Aseptic Transfer Interface With Locking Doors Between Process Units
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Solution Overview
Problem
The challenge in the pharmaceutical field is to efficiently and aseptically transition between process units while maintaining sterility, particularly for personalized therapeutics with high costs and limited scalability.
Innovation Solution
A transfer device with door elements and locking apparatuses is installed in each process unit, allowing for automated, aseptic transitions by engaging and sealing door elements for sterile access between units, using magnetic, vacuum, or form-fitting mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If door elements are engaged and locked between process units, then sterility and contamination prevention are improved, but device complexity and operation time increase
Solution Approach 1:
The transfer device is divided into separate door elements that can be independently engaged with each process unit. Each door element can be locked separately, allowing for modular assembly and disassembly while maintaining sterility barriers between process units.
Solution Approach 2:
The door elements act as intermediary barriers between process units. When engaged and locked, they create a sterile interface that prevents contamination while allowing controlled material transfer through defined pathways.
2Ease of operation
If door elements are manually operated for access, then ease of operation is improved, but productivity and automation level worsen
Solution Approach 1:
The locking apparatus is designed to automatically engage and lock door elements when process units are connected. The system performs the locking function autonomously without requiring manual intervention, thereby maintaining ease of operation while significantly improving productivity and automation level.
Solution Approach 2:
The door elements and locking mechanisms are pre-configured on each process unit before connection. When units are brought together, the locking apparatus automatically engages the pre-positioned door elements, eliminating the need for manual assembly or adjustment during operation.
3Ease of operation
If door elements are removed for access, then ease of operation is improved, but sterility and contamination risk worsen
Solution Approach 1:
The door elements serve as intermediary barriers that can be opened and closed without removing the entire transfer device. When opened, they allow access while maintaining the sterile barrier function, thus enabling ease of operation without increasing contamination risk.
Solution Approach 2:
The door elements function as flexible barriers that can be dynamically opened and closed. This flexibility allows for operational access while maintaining the sterile enclosure when closed, resolving the contradiction between ease of operation and contamination prevention.
4Reliability
If locking apparatus is installed in each process unit, then reliability of sterile connection is improved, but device complexity and manufacturing cost worsen
Solution Approach 1:
The locking apparatus is segmented and integrated into each process unit individually. This modular approach allows each unit to be manufactured with its own locking mechanism, improving reliability of sterile connections while enabling standardized manufacturing processes that can reduce overall complexity and cost.
Solution Approach 2:
The locking apparatus is designed with universal features that can be standardized across different process units. This multi-functionality allows the same basic design to be used in multiple units, simplifying manufacturing while maintaining high reliability through consistent, proven technology.
Data Source
AI summary
A transfer device for enabling an aseptic transition between a first object, in particular a first process unit, and a second object, in particular a second process unit. Furthermore, a system consisting of at least two objects, in particular process units, and to a system consisting of three or four or more objects and/or process units.