Multidose Vial Adapter with Camming Retention
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Solution Overview
Problem
Multidose vials face sterility issues after the initial dose withdrawal due to puncture holes and potential fragmentation of self-sealing septums, and withdrawal spikes are prone to displacement, leading to inefficiencies and contamination risks.
Innovation Solution
An adapter is designed to securely couple a withdrawal spike with a multidose vial, using retaining members with camming surfaces and resilient tabs to ensure proper alignment and prevent axial or orientational displacement, along with a swabbable valve to minimize contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a withdrawal spike is used to access multidose vial contents, then multiple doses can be withdrawn, but the spike is prone to displacement which compromises sterility and causes fragmentation
Solution Approach 1:
An adapter is introduced as an intermediary component between the multidose vial and the withdrawal spike. The adapter includes a first retaining member that couples to the vial and a second retaining member that couples to the spike, ensuring stable positioning and preventing displacement while maintaining sterility throughout multiple dose withdrawals
Solution Approach 2:
The system is divided into separate functional components: the multidose vial, the adapter (with retaining members), and the withdrawal spike. This segmentation allows each component to be optimized independently and assembled together, improving both reliability and productivity
2Reliability
If a self-sealing septum is used to seal the vial opening, then sterility is maintained, but fragmentation occurs during spike insertion
Solution Approach 1:
The adapter serves as a mediator that distributes the insertion force across multiple retaining members rather than concentrating it on a single septum, reducing the risk of fragmentation while maintaining sterility through the adapter's sterile barrier
3Ease of operation
If the withdrawal spike is positioned manually, then alignment can be adjusted, but displacement occurs during use leading to contamination
Solution Approach 1:
The adapter incorporates resilient tabs that provide dynamic adjustment capability during assembly, allowing the retaining members to flex and accommodate minor misalignments while maintaining secure coupling and preventing displacement during actual use
Solution Approach 2:
The adapter is pre-assembled with the retaining members positioned to engage the vial and spike before use, establishing correct alignment in advance and preventing displacement during the withdrawal process
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 adapter maintains sterility and ensures consistent, efficient withdrawal of multiple doses by preventing spike displacement and reducing contamination risks, thereby minimizing wastage and ensuring safe vaccine delivery.
Implementation Method 1
resilient tabs to ensure proper alignment and prevent axial or orientational displacement
Implementation Method 2
retaining members with camming surfaces
Data Source
AI summary
A multidose vial assembly which comprises a multidose vial (10), a withdrawal spike (30), and an adapter (60) that couples the multidose vial and the withdrawal spike together in a safe and secure manner.