Frangible Container Sterilization Indicator

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Solution Overview

Problem

Current biological sterilization indicators face challenges in providing immediate and reliable feedback on the effectiveness of sterilization processes, as existing methods can be time-consuming and prone to errors, such as personal injury and reduced liquid availability for spore growth detection.

Innovation Solution

A biological sterilization indicator with a housing design that includes a frangible container and a movable portion to safely release a liquid nutrient medium to spores, ensuring minimal cross-sectional area for sterilant path consistency and optimal liquid transfer, while preventing spore and signal diffusion for enhanced detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional biological sterilization indicators are used with spores incubated in nutrient medium, then spore growth detection can confirm sterilization insufficiency, but the time period for determination is undesirably long

Engineering Contradiction:
Improvesterilization effectiveness confirmationVSAvoiddetermination time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The nutrient medium is pre-loaded into the frangible container before sterilization. The container is designed to automatically release the pre-positioned nutrient medium upon sterilization completion, eliminating the need for post-sterilization medium addition and significantly reducing determination time while maintaining reliable spore growth detection

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If manual handling of frangible containers is used to release liquid to spores, then liquid can be transferred to spores, but personal injury risk and liquid availability issues occur

Engineering Contradiction:
Improveliquid transfer to sporesVSAvoidpersonal injury risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The system automatically transfers the nutrient medium from the frangible container to the spores through a self-activating mechanism triggered by sterilization conditions. The movable portion and projection work together to fracture the container and position the liquid without requiring manual intervention, eliminating personal injury risks and ensuring consistent liquid delivery

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The frangible container is pre-loaded with the exact amount of nutrient medium needed, and the mechanical structure is pre-configured to automatically release the liquid to the spores upon sterilization completion, ensuring proper liquid availability without manual handling

Inventive Principle:
Principle #10Preliminary action

3Productivity

If the movable portion is designed to fracture the container, then liquid release can be achieved, but spore and signal diffusion may occur reducing detection reliability

Engineering Contradiction:
Improvesterilization feedback speedVSAvoidspore growth detection
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The housing is designed with differentiated zones: a first portion containing the spores and a second portion containing the frangible container. The movable portion selectively transfers liquid from the second portion to the first portion while maintaining spatial separation that prevents spore diffusion. The detection window is positioned to provide localized optical access to the spore region without compromising containment

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The system is divided into distinct functional segments: the frangible container holding nutrient medium, the spore reservoir, the movable portion for liquid transfer, and the detection chamber. This segmentation allows controlled liquid release while maintaining physical barriers that prevent spore and signal diffusion, ensuring detection reliability

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP2456882B1Biological sterilization indicator and method of using same
Publication Date: 2017.10.11 3M INNOVATIVE PROPERTIES CO
  • EP2456882B1 patent drawingFigure 1
  • EP2456882B1 patent drawingFigure 2~3
  • EP2456882B1 patent drawingFigure 4~5

AI summary

A biological sterilization indicator (BI) and a method of using same for assaying the lethality of a sterilization process. The BI can include a housing, which can include a first portion (104), and a second portion (106), which can be movable with respect to the first portion between a first and second position. The BI can further include a frangible container (120) comprising a liquid. The BI can further include a spore reservoir (114) and a projection (158) positioned in the housing. The projection can be configured to fracture the container when the second portion of the housing is moved from the first position to the second position. The method can include maintaining a minimal cross-sectional area of space around the container when the second portion of the housing is in the first position, and fracturing the container in response to moving the second portion between the first and second positions.