Fluid Transfer Interface Cast Seal for Bioreactor Bags
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Solution Overview
Problem
Existing fluid transfer interfaces for vessels, particularly in pharmaceutical and biotechnology applications, face issues with leakage and contamination due to barbed or luer connections, which compromise sterility and reliability, and require costly sterilization processes.
Innovation Solution
A fluid transfer interface with continuous fluid conduits secured through a cast seal, eliminating the need for barbed or luer connections, providing a leak-free and aseptic pathway using a disposable, pre-sterilized design that integrates with vessels like bioreactor bags, utilizing thermoplastic and thermoset materials with silicone seals for secure and flexible connections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If barbed or luer connections are used for fluid transfer, then ease of connection is improved, but reliability and leak-free operation deteriorate
Solution Approach 1:
The patent removes the barbed or luer connection components from the fluid transfer interface, replacing them with a cast seal that integrates the conduit directly into the interface body. This extraction of problematic connection elements eliminates the source of leakage while maintaining fluid transfer functionality through a monolithic sealed structure.
Solution Approach 2:
The patent merges the conduit connection with the interface body by casting the conduit directly into the body material, creating an integrated monolithic structure. This merging eliminates separate connection components and their associated leakage risks, achieving both ease of operation and reliability through a unified sealed assembly.
2Object-affected harmful factors
If sterilization processes are applied to fluid transfer interfaces, then sterility is improved, but the interface may be damaged and rendered useless
Solution Approach 1:
The patent employs a disposable fluid transfer interface designed for single use, eliminating the need for repeated sterilization processes. The low-cost disposable nature allows the interface to be discarded after one use, ensuring sterility without subjecting the interface to damaging sterilization cycles, thus maintaining reliability.
Solution Approach 2:
The patent implements pre-sterilization of the disposable interface during manufacturing, performing the sterilization action in advance before the interface is put into service. This preliminary sterilization ensures sterility is achieved once during production under controlled conditions, avoiding the need for subsequent sterilization that could damage the interface.
3Reliability
If continuous fluid conduits are secured through cast seal, then reliability and leak prevention are improved, but device complexity increases
Solution Approach 1:
The patent combines the conduit and interface body into a single integrated component through the cast seal process, where the conduit is embedded directly into the body material. This merging achieves superior leak prevention through a unified monolithic structure while the integration is accomplished through a single casting operation, managing complexity through process consolidation rather than assembly of multiple parts.
Solution Approach 2:
The patent extracts the need for separate sealing components and connection mechanisms by directly casting the conduit into the interface body. This removal of separate sealing elements simplifies the overall device structure while achieving enhanced leak prevention through the integrated cast seal, resolving the apparent complexity increase by eliminating the need for additional sealing parts.
4Ease of operation
If disposable pre-sterilized interfaces are used, then ease of operation and sterility are improved, but cost increases
Solution Approach 1:
The patent designs the fluid transfer interface as a low-cost disposable component that can be pre-sterilized during manufacturing and then discarded after single use. The low base cost of the disposable interface allows pre-sterilization to be economically viable, and the elimination of cleaning, sterilization, and maintenance operations for reusable components offsets the manufacturing cost, achieving both ease of operation and cost-effectiveness.
Data Source
AI summary
Fluid transfer interfaces for transferring fluid into or out of vessels, namely flexible polymeric bags. The fluid transfer interfaces have a body for use in connection with a vessel, or combined therewith, one or more apertures extending through the body, and one or more fluid transfer conduits secured to the body by way of a cast seal and extending continuously and axially through the one or more apertures. Also disclosed is a vessel closure having one or more fluid transfer conduits extending through the closure, the fluid transfer conduits affixed to the closure by a cast seal.