Sterilization Indicator Incubator with Fixed Optical Detection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing sterilization indicator systems require moving parts, which can lead to mechanical failures and alignment issues, and need baseline fluorescence determination, making them unreliable and time-consuming for assessing sterilization efficacy.
Innovation Solution
A combined sterilization indicator incubator and reader system with independently operable incubator blocks, a light source, and a photodetector that can detect exit light without requiring baseline fluorescence, allowing for early and reliable assessment of sterilization efficacy by calculating the slope of output readings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If moving parts are used in the detector alignment mechanism, then the system can detect fluorescence from multiple sample locations, but the system becomes unreliable due to mechanical failures and light path misalignments
Solution Approach 1:
The patent replaces the mechanical detector movement system with a fixed detector position and multiple fixed light sources. Instead of moving the detector to align with different sample locations, the system uses multiple stationary UV light sources positioned to illuminate different sample locations simultaneously, with a single stationary detector reading all samples through fixed optical paths. This eliminates mechanical failures and alignment issues while maintaining the ability to detect fluorescence from multiple sample locations.
Solution Approach 2:
The patent divides the illumination function into multiple separate UV light sources, each dedicated to a specific sample location. This segmentation allows each light source to be optimally positioned for its specific sample location without requiring mechanical movement, while the detector remains stationary. The system processes multiple samples in parallel through fixed optical paths, eliminating the need for moving parts.
2Device complexity
If a single heater block is used, then the device complexity is reduced, but the adaptability to different temperature requirements is limited
Solution Approach 1:
The patent divides the heating function into multiple independent heater blocks, each capable of being set to different temperatures. This allows simultaneous incubation of multiple biological indicators at different temperatures (e.g., 37°C, 57°C, 25°C) without requiring a single complex multi-zone heater. Each heater block is a simple, reliable unit that can be independently controlled, providing temperature adaptability while maintaining low device complexity.
Solution Approach 2:
Each heater block is designed to be universally applicable to different biological indicator types by allowing independent temperature programming. The same physical heater block structure can serve multiple temperature requirements by simply changing the setpoint, making the system versatile without requiring different hardware for different temperature needs.
3Measurement precision
If baseline fluorescence determination is required, then the measurement precision can be improved, but the time required for assessment increases
Solution Approach 1:
The patent performs preliminary action by pre-programming threshold values into the system memory during manufacturing, based on extensive characterization of the biological indicators and fluorescence signals. These pre-determined thresholds represent the expected fluorescence levels for positive and negative results. During operation, the system simply compares measured fluorescence against these pre-established thresholds, eliminating the need for time-consuming baseline determination while maintaining measurement precision through factory-calibrated reference values.
Solution Approach 2:
The system uses self-service by automatically comparing fluorescence readings against pre-programmed thresholds and directly determining pass/fail results without requiring manual baseline establishment. The embedded controller performs the entire assessment autonomously by comparing measured values against stored reference thresholds, eliminating time-consuming manual operations while maintaining accurate measurement through pre-characterized reference data.
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
The system provides a durable, reliable, and rapid indication of sterilization efficacy, eliminating the need for baseline determination and reducing the time required for assessment, while maintaining flexibility and ease of use.
Implementation Method 1
fluorescence has been used to detect the activity of enzymes that are produced by the test organisms by adding a fluorogenic enzymatic substrate to the growth media
Implementation Method 2
a photodetector positioned to detect exit light emanating from the interior cavity
Implementation Method 3
at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures
Data Source
Figure 1~3B
Figure 2
Figure 4A~4D
AI summary
A combined sterilization indicator incubator and reader system, including a sterilization indicator vial containing one of a variety of selected biological indicators and a liquid, at least two incubator blocks, each incubator block independently operable to incubate the sterilization indicator vial at a plurality of independently selectable temperatures, each of the incubator blocks including at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures; a light source, a photo detector and a control system configured to operate the combined system to determine the efficacy of a variety of sterilization processes. The system calculates and compares a slope to a predetermined threshold slope for the biological indicator, and provides output based only on the comparison of the calculated slope to the predetermined threshold slope without first determining either a baseline or a minimum value of the output from the photo detector.