Annular Biological Indicator for Syringe Sterilization Verification
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Solution Overview
Problem
Conventional biological indicator (BI) strips used for sterilization verification in syringes can create an open channel between the elastomeric insert and the barrel tip, leading to skewed sterilization verification results.
Innovation Solution
A syringe sterilization verification assembly that includes a syringe with a barrel and a tip cap assembly, where a biological indicator (BI) member with an annular portion is disposed around the tapered tip, ensuring consistent and reliable sterilization verification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a conventional flat rectangular BI strip is used, then the sterilization verification process can be performed, but it creates an open channel between the elastomeric insert and the barrel tip, leading to skewed verification results
Solution Approach 1:
The patent applies curvature by transforming the conventional flat rectangular BI strip into an annular (curved ring) configuration. This annular BI member conforms to the curved interface between the elastomeric insert and the tapered barrel tip, eliminating gaps and open channels that would occur with a flat strip. The curved geometry ensures complete contact with the sterilization interface, providing accurate and reliable verification results.
2Ease of operation
If a BI strip is positioned between the elastomeric insert and barrel tip, then sterilization verification can be performed, but the flat geometry cannot conform to the tapered interface, creating gaps
Solution Approach 1:
The annular BI member's curved geometry matches the tapered cylindrical interface between the elastomeric insert and barrel tip. This curvature allows the BI to conform perfectly to the conical surface, eliminating gaps and ensuring complete coverage of the sterilization interface while maintaining simple placement procedures.
Solution Approach 2:
The annular BI member is designed as a thin, flexible ring that can elastically deform to conform to the tapered interface geometry. This flexibility allows the BI to adapt to the curved surface of the barrel tip and elastomeric insert interface, ensuring complete contact without creating open channels, while still being easy to place and remove.
Data Source
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AI summary
A syringe sterilization verification assembly includes a syringe, a tip cap assembly, and a biological indicator (Bl) member. The syringe includes a barrel having a tip. The tip cap assembly includes an insert having a skirt configured to receive the tip. And the biological indicator (Bl) member has an annular portion disposed around at least a portion of the tip and disposed radially between the tip and the skirt of the insert.