Thermosetting Plastic Membrane Framework for Void-Free Chromatography
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Solution Overview
Problem
Thermoplastic chromatography devices used in biopharmaceutical processing often suffer from shrinkage during manufacturing, leading to voids and performance reduction in bind and elute chromatography applications, as well as challenges in creating an integral seal for wet or semi-wet membranes.
Innovation Solution
A disposable chromatography unit with polymeric filter plates and end plates, where membranes are bonded to a polyphenylene ether/polystyrene blend framework using a thermosetting plastic, eliminating secondary molding operations and ensuring a flat, void-free membrane configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If thermoplastic devices are manufactured using secondary molding operations, then the device structure is formed, but the thermoplastic shrinks during cooling causing membrane warping and void formation that reduces device performance
Solution Approach 1:
The patent changes the material parameter from thermoplastic to thermosetting plastic. Thermosetting plastics undergo irreversible chemical curing rather than physical cooling, eliminating the shrinkage that occurs during thermoplastic cooling. This parameter change resolves the contradiction by maintaining membrane flatness while still enabling device structure formation through the curing process.
Solution Approach 2:
The patent uses composite materials consisting of a thermosetting plastic framework combined with the membrane material. The thermosetting plastic provides structural support without shrinking, while the membrane maintains its flat configuration. This composite approach allows both the device structure to be formed and the membrane to remain flat and void-free.
2Ease of manufacture
If thermoplastic devices use secondary molding operations with window frames, then the device can be assembled, but voids are created inside the device that reduce chromatography performance
Solution Approach 1:
Changing from thermoplastic to thermosetting plastic eliminates the shrinkage parameter that creates voids. The thermosetting plastic cures in place without the dimensional changes that occur during thermoplastic cooling, thereby eliminating void formation while still allowing device assembly.
Solution Approach 2:
The patent employs a disposable device design where the entire assembly including the framework and membrane is discarded after single use. This eliminates the need for complex assembly and disassembly procedures, and any voids formed during manufacturing would not affect subsequent uses since the device is not reused. However, the primary solution remains the thermosetting plastic that prevents void formation.
3Ease of manufacture
If disposable chromatography devices are used, then cleaning validation costs are reduced, but manufacturing precision must be maintained to ensure performance
Solution Approach 1:
The parameter change to thermosetting plastic ensures that the membrane remains flat and properly configured during the disposable device manufacturing process. This material change provides inherent dimensional stability that maintains manufacturing precision without requiring additional corrective steps, thereby ensuring performance while keeping the device disposable and cost-effective.
Solution Approach 2:
The thermosetting plastic framework is designed to pre-establish the correct geometric configuration and support structure before the membrane is attached. This preliminary action ensures that when the membrane is bonded to the framework, it maintains its flat configuration without requiring post-manufacturing adjustments, thus maintaining precision while keeping the device disposable.
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 results in improved membrane performance by maintaining membrane flatness and volume, enhancing dynamic binding capacity and elution efficiency without the need for external housings, and reducing cleaning validation costs.
Implementation Method 1
one or more membranes bonded to a polymeric framework in a filtration zone with a thermosetting plastic
Implementation Method 2
bind and elute chromatography applications
Implementation Method 3
membrane based bind/elute chromatography
Data Source
AI summary
Single-use integral chromatography unit having an inlet and an outlet, and comprising one or more plates or pairs of filter plates interposable between a pair of end plates. In certain embodiments, each of the filter plates comprises a polymeric framework with one or more membranes supported therein. The filter plates and end plates may be assembled to form a substantially fixed, substantially water-tight, integral stack. Fluid entering the unit through a common inlet passes the membrane or membranes of each filter plate substantially contemporaneously prior to exiting the unit through a common outlet (cf, “parallel” flow). The assembly is a modular design, as multiple pairs of plates can be stacked in a suitable holder to form a single chromatography unit.