Aseptic Transfer Coupling With Compensator for Alignment Tolerance
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Solution Overview
Problem
Existing transfer systems for aseptic pharmaceutical transfers face challenges such as precise handling of heavy containers, potential alignment errors leading to system damage, and complex sterilization requirements, which complicate the aseptic process and increase the risk of contamination.
Innovation Solution
A transfer arrangement with a compensator that allows manual alignment and coupling of a funnel assembly to a container, compensating for alignment tolerances and enabling separate sterilization of components, thereby simplifying the process and reducing the risk of damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a lifting system is used to position the container, then the container can be moved into position, but precise handling is required and positioning errors can occur
Solution Approach 1:
The compensator acts as an intermediary element between the isolator and the container. It absorbs positioning errors and alignment tolerances through its expandable/compressible section, eliminating the need for precise lifting and positioning operations while maintaining reliable connection between components
2Adaptability or versatility
If the compensator is stretched to accommodate container movement, then alignment flexibility is improved, but material fatigue can cause cracks
Solution Approach 1:
Instead of stretching the compensator to accommodate movement, the design inverts the approach by allowing the compensator to compress and expand within a defined range. This compression-expansion mechanism maintains alignment flexibility while preventing the material fatigue and cracking associated with continuous stretching
3Reliability
If the coupling element and funnel assembly are always sealed, then aseptic conditions are maintained, but complex sterilization procedures are required
Solution Approach 1:
The transfer arrangement is segmented into separable components: the isolator, the compensator, and the funnel assembly. This segmentation allows each component to be sterilized separately and assembled afterwards, maintaining aseptic conditions while simplifying the sterilization procedure compared to sterilizing the entire assembled system
Data Source
Figure 1
Figure 2
Figure 3a~3b
AI summary
The invention relates to a transfer arrangement (2) for the aseptic transfer of a pharmaceutical agent from an isolator (4) into a container (6), comprising a coupling element (10) connectable to the container (6), a passage (12), and an actuable first closure means (14), which in an open position (O1) releases a passage (12) through the coupling element (10) and in a closed position (S1) blocks the passage (12) through the coupling element (10), and a funnel arrangement (16) with a connecting section (18) which is configured to be reversibly coupled to the coupling element (10), wherein the connecting section (18) has a second closure means (20) which in an open position (O2) releases a passage through the funnel arrangement (16) and in a closed position (S2) blocks a passage through the funnel arrangement (16).According to the invention, a compensator 8 that can be connected to the insulator 4 is proposed, wherein the funnel arrangement (16) can be inserted into the compensator (8) and, in the inserted state, is tightly, in particular hermetically, sealed with the compensator (8), in particular wherein the compensator (8) can be removed for sterilization.