Sterile Sanitary Fitting With Valve for Bag Fluid Transfer
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Solution Overview
Problem
Current sanitary fittings lack an efficient and sterile method for coupling fluid conduits to flexible containers, such as bags, which is essential for biomedical applications, as they often fail to maintain sterility and facilitate easy connection and disconnection.
Innovation Solution
A sanitary fitting comprising a first annular member with a flange for hermetic sealing to a bag and a second annular member with a valve assembly that aligns bores to create a fluid flow passageway, allowing for sterile fluid transfer while being easily connectable and disconnectable.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional connection methods are used to couple fluid conduits to flexible containers, then connection can be established, but sterility cannot be maintained and biofilm growth occurs
Solution Approach 1:
The connection system is divided into sterile and non-sterile segments. The flexible container and its port remain in a sterile environment, while the external connection mechanism operates outside the sterile field. A sterile barrier or seal separates these zones, allowing fluid transfer without compromising sterility or enabling biofilm growth at the connection interface.
Solution Approach 2:
A sterile adapter or intermediary component is introduced between the flexible container port and the external fluid conduit. This intermediary maintains the sterile boundary while enabling connection, preventing direct exposure of the sterile container to non-sterile external components that would otherwise allow biofilm formation.
2Reliability
If tight sealing is used to maintain sterility, then sterility is preserved, but connection and disconnection becomes difficult
Solution Approach 1:
The sealing mechanism incorporates dynamic elements such as flexible seals, collapsible barriers, or movable components that automatically adjust during connection and disconnection. The seal remains tight during fluid transfer to maintain sterility, but can be easily opened or collapsed when disconnecting, allowing operation without compromising either sterility or ease of use.
Solution Approach 2:
The connection system includes self-sealing or self-locking features that automatically maintain sterility without requiring complex manual operations. The seal engages automatically upon connection and maintains itself during fluid transfer, then can be easily released for disconnection, reducing operational complexity while preserving sterility.
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.