External Sterilization Indicator for Sealed Package Verification

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Solution Overview

Problem

Existing sterilization procedures for medical instruments lack effective methods to assess sterilization effectiveness without opening the sterilization package, leading to potential contamination and operational inefficiencies.

Innovation Solution

Development of externally visible, internally sampling sterilization indicators that provide a visual indication of sterilization parameters without opening the package, using a cover, indicator, and seal to form a microorganism barrier and fluidly couple with the internal cavity, allowing assessment of sterilant exposure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sterilization packages are opened to assess internal indicators, then sterilization effectiveness can be determined, but operator errors increase, costs increase, and surgeries are delayed

Engineering Contradiction:

Improvesterilization effectiveness assessmentVSAvoidpackage opening requirement

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

An external indicator device is introduced as an intermediary between the sterilization package and the operator. This device samples sterilant through the package wall and provides visual indication of sterilization effectiveness without requiring package opening, thereby eliminating operator exposure to potentially contaminated instruments and reducing errors

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The external indicator device creates a copy or representation of the internal sterilization condition by sampling sterilant through the package wall. The indicator changes state based on sterilant exposure, providing an external visual copy of the internal sterilization status without direct observation of internal indicators

Inventive Principle:

Principle #26Copying

2Reliability

If internal sterilization indicators are used, then sterilization effectiveness can be determined, but the need for test packs and transparent windows increases complexity and cost

Engineering Contradiction:

Improvesterilization effectiveness determinationVSAvoidtest packs and transparent windows

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The indicator function is extracted from the internal package environment and placed on the external surface. The external indicator device samples sterilant through the package wall, eliminating the need for internal indicators, test packs, and transparent windows while maintaining reliable sterilization effectiveness determination

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The external indicator device serves multiple functions: it samples sterilant, provides visual indication of sterilization effectiveness, and eliminates the need for separate test packs or transparent windows. This multi-functional approach reduces overall system complexity

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Loss of information

If packages are opened for indicator assessment, then sterilization status is visible, but instrument contamination risk increases and processing throughput decreases

Engineering Contradiction:

Improvesterilization status visibilityVSAvoidprocessing throughput

Core Design Contradiction:

Loss of informationVSProductivity

Solution Approach 1:

The external indicator provides sterilization status information before the package is opened and before instruments are moved to the operating room. This preliminary assessment prevents unnecessary package openings and instrument handling, thereby maintaining productivity and preventing contamination

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The external indicator acts as an intermediary that provides sterilization status information without requiring package opening. This eliminates the need to open packages for assessment, preventing potential contamination and maintaining processing throughput

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

Enables efficient assessment of sterilization effectiveness before use, reducing contamination risks, operational delays, and costs associated with internal indicators and transparent windows, while minimizing operator error.

Implementation Method 1

The indicator is configured to fluidly couple with an internal cavity of a sterilization package and indicate an exposure to a sterilant

Methodology Applied

Scientific EffectChemical indicator exposure: Chemical Bonding

Implementation Method 2

The seal is configured to form a microorganism barrier between an exterior of the cover and an internal cavity of a sterilization package

Methodology Applied

Scientific EffectPhysical barrier: Physical Containment

Data Source

PatentUS12611478B2Determining effectiveness of sterilization procedure from outside the sterilization package

Publication Date: 2026.04.28 SOLVENTUM INTELLECTUAL PROPERTIES CO

AI summary

An example sterilization indicator (102) includes a cover (122), an indicator (102), and a seal (142). The cover (122) defines at least a portion of a cavity (138). The indicator (102) is disposed within the cavity (138). The indicator (102) is configured to fluidly couple with an internal cavity (110) of a sterilization package (package) and indicate an exposure to a sterilant. The seal (142) is configured to form a microorganism barrier between an exterior of the cover (122) and an internal cavity (110) of a sterilization package (100).