Membrane-Concentrated FIA Analysis for Stable Low-Level Endotoxin Detection

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing online analysis methods for endotoxins in water used in drug manufacture face challenges in accurately and stably quantifying low concentrations, particularly when using a flow injection analysis (FIA) method.

Innovation Solution

An analysis device incorporating a membrane filtration device with a microfiltration or ultrafiltration membrane, a flow injection system, and a sample water pump, where the outlet pipe diameter is smaller than the inlet pipe, allowing concentrated sample water to be pressurized and analyzed with a higher downstream pressure, stabilizing flow rates and enhancing concentration factors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a flow injection analysis method is used for online endotoxin detection, then the analysis can be performed continuously, but the ability to quantitatively analyze low concentrations is insufficient

Engineering Contradiction:
Improvecontinuous analysis capabilityVSAvoidquantitative analysis ability at low concentrations
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies preliminary action by concentrating the detection target (endotoxins) in the sample water before the actual analysis. The concentration step is performed in advance through membrane filtration, which accumulates the detection target from a large volume of sample water into a smaller volume. This preliminary concentration enables the subsequent flow injection analysis to achieve accurate quantitative measurement even at originally low concentrations, while maintaining continuous online analysis capability.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If the outlet pipe diameter in the flow injection system is reduced, then the downstream pressure increases and flow rate stabilizes, but the device complexity increases

Engineering Contradiction:
Improveflow rate stability and measurement accuracyVSAvoidpiping configuration complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies local quality by creating a localized pressure increase at the outlet pipe of the flow injection system. Instead of increasing pressure throughout the entire system, the smaller outlet pipe diameter specifically at the exit creates a pressure bottleneck that stabilizes the flow rate entering the detection cell. This localized structural modification improves measurement reliability without requiring complex pressure control systems throughout the entire apparatus.

Inventive Principle:
Principle #3Local quality

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 enables accurate and stable quantitative analysis of endotoxins by maintaining higher pressure downstream, stabilizing flow rates, and simplifying the device configuration by eliminating the need for separate carrier water acquisition.

Implementation Method 1

a membrane filtration device provided with a microfiltration membrane or an ultrafiltration membrane

Methodology Applied
Scientific EffectMembrane filtration: Filter (physical)

Implementation Method 2

a membrane filtration device provided with a microfiltration membrane or an ultrafiltration membrane

Methodology Applied
Scientific EffectUltrafiltration: Filter (physical)

Implementation Method 3

a sample water pump that pressurizes the sample water in the first piping

Methodology Applied
Scientific EffectPump pressurization: Pump

Implementation Method 4

The water pressure of the sample water at the downstream side of the pump on the first piping can accordingly be maintained in a higher pressure state than the water pressure at the upstream side of the pump

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 5

a flow injection system that analyzes sample water from a reaction between a detection target contained in the sample water and a reagent that is contained in carrier water and that reacts with the detection target

Methodology Applied
Scientific EffectChemical reaction: Chemical Bonding

Data Source

PatentEP4592674A1Analysis device and analysis method
Publication Date: 2025.07.30 NOMURA MICRO SCI CO LTD
  • EP4592674A1 patent drawingFigure 1
  • EP4592674A1 patent drawingFigure 2
  • EP4592674A1 patent drawingFigure 3

AI summary

An analysis device includes: a membrane filtration device provided with a microfiltration membrane or an ultrafiltration membrane; a flow injection system that analyzes sample water from a reaction between a detection target that is included in the sample water, and a reagent that is included in carrier water and that reacts with the detection target; first piping that passes concentrated water, in which the detection target has been concentrated by the membrane filtration device, to the flow injection system as the sample water; and a sample water pump that pressurizes the sample water in the first piping, an internal pipe diameter of an outlet pipe in the flow injection system being smaller than an internal pipe diameter of the first piping.