Labeled Polypeptide Test Soil for Visible Cleaning Residue Detection

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Solution Overview

Problem

Existing methods for evaluating the cleaning effectiveness of medical instruments struggle to visually detect residual contaminants, as direct evaluation methods fail to show remaining test soils, and indirect methods do not accurately assess contaminant presence on the instruments themselves.

Innovation Solution

A test soil comprising labeled polypeptides with a dye covalently bonded, achieving a color tone index (X) of 100,000 or more, allowing visual detection of residual contaminants post-cleaning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a direct evaluation method using sheep blood as test soil is used, then the cleaning process can be evaluated, but the remaining test soil becomes difficult to visually detect after cleaning

Engineering Contradiction:
Improvecleaning evaluation reliabilityVSAvoidvisual detection difficulty
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent applies color changes principle by incorporating dyes (such as erythrosine B, rose bengal, or fluorescein) into the test soil composition. These dyes provide strong coloration that remains visible after cleaning operations, enabling easy visual detection of residual contaminants. The dye molecules are designed to maintain their chromogenic properties through the cleaning process, solving the detection difficulty while preserving evaluation reliability.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent changes the optical parameters of the test soil by incorporating highly chromogenic dyes with specific molar absorption coefficients. This parameter change enhances the visual detectability of the test soil remnants without affecting its cleaning evaluation function. The dye concentration and type are optimized to ensure sufficient color intensity even after thorough cleaning operations.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If an indirect evaluation method using an indicator is used, then the washer disinfector performance can be checked, but the contaminant presence on the medical instrument itself cannot be accurately assessed

Engineering Contradiction:
Improvewasher disinfector performance evaluationVSAvoidcontaminant detection accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent merges the advantages of both direct and indirect evaluation methods by creating a test soil that can be applied directly to medical instruments while maintaining visual detectability. The labeled polypeptide test soil combines the direct application approach with enhanced visual properties, allowing simultaneous evaluation of both the washing process and the actual contaminant removal from instruments.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent uses labeled polypeptides as an intermediary substance that mimics actual biological contaminants (such as blood proteins) but with enhanced detection properties. This intermediary test soil serves as a surrogate that provides accurate information about contaminant removal while being easily detectable, bridging the gap between realistic contamination scenarios and visual evaluation capabilities.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enables accurate visual evaluation of cleaning effectiveness by detecting labeled polypeptides post-cleaning, ensuring thorough removal of contaminants on medical instruments.

Implementation Method 1

the labeled polypeptide is a polypeptide to which a dye is added by a covalent bond

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Implementation Method 2

the value of X calculated by the following formula is 100,000 or more: X=(Number of dyes comprised in one molecule of labeled polypeptide)×(Molar absorption coefficient of dye (M−1 cm−1))

Methodology Applied
Scientific EffectLight absorption: Absorption (EM radiation)

Data Source

PatentUS12480921B2Test soil, method for cleaning object, and method for controlling accuracy of cleaning operation
Publication Date: 2025.11.25 SYSMEX CORP
  • US12480921B2 patent drawing
  • US12480921B2 patent drawing
  • US12480921B2 patent drawing

AI summary

Disclosed is a test soil comprising a plurality of molecules of labeled polypeptides, wherein the labeled polypeptide is a polypeptide to which a dye is added by a covalent bond, and the value of X calculated by the following formula is 100,000 or more:X=(Number of Dyes Comprised in One Molecule of Labeled Polypeptide)×(Molar absorption coefficient of dye (M−1 cm−1))