Barrier Filter with Dual Permeability Paths for Redundant Sterile Filtration

Solution Overview

Problem

The complexity and cost associated with redundant sterile filtration systems in biopharmaceutical production, particularly due to the need for additional filters and increased operator interaction, which can lead to sterility breaches and product loss, are not adequately addressed by existing technologies.

Innovation Solution

A redundant filtration system that incorporates barrier filters with both hydrophilic and hydrophobic paths, allowing for both fluid and gas permeability, which eliminates the need for intermediate drain and air filters, enabling easier operation and reduced product loss by allowing for series drying and venting without separate vent filters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If redundant sterile filtration is implemented using two sterilizing grade hydrophilic capsule filters in series, then the risk of losing a batch due to integrity failure is reduced, but the device complexity and operator interaction requirements increase significantly

Engineering Contradiction:

Improvebatch retention riskVSAvoidfiltration system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the venting function and filtration function into a single barrier filter device. The barrier filter integrates both hydrophilic and hydrophobic paths within one device, eliminating the need for separate vent filters and intermediate drain filters that would otherwise be required in a conventional two-filter redundant system. This merging reduces device complexity while maintaining the redundancy benefit.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The barrier filter performs multiple functions simultaneously: it provides sterilizing filtration through its hydrophilic path and allows air venting through its hydrophobic path. This multi-functionality eliminates the need for separate dedicated vent filters and drain filters, reducing the overall number of components and simplifying the system architecture while maintaining redundant filtration capability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If two sterilizing grade hydrophilic capsule filters are used in series with separate venting, then sterilizing filtration is ensured, but the quantity of filters and intermediate components increases

Engineering Contradiction:

Improvesterilizing filtration assuranceVSAvoidnumber of filters and components

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The patent merges the venting function and filtration function into a single barrier filter device. The barrier filter integrates both hydrophilic and hydrophobic paths within one device, eliminating the need for separate vent filters and intermediate drain filters that would otherwise be required in a conventional two-filter redundant system. This merging reduces device complexity while maintaining the redundancy benefit.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The barrier filter performs multiple functions simultaneously: it provides sterilizing filtration through its hydrophilic path and allows air venting through its hydrophobic path. This multi-functionality eliminates the need for separate dedicated vent filters and drain filters, reducing the overall number of components and simplifying the system architecture while maintaining redundant filtration capability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If hydrophilic filters are used for redundant filtration, then sterilizing grade filtration is achieved, but air passage is blocked once the filters are wet

Engineering Contradiction:

Improvesterilizing filtration performanceVSAvoidair venting capability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The barrier filter employs local quality by having different regions with different properties within the same device. The hydrophilic region provides sterilizing filtration for liquid flow, while the hydrophobic region allows air passage for venting operations. This spatial differentiation of properties within the single barrier filter device resolves the contradiction by allowing both functions to coexist without interfering with each other.

Inventive Principle:

Principle #3Local quality

4Ease of operation

If intermediate drain filters and separate air filters are placed between sterilizing filters, then pre-use preparation is enabled, but the device complexity and product loss increase

Engineering Contradiction:

Improvepre-use preparation capabilityVSAvoidproduct loss

Core Design Contradiction:

Ease of operationVSLoss of substance

Solution Approach 1:

The patent merges the venting function and filtration function into a single barrier filter device. The barrier filter integrates both hydrophilic and hydrophobic paths within one device, eliminating the need for separate vent filters and intermediate drain filters that would otherwise be required in a conventional two-filter redundant system. This merging reduces device complexity while maintaining the redundancy benefit.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The barrier filter performs multiple functions simultaneously: it provides sterilizing filtration through its hydrophilic path and allows air venting through its hydrophobic path. This multi-functionality eliminates the need for separate dedicated vent filters and drain filters, reducing the overall number of components and simplifying the system architecture while maintaining redundant filtration capability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 filtration process, reduces operator interaction, and minimizes product loss by eliminating the need for additional filters and venting operations, while maintaining sterility and ensuring efficient filtration and drying processes.

Implementation Method 1

the barrier filter having both hydrophilic and hydrophobic paths, allowing both fluid and gas permeability

Methodology Applied

Scientific EffectHydrophilic path: Hydrophile

Implementation Method 2

the barrier filter having both hydrophilic and hydrophobic paths, allowing both fluid and gas permeability

Methodology Applied

Scientific EffectHydrophobic path: Hydrophobe

Implementation Method 3

the barrier filter having both hydrophilic and hydrophobic paths, allowing both fluid and gas permeability

Methodology Applied

Scientific EffectSelective permeability: Semipermeable Membrane

Data Source

PatentUS10195544B2Methods and devices used for redundant sterile filtration

Publication Date: 2019.02.05 EMD MILLIPORE CORP

AI summary

Redundant filtration system that includes at least one barrier filter as a process filter, the barrier filter having both hydrophilic and hydrophobic paths, allowing both fluid and gas permeability. The need for vents is eliminated, as is an intermediate drain filter. The device also can be dried in series. The filtration system includes a network of conduits and receptacles, the network receiving liquid raw and/or starting material at one end, conducting it through the process stream defined thereby, and producing the desired liquid product at another end. The network is provided with one or more inputs for introducing liquid raw material into the fluid process stream, and one or more output ports for discharging fluid out of the fluid process stream. The network is preferably an essentially closed network, and also, preferably sterile and/or aseptic.