Sterilization Indicator Composition Color Change
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Solution Overview
Problem
Existing sterilization indicators for high-pressure steam and ethylene oxide gas sterilization are difficult to apply and detect completion of sterilization due to dispersion issues in nonpolar binders, often cause sulfurous smells, and have color changes that are hard to visually observe, especially during rapid sterilization processes.
Innovation Solution
A composition comprising a saccharide and a monoazo dye, specifically benzathiazoleazobenzenes or azobenzenes, with an organic acid, which forms a color-changing layer that clearly discolors upon reaction with high-pressure steam or ethylene oxide gas without sulfurous smells, allowing for easy application and visual detection of sterilization completion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a monoazo dye composition including polar organic acid and metal salt is used for sterilization indicator, then the sterilization detection function is improved, but the composition becomes difficult to apply onto substrate due to poor dispersion in nonpolar binders
Solution Approach 1:
The patent introduces a nonpolar solvent as an intermediary carrier to transport the polar organic acid and metal salt components through the nonpolar binder system. The solvent mixture (nonpolar solvent with small amount of polar solvent) acts as a mediator that enables temporary compatibility between polar indicator components and nonpolar binder, allowing easy application onto substrate while maintaining the sterilization detection function.
2Reliability
If sulfur or sulfur compound is included in the sterilization indicator composition, then the sterilization detection capability is improved, but sulfurous smell is generated during high-pressure steam sterilization
Solution Approach 1:
The patent extracts and removes the sulfur component from the indicator composition entirely. Instead of using sulfur or sulfur compounds as the reactive component, the invention employs an organic acid-metal salt system that provides equivalent sterilization detection capability without generating sulfurous odor during high-pressure steam sterilization processes.
3Reliability
If conventional sterilization indicator composition is used, then sterilization detection is possible, but the color change becomes dark and difficult to visually observe
Solution Approach 1:
The patent selects specific organic acids and metal salts whose reaction products produce bright, contrasting color changes (such as yellow to red, or colorless to colored) that are easily visible to the human eye. The composition is designed to generate intense chromatic color changes rather than dark or muted tones, significantly improving visual detectability of sterilization completion.
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 composition provides a clear and visible color change upon sterilization, ensuring effective detection of sterilization completion without sulfurous odors, facilitating efficient and economical production, and can be applied to various substrates for high-yield results.
Implementation Method 1
the polar organic acid and the metal salt thereof, which are necessary to be included in the composition in large amounts for sublimating the monoazo dye to discolor thereof
Implementation Method 2
A composition comprising a saccharide and a monoazo dye... which forms a color-changing layer that clearly discolors upon reaction with high-pressure steam or ethylene oxide gas
Data Source
Figure 1~2

AI summary
It is an object of the present invention to provide a simple and sanitary composition of a sterilization indicator for detecting completion of sterilization by clearly changing the color hue thereof without any bad smell, which is used mainly for high-pressure steam sterilization and where necessary simply applicable for ethylene oxide gas sterilization. Thereby the sterilization indicator composition comprises a saccharide and a monoazo dye.