP3063506B1 patent drawingFigure 2A~2D
  • EP3063506B1 patent drawingFigure 2E~2I

AI summary

A fluid monitoring assembly includes a segment of tubing having a wall defining a lumen through which the fluid passes and a sensor at least partially embedded within a wall of the tubing. The assembly includes a housing having first and second portions connected to one another at a hinge, the housing defining an interior portion configured to hold the segment of tubing and the sensor. The housing may be opened and closed as needed using a fastener.