Sterile Reconnectable Coupling for Wet Fluid Transfer Under Pressure
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Solution Overview
Problem
Current fluid transfer devices for biopharmaceutical applications face challenges such as laborious sterilization, difficulty in integration with existing systems, limited aseptic sampling capabilities, and the need for piercing septums, which disrupt sterile processes and are not reusable.
Innovation Solution
A fluid transfer device that enables sterile wet connections under pressure, allows dripless disconnection, and maintains a sterile flow path, featuring a connector or valve design with interlocking housings and valve sleeves for seamless fluid communication, made from materials like polysulfone and stainless steel, ensuring biocompatibility and resistance to sterilization conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stainless steel valves and piping are used for fluid sampling, then sterilization capability is achieved, but sterilization process becomes laborious and time-consuming
Solution Approach 1:
The patent changes the material parameter from stainless steel to polysulfone plastic, which allows for different sterilization parameters (autoclaving at standard conditions) that are less laborious and time-consuming while maintaining sterilization capability
Solution Approach 2:
The invention employs disposable pre-sterilized plastic sampling devices that eliminate the need for repeated sterilization cycles, reducing time loss for sterilization processes while maintaining reliability through factory pre-sterilization
2Adaptability or versatility
If custom-fitted ports are installed onto host fluid receptacle, then integration capability is improved, but device complexity and installation difficulty increase
Solution Approach 1:
The sampling device is designed with universal adaptability to interface with standard port configurations (e.g., Luer locks, bayonet connectors) already present on bioreactors and fermenters, eliminating the need for custom-fitted ports and reducing installation complexity while maintaining integration capability
Solution Approach 2:
The device is segmented into modular components (sampling needle, connector, valve) that can be independently assembled and configured for different applications, reducing overall system complexity while maintaining versatility
3Adaptability or versatility
If multiple sampling fixtures are used for different sampling needs, then sampling versatility is achieved, but device complexity and cost increase
Solution Approach 1:
The sampling device incorporates multiple functions within a single integrated fixture, including sample withdrawal, filtration, and disposal capabilities, eliminating the need for multiple separate sampling fixtures and reducing system complexity while maintaining versatility
Solution Approach 2:
The invention merges the sampling needle, filter, and disposal mechanism into a single integrated disposable unit, combining multiple sampling functions that would traditionally require separate fixtures, thereby reducing overall system complexity and cost
4Ease of operation
If hypodermic needle is used to pierce septum, then fluid access is achieved, but sterile process is disrupted and device cannot be reused
Solution Approach 1:
The sampling needle with attached filter is designed as a disposable single-use component that is discarded after one sampling operation, eliminating the risk of sterile process disruption from repeated use and eliminating the need for sterilization between uses
Solution Approach 2:
The filter acts as an intermediary component between the sampling needle and the fluid system, allowing fluid access while maintaining sterile barrier integrity, and the entire assembly is designed for single use to prevent contamination
Data Source
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AI summary
Fluid transfer device and method that allows for sterile wet connections, allows the connection to be reversed, and allows the connection to be reconnected, while leaving the connectors sterile and reusable under pressure. In certain embodiments, the device includes a first member and a second member, the latter adapted to receive the former in locking engagement upon actuation of the device to create fluid communication between the two in a sterile manner. Each of the members include a door that when opened, allows the first member to be linearly displaced into the second member to allow fluid to be transferred. When fluid transfer is complete, the first member can be retracted from the second member, and the doors closed.