Aseptic Connector Assembly With Reusable Valve and Door Interlock
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Solution Overview
Problem
Conventional sterile fluid connectors are limited to one-time use, require multiple connecting points, and involve complex handling steps, making them inefficient for bioprocessing and cell manufacturing processes, and single-use disposable connectors are costly and hard to manage.
Innovation Solution
A reusable connector system with a pair of connector components featuring a connector housing, a moveable door, and a valve unit with a resilient deformable valve member that allows for aseptic connections through a three-step process, including alignment, rotation, and locking, with built-in fail-safe mechanisms to prevent contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If single-use sterile disposable connectors are used, then sterility is maintained, but cost increases and management becomes difficult
Solution Approach 1:
The connector housing and valve unit are designed to be reusable after sterilization, while only the seal elements are discarded after single use. This hybrid approach maintains sterility through the reusable sterilizable housing while reducing costs by replacing only the consumable seal elements rather than the entire connector assembly.
Solution Approach 2:
The connector is divided into reusable components (housing, valve unit) and disposable components (seal elements). This segmentation allows the expensive sterilizable parts to be reused multiple times while only the inexpensive seal elements are replaced, optimizing both cost and sterility management.
2Reliability
If tube welding is used for sterile fluid connections, then connections can be made, but the process requires specialised training and operator-dependent quality
Solution Approach 1:
The connector incorporates self-aligning features including guide surfaces and positioning structures that automatically align the connector components during assembly. This eliminates the need for operator skill in alignment, making the connection process independent of training while ensuring consistent quality.
Solution Approach 2:
The invention replaces the complex tube welding mechanical process with a simpler snap-fit or bayonet connection mechanism that uses elastic deformation of seal elements and mechanical interlocking features. This substitution eliminates the need for specialized welding equipment and training while maintaining connection reliability.
3Adaptability or versatility
If manifold assembly with multiple single-use connectors is configured, then connection needs are satisfied, but the assembly becomes extensive and hard to manage
Solution Approach 1:
The reusable connector housing and valve unit can be configured with different seal elements to accommodate various connection protocols and configurations. This universality allows a single manifold assembly to be reconfigured for different applications without requiring complete replacement of the assembly, reducing complexity while maintaining adaptability.
Solution Approach 2:
The valve unit incorporates a resilient deformable valve member that can dynamically open and close to control fluid flow. This dynamic capability allows the same connector to adapt to different flow requirements and connection states without requiring multiple static configurations, simplifying the overall assembly management.
4Ease of operation
If aseptic barrier is broken in single-use connectors, then fluid flow is established, but the connector is exhausted and requires removal by tube sealing
Solution Approach 1:
The seal element is designed as a disposable component that is replaced rather than the entire connector. After the aseptic barrier is broken and fluid flow is established, the exhausted seal element can be simply replaced by removing and inserting a new seal element, eliminating the need for complex tube sealing operations to remove the entire connector.
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 connector system enables multiple aseptic connections, maintains sterility without additional isolation equipment, supports small volume transfers, and reduces operational complexity, while being cost-effective and easy to manage.
Implementation Method 1
a valve unit having a resilient deformable valve member operable to control fluid flow through the valve unit between the fluid port of the base member and the fluid channel of the engagement piece
Data Source
AI summary
A connector system having a pair of connector components capable of being used as a reuseable aseptic connection in bioprocessing and/or cell manufacturing processes. Each connector component includes a connector housing having a mating surface with an opening and a door moveable to close and open the opening, and a connector assembly therein. The connector assembly includes a base member having a fluid port; an engagement piece having a pusher portion; and a valve unit therebetween, the valve unit having a resilient deformable valve member. The pusher portion is moveable to cause the pusher portion to urge open the resilient deformable valve member for enabling the fluid flow. When the pair of connector components are interlocked, the doors open and the connector assemblies move and engage with each other through the openings causing the resilient deformable valve members to open for establishing a fluid connection.