Sterilization Indicator Composition for Oxidative Monitoring

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Solution Overview

Problem

Prior art chemical indicators for monitoring oxidative sterilization processes face challenges due to difficult color perception and indeterminate end points, with color changes occurring over extended time periods and concentration ranges.

Innovation Solution

A sterilization indicator composition comprising iodide salts, binders, carbonate or sulfate salts, antioxidants, dyes, complexing agents, solvents, and inhibitors, applied to a support, which undergoes a distinct color change within a shorter transition period, facilitating accurate monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If prior art chemical indicators are used for oxidative sterilization monitoring, then the indicator can detect active ingredient exposure, but the color change is difficult to perceive and the end point is difficult to determine

Engineering Contradiction:
Improvecolor change detection accuracyVSAvoidcolor change perception difficulty
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The patent employs a multi-component indicator system comprising a dye, iodide salt, carbonate or sulfate salt, and antioxidant that produces a distinct color change from blue to yellow-green upon oxidation. This color transformation is specifically designed to be easily perceptible and provides a clear end point indication for sterilization monitoring, directly resolving the color perception and endpoint determination difficulties of prior art indicators.

Inventive Principle:
Principle #32Color changes

2Duration of action of moving object

If prior art chemical indicators are used, then the indicator can respond to sterilant exposure, but the color change occurs over an extended time period and extended concentration range

Engineering Contradiction:
Improvecolor change transition periodVSAvoidsterilization process monitoring efficiency
Core Design Contradiction:
Duration of action of moving objectVSProductivity

Solution Approach 1:

The patent modifies the chemical parameters of the indicator system by incorporating specific components (iodide salt, carbonate or sulfate salt, antioxidant) in controlled amounts. These parameter changes result in a color change transition that occurs rapidly over a concentrated time and concentration range, thereby improving sterilization process monitoring efficiency while maintaining accurate sterilant exposure detection.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If prior art indirect mechanism indicators are used, then the indicator can detect sterilization exposure, but the color change mechanism is complex and less reliable

Engineering Contradiction:
Improvesterilization detection reliabilityVSAvoidindicator mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent utilizes an intermediary mechanism where the iodide salt acts as a mediator between the oxidizing sterilant and the dye. The iodide salt reacts with the sterilant to form iodine, which then interacts with the dye to produce the color change. This intermediary approach simplifies the overall mechanism while enhancing reliability, as the iodide salt provides a consistent and predictable reaction pathway that is less susceptible to variability compared to direct dye oxidation.

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

The solution provides a more distinct and timely color change, enhancing the usability and accuracy of sterilization process monitoring, ensuring effective interpretation of results.

Implementation Method 1

The chemical indicator may include a dye that reacts with the active ingredient in the sterilization medium such as by oxidative bleaching of the dye. Upon oxidation the dye may change color or exhibit a change in color intensity based on the concentration of the active ingredient.

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 2

The indicator composition may comprise: (a) at least one iodide salt, (b) at least one binder, (c) at least one carbonate salt, at least one sulfate salt, or a mixture thereof, and (d) at least one antioxidant.

Methodology Applied
Scientific EffectAntioxidation: Oxidation

Data Source

PatentUS8512633B2Indicator for monitoring a sterilization process
Publication Date: 2013.08.20 AMERICAN STERILIZER CO
  • US8512633B2 patent drawing
  • US8512633B2 patent drawing
  • US8512633B2 patent drawing

AI summary

The disclosed invention relates to an indicator composition comprising at least one iodide salt, at least one binder, at least one carbonate salt and/or at least one sulfate salt, and at least one antioxidant. The indicator composition may contain at least one dye, complexing agent, inhibitor, and/or solvent. A sterilization indicator comprising the foregoing indicator composition is disclosed. The sterilization indicator may be used for monitoring sterilization processes involving oxidative chemistries.