Electromechanical Sensor for Rapid Sterilization Viability Detection

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Solution Overview

Problem

Current methods for determining the efficacy of sterilization processes using biological indicators require a lengthy incubation period of 24 to 72 hours, which is impractical and inefficient for settings with limited resources that need to reuse sterilized articles quickly.

Innovation Solution

A process involving a viability detection medium with hydrogen peroxide, which produces a gaseous reaction product when viable test microorganisms are present, combined with an electromechanical sensor to rapidly detect the presence or absence of viable organisms, allowing for instantaneous or near-instant determination of sterilization effectiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional incubation methods are used to determine sterilization efficacy, then measurement precision is improved, but loss of time increases significantly

Engineering Contradiction:
Improvesterilization efficacy determination accuracyVSAvoidincubation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the traditional biological incubation system with an electromechanical sensor system that detects gaseous reaction products. Instead of waiting for microbial growth and metabolic changes over 24-72 hours, the system uses sensors to detect gases produced by viable organisms in real-time, substituting a mechanical/electrical detection system for a biological time-dependent system.

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

Solution Approach 2:

The patent introduces a gaseous reaction product as an intermediary between the viable test microorganisms and the detection system. The viable organisms produce detectable gases that serve as mediators, allowing the sensor to indirectly detect organism viability without requiring direct observation of growth or metabolic activity over extended periods.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If rapid detection methods are implemented, then productivity is improved, but device complexity increases

Engineering Contradiction:
Improvesterilization validation speedVSAvoiddetection system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent extracts the detection function from the complex biological incubation process and isolates it into a separate electromechanical sensor module. This allows the rapid detection capability to be implemented as a distinct component that can be integrated into existing sterilization systems without requiring complete system redesign.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The electromechanical sensor system is designed to detect gaseous reaction products from viable test microorganisms, which can be applied across different sterilization processes and biological indicator types. This multi-functional approach allows a single detection system to serve multiple sterilization validation purposes, reducing overall system complexity.

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 method significantly reduces the time required to determine the viability of test microorganisms, potentially down to seconds, enabling quicker validation of sterilization processes without the need for extensive incubation, thus improving efficiency and practicality.

Implementation Method 1

the viability detection medium causes viable test microorganisms of the biological indicator to metabolically respond and produce the gaseous reaction product

Methodology Applied
Scientific EffectMetabolic response:

Implementation Method 2

exposing the biological indicator to a viability detection medium comprising hydrogen peroxide, the biological indicator including test microorganisms on a carrier, the exposing the biological indicator to the viability detection medium comprising hydrogen peroxide producing a gaseous reaction product comprising oxygen

Methodology Applied
Scientific EffectHydrogen peroxide reaction: Hydrogen Peroxide

Implementation Method 3

detecting with a sensing device the presence or absence of the gaseous reaction product produced by the biological indicator combined with the viability detection medium, the sensing device including an electromechanical sensor

Methodology Applied
Scientific EffectElectromechanical sensing:

Implementation Method 4

the sensing device includes an electronic device capable of measuring a change in a frequency of oscillation of the electromechanical sensor when the gaseous reaction product interacts with a coating of the electro-mechanical sensor

Methodology Applied
Scientific EffectFrequency oscillation measurement:

Implementation Method 5

the electro-mechanical sensor includes a quartz crystal microbalance including a coating on a surface of the substrate configured to absorb the gaseous reaction product produced by the biological indicator

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentEP3652332B1Process for determining viability of test microorganisms of biological indicator and sterilization detection device for determining same
Publication Date: 2021.09.15 AMERICAN STERILIZER CO
  • EP3652332B1 patent drawingFigure 1
  • EP3652332B1 patent drawingFigure 2A~2B
  • EP3652332B1 patent drawingFigure 3~4

AI summary

A process for determining the viability of a biological indicator includes exposing the biological indicator to a viability detection medium, the biological indicator including test microorganisms, the exposing the biological indicator to the viability detection medium producing a gaseous reaction product when one or more of the test microorganisms are viable. The presence or absence of the gaseous reaction product produced by the biological indicator combined with the viability detection medium is detected with a sensing device, the sensing device comprising an electro-mechanical sensor, wherein the presence of the gaseous reaction product indicates the presence of viable test microorganisms and the absence of the gaseous reaction product indicates the absence of viable test microorganisms. A sterilization detection device includes a container configured to contain the biological indicator, a viability detection medium, and the sensing device.