Sterilization Indicator With Sonic Welded Carrier
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Solution Overview
Problem
Conventional sterilization indicators require lengthy incubation periods to determine the effectiveness of sterilization processes, which is impractical for healthcare facilities that need to reuse sterilized instruments quickly, and they are not suitable for liquid sterilization processes.
Innovation Solution
A sterilization indicator with a carrier and support structure that minimizes biological indicator handling, allowing for rapid detection of sterilization efficacy using a self-contained kit with separate compartments for the indicator and incubation medium, suitable for both gaseous and liquid sterilization processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization indicators with substrate and spores are used, then sterilization effectiveness can be monitored, but handling complexity increases and risk of spore loss or contamination occurs
Solution Approach 1:
The patent combines the biological indicator (spores), substrate, and handling features into a single integrated sterilization indicator assembly. The spores are applied directly to the substrate which also serves as the handling surface, eliminating separate handling clips and reducing steps for the user while maintaining sterilization monitoring capability
2Measurement precision
If substrate is fully covered with spores to ensure detection sensitivity, then measurement precision improves, but spore loss during handling increases
Solution Approach 1:
The patent employs a substrate with color-changing properties that indicate the presence and viability of spores. This visual indicator system allows detection of spore presence without requiring large numbers of spores, thereby maintaining measurement precision while reducing the total spore load and associated loss risks during handling
3Quantity of substance
If minimum substrate size is used to reduce resource consumption, then volume of incubation medium decreases, but handling becomes more difficult
Solution Approach 1:
The patent merges the substrate functionality with an integrated handle or gripping feature, allowing the indicator to maintain a compact size that minimizes incubation medium volume while the integrated handle provides ease of handling. This combination resolves the contradiction between small size and handling difficulty
4Measurement precision
If incubation period is extended to 2-7 days to ensure adequate spore detection, then measurement precision improves, but productivity decreases due to delayed instrument reuse
Solution Approach 1:
The patent modifies the incubation conditions by optimizing temperature, medium composition, and pH to accelerate spore germination and detection. These parameter changes reduce the incubation period from 2-7 days to a shorter timeframe, enabling faster results and higher instrument reuse rates while maintaining detection accuracy through enhanced incubation efficiency
5Ease of operation
If self-contained sterilization indicator with separate compartments is used, then ease of operation improves and spore handling is minimized, but device complexity increases
Solution Approach 1:
The patent divides the sterilization indicator into distinct functional compartments: a spore-containing chamber, an incubation medium chamber, and a detection chamber. This segmentation allows each component to be optimized independently and simplifies the user operation by clearly separating functions, while the modular design manages overall device complexity through organized functional zones
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 rapid determination of sterilization effectiveness within a short period, reducing the time and resources required for sterility verification and accommodating both gaseous and liquid sterilization methods.
Implementation Method 1
the second surface of the carrier being adhered to the first section of the support
Data Source
AI summary
The disclosed technology relates to a sterilization indicator, including a carrier, the carrier having a first surface and a second surface; a support, the support having a first section and a second section, the carrier overlying the first section of the support, the second surface of the carrier being adhered to the first section of the support; and a biological indicator supported by the carrier; the sterilization indicator being formed by applying the biological indicator to the carrier and then adhering the carrier to the support, the carrier being adhered to the support using sonic welding, in which the sonic welding, when applied to the carrier with the biological indicator applied, exhibits no significant difference in viability of the biological indicator following the sonic welding as compared to prior to the sonic welding.