Flexible Sterilization Holder for Reproducible Indicator Placement
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Solution Overview
Problem
Current methods for attaching biological indicators and thermocouples in sterilization processes are amateurish, leading to damage, contamination, and non-reproducible measurement results due to improper placement, which is critical in industries like pharmaceuticals where reproducibility is crucial.
Innovation Solution
A holder system with flexible, tube-shaped or flat components that securely positions biological indicators and thermocouples, ensuring accurate and reproducible placement by using sealing caps and adhesive elements, minimizing contact with surfaces to prevent damage and contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If biological indicators and thermocouples are attached using tape or placed manually in the system, then the placement process is simple and quick, but the biological indicators are easily damaged and measurement results are not reproducible
Solution Approach 1:
The holder is divided into multiple components: a flexible base part with holes for positioning, and separate sealing caps that can be attached to enclose the biological indicators and thermocouples. This segmentation allows for easy assembly and disassembly while maintaining secure positioning, resolving the contradiction between simple placement and reliable measurement.
Solution Approach 2:
The holder acts as an intermediary device between the manual placement process and the measurement system. It provides a standardized interface that ensures consistent positioning of biological indicators and thermocouples, thereby improving measurement reproducibility without complicating the placement process.
2Ease of manufacture
If biological indicators are placed directly on surfaces using tape, then the placement method is simple, but contamination of the system and product may occur
Solution Approach 1:
The holder serves as an intermediary barrier between the biological indicators and the sterilization system environment. By enclosing the indicators within the holder structure with sealing caps, it prevents direct contact with potential contaminants while maintaining the simplicity of the placement method through the flexible base design.
Solution Approach 2:
The flexible base part of the holder can conform to various surfaces within the sterilization system, providing a protective enclosure for the biological indicators. This flexibility allows the holder to adapt to different system geometries while maintaining the integrity and cleanliness of the indicators, thus reducing contamination risk.
3Ease of operation
If adhesive tape is used to attach biological indicators, then attachment is achieved, but residual glue residues can cause contamination
Solution Approach 1:
The invention extracts the harmful adhesive function from the attachment process by replacing tape with a mechanical holding system. The flexible base part with holes provides structural support and positioning, while sealing caps provide enclosure, eliminating the need for adhesive materials that could leave harmful residues.
Solution Approach 2:
The holder appears to be designed as a disposable component that can be easily attached and removed after use. This approach eliminates the need for complex attachment mechanisms while ensuring no residues are left in the system, as the entire holder can be discarded after a single use.
Data Source
AI summary
A holder for holding one or more biological indicators and/or one or indicators and one or more thermocouples. The holder includes one or more basic parts, being at least one first basic part where one or more biological indicators and/or one or more thermocouples can be placed in the basic part. The basic part is provided at the location where the biological indicator or indicators can be located with one or more holes. The holder is provided with means for securing the one or more thermocouples and/or biological indicators in the holder. At least one of the one or more basic parts is flexible.