Filter Unit Validation via Alternating Electric Field Detection

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Solution Overview

Problem

Traditional methods for validating filter units are time-consuming and highly manual, relying on analytical filters and microbial growth detection, which are inefficient and prone to human error.

Innovation Solution

A method and apparatus that utilize an alternating electric field to detect cells passing through a filter unit, generating an electric signal that indicates the filter's validity, allowing for automated and efficient validation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional analytical filter and agar plate incubation method is used, then cell detection is achieved, but testing time is excessively long (days to weeks)

Engineering Contradiction:
Improvecell detection accuracyVSAvoidtesting duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the biological incubation system (agar plates requiring days of microbial growth) with an electrical measurement system using alternating electric fields. This substitution enables immediate detection of cells passing through the filter unit by measuring changes in electrical properties, reducing testing time from days/weeks to seconds while maintaining detection capability

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the detection parameter from biological growth (macroscopically visible colonies after incubation) to electrical properties (changes in capacitance, conductance, or impedance caused by cells in the electric field). This parameter transformation enables rapid, real-time detection without the time-consuming incubation process

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If agar plate incubation method is used, then cell growth detection is achieved, but the process is highly manual and prevents automation

Engineering Contradiction:
Improvecolony-forming units detectionVSAvoidtesting automation capability
Core Design Contradiction:
Measurement precisionVSExtent of automation

Solution Approach 1:

The patent replaces the manual biological assay process (incubating agar plates and manually counting colonies) with an automated electrical measurement system. The alternating electric field method allows for automatic, real-time detection of cells passing through the filter, enabling full automation of the integrity testing workflow without manual intervention

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The electrical measurement system performs self-detection and self-measurement of cell passage through the filter unit. The system automatically measures changes in electrical properties caused by cells in the alternating electric field, eliminating the need for manual sampling, incubation, and counting operations

Inventive Principle:
Principle #25Self-service

3Measurement precision

If Raman spectroscopy is used for cell identification, then cell detection capability is achieved, but detection time is too long for efficient testing

Engineering Contradiction:
Improveviable cells identificationVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the complex spectroscopic measurement system (Raman spectroscopy requiring lengthy analysis) with a simpler electrical measurement system using alternating electric fields. This substitution provides rapid cell detection by measuring electrical property changes, achieving both cell identification capability and time efficiency that Raman spectroscopy cannot provide

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Measurement precision

If fluorescence-based measurements are used, then cell detection is achieved, but the fluorophore labels affect cell properties and falsify test results

Engineering Contradiction:
Improvecell detection sensitivityVSAvoidtest result accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent replaces the fluorescence labeling system (which requires chemical modification of cells) with an electrical measurement system using alternating electric fields. This substitution detects cells based on their inherent electrical properties without any chemical labels, ensuring that cell behavior and test results remain unaffected and truly representative of actual filter performance

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 method provides a rapid and automated means to validate filter units, reducing the time and manual effort required, while accurately detecting cell passage and determining filter integrity.

Implementation Method 1

within the measurement area the fluid is exposed to at least one alternating electric field between at least two electrodes

Methodology Applied
Scientific EffectElectric field: Electric Field

Implementation Method 2

obtaining at least one electric signal between the at least two electrodes, wherein the at least one electric signal is at least affected by whether one or more cells of a plurality of cells in the fluid pass through the measurement area

Methodology Applied
Scientific EffectElectric signal detection: Electrical Resistance

Data Source

PatentUS20250164372A1Method and apparatus for validating a filter unit
Publication Date: 2025.05.22 SARTORIUS STEDIM BIOTECH GMBH
  • US20250164372A1 patent drawing
  • US20250164372A1 patent drawing
  • US20250164372A1 patent drawing

AI summary

A method for validating a filter unit. The method includes guiding a fluid flow of a fluid after the fluid flow passed through the filter unit to a measurement area that is connected to the filter unit. The measurement area the fluid is exposed to is at least one alternating electric field between at least two electrodes. The method includes obtaining at least one electric signal between the at least two electrodes. The at least one electric signal is at least affected by whether one or more cells of a plurality of cells in the fluid pass through the measurement area. The method includes determining, at least partially based on the obtained at least one electric signal, at least one validity information indicating a validity of the filter unit.