Non-particulate Adsorbent Qualification via Secondary Reaction

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Solution Overview

Problem

Current methods for qualifying non-particulate adsorbents, such as ion exchange systems, are not highly sensitive, robust, or non-destructive, and often require the use of organic adsorbents that need to be eluted, posing regulatory, economic, and process safety challenges.

Innovation Solution

A method involving a secondary reaction to detect defects in non-particulate adsorbents by loading them with ions under conditions where they are retained, using a secondary reaction to detect breakthrough ions with high sensitivity, and comparing the breakthrough characteristics to those of a known intact adsorbent, allowing for the detection of even slight impairments without impairing the adsorbent's functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If conventional chromatography gels are used for contaminant removal, then the separation process can be performed, but the columns require significant cleaning and validation effort and are operated oversized to achieve sufficient flow rates

Engineering Contradiction:
Improveflow rateVSAvoidcolumn size
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces conventional particulate chromatography gels with membrane-based adsorbents, substituting a mechanical packing system with a membrane structure that enables convective flow. This substitution allows for compact column design while maintaining high flow rates, as the membrane structure eliminates the need for oversized columns required by particulate gels.

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

2Speed

If adsorption membranes are used to achieve convective mass transport, then diffusion limitation is avoided, but the method for qualifying these membranes lacks high sensitivity and robustness

Engineering Contradiction:
Improvemass transport rateVSAvoiddetection sensitivity
Core Design Contradiction:
SpeedVSMeasurement precision

Solution Approach 1:

The patent changes the detection parameter from simple concentration measurement to secondary reaction-based detection. By introducing a secondary reaction that produces a measurable signal (such as color change or fluorescence), the detection sensitivity is significantly enhanced, allowing for robust qualification of membrane performance at high mass transport rates.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If organic adsorbents are used for qualification testing, then the adsorbent function can be tested, but the adsorbent must be eluted which poses regulatory, economic, and process safety challenges

Engineering Contradiction:
Improveadsorbent function verificationVSAvoidelution requirements
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent employs a qualification method that uses inexpensive, easily removable test substances instead of organic adsorbents. The test substances are designed to be temporarily bound and then completely removed without requiring complex elution procedures, eliminating regulatory, economic, and safety concerns associated with organic adsorbent elution.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Quantity of substance

If the capacity of an adsorbent is based on a fixed amount, then the absorption capacity can be quantified, but slight impairments in adsorbent integrity are difficult to detect

Engineering Contradiction:
Improveabsorption capacityVSAvoidintegrity detection accuracy
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent introduces a secondary reaction as an intermediary detection mechanism. This secondary reaction amplifies the signal from the adsorbent's binding capacity, enabling the detection of slight impairments in adsorbent integrity that would be imperceptible through direct capacity measurement alone.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 method enables highly sensitive, robust, and non-destructive detection of defects in non-particulate adsorbents, ensuring the integrity and functionality of ion exchange systems, particularly in biotechnological applications, with improved sensitivity and accuracy compared to existing methods.

Implementation Method 1

loading the non-particulate adsorbent with an adsorbate which comprises ions, under conditions under which the ions are retained by the non-particulate adsorbent

Methodology Applied
Scientific EffectIon exchange: Ion Exchange

Implementation Method 2

detecting the broken-through ions by means of a secondary reaction

Methodology Applied
Scientific EffectSecondary reaction: Chemical Bonding

Data Source

PatentEP2521608B1Method for qualifying a non-particulate adsorbent by means of a secondary reaction
Publication Date: 2019.03.27 SARTORIUS STEDIM BIOTECH GMBH
  • EP2521608B1 patent drawingFigure 1
  • EP2521608B1 patent drawingFigure 2
  • EP2521608B1 patent drawingFigure 3

AI summary

The invention relates to a method for qualifying a non-particulate adsorbent by means of a secondary reaction, and to a kit for qualifying a non-particulate adsorbent by means of a secondary reaction.