Single-Use Bioprocess Valve to Eliminate Dead Legs
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Solution Overview
Problem
Bioprocess industries face challenges with cross-contamination and cell growth issues due to 'dead legs' in pinch valve systems, which affect the performance of cell cultures and require costly cleaning and sterilization processes.
Innovation Solution
A single-use valve with a plunger arrangement and solenoid actuation, using ferrite materials for magnetic interaction, that eliminates the need for dead legs by providing aseptic and pre-sterilized flow paths, allowing for easy integration into bioprocess liquid handling systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pinch valves are used for on/off control of liquid flow, then flow control capability is achieved, but dead legs are created causing cross-contamination and cell growth issues
Solution Approach 1:
The patent removes the problematic dead leg section from the flow path by using a valve design where the closure element directly occludes the flow path without creating stagnant segments. The valve body and closure element are configured so that when closed, they seal against each other without leaving any residual flow path segments where contamination or cell growth could occur.
Solution Approach 2:
The patent employs single-use disposable flow path components made from biocompatible materials. These disposable components eliminate the need for repeated cleaning and sterilization, preventing cross-contamination between batches. After use, the entire flow path including the valve can be discarded, ensuring no carry-over contamination to subsequent processes.
2Object-affected harmful factors
If disposable single-use components are used, then contamination is minimized and sterilization costs are reduced, but device complexity increases
Solution Approach 1:
The patent integrates the valve directly into the flow path as a single unified disposable component. The valve body, flow path, and closure mechanism are combined into one monolithic structure that can be manufactured as a single piece or pre-assembled unit. This integration eliminates the need for separate valve assemblies, connectors, and sterilization procedures for multiple components, reducing overall system complexity despite the disposable nature.
3Object-affected harmful factors
If cleaning and sterilization processes are implemented, then cross-contamination is prevented, but productivity decreases and costs increase
Solution Approach 1:
The patent replaces reusable components requiring cleaning and sterilization with single-use disposable components. Each disposable flow path and valve assembly is pre-sterilized during manufacturing and maintains sterility throughout its use. After completion of a process run, the entire assembly is discarded, eliminating all cleaning, sterilization, and validation steps between batches, thereby maximizing productivity and reducing costs.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution minimizes contamination, reduces regulatory burdens, and decreases costs by eliminating the need for cleaning and sterilization, while enabling the production of multiple biopharmaceuticals using a single process line.
Implementation Method 1
The plunger arrangement preferably comprises a ferrite material that is capable of interaction with magnetic fields provided by the solenoid arrangements
Implementation Method 2
Actuation of the valve (i.e. actuation of the plunger arrangement) is made through solenoid arrangements, e.g. in the form of induction coils, arranged externally over the valve
Data Source
Figure 1~2b
Figure 3a~4d
Figure 4e~7
AI summary
A valve (100) for a bioprocess liquid apparatus (199) comprises tubular sections (101, 102, 103) inside which valve seat means (155) are arranged. A plunger arrangement (150) is configured to selectively interact with the valve seat means to close and open the tubular sections in response to a magnetic field provided by solenoid arrangements (104, 105), the solenoid arrangements being arranged at the bioprocess liquid apparatus. A flow path device comprising such a valve and a bioprocess liquid apparatus and a method of handling a bioprocess liquid are also disclosed.