Chromatography Membrane Sealing Layer for Virus Clearance and Flow Control
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Solution Overview
Problem
Existing membrane chromatography devices face challenges in achieving adequate sealing at the interface between the membrane layer and the housing, leading to reduced Log Reduction Value (LRV) of virus clearance, particularly when functionalized membranes are used, and there is a need to enhance Dynamic Binding Capacity (DBC) while maintaining effective fluid flow.
Innovation Solution
Incorporation of a non-functionalized sealing layer as the last layer in contact with the housing, combined with a spacer ring to create an air gap between media layers, ensuring a compressive seal and improving fluid dispersion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If functionalized membranes are used as the last layer in contact with the housing for sealing, then virus adsorption capacity is improved, but sealing effectiveness deteriorates leading to lower LRV
Solution Approach 1:
The device separates the sealing function from the virus adsorption function by using different layers for each purpose. The functionalized membrane layer handles virus adsorption while a separate non-functionalized membrane layer handles sealing, allowing each layer to optimize its specific function without compromise
Solution Approach 2:
Different regions of the membrane stack are assigned different properties: the functionalized membrane has high virus binding capacity while the non-functionalized membrane has high sealing capability. This local differentiation allows the system to achieve both high LRV and effective sealing simultaneously
2Reliability
If compression sealing is applied to functionalized membranes, then sealing is achieved, but membrane permeability is reduced in localized zones
Solution Approach 1:
The sealing function is segmented to a dedicated non-functionalized membrane layer that is specifically positioned to receive compression forces. This prevents the functionalized membrane from being compressed, thereby maintaining its permeability and virus adsorption capacity while still achieving effective sealing through the separate layer
3Device complexity
If media layers are placed directly adjacent to each other, then device complexity is reduced, but fluid tunneling occurs reducing LRV
Solution Approach 1:
Spacer rings are introduced as intermediary elements between media layers to prevent direct fluid tunneling pathways. These spacers force fluid to follow a more tortuous path through the media, increasing contact time and improving virus clearance effectiveness without significantly increasing overall device 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
The solution enhances LRV to achieve 12-15 LRV for endogenous viruses and 6-8 LRV for adventitious viruses, while increasing DBC by preventing premature fluid tunneling and accommodating media swelling, thus ensuring effective viral clearance and protein binding capacity.
Implementation Method 1
a margin of the sealing layer in contact with the housing; the margin being compressed by the housing forming a compressive seal to prevent fluid from leaking to the outlet past the compressive seal
Implementation Method 2
the air gap can provide a space to accommodate swelling of the functionalized media that might otherwise cause a high compressive stress within media layers adjacent to one another as they swell against each other
Implementation Method 3
membrane chromatography devices aimed for virus removal can utilize membranes coated, grafted, or otherwise functionalized with certain functional chemistries to adsorb viruses and VLPs
Data Source
AI summary
A chromatography device having a housing having an inlet and an outlet. At least two layers of media disposed between the inlet and the outlet inside of the housing forming a media stack, with at least one of the layers comprising a functionalized layer. An optional spacer ring disposed between the two layers of media forming an air gap between them. A non-functionalized sealing layer disposed between the inlet and the outlet inside of the housing as the last layer of media in the media stack within the housing as a fluid passes from the inlet to the outlet through the media stack. A margin of the sealing layer in contact with the housing; the margin being compressed by the housing forming a compressive seal to prevent fluid from leaking to the outlet past the compressive seal.