Yinhuang Technology YH-MIP-0103Microscopic countingInsoluble Particle AnalyzerApplication and Analysis

Emulsion injections (such as fat emulsions and drug loaded emulsions) are widely used in anti-tumor and anti infective treatments due to their advantages of sustained release and targeting. However, its milky white and turbid appearance, as well as the optical properties of the milk particles, render traditional photoresist detection ineffective.The refractive index of emulsion particles is similar to that of insoluble particles, and the laser signal is easily interfered with, leading to misjudgment (such as counting emulsion particles as insoluble particles)，The United States Pharmacopeia (USP<788>) and the Chinese Pharmacopoeia (2020 edition, Chapter 0903) explicitly require that samples that are milky white, highly viscous, or prone to bubble formation must be counted using microscopic counting method (Method 2).

Derived from USP<787>3.1 Testing Considerations

The core instrument for detection is the Yinhuang Technology YH-MIP-0103 Microscopic Counting Insoluble Particle Analyzer, which uses a white microporous filter membrane (pore size 0.45 μ m, diameter 25mm). Pre inspection confirms that the filter membrane and particle inspection water meet the requirements of the pharmacopoeia, and the entire process is operated in a clean workbench to prevent particle contamination.

Due to the fact that the sample is packaged in a three chamber bag, the testing plan is to separately sample and filter the single chamber bag for testing. After the three chamber sample is fully mixed, it will be sampled and filtered for testing; After filtering the sample, rinse the filter tube wall with an appropriate amount of inspection water to avoid sample residue hanging on the wall. Then dry, scan, analyze, and issue a report.

Test results:

Based on the results and analysis of the filter membrane images, a large number of black amorphous particles were accumulated in the amino acid chamber bag of sample two, while the particles in the filter membrane of the remaining chambers were evenly distributed without aggregation. The reason for the non conformance of insoluble particles in sample two is that the amino acid pocket particles exceed the standard. Successfully distinguishing emulsion particles (filtered out) from real insoluble particles (intercepted) through microscopic counting method to avoid false positives. Detected excessive particles, indicating that there is room for improvement in the production and raw material drug processes. Thus providing direction for enterprises to solve the problem of excessive particulate matter.

Yinhuang Technology YH-MIP-0103 Microscopic Counting Insoluble Particle Analyzer directly observes particle morphology, avoiding optical interference, especially suitable for complex systems such as emulsions, liposomes, and suspension injections, providing accurate detection results; The equipment automatically scans the entire filter membrane instead of manual technology, reducing errors. The software meets the requirements of 21CFR Part 11 and GMP for data integrity, and automatically generates audit tracking reports. AI intelligent classification software identifies the source of particles (such as rubber particles from sealing plugs, fibers from the environment) and guides process optimization.

Microscopic counting method is an arbitration method for detecting insoluble particles, especially for special formulations such as emulsions. Its combination of automated instruments and intelligent analysis not only meets pharmacopoeia compliance, but also provides root cause analysis of particle pollution for enterprises, achieving quality control throughout the entire lifecycle from raw material control, production environment to packaging materials.