Tamper-Evident Closure Retainer Segmentation for Medical Containers
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional medical closures for pre-filled syringes and containers lack effective tamper-evident mechanisms that maintain sterility and prevent complete disconnection of components during access, leading to concerns about contamination and unauthorized access.
Innovation Solution
A closure assembly featuring a retainer made of separable material, such as metallic or plastic foil, which remains captured within the sleeve after removing the tip cap, preventing complete detachment and ensuring that any tampering is evident through controlled separation of segments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional tamper evident closures are used, then tamper indication is provided, but complete disconnection of components may occur during access
Solution Approach 1:
The retainer is divided into multiple segments that can separate from each other during tip cap removal, but remain connected through the connecting structure. This segmentation allows the tip cap to be removed while preventing complete disconnection of the retainer components, resolving the contradiction between component retention and ease of operation.
Solution Approach 2:
The retainer transitions from a static, rigid structure to a dynamic, flexible structure capable of controlled deformation. The flexible connecting structure allows the segments to move and separate during tip cap removal, then return to a captured position, enabling both easy removal and reliable retention.
2Reliability
If frangible tabs are used for tamper indication, then tamper evidence is provided, but small parts may break off and expose users to contamination
Solution Approach 1:
The retainer is formed from a flexible material that can deform and separate in a controlled manner during tip cap removal. This flexible structure prevents brittle fragmentation into small parts, eliminating the contamination risk associated with traditional frangible tabs while still providing clear tamper indication through visible separation.
3Ease of operation
If the retainer is made of separable material, then controlled separation is achieved, but complete detachment must be prevented
Solution Approach 1:
The retainer segments are nested within the sleeve structure, with the flexible connecting structure anchoring them in place. During tip cap removal, the segments can separate and move outward, but the connecting structure prevents complete detachment, maintaining the nested relationship and ensuring the retainer remains captured within the sleeve.
Data Source
AI summary
A closure assembly for a medical container having a sleeve with a tip cap disposed therein in an accessible position relative to an access opening. A cover is fixedly secured to one end of said sleeve, opposite to said access opening and a retainer is fixedly secured within the sleeve, adjacent the cover and in a removably retaining engagement with the tip cap. The removably retaining engagement includes the retainer having one or more segments disposed in retaining engagement with an exterior of the tip cap. Upon detachment of the tip cap from the retainer and the removal thereof from the sleeve, the one or more segments are separable from one another and/or a remainder of the retainer, while being maintained in a captured position within the sleeve.