Sterile Liquid Transfer Connector With Protected Flow Path Alignment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The challenge in bioprocess engineering is to maintain sterile conditions during the transfer of liquid media between containers or bioreactors, as existing connection systems like Luer connectors risk contamination, necessitating costly and complex cleanroom procedures to prevent contamination.
Innovation Solution
A sterile connector system with two coupling devices, where the channel and outlet/inlet openings are initially protected and only aligned for fluid transfer after connection, ensuring that only sterile parts come into contact, reducing the risk of contamination by keeping non-sterile regions away from the fluid path.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional connection systems like Luer connectors are used for transferring liquid media, then the transfer process is simple and fast, but contamination risk increases at the coupling point
Solution Approach 1:
The connector is divided into two separate coupling devices (first and second coupling devices) that connect to each other. Each coupling device has its own sterile barrier, so that if one barrier is compromised, the other remains intact and protects the liquid medium. This segmentation isolates potential contamination sources while maintaining efficient fluid transfer capability.
Solution Approach 2:
Sterile barriers are pre-installed on the coupling devices before use. The first coupling device has a sterile barrier that is already in place before connection, and the second coupling device receives this barrier in a sterile manner. This preliminary preparation ensures sterility is established before the actual connection and fluid transfer occurs, eliminating the need for complex cleanroom procedures during operation.
2Reliability
If sterile barriers are pre-installed on coupling devices, then sterility is maintained, but device complexity increases
Solution Approach 1:
The sterile barrier is nested within the coupling device structure. The barrier is inserted into the first coupling device and then received by the second coupling device in a nested manner. This nesting approach integrates the sterile barrier as an integral part of the coupling device rather than a separate component, reducing overall system complexity while maintaining sterility.
Solution Approach 2:
The coupling devices are designed to automatically establish sterile connections through their inherent structure. The first coupling device with its pre-installed sterile barrier connects to the second coupling device in such a way that the sterile barrier self-seals or self-positions to maintain sterility without requiring additional manual operations or complex control mechanisms.
3Reliability
If cleanroom procedures are used to prevent contamination, then sterility is maintained, but production costs increase
Solution Approach 1:
The coupling devices are designed as single-use, disposable components with pre-installed sterile barriers. After one use, the entire coupling device is discarded rather than sterilized and reused. This approach eliminates the need for expensive cleanroom facilities and complex sterilization procedures, significantly reducing production costs while maintaining sterility throughout the product lifecycle.
Solution Approach 2:
Sterile barriers are pre-installed on the coupling devices during manufacturing under controlled conditions. This preliminary sterilization and assembly are performed once during production, allowing the devices to be stored and used without requiring ongoing cleanroom facilities. The preliminary action shifts the sterility assurance from operational phase to manufacturing phase, reducing operational costs.
Data Source
AI summary
Various embodiments provide a connector for the sterile transfer of a liquid medium from a container to a bioprocess engineering system. The connector has two coupling devices. The coupling devices each have a housing and a control element which is adjustably mounted in the housing interior and forms a channel. The channel extends from a control element inlet opening to a control element outlet opening. The housings are able to be mechanically connected to one another and have a fluid inlet and a fluid outlet. The fluid outlet of one housing and the fluid inlet of the other housing overlap. The control elements are each adjustable from a starting position, into an operating position, in which the control element inlet opening is fluidically connected to the fluid inlet and the control element outlet opening is fluidically connected to the fluid outlet.