Aseptic Transfer Container With Deformable Sealed Wall
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Solution Overview
Problem
Current methods for transferring fluids between flexible bags and rigid containers, such as in blood transfusion systems, often require specialized stoppers that are costly and can compromise sterility, and do not allow for aseptic transfer without contaminating the ambient air.
Innovation Solution
A container system with a deformable and sealed wall that forms a closed, sterile space for fluid transfer, using a fluid communication device and closure means that can be operated between open and closed positions, allowing for aseptic transfer without the need for a separate stopper and maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a specialized stopper is used to enable fluid transfer between flexible bags and rigid containers, then fluid transfer is enabled, but manufacturing cost increases and sterility may be compromised
Solution Approach 1:
The invention removes the specialized stopper component entirely from the system. Instead of using a complex stopper with integrated sealing and transfer mechanisms, the solution extracts this function and replaces it with a simple cap that can be crimped onto the container neck, significantly simplifying manufacturing while maintaining fluid transfer capability through alternative means (e.g., piercing the cap or using the cap as an access point)
Solution Approach 2:
The invention separates the functions of sealing and fluid transfer into distinct operational stages. The cap provides sealing during storage and transport, while fluid transfer is enabled through a separate controlled action (such as piercing the cap with a sterile needle or opening it in a controlled manner), allowing each function to be optimized independently without requiring an expensive integrated stopper
2Ease of operation
If a specialized stopper is used to enable fluid transfer, then fluid transfer is enabled, but the risk of contamination from ambient air increases
Solution Approach 1:
The invention introduces a sterile barrier or intermediary mechanism between the ambient air and the fluid path. This could be a sterile piercing needle, a controlled opening mechanism that maintains positive pressure, or a sterile adapter that connects the container to the flexible bag without exposing the fluid to ambient air, thereby enabling transfer while preventing contamination
Solution Approach 2:
The invention prepares the transfer interface in advance by maintaining the cap-sealed container in a sterile state during storage and transport. The cap acts as a pre-established sterile barrier, and the transfer process is designed to maintain this barrier throughout the operation, preventing ambient air contamination from the outset
3Reliability
If a deformable and sealed wall forming a closed sterile space is used, then aseptic transfer is enabled without specialized stoppers, but device complexity increases
Solution Approach 1:
The invention employs a deformable and sealed wall made from flexible materials that can be molded into the container structure. This flexible membrane forms the closed sterile space and can be deformed during manufacturing or use to enable fluid transfer while maintaining sterility, avoiding the need for complex mechanical stopper assemblies and reducing overall device complexity
Data Source
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AI summary
The invention relates to a container (1) comprising a body (2) for containing a fluid and an orifice (3) through which said fluid can be introduced into said body, said container (1) being equipped with a system for transferring (4) in a sterile manner the fluid into said body (2), said transfer system comprising: - a deformable and sealed wall (5), said wall (5) being disposed relative to the container (1) so as to form a closed and sterile space in which the orifice (3) is disposed; - a fluid communication device (6) between the closed space and the outside of the container, said device (6) being actuable in a sterile manner; - a means for closing (7) the orifice (3), said means being at least partially disposed in the closed space so as to be actuable between an open position and a closed position of the orifice.