Weld Integrity Pressure Testing for Aseptic Vial Connectors
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Solution Overview
Problem
Current methods for aseptic transfer of cells to bioreactors lack effective means to ensure weld integrity and maintain sterility, particularly with the advent of single-use bioreactors where steam sterilization is not feasible, leading to incomplete transfer and potential fluid loss.
Innovation Solution
A computer-implemented method and kit for determining weld integrity using a system that welds a vial to a connector with conduits, generates fluid pressure different from ambient pressure, and measures pressure changes to assess the seal integrity, ensuring a fluid-tight connection and maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If gravity transfer is used to transfer micro carriers to the bioreactor vessel, then the transfer process is simple, but the transfer is incomplete as some micro carriers stick to the walls
Solution Approach 1:
The patent uses fluid flushing (hydraulic principle) to remove micro carriers stuck on container walls. A fluid is introduced into the container to wash the walls and carry detached micro carriers into the bioreactor vessel, improving transfer completeness while maintaining process simplicity
2Reliability
If steam sterilization is performed inside the bioreactor, then sterilization is effective, but it is no longer possible with single-use bioreactors
Solution Approach 1:
The patent performs sterilization in advance (pre-sterilization) of the single-use bioreactor and transport containers before cell culture. This eliminates the need for in-situ steam sterilization, enabling single-use configuration while maintaining sterilization effectiveness through prior autoclaving or other sterilization methods
3Reliability
If pre-sterilized transport containers are used for aseptic transfer, then sterility is maintained, but weld integrity cannot be verified
Solution Approach 1:
The patent implements a feedback mechanism by measuring fluid pressure inside the transport container after welding. The system monitors pressure changes to detect leaks or defects in the weld between the transport container and connector, providing real-time verification of weld integrity while maintaining the pre-sterilized single-use configuration
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 solution effectively maintains pre-sterilized conditions and prevents fluid loss by ensuring a reliable fluid-tight seal between the vial and connector, enhancing the aseptic transfer process in bioreactors.
Implementation Method 1
generating a fluid pressure different to an ambient fluid pressure at an opposite end of the other conduit
Implementation Method 2
measuring a fluid pressure within at least one of the conduits
Data Source
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AI summary
The present invention relates to a computer implemented method for determining a weld integrity test result performed by a system configured to aseptically transferring cells to a container (BR), the method comprising welding (710) a vial to a connector to obtain a fluid-tight seal between the vial (V) and a connector (C), the connector being provided with a pair of conduits each having one end protruding through the connector and into the vial, sealing (720) an opposite end of one of the conduits, generating (730) a fluid pressure different to an ambient fluid pressure at an opposite end of the other conduit, measuring (740) a fluid pressure within at least one of the conduits, determining (750) a fluid pressure change based on the ambient pressure and the measured fluid pressure, determining (760) the weld integrity test result as pass or as fail based on the fluid pressure change.