Sterilization Challenge Device With Controlled Gas Flow Paths

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing sterilization verification methods are not accurate and cost-effective, necessitating an improved device for verifying the efficacy of gas sterilization processes.

Innovation Solution

A sterilization challenge device comprising a container, insert member, and cap, which provides a controlled flow path for gaseous sterilants to verify the efficacy of sterilization processes, using a biological indicator and optional spacer member to enhance flow restriction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If existing sterilization verification methods are used, then the verification process can be completed, but the accuracy and cost-effectiveness are insufficient

Engineering Contradiction:

Improveaccuracy of sterilization verificationVSAvoidcomplexity of verification device

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The device is segmented into distinct functional components: a container for holding the biological indicator, an insert member with restricted flow paths, and a cap. This segmentation allows each component to be optimized for its specific function while maintaining overall simplicity, thereby improving measurement precision without excessively increasing device complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insert member acts as an intermediary element between the sterilant source and the biological indicator. It introduces controlled flow restrictions that simulate challenging sterilization conditions, enabling more accurate verification of sterilization efficacy while maintaining a relatively simple device structure.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If flow restriction is increased to enhance verification accuracy, then measurement precision improves, but device complexity increases

Engineering Contradiction:

Improveaccuracy of sterilization verificationVSAvoidcomplexity of flow restriction structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

Flow restriction is applied locally at specific points within the insert member rather than throughout the entire device. The insert member contains designated restricted flow paths that create controlled resistance to sterilant flow, enabling accurate verification without requiring complex flow restriction mechanisms throughout the entire device.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The insert member incorporates porous or restricted flow path structures that provide controlled resistance to sterilant flow. These porous elements create predictable flow restrictions that enhance verification accuracy while maintaining a simple overall device design, avoiding the need for complex mechanical flow control mechanisms.

Inventive Principle:

Principle #31Porous materials

3Measurement precision

If a biological indicator is exposed to sufficient sterilant, then verification accuracy improves, but the device structure becomes more complex

Engineering Contradiction:

Improveaccuracy of sterilization verificationVSAvoidcomplexity of container structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The container, insert member, and cap are merged into an integrated assembly that provides both structural containment and flow restriction functions. This merging eliminates the need for separate complex mechanisms to achieve both sterilant exposure and flow restriction, thereby improving verification accuracy while keeping the overall device structure relatively simple.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The insert member serves multiple functions simultaneously: it provides structural support, creates flow restrictions, and positions the biological indicator. This multi-functionality reduces the need for additional separate components, enabling sufficient sterilant exposure for accurate verification while maintaining a simple device structure.

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

The device effectively verifies the efficacy of sterilization processes by ensuring adequate exposure of biological indicators to sterilants, thereby enhancing the accuracy and cost-effectiveness of sterilization verification.

Implementation Method 1

The at least one opening may be configured to provide a flow path for gaseous sterilant into the chamber

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 2

The at least one opening may be configured to provide a flow path for gaseous sterilant into the chamber

Methodology Applied

Scientific EffectConvection: Convection

Data Source

PatentUS20250295825A1Sterilization process challenge device

Publication Date: 2025.09.25 AMERICAN STERILIZER CO

AI summary

A sterilization challenge device for verifying the efficacy of a sterilization process includes a container, an insert member, a sterilization indicator, and a cap. The container includes an open end, a closed end, a chamber configured to contain the biological indicator and the insert member, and at least one hole arranged proximate the open end. The cap is configured to engage with the container to close the open end, and the at least one hole is configured to provide a flow path for the gaseous sterilant into the chamber.