Twist-Breakable Pre-Filled Syringe Cap for Tamper-Resistant Opening
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Solution Overview
Problem
Pre-filled syringes require a tamper-resistant and reliable opening mechanism that ensures sterility at the point of use, as existing elastomer closures are not sufficiently fluid-tight and may lead to incorrect opening in emergency situations.
Innovation Solution
A twist-breakable cap system with snap-fastening lugs and grooves that securely fix to the syringe tip, allowing only twisting action for opening, ensuring the breakable stopper ruptures reliably, providing visual or audible confirmation of correct action and preventing unwanted opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If elastomer closures are used to seal the syringe tip, then the syringe can be opened easily, but the closure is not sufficiently fluid-tight and may lead to leakage during storage
Solution Approach 1:
The closure is changed from elastomer material to a rigid plastic material (polypropylene or similar), fundamentally changing the material parameter to achieve both fluid-tightness and ease of opening through screw-thread engagement
Solution Approach 2:
The closure system is divided into separate components: a removable cap and a breakable stopper, each performing specific functions. The cap provides sealability while the stopper provides tamper-evident opening
2Reliability
If a secure closure system is implemented to ensure tamper-resistance, then sterility is maintained, but the opening mechanism becomes more complex
Solution Approach 1:
The cap is pre-screwed onto the tip during manufacturing, creating an initial secure state. The breakable stopper is pre-positioned inside the cap, ready to break upon twisting, eliminating the need for complex multi-step opening mechanisms
Solution Approach 2:
The breakable stopper is extracted as a separate, simple component that can be easily removed by twisting, separating the tamper-resistance function from the opening action and simplifying the overall mechanism
3Reliability
If a breakable stopper is used to ensure reliable opening, then tamper-resistance is achieved, but visual or audible confirmation of correct action is not provided
Solution Approach 1:
The breakable stopper incorporates visual indicators such as color-coded zones or visible break lines that change appearance when broken, providing immediate visual confirmation to the user that the correct opening action has been performed
Solution Approach 2:
The breaking of the stopper generates audible sounds (clicks or snaps) that provide tactile and auditory feedback to the user, confirming that the stopper has successfully broken and the syringe is ready for use
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
Ensures reliable and tamper-resistant access to the medicinal product, maintaining sterility and preventing incorrect opening, while allowing simple and effective operation of the syringe.
Implementation Method 1
a breakable zone (130) connected to the free end of the tubular part (10) of the tip
Implementation Method 2
at least one snap-fastening lug (90) and at least one snap-fastening opening or groove collaborating in snap-fastening with the snap-fastening lug
Data Source
AI summary
A pre-filled syringe (1) has a cap (14) which is snap-fastened/click-fitted onto the connecting tip (9) or the tubular body of the syringe, and inside which a breakable plug (13) is secured or connected. The plug is guaranteed to rupture when at least one portion of the cap is twisted about the longitudinal axis (X) of the syringe.