Multi-layer membrane filtration device performance variability reduction
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Solution Overview
Problem
Existing virus filtration technologies in biopharmaceutical manufacturing struggle to achieve high viral clearance while maintaining high product flux and consistency, leading to performance variability and reduced production efficiency.
Innovation Solution
The use of multi-layer membrane filtration devices with similarly rated membranes, where the upstream membrane is carefully selected based on performance rating to control the overall device performance, reducing capacity variability and enhancing mean capacity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard non-selective layering is used in multi-layer filtration devices, then device complexity is reduced and manufacturing is simpler, but performance variability increases and consistency decreases
Solution Approach 1:
The patent applies preliminary action by pre-rating individual membrane layers according to their performance characteristics before assembly. Each layer is assigned a performance rating based on manufacturing variability assessment, and this rating information is used to guide the selective layering process. This preliminary characterization enables consistent device performance without requiring complex real-time monitoring during assembly.
Solution Approach 2:
The patent changes the parameter of layer selection from random or standard ordering to selective ordering based on performance ratings. By adjusting which layers are placed in which positions based on their rated performance characteristics, the system optimizes overall device consistency. This parameter change transforms the layering process from a simple stacking operation to a controlled assembly process that compensates for manufacturing variability.
2Manufacturing precision
If membrane manufacturing variability is reduced through tighter controls, then device-to-device consistency improves, but manufacturing cost and complexity increase
Solution Approach 1:
The patent implements feedback by measuring and rating the performance of individual membrane layers after manufacturing but before final device assembly. This feedback loop provides information about each layer's actual performance characteristics, allowing the assembly process to compensate for manufacturing variability. Rather than attempting to eliminate variability at the manufacturing stage, the system accepts the variability and uses feedback to manage it during assembly.
Solution Approach 2:
The patent changes the approach from controlling manufacturing parameters tightly to characterizing and selecting based on performance parameters. Instead of focusing solely on reducing manufacturing variability through tighter process controls, the system rates membranes based on their actual performance and uses this information to guide assembly decisions. This shifts the focus from prevention to compensation.
3Reliability
If high viral clearance is prioritized in filter design, then product safety is improved, but product flux and throughput capacity are reduced
Solution Approach 1:
The patent applies local quality by assigning different functional roles to different layers within the multi-layer device. Rather than requiring every layer to provide equal viral clearance, the system allows certain layers to specialize in retention while others optimize for flux. This local differentiation of function enables the overall device to achieve both high viral clearance and maintained throughput capacity.
Solution Approach 2:
The patent uses composite materials by combining multiple membrane layers with different performance characteristics into a single multi-layer device. Each layer contributes different properties to the overall system, creating a composite structure that achieves performance characteristics superior to individual layers. The selective layering of these composite materials optimizes both retention and flux properties.
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 approach results in higher average capacity and reduced performance variability of the filtration devices, ensuring consistent throughput and virus retention across multiple batches, thereby improving production efficiency and cost-effectiveness.
Implementation Method 1
Virus removal from liquid streams, particularly process streams in the biotech and pharmaceutical industry, has been practiced for some time
Implementation Method 2
Methods used to reduce variability in a device through selective layering are described herein
Data Source
Figure 1~1a
Figure 2
Figure 3~4
AI summary
The present invention concerns multi-layer membrane devices with reduced performance variability, and methods of reducing performance variability of such devices. The variability is reduced by combining two or more membranes with similar pore sizes, and carefully selecting the upstream membrane based upon its performance rating, in order to control the performance of the overall device. Selective layering reduces the capacity range of the device when compared to random layering, with the mean capacity greater than overall population mean. The flux range also can be reduced, with the mean near the overall population mean. The LRV range also can be reduced, with the mean LRV near or higher than the overall population mean.