Sterile Coupler with UV-C Valve Sterilization
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Solution Overview
Problem
Existing coupler assemblies for sterile/aseptic environments face challenges in maintaining a tight seal to prevent contamination and material loss during the transfer of pharmaceutical powders or other materials, particularly with heavy passive valves and issues like powder hang-up on valve diaphragms and gaskets.
Innovation Solution
A coupler assembly with an active valve and passive valve assembly that includes a UV-C sterilization device, where the UV-C emitter assembly is positioned to expose the valve surfaces to UV light before material transfer, ensuring cleanliness and preventing contamination, and a spigot mechanism that protects the valves from material exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single ring welded around the container opening is used to create a tight seal, then sealing reliability is improved, but manufacturing complexity and time increase
Solution Approach 1:
The connection assembly is divided into multiple separate components: a first connection element that attaches to the container opening and a second connection element that interfaces with the filling/emptying apparatus. These segments are designed to connect through a docking interface with sealing elements, eliminating the need for complex welding while maintaining seal integrity.
Solution Approach 2:
A docking interface with sealing elements (such as gaskets or seals) acts as an intermediary between the container and the filling/emptying apparatus. This intermediary component provides the tight seal without requiring direct welding of the container opening, simplifying the manufacturing process while ensuring reliability.
2Reliability
If a heavy passive valve assembly is used in the coupler, then sealing reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The valve assembly is segmented into an active valve assembly and a passive valve assembly, each with its own docking interface. This segmentation allows the passive valve to be lighter while maintaining sealing reliability through the docking interface with the active valve assembly.
Solution Approach 2:
The docking interface with sealing elements serves as an intermediary that transfers and distributes sealing forces across the connection point. This allows the use of lighter valve assemblies while maintaining reliable sealing through the distributed sealing mechanism at the docking interface.
3Device complexity
If traditional coupler assemblies are used without sterilization, then device complexity is reduced, but contamination risk increases
Solution Approach 1:
A UV-C sterilization device is incorporated into the coupler assembly to perform preliminary sterilization of the connection surfaces before materials are transferred. The sterilization function is activated automatically when the passive and active valve assemblies are docked together, ensuring contamination-free operation without significantly increasing overall device complexity.
4Productivity
If powder transfer is performed without protective mechanisms, then productivity is improved, but material loss increases
Solution Approach 1:
A spigot acts as an intermediary protective mechanism during powder transfer. The spigot extends into the material flow path to protect the valve diaphragms and gaskets from direct powder contact, preventing hang-up and material loss while maintaining high transfer productivity through the open valve passages.
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 UV-C sterilization enhances the cleanliness of the coupler assembly, reducing contamination risks and material loss by ensuring the exposed surfaces are sterilized before material transfer, and the spigot mechanism prevents material contact with the valves, maintaining a sterile environment during transfer and disconnection.
Implementation Method 1
a UV emitter assembly arranged in use to emitting UV light into the void such that the exposed outer surfaces of at least the passive valve and active valve are exposed to UV light emitted by the emitter assembly
Data Source
AI summary
A system for contained sterile/aseptic transfer of materials comprises a coupler assembly (6) including an active valve assembly (9) having an active valve and docking part and a passive valve assembly (7) which comprises a passive valve and a complimentary docking part, the two docking parts enabling the two valve assemblies to be secured together in a first position with a void formed between the two facing surfaces of the closed valves. A sterilisation device (20) including a UV emitter assembly is arranged to emit UV light into the void such that the exposed outer surfaces of at least the passive valve and active valve are exposed to UV light emitted by the emitter assembly after the two docking parts are secured together in the first position, and prior to moving of the passive/active valve to a second position where material may transfer through the opened valves.


