Biopharmaceutical Valve With Nested Seals and Rounded Transitions
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current valves for biopharmaceutical containers are limited in their ability to operate both for drainage and filling, often create dead zones, and are prone to contamination due to high stress concentrations on seals, which can lead to damage and bacterial contagion risks.
Innovation Solution
A valve with selective operation that includes a female and male part with axial sliding capability, featuring three annular seals to prevent fluid and contaminant passage, and a design that avoids sharp angles to reduce seal stress, allowing for both drainage and filling without dead zones and minimizing contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a valve with movable part in projecting position is used for emptying operation, then the emptying function is achieved, but dead zones are created in the container interior space
Solution Approach 1:
The valve design inverts the conventional approach by having the movable part retract into the container wall rather than project into the interior space. The male part retracts axially into the female part's receiving portion, positioning the valve mechanism within the wall thickness rather than extending into the container volume, thereby eliminating dead zones while maintaining emptying functionality
Solution Approach 2:
The valve employs a nested structure where the male part is received within the female part's hollow body and receiving portion. The male part can slide axially within the confines of the female part, with the movable portion nested inside the wall structure rather than protruding outward, eliminating interior dead zones while preserving drainage capability
2Device complexity
If a valve with two seals is used, then the structure is simple, but the risk of bacterial contagion increases
Solution Approach 1:
The valve implements local quality enhancement by adding a third seal specifically at the critical interface between the movable male part and the stationary female part. This additional seal is positioned precisely where the movable portion transitions from the interior to exterior environment, providing enhanced containment at the most vulnerable point for bacterial contamination while maintaining overall structural simplicity
Solution Approach 2:
The valve employs beforehand cushioning by pre-positioning three seals at potential contamination pathways before any bacterial contamination can occur. The seals are installed in advance at all critical interfaces, including the additional seal on the movable male part, creating multiple barriers that prevent bacterial contagion before it can compromise the biopharmaceutical product
3Ease of manufacture
If seals are positioned at sharp portions of the valve, then the manufacturing is simple, but the seals are subjected to high stress concentrations and may be cut or damaged
Solution Approach 1:
The valve applies spheroidality by replacing sharp corners and edges with curved surfaces and rounded transitions throughout the valve structure. The female part and male part feature rounded internal and external surfaces where seals make contact, eliminating stress concentration points that would otherwise exist at sharp portions, thereby protecting seal integrity while maintaining manufacturing feasibility through standard molding techniques
Data Source
Figure 1
Figure 2
AI summary
Selective operation valve for a recipient for biopharmaceutical use. The valve comprises a female part (3) having a closed, transverse, proximal end wall, and a tubular wall integral with a flange part(8), a lateral valve opening (9) being formed on the proximal section of the tubular wall, a male part (4) having a tubular wall forming, on the proximal side, a closing/opening part (15a) having an open, transverse, proximal end; the closing/opening part (15a) has an external shape and an external dimension that fit the internal shape and internal dimension of the proximal receiving part (10) of the female part (3); the sealing means comprise three ring seals separated from one another in an axial direction, supported by the upper surface of the tubular wall of the male part (4) and engaging with the female part, a proximal seal (20) to the fluid product, associated with the closing/opening part (15a), a distal seal (21) to contaminants of external origin, the furthest from the proximal seal (20), and an intermediate seal (22) to the fluid product and to contaminants of external origin between the proximal seal (20) and the distal seal (21).