Submicron Particle Detection in Liquid Beneficial Agents
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Solution Overview
Problem
Current methods for detecting submicron particles in liquid beneficial agents, such as those in pre-filled syringes, lack high-throughput and sensitivity, particularly for low concentrations, and often require invasive techniques that reduce sample throughput.
Innovation Solution
A method and system that selectively illuminates the liquid beneficial agent, obtains images using an image detector, and analyzes the data with a processor to determine particle concentration and quality, utilizing techniques like light scattering and intrinsic fluorescence to detect particles as small as submicrons, and calibrates the system for high-throughput analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If naked eye inspection is used, then the method is simple and noninvasive, but the sensitivity to detect low concentrations of particles is insufficient
Solution Approach 1:
The patent introduces light scattering as an intermediary physical phenomenon to enable detection of subvisible particles. By measuring the scattering of light by particles in the liquid beneficial agent, the system achieves sensitive detection without requiring complex invasive sampling or sophisticated imaging equipment, thus resolving the contradiction between detection sensitivity and system complexity.
2Measurement precision
If automated commercial systems are used, then high throughput is achieved, but only particles larger than 10-25 microns can be detected
Solution Approach 1:
The patent changes the detection parameter from direct visual inspection or conventional imaging to light scattering measurement. This parameter change enables detection of much smaller particles (down to submicron sizes) while maintaining automated high-throughput operation, as light scattering is sensitive to particle size across a broad range and can be measured rapidly without manual intervention.
3Measurement precision
If invasive techniques like DLS or NTA are used, then high resolution particle detection is achieved, but sample throughput is reduced
Solution Approach 1:
The patent extracts the essential detection function from complex invasive techniques by using only light scattering measurement. This simplified approach removes the need for manual sampling, complex instrument setup, and lengthy measurement protocols associated with DLS and NTA, thereby achieving high-resolution particle detection while maintaining high sample throughput through automated operation.
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
Enables noninvasive, high-throughput detection of submicron particles in liquid beneficial agents, ensuring quality by accurately determining particle concentration and average molecular mass, even at low concentrations, thereby improving the reliability of quality control in pre-filled syringes.
Implementation Method 1
utilizing techniques like light scattering and intrinsic fluorescence to detect particles as small as submicrons
Implementation Method 2
utilizing techniques like light scattering and intrinsic fluorescence to detect particles as small as submicrons
Data Source
AI summary
Detection of particles in a liquid beneficial agent contained within a container includes selectively illuminating at least a portion of the liquid beneficial, obtaining an image from the illuminated portion of the liquid beneficial agent, analyzing image data representing the image, using a data processor, to obtain a particle concentration, measuring an image intensity value of the image data using the data processor, and determining a quality level of the liquid beneficial agent using the data processor based on the particle concentration and the measured image intensity value.