Disposable Multiport Pinch Valve Block for Sterile Batch Changeovers
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Solution Overview
Problem
Current bioprocessing pinch valve assemblies require complex and time-consuming batch change-outs, with a high risk of contamination and human error, due to the need to disassemble and reassemble multiport systems with separate stainless steel and polymeric components.
Innovation Solution
A single-piece, disposable pinch valve assembly with embedded sealable barriers and integrated fluid channels, allowing for easy replacement and connection of fluid conduits, eliminating the need for separate tubing and reducing the complexity of batch changes by integrating the sealing mechanism within the block.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If hybrid stainless steel multiport assemblies are used to improve durability and reusability, then the valve can be reused from batch-to-batch, but the complexity of disassembly and reassembly increases, requiring partial or complete disassembly of the valve body base to replace the product contact silicon liner
Solution Approach 1:
The patent applies the disposable principle by making the entire valve body base (including internal channels and product contact surfaces) single-use. The base is discarded after one batch and replaced with a new sterile base, eliminating the need to disassemble and reassemble multiport assemblies. This resolves the contradiction by sacrificing the reusability of the base itself while maintaining system reusability through rapid replacement, and dramatically reducing the complexity of batch changes.
Solution Approach 2:
The patent segments the valve system into two independent parts: a reusable topworks assembly (containing compressor elements and actuation mechanisms) and a disposable valve body base (containing internal channels and product contact surfaces). This segmentation allows the base to be quickly removed and replaced without affecting the reusable components, resolving the contradiction by enabling batch-to-batch reusability of critical components while eliminating complex disassembly requirements for the disposable base.
2Duration of action of stationary object
If hybrid stainless steel multiport assemblies are used to improve durability, then the valve can be reused, but the time required for batch change-out increases due to the need to disassemble and reassemble components
Solution Approach 1:
The disposable valve body base eliminates time-consuming disassembly and reassembly operations. The base can be quickly removed and replaced as a single unit, reducing batch change-out time from potentially hours to minutes. The reusable topworks assembly maintains durability across batches while the disposable base eliminates the time penalty associated with complex reassembly procedures.
Solution Approach 2:
By segmenting the system into reusable topworks and disposable base, the patent enables rapid batch changes. The pre-assembled disposable base with integrated channels and liners can be quickly installed on the reusable topworks without requiring disassembly of the actuation mechanisms or compressor elements, dramatically reducing the time required for batch change-out while maintaining reusability of critical components.
3Duration of action of stationary object
If hybrid stainless steel multiport assemblies are used to improve durability, then the valve can be reused, but the risk of contamination and human error increases due to the complex disassembly and reassembly process
Solution Approach 1:
The disposable valve body base is supplied pre-sterilized and pre-assembled with product contact liners, eliminating the need for operator intervention in disassembly and reassembly operations. This eliminates human error risks such as incorrect reassembly, contamination during handling, and improper liner installation. The reusable topworks assembly maintains durability while the disposable base ensures reliability through elimination of complex manual operations.
Solution Approach 2:
The segmentation into disposable base and reusable topworks isolates the product contact surfaces to a disposable component that can be replaced as a single sterile unit. This prevents contamination risks associated with exposing internal channels and liners during disassembly and reassembly of multiport assemblies. The reusable topworks containing compressor elements remains outside the sterile barrier, eliminating the need to open sterile assemblies during batch changes and thereby preventing contamination.
4Adaptability or versatility
If separate tubing is used for fluid transfer within the block to improve flexibility, then fluid paths can be customized, but the number of components and connection points increases, complicating the batch change process
Solution Approach 1:
The patent merges the internal fluid channels directly into the valve body base structure, eliminating the need for separate tubing components. The channels are molded or machined as integral features of the base, reducing the number of parts and connection points. This maintains fluid path flexibility through different channel configurations while dramatically simplifying the batch change process, as the entire channel system is replaced with the base rather than requiring disconnection and reconnection of multiple tubing segments.
Solution Approach 2:
The valve body base is constructed as a composite structure combining rigid support material (such as PEEK or other engineering plastics) with integrated fluid channels. This allows customization of fluid paths through different base designs while maintaining structural integrity. The composite construction enables complex internal channel geometries to be formed as single-piece components, eliminating the need for separate tubing and reducing assembly complexity.
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
This solution simplifies the batch change process, reduces contamination risks, and minimizes downtime by enabling the entire block to be replaced as a single unit, maintaining sterility and reducing the need for complex multi-compressor assemblies.
Implementation Method 1
a compressor element connected to one of the one or more openings is moveable towards and through the opening for compression of the embedded sealable barrier in one of the internal channels to seal the internal channel
Data Source
AI summary
A pinch valve assembly is provided comprising a single piece block comprising one or more internal channels within the block for distribution of fluids, each of the one or more channels comprising an embedded sealable barrier, the single piece block further comprising one or more outlets for connection of one or more fluid conduits to the channels.