Biological Indicator Reader for Direct Live-Spore Detection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current sterilization efficacy technologies using biological indicators are unreliable and require prolonged time for sterility assurance, often taking 24 hours or more for results, and rely on indirect measurements susceptible to exogenous factors, leading to inaccurate assessments.
Innovation Solution
A biological indicator reader system that allows for concurrent sterility testing of multiple indicators, providing direct readings of live spores within minutes, utilizing a biological indicator, process challenge device, and reader to accurately determine sterilization efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional biological indicator assays are used to determine sterilization efficacy, then sterility assurance can be achieved, but the testing time is prolonged (24 hours for direct measurement or 20 minutes for indirect measurement)
Solution Approach 1:
The patent replaces conventional mechanical/cultural assay methods with optical detection systems. The biological indicator uses fluorescent markers that emit light when exposed to specific wavelengths, allowing rapid optical detection of spore viability without requiring prolonged incubation or manual observation periods
Solution Approach 2:
The patent changes the detection parameter from time-based observation (incubation periods) to wavelength-based optical detection. By using fluorescent markers that respond to specific light wavelengths, the system achieves rapid results within minutes rather than hours or days
2Loss of time
If indirect measurement methods are used to assess microorganism survival, then testing can be performed quickly, but measurement accuracy is reduced due to susceptibility to exogenous factors
Solution Approach 1:
The patent employs fluorescent markers that undergo wavelength-specific emission changes based on spore viability. Live spores and dead spores emit different fluorescent signals at specific wavelengths, providing direct and accurate visual differentiation without susceptibility to external environmental factors
Solution Approach 2:
The patent introduces fluorescent markers as intermediary substances that directly indicate spore viability. These markers serve as reliable mediators between the spore state and detection, providing consistent and accurate signals that are not influenced by exogenous variables affecting conventional indirect methods
3Reliability
If conventional biological indicator systems are used, then sterilization efficacy can be assessed, but the system complexity and operational procedures are cumbersome
Solution Approach 1:
The patent combines multiple functions into a single integrated biological indicator device. The indicator simultaneously contains spores, fluorescent markers, and detection mechanisms in one unit, eliminating the need for separate incubation chambers, multiple reagent additions, and complex procedural steps required by conventional systems
Solution Approach 2:
The biological indicator is designed to be self-contained and self-indicating. The fluorescent markers automatically respond to spore viability changes without requiring external reagents or complex processing, and the optical detection can be performed directly on the indicator itself, reducing operational complexity
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 sterility assurance within minutes, significantly reducing the time needed for determining sterilization success, allowing equipment to be used sooner and improving accuracy through direct spore detection.
Implementation Method 1
Current sterility assurance technologies that make use of biological indicators utilize assays that require at least one day for direct (and at least 20 minutes for indirect) measurements of microorganism survival within the biological indicator
Data Source
AI summary
A biological indicator includes: a BI housing; a germinant container inside the BI housing and housing a germinant composition; a germinant releaser configured to release the germinant composition from the germinant container; a germinant releaser support supporting the germinant releaser and configured to bring the germinant releaser into contact with the germinant container upon application of a force to the germinant releaser support or the germinant container; a first spore carrier inside the BI housing, the first spore carrier having a plurality of spores deposited at a first surface thereof; and an imaging window at a first surface of the BI housing. A BI reader is configured to detect and quantify the presence of live spores in the BI, and includes an excitation source, a camera for capturing images of the spores over time, and a processor for analyzing the images to determine the presence of live spores.