Self-Contained Biological Indicator Top Disc Placement
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Solution Overview
Problem
Biological indicators used in ambient air isolator systems for sterilization and decontamination processes often fail to provide accurate results due to incomplete exposure of the sterilant to the inoculated carrier, especially when the carrier is positioned at the bottom or side, leading to ineffective monitoring of sterilization/decontamination cycles.
Innovation Solution
A self-contained biological indicator (SCBI) comprising a body, a glass media ampoule, an inoculated stainless steel disc positioned near the top, filter paper, and a cap, designed for use in ambient air pressure systems, ensuring the sterilant reaches the spores effectively by allowing the sterilant to penetrate through the filter paper and interact with the disc during the sterilization/decontamination process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If the inoculated carrier is positioned at the bottom or side of the SCBI, then the SCBI structure is simplified, but the sterilant cannot reach the spores effectively in ambient air isolator systems
Solution Approach 1:
The patent inverts the conventional positioning of the inoculated carrier from the bottom or side to the top opening of the SCBI. This inversion allows the sterilant to directly contact the spores on the carrier surface during the sterilization process, ensuring effective exposure while maintaining structural simplicity of the SCBI design.
2Reliability
If the sterilization chamber evacuates all ambient air, then the sterilant reaches all parts of the load effectively, but the process becomes incompatible with isolator systems that maintain ambient air pressure
Solution Approach 1:
The patent applies local quality by concentrating the spore inoculation at the top opening of the SCBI where sterilant exposure is most accessible. This localized placement ensures that even in ambient air isolator systems without complete vacuum, the critical spore carrier receives adequate sterilant contact, making the SCBI adaptable to both vacuum and ambient pressure sterilization systems.
3Reliability
If the SCBI is designed for vacuum sterilization systems, then sterilization effectiveness is maximized, but the SCBI cannot be used in ambient air isolator systems
Solution Approach 1:
The patent designs the SCBI with universal applicability by positioning the inoculated carrier at the top opening and using a cap that can be removed or left in place depending on the sterilization system. This configuration allows the same SCBI to function effectively in both vacuum sterilization systems and ambient air isolator systems, achieving multi-functionality and broad system compatibility.
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 SCBI provides accurate determination of the effectiveness of sterilization/decontamination processes by ensuring the sterilant reaches the spores, allowing for reliable validation of cycle efficacy through the use of a growth media that indicates spore presence after incubation.
Implementation Method 1
allowing the sterilant to penetrate through the filter paper and interact with the disc during the sterilization/decontamination process
Data Source
AI summary
A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.