Sterilization Challenge Pack Sealing for Accurate Steam Penetration

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Solution Overview

Problem

Existing sterilization processes in steam sterilizers may be ineffective due to air pockets and non-condensable gases, leading to inadequate steam penetration and reduced sterilization efficacy, which is not accurately monitored by current Bowie-Dick test devices.

Innovation Solution

A process challenge device comprising a stack of test sheets with a test indicator enclosed by flexible sheets, sealed with a continuous peripheral seal, ensuring precise packing density and eliminating manual folding, thereby improving the accuracy of Bowie-Dick test results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If manual folding methods are used to assemble process challenge devices, then device assembly is simple, but manufacturing precision and packing density consistency are poor

Engineering Contradiction:

Improvepacking densityVSAvoidassembly process

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The device is segmented into modular components (stack of test sheets, flexible packaging material, sealing system) that can be independently manufactured and then assembled through a standardized forming process, enabling consistent packing density while maintaining assembly simplicity

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The packaging material undergoes parameter changes through thermal or mechanical forming processes that transform it from a flat state to a three-dimensional configuration with precise packing density, eliminating the need for manual folding while ensuring manufacturing precision

Inventive Principle:

Principle #35Parameter changes

2Reliability

If flexible sheets are used to enclose the stack, then steam leakage is prevented, but device complexity increases due to sealing requirements

Engineering Contradiction:

Improvesteam containmentVSAvoidsealing structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Flexible packaging sheets are used to enclose the stack, providing effective steam containment through the inherent flexibility and conformability of the material, which adapts to the stack geometry without requiring complex rigid sealing structures

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The flexible packaging material is designed to self-seal or self-configure through its material properties (elasticity, memory), reducing the need for additional sealing components and simplifying the overall sealing structure while maintaining reliability

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS20260007794A1Process challenge device and method of manufacturing thereof

Publication Date: 2026.01.08 SOLVENTUM INTELLECTUAL PROPERTIES CO

AI summary

A process challenge to be used for determining the effectiveness of a sterilization procedure is provided. The process challenge device includes a stack including a plurality of test sheets disposed on top of each other. The process challenge device further includes a test indicator disposed within and enclosed by the plurality of test sheets of the stack. The process challenge device further includes a first flexible sheet including a bottom wall receiving the stack thereon, a plurality of side walls, and a peripheral flange extending from the plurality of side walls. The process challenge device further includes a second flexible sheet disposed on and at least partially engaging with the stack and the peripheral flange. The process challenge device further includes a continuous peripheral seal coupling the second flexible sheet to the peripheral flange. The stack is fully enclosed by the first flexible sheet and the second flexible sheet.