XRF Spectrometry for Bilayer Diagnostic Strip Coating

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Solution Overview

Problem

Current methods for producing diagnostic test elements, such as blood glucose test strips, fail to accurately measure the surface weight of bilayer structures and lack effective quality control, especially in the final dry product, as they only register water content and provide relative signals, making it difficult to assess homogeneity and functional ingredient proportions.

Innovation Solution

The method involves using X-ray fluorescence (XRF) spectrometry to detect metallic components in a bilayer structure on a carrier foil, allowing for contactless, quantitative analysis of the surface weight of each layer without disrupting the product, and calibrating signals using comparison elements to determine absolute values, thereby improving quality control and manufacturing efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If infrared spectrometry is used to monitor the coating in wet state, then the water content of the coating can be registered, but the proportion of functional ingredients cannot be determined and only relative signals are achieved

Engineering Contradiction:
Improvemeasurement accuracyVSAvoidfunctional ingredient proportion
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent changes the measurement parameter from infrared spectrometry (which measures water content) to X-ray fluorescence spectrometry (which measures metallic component content). This parameter change enables direct measurement of the absolute quantity of functional ingredients in the coating layers, resolving the information loss about functional ingredient proportions while maintaining measurement capability.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If measurement is performed on the wet coating, then the coating can be monitored during production, but the final dry product quality cannot be assessed

Engineering Contradiction:
Improvereal-time monitoringVSAvoidfinal product quality assessment
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The X-ray fluorescence measurement system is designed to be universally applicable to both wet and dry coating states. The metallic component signals remain detectable in both states, allowing the same measurement method to serve dual purposes: real-time process monitoring during production and final quality assessment of the dry product, eliminating the need for separate measurement methods.

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

3Ease of manufacture

If conventional coating methods are used, then the bilayer structure can be produced, but the surface weight and homogeneity cannot be accurately determined

Engineering Contradiction:
Improvebilayer productionVSAvoidsurface weight determination
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent replaces mechanical/chemical analysis methods with X-ray fluorescence spectrometry for determining surface weight and homogeneity. The XRF method provides non-contact, rapid, and accurate measurement of metallic component distribution, enabling precise determination of surface weight and homogeneity of the bilayer structure without complicating the manufacturing process.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If multiple measurement methods are used for quality control, then comprehensive quality assessment can be achieved, but the process complexity increases

Engineering Contradiction:
Improvequality control comprehensivenessVSAvoidmeasurement system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The X-ray fluorescence measurement system is designed to be universally applicable to both wet and dry coating states. The metallic component signals remain detectable in both states, allowing the same measurement method to serve dual purposes: real-time process monitoring during production and final quality assessment of the dry product, eliminating the need for separate measurement methods.

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

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 approach enables fast, accurate, and non-destructive measurement of the surface weight of bilayer structures, enhancing the quality and consistency of diagnostic test products by providing absolute values of metallic components, reducing manufacturing costs, and improving diagnostic test accuracy.

Implementation Method 1

detecting X-ray fluorescence (XRF) signals of the metallic components in the composite of the first and second layer using XRF spectrometry

Methodology Applied
Scientific EffectX-ray fluorescence: Fluorescence

Data Source

PatentEP3143385B1Method for monitoring a product property of a disposable diagnostic test product
Publication Date: 2020.12.09 ROCHE DIABETES CARE GMBH
  • EP3143385B1 patent drawingFigure 1~2
  • EP3143385B1 patent drawingFigure 3~4
  • EP3143385B1 patent drawing

AI summary

Methods are provided for producing disposable diagnostic test elements and monitoring a property thereof, where such methods include detecting X-ray fluorescent (XRF) signals of one or more metallic components in a composite of first and second layers applied to a substrate using XRF spectrometry, determining a quantity value for each metallic component in a measured area from the XRF signals, and then calculating an areal coating quantity of the first and the second layers using the quantity values of the metallic components. Additionally or alternatively, the methods can include determining a batch specific code from the XRF signals that can be used when performing a test with a test element. Further provided are systems for monitoring a property of disposable test elements.