Self-Contained Biological Indicator With Color Change Activation Control
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Solution Overview
Problem
Standard self-contained biological indicators (SCBIs) often fail to activate properly, leading to misleading pass results due to incorrect handling, where users do not crack the glass ampoule containing the growth medium, resulting in non-sterile goods being released and potential infections.
Innovation Solution
The SCBI design includes a color change indicator (CCI) placed outside the ampoule within the vial, allowing for visible activation confirmation by color change when the ampoule is broken, ensuring the growth medium mixes with the biological indicator, and preventing interference with microorganism growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If the color change indicator is placed inside the ampoule with the growth medium, then the color change is visible, but the indicator interferes with microorganism growth
Solution Approach 1:
The SCBI is divided into separate compartments: the ampoule containing growth medium and biological indicator, and the vial containing the color change indicator. This segmentation prevents interference between the indicator and microorganism growth while allowing visual detection when components are mixed.
Solution Approach 2:
The breakable ampoule acts as an intermediary barrier that separates the color change indicator from the growth medium during storage and transport, but can be broken to allow mixing when activation is required. This intermediary structure enables both protection and interaction on demand.
2Ease of operation
If the glass ampoule is made breakable for activation, then the growth medium can mix with the biological indicator, but users may accidentally break it during handling
Solution Approach 1:
The ampoule is pre-designed with specific structural features (thin walls, predetermined weak points) that enable easy breaking when force is applied to the vial, but resist accidental breakage during normal handling. The breaking action is prepared in advance through specific design choices.
Solution Approach 2:
The ampoule has different structural properties in different locations: thin walls at specific areas for easy breaking, and relatively stronger sections for handling. This local variation in quality enables both easy activation and resistance to accidental breakage.
3Object-affected harmful factors
If the vial is made opaque to protect contents, then the SCBI is protected from external contamination, but the color change cannot be visually detected
Solution Approach 1:
The vial is segmented into regions: opaque or translucent sections for protection, and transparent windows or sections for visual observation. This segmentation allows simultaneous protection and observation functions.
Solution Approach 2:
The vial wall acts as an intermediary that can be made translucent rather than fully opaque, allowing light transmission for visual detection while still providing physical protection and contamination barrier. This intermediary property balances protection and observation needs.
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
This design ensures accurate sterilization process detection by visually confirming activation, reducing the risk of false positive results and preventing non-sterile operations, making the process safer and more reliable.
Implementation Method 1
the first color of the growth medium is changed by the second color of the at least one color change indicator when the growth medium is mixed with the at least one color change indicator
Implementation Method 2
If microorganisms are alive in the BI they will grow in the growth medium producing metabolites and thereby changing the color of the CCI
Data Source
AI summary
The invention relates to a self-contained biological indicator comprising a vial, an ampule arranged inside said vial, a growth medium for growing microorganisms, the growth medium being arranged inside the ampule and the growth medium having a first color, a biological indicator, a carrier for holding the biological indicator, wherein the biological indicator is arranged on the carrier, and at least one color change indicator having a second color, wherein the at least one color change indicator is arranged inside the vial but outside the ampoule, the growth medium does not contain any of the at least one color change indicator and the first color of the growth medium is changed by the second color of the at least one color change indicator when mixed with the at least one color change indicator.