Residual Sterilant Test Method Using Collector Solution

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Solution Overview

Problem

Existing methods face challenges in efficiently and reliably removing residual sterilants, such as hydrogen peroxide, from surfaces after disinfection or sterilization processes, particularly in large areas or sensitive equipment, due to the difficulty in achieving low enough residue levels to meet safety and regulatory standards, and the need for quick certification of sterilant removal.

Innovation Solution

A method involving a test piece with a predetermined surface area is subjected to the sterilization regime, and the residual sterilant is collected and measured using a collector solution, or by reacting with species like iodide and thiosulfate to visually indicate if the residual level exceeds a threshold, allowing for direct or indirect quantification of the sterilant amount.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sterilization methods are used, then sterilization effectiveness is achieved, but residual sterilant remains on surfaces making it difficult to meet safety standards

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidresidual sterilant on surfaces
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The test method extracts and isolates the residual sterilant from the sterilized surface by collecting it in a collector solution, separating the harmful residue from the treated object for measurement and evaluation

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

A collector solution acts as an intermediary medium to transfer and concentrate residual sterilant from the test piece surface, enabling accurate measurement through chemical reaction with indicator species

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If extensive residual sterilant removal procedures are implemented, then safety standards are met, but process time and complexity increase

Engineering Contradiction:
Improveresidual sterilant levelsVSAvoidprocess time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The test method performs preliminary assessment by placing the test piece in the sterilization space before full sterilization, allowing prediction of residual sterilant levels and optimization of removal procedures beforehand

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The collector solution automatically reacts with residual sterilant through chemical interaction with indicator species, providing self-indicating measurement without requiring complex external analysis equipment or extensive processing

Inventive Principle:
Principle #25Self-service

3Measurement precision

If advanced measurement equipment and trained personnel are used, then measurement precision is improved, but device complexity and operational difficulty increase

Engineering Contradiction:
Improveresidual sterilant quantification accuracyVSAvoidmeasurement system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The method replaces complex mechanical/electronic measurement systems with a chemical-based detection system using collector solutions and indicator species that provide visual or measurable results through chemical reactions

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

Solution Approach 2:

The test method changes the measurement parameter from direct physical measurement of residual sterilant to indirect measurement through chemical reaction products, simplifying the measurement system while maintaining precision

Inventive Principle:
Principle #35Parameter changes

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 method enables accurate determination of residual sterilant levels, providing a quick 'go/no-go' confirmation of whether the sterilant has been removed to a safe level, ensuring compliance with safety and regulatory standards, and is suitable for on-site validation without requiring extensive training or equipment.

Implementation Method 1

collecting the residual sterilant from the test piece in a collector solution

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

placing the test piece into a first solution containing a known amount of a first species reactive with the sterilant

Methodology Applied
Scientific EffectChemical reaction: Chemical Bonding

Implementation Method 3

adding to the first solution a known amount of a second species reactive with the first species, whereby the first species and second species are reactive to provide a result having a first visual appearance

Methodology Applied
Scientific EffectChemical reaction: Chemical Bonding

Data Source

PatentUS9448213B2Residual sterilant test method
Publication Date: 2016.09.20 SABAN VENTURES PTY LTD

AI summary

Methods for determining the amount of residual sterilant remaining on the surface of an object at the end of a disinfection process are described. One method of determining the amount of residual sterilant on a test piece after a sterilization regime in a sterilization space includes the steps of: placing a test piece having a predetermined surface area into the sterilization space; subjecting the test piece to the sterilization regime; collecting the residual sterilant from the test piece in a collector solution; and measuring the amount of residual sterilant in the collector solution.