Image method, microscopic counting method, insoluble particle analyzerIt is a fully automatic detection device based on microscopic imaging technology, mainly used for precise analysis of insoluble particles in samples such as drugs and injections. The core principle is to filter the sample through a filter membrane, and then automatically scan, identify, and count the particles using high-power microscopy and image processing technology, while retaining the original morphology information of the particles.

There are two types of insoluble particle inspection methods, namely photoresist insoluble particle inspection and microscopic counting insoluble particle inspection. When the results of the light resistance method do not meet the requirements or the test sample is not suitable for the light resistance method, the microscopic counting method should be used for determination, and the results of the microscopic counting method should be used as the basis for judgment. The photoresist method is not suitable for formulations with high viscosity and easy crystallization, nor for injections that are prone to generating bubbles when entering the sensor. For such preparations, microscopic counting method is required for determination.

The advantages of image based microscopic counting method:

Reduce human error: Automatic segmentation and counting algorithms avoid subjective judgments.

Complex scene adaptation: Processing noise, reflections, and other interferences through deep learning models, suitable for industrial quality inspection.

Limitations of image-based microscopic counting method:

Dependent on training data: The model requires a large amount of annotated data and has limited generalization ability for rare defects or new sample types.

Environmental sensitivity: Uneven lighting or sample contamination may lead to false positives and require strict pre-treatment.

Improvement method:

Fully automatic detection process:

Integrate LIMS system to achieve sample barcode recognition, automatic sampling, and result transmission, avoiding manual operation errors.

Real time monitoring of equipment status and automatic calibration of deviations (such as reagent stability issues).

Pharmacopoeia compliance calibration:

Use a static AI model (deterministic output) to ensure that the results are verifiable and comply with the requirements of the 25th edition of the pharmacopoeia.

By using AI intelligent agents to automatically update inspection standard SOPs, single variety file revisions can be completed within 2 minutes, reducing manual errors.