Sanitary Fitting With Integrated Valve for Sterile Bag Transfer
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Solution Overview
Problem
Current sanitary fittings lack effective solutions for securely and easily connecting fluid conduits to flexible containers while maintaining sterility, especially in biomedical applications, where secure and sterile fluid transfer is crucial.
Innovation Solution
A sanitary fitting comprising a first annular member with a flange for hermetic sealing to a flexible container and a second annular member with a valve assembly to control fluid flow, allowing for easy connection and disconnection while ensuring sterility, utilizing polymeric materials for weldability and including features like annular lips and protrusions for enhanced sealing and fluid flow management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sanitary fitting is designed to securely connect fluid conduits to flexible containers, then connection reliability is improved, but device complexity increases
Solution Approach 1:
The sanitary fitting is divided into multiple functional segments: a first annular member for connecting to the flexible container, a second annular member for connecting to the fluid conduit, and a valve assembly for flow control. Each segment performs a specific function, allowing the overall system to achieve high reliability through modular design while maintaining manageable complexity by assigning dedicated functions to each component.
Solution Approach 2:
The valve assembly is nested within the second annular member, with the valve body positioned inside the annular structure. This nesting arrangement allows the valve to be integrated into the fitting without requiring separate external components, thereby improving connection reliability while minimizing the increase in device complexity through space-efficient design.
2Ease of operation
If a valve assembly is integrated into the sanitary fitting to control fluid flow, then fluid flow control is improved, but device complexity increases
Solution Approach 1:
The valve assembly is merged with the second annular member as an integrated unit. The valve body, valve seat, and actuation mechanism are combined within the annular structure, allowing fluid flow control to be achieved without adding separate external valve components. This merging reduces the number of separate parts and simplifies the overall device while maintaining ease of operation.
Solution Approach 2:
The second annular member serves multiple functions: it provides the connection interface for the fluid conduit, houses the valve assembly, and contributes to the overall structural integrity of the fitting. This multi-functionality allows fluid flow control to be integrated without proportionally increasing device complexity, as the annular member already performs several critical roles.
3Reliability
If hermetic sealing features are added to maintain sterility, then sterility maintenance is improved, but manufacturing precision requirements increase
Solution Approach 1:
The first annular member is designed to connect to a flexible container, utilizing the flexibility of the container material to achieve hermetic sealing. The sealing interface leverages the elastic properties of the flexible container to conform to the annular member, creating a sterile barrier without requiring extremely tight manufacturing tolerances on the rigid fitting components themselves.
Solution Approach 2:
The sanitary fitting employs different materials with complementary properties: the first annular member is designed for weldability to flexible containers, while the second annular member provides structural support and houses the valve. This composite approach allows each material to be optimized for its specific function, reducing the overall manufacturing precision requirements while maintaining hermetic sealing capability.
4Ease of operation
If the sanitary fitting is designed for easy connection and disconnection, then ease of operation is improved, but connection reliability may worsen
Solution Approach 1:
The first annular member includes a flange with a substantially planar face designed for preliminary positioning and alignment before final connection to the flexible container. This preliminary action facilitates easy alignment and connection while the subsequent welding or sealing process ensures reliable, hermetic attachment that maintains sterility.
Solution Approach 2:
The flange structure acts as an intermediary element between the sanitary fitting and the flexible container. It provides a standardized interface that simplifies connection and disconnection operations while ensuring reliable attachment through its design features that facilitate proper positioning and secure bonding.
Data Source
AI summary
Disclosed herein are embodiments of a sanitary fitting for coupling a fluid conduit to a flexible container to facilitate sterile transfer therebetween, and methods of making and using such a sanitary fitting, whereby the sanitary fitting includes a first annular member having a first annular member bore extending between first annular member first and second ends, the first annular member second end terminating in a flange radially outwardly extending therefrom, the flange comprising a substantially planar face; a second annular member having a second annular member bore extending between second annular member first and second ends, the second annular member couplable to the first annular member to axially align the first and second annular member bores to provide a first fluid flow passageway; and a valve coupled to the second annular member, the valve operable to interrupt fluid flow through a fluid flow path which includes the first fluid flow passageway.


