Particle Standard for Optical Analyzer Calibration

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Solution Overview

Problem

Conventional methods for calibrating or validating optical particle analyzers in the pharmaceutical industry using particle standards with optical properties dissimilar to water-based carriers result in unreliable and unrepeatable analysis of biological samples, as these standards do not challenge detection sensitivity and are not stable for practical use.

Innovation Solution

A particle standard with particles having optical properties similar to a water-based carrier, dispersed within the carrier, is used to calibrate or validate an optical particle analyzer by comparing detection sensitivity with a reference analyzer, ensuring that less than all particles are detectable, thereby standardizing detection sensitivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a particle standard with particles having optical properties dissimilar to the water-based carrier is used, then the particles are easily detected by the optical particle analyzer, but the analyzer does not challenge detection sensitivity and results are unreliable and unrepeatable

Engineering Contradiction:

Improveparticle detection accuracyVSAvoiddetection sensitivity challenge

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent applies homogeneity by using particles with optical properties similar to the water-based carrier, making the particle standard optically homogeneous with the carrier medium. This ensures the particle standard challenges the detection sensitivity of the optical particle analyzer in a manner comparable to actual biological samples, thereby improving reliability and repeatability of detection results.

Inventive Principle:

Principle #33Homogeneity

2Reliability

If a particle standard with particles having optical properties similar to the water-based carrier is used, then detection sensitivity is challenged and results are reliable and repeatable, but the particle standard is unstable and cannot be practically used

Engineering Contradiction:

Improvedetection sensitivity challengeVSAvoidparticle standard stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent uses a stable particle standard that copies or mimics the optical properties of biological material particles in water-based carriers. By creating a stable surrogate standard with matched optical characteristics (refractive index, absorption, scattering), the system achieves both reliability in challenging detection sensitivity and practical stability for repeated use.

Inventive Principle:

Principle #26Copying

3Ease of manufacture

If conventional particle standards with dissimilar optical properties are used, then calibration is simple and particles are easily detected, but the fraction of particles detected varies significantly between analyzers and times

Engineering Contradiction:

Improveparticle standard preparationVSAvoidparticle detection consistency

Core Design Contradiction:

Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent changes the optical parameters of the particle standard to match those of the water-based carrier and biological samples. By adjusting the refractive index, absorption coefficient, and scattering properties of the standard particles to be similar to actual samples, the system achieves consistent detection fractions across different analyzers and times, improving measurement precision while maintaining ease of manufacture.

Inventive Principle:

Principle #35Parameter changes

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 approach provides reliable and repeatable analysis by standardizing detection sensitivity, allowing for consistent particle detection across different times and locations, and ensuring the particle standard serves as a stable optical surrogate for biological samples.

Implementation Method 1

an optical particle analyzer is frequently used to analyze samples including particles of biological material dispersed in a water-based carrier

Methodology Applied

Scientific EffectLight scattering: Scattering

Implementation Method 2

the optical properties of the particles in such samples are similar to those of the carrier

Methodology Applied

Scientific EffectLight absorption: Absorption (EM radiation)

Data Source

PatentUS8102528B2Particle standard and method of calibrating or validating an optical particle analyzer

Publication Date: 2012.01.24 PROTEINSIMPLE

AI summary

The present invention provides a particle standard including particles having optical properties similar to those of a carrier in which the particles are dispersed, as well as a method of calibrating or validating a subject optical particle analyzer with respect to a reference optical particle analyzer by using the particle standard. In the method, the particle standard is analyzed with the reference optical particle analyzer to obtain a reference particle concentration and a reference particle-size distribution. Analogously, the particle standard is analyzed with the subject optical particle analyzer to obtain a subject particle concentration and a subject particle-size distribution. The subject particle concentration and the subject particle-size distribution are then compared to the reference particle concentration and the reference particle-size distribution, respectively, and the subject optical particle analyzer is adjusted accordingly.