Multispectral Quality Inspection for Lyophilized Products

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Solution Overview

Problem

Existing methods for inspecting lyophilized and powdered pharmaceutical products are inadequate for non-destructive, detailed quality assessment, particularly in detecting moisture content and variations, due to limitations in conventional destructive sampling and non-destructive appearance inspection techniques.

Innovation Solution

A quality inspection apparatus utilizing a multispectral light receiver and hardware processor to calculate absorption spectra, enabling detailed inspection of lyophilized and powdered pharmaceutical products by imaging their lateral surfaces and analyzing light scattering and absorption properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If destructive sampling inspection is used to inspect components of lyophilized products, then manufacturing precision of component inspection is improved, but productivity deteriorates due to loss of inspection samples and inability to perform 100% inspection

Engineering Contradiction:
Improvecomponent inspection precisionVSAvoidinspection throughput
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent replaces the mechanical/physical destruction method with optical measurement using a multispectral light receiver. Light is transmitted through the transparent container and sample, and absorption spectra are obtained without physically damaging the product. This substitution enables non-destructive inspection while maintaining component detection capability.

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

Solution Approach 2:

The patent introduces a transparent container as an intermediary medium that allows light transmission while holding the inspection sample. The container enables optical access to the sample for spectral analysis without requiring direct contact or destruction of the product itself.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If conventional non-destructive appearance inspection is used, then productivity is improved by enabling 100% inspection, but manufacturing precision deteriorates because internal defects and component amounts cannot be directly measured

Engineering Contradiction:
Improveinspection coverageVSAvoidcomponent measurement accuracy
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent changes the measurement parameter from visual appearance to optical absorption spectrum across multiple wavelengths. By measuring absorption at different wavelengths, the system can identify and quantify specific components (water, active ingredients, excipients) based on their characteristic spectral signatures, providing precise component analysis while maintaining non-destructive inspection.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent transitions from two-dimensional visual appearance inspection to three-dimensional spectral analysis by measuring light absorption across multiple wavelengths. This adds a spectral dimension to the inspection, enabling detection of internal composition and component quantities that are invisible to conventional appearance inspection.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Productivity

If production apparatus size is increased to meet demand, then productivity is improved, but manufacturing precision deteriorates due to variations in water amount among products

Engineering Contradiction:
Improveproduction capacityVSAvoidwater content uniformity
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent implements a feedback mechanism by measuring the actual water content and component amounts of each product using absorption spectrum analysis. This measurement feedback enables detection of products with abnormal water content or component variations, allowing for quality control and corrective actions in the production process to maintain uniformity despite scale increases.

Inventive Principle:
Principle #23Feedback

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 non-destructive, 100% inspection of lyophilized and powdered pharmaceutical products, detecting components like active ingredients and moisture with precision, ensuring product safety and quality by identifying contamination and variations.

Implementation Method 1

a multispectral light receiver that obtains an image of a lateral surface of the transparent container; and a hardware processor that calculates an absorption spectrum at multiple wavelengths, based on a light reception result by the multispectral light receiver

Methodology Applied
Scientific EffectAbsorption spectroscopy: Absorption Spectroscopy

Implementation Method 2

a hardware processor that calculates an absorption spectrum at multiple wavelengths, based on a light reception result by the multispectral light receiver, and that detects an inspection target component contained in the inspection target sample, based on the calculated absorption spectrum

Methodology Applied
Scientific EffectLight absorption: Absorption (EM radiation)

Data Source

PatentUS20250290847A1Quality inspection apparatus, quality inspection method, and storage medium
Publication Date: 2025.09.18 KONICA MINOLTA INC
  • US20250290847A1 patent drawing
  • US20250290847A1 patent drawing
  • US20250290847A1 patent drawing

AI summary

A quality inspection apparatus is configured to inspect quality of an inspection target sample filled in a transparent container. The inspection target sample is a lyophilized product or a powdery pharmaceutical product. The quality inspection apparatus includes: an illuminator that illuminates a bottom surface of the transparent container; a multispectral light receiver that obtains an image of a lateral surface of the transparent container; and a hardware processor. The hardware processor calculates an absorption spectrum at multiple wavelengths, based on a light reception result by the multispectral light receiver, and detects an inspection target component contained in the inspection target sample, based on the calculated absorption spectrum.