Sterile Vial Connection Assembly With Foil-Sealed Fluid Path
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Solution Overview
Problem
Existing devices for connecting containers under sterile conditions, such as vials, require additional effort and expensive equipment to maintain sterility during piercing and connecting, especially when transferring liquids or solids from vials with standard sizes and shapes defined by DIN ISO 8362.
Innovation Solution
An assembly comprising a container with a first opening covered by a foil and a coupling means, and an adapter with a second opening covered by a foil and a coupling means, which engage mechanically to create a closed fluidic pathway that opens upon removal of a handle, allowing aseptic fluid transfer without the need for expensive equipment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual piercing and connecting of vials is performed under sterile conditions, then sterility is maintained, but additional effort and expensive equipment (sterile benches or clean rooms) are required
Solution Approach 1:
The device is divided into separate components: a vial adapter with first and second openings covered by foils, and a handle with a third opening. This segmentation allows each component to be independently sealed and manipulated, enabling sterile connection without requiring a sterile bench or clean room environment.
Solution Approach 2:
The vial adapter acts as an intermediary device between the vial and the handle. It provides a mechanical interface that allows the handle to be attached to the vial through the foils, enabling sterile fluid transfer without direct manual piercing or complex sterile equipment.
2Reliability
If foils are used to cover openings for aseptic flow, then sterility is ensured, but the connection mechanism becomes more complex
Solution Approach 1:
The foils covering the first and second openings are merged with the handle assembly. When the handle is attached to the adapter, the foils are simultaneously engaged with the handle's third opening, creating a unified sealed connection that simplifies the overall mechanism while maintaining aseptic flow.
Solution Approach 2:
The foils are pre-positioned to cover the openings in the adapter and handle before assembly. This preliminary sealing action ensures that when the components are assembled, the openings are automatically sealed without requiring additional sealing steps or complex mechanisms.
3Adaptability or versatility
If standard vial sizes and shapes are used, then compatibility with existing containers is ensured, but adaptation to sterile connection mechanisms is limited
Solution Approach 1:
The vial adapter is designed with a universal interface that accommodates standard vial sizes and shapes defined by DIN ISO 8362. The adapter's coupling means can mechanically engage with various vial configurations, providing a multi-functional connection mechanism that maintains compatibility with existing containers while enabling sterile fluid transfer.
Data Source
AI summary
An assembly (10) contains a aseptic flow of a liquid out of a container (20). The container (20) holding the liquid and an adapter (30) is configured to mechanically engage with the container (20)