Sterilization Test Pack with Restricted Flow Channels

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Solution Overview

Problem

Existing sterilization test packs are complex, costly to manufacture, and difficult to use, lacking simplicity and ease of application in ensuring effective sterilization of secluded areas within sterilizers.

Innovation Solution

A sterilization test pack design featuring a sealed enclosure with external channels providing restricted flow of gaseous sterilization medium to recessed compartments, containing biological and chemical indicators, which are easy to manufacture, require fewer parts, and are straightforward to use, allowing for adjustable channel configurations for various applications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional sterilization test packs are used, then sterilization monitoring function is achieved, but device complexity and manufacturing cost increase

Engineering Contradiction:

Improvesterilization monitoring functionVSAvoidpack structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple functional components (sterilant absorber, indicator chambers, fluid communication pathways) into a single integrated test pack structure. The absorber is positioned within the sealed enclosure to directly interact with sterilant delivery, while indicator chambers receive sterilant through controlled fluid communication, eliminating the need for separate monitoring devices and reducing overall system complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The test pack structure serves multiple functions simultaneously: the sealed enclosure provides both sterilant absorption and a controlled environment for indicators; the fluid communication system both delivers sterilant to indicators and prevents contamination; the single chamber design both contains indicators and manages fluid flow. This multi-functionality reduces the number of parts needed while maintaining reliable sterilization monitoring.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If traditional sterilization test packs are used, then sterilization monitoring function is achieved, but manufacturing cost increases

Engineering Contradiction:

Improvesterilization monitoring functionVSAvoidmanufacturing cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

By integrating the sterilant absorber, indicator chambers, and fluid communication pathways into a single molded structure, the patent reduces the number of discrete parts that require assembly. This integration simplifies manufacturing processes, reduces assembly steps, and lowers overall manufacturing cost while maintaining the reliable sterilization monitoring function.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The test pack is designed as a disposable single-use device with integrated components that can be manufactured inexpensively through molding processes. The single-chamber design with embedded indicators eliminates the need for expensive reusable components and complex assembly, making the device cost-effective for single-use sterilization verification.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Reliability

If traditional sterilization test packs are used, then sterilization monitoring function is achieved, but ease of use decreases

Engineering Contradiction:

Improvesterilization monitoring functionVSAvoidease of use

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent combines indicator chambers and sterilant absorption functionality into a single integrated chamber structure, eliminating the need for users to assemble multiple components or navigate complex configurations. This integration makes the test pack straightforward to use while maintaining reliable sterilization monitoring through controlled fluid communication between the absorber and indicators.

Inventive Principle:

Principle #5Merging (Combining)

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 test pack effectively indicates sterilization efficacy with simple and reliable results, comparable to standard packs, while being easier to manufacture and use, ensuring accurate assessment of sterilization processes across different sterilization mediums and environments.

Implementation Method 1

an external channel providing restricted flow of a gaseous sterilization medium into the sealed enclosure

Methodology Applied

Scientific EffectRestricted flow:

Data Source

PatentEP2766054B1Test pack to monitor effectiveness of sterilization process

Publication Date: 2015.11.25 AMERICAN STERILIZER CO

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Figure 3~5

AI summary

A sterilization test pack, including a base comprising a pair of recessed compartments, wherein the recessed compartments are arranged in a non-concentric relationship and are in fluid communication with each other; a cover attached to the base and forming a sealed enclosure for the recessed compartments; an external channel providing the only fluid communication between the sealed enclosure and an external environment; a selected sterilization indicator in a first of the recessed compartments; and a chemical integrator and/or a chemical indicator in a second of the recessed compartments, in which the external channel is configured to allow only restricted flow of a gaseous sterilization medium into the recessed compartments and the base and cover are otherwise impenetrable by the gaseous sterilization medium.