Microscopic Counting Method - Medical Packaging Material Particle Detector

Microscopic Counting Method - Medical Packaging Material Particle DetectorCompliant with USP788 and the 2025 edition of the Chinese Pharmacopoeia CP0903 for detecting insoluble particles in injections, infusions, sterile powders, etc., suitable for particle detection and analysis in samples with color, high viscosity, easy to produce bubbles, trace amounts, mRNA, etc.

The implementation standards include GB 8368 and USP788, USP789, 2025 edition of the Chinese Pharmacopoeia for insoluble particle detection CP0903, Japanese Pharmacopoeia, European Pharmacopoeia EP, YBB 00272004 Packaging Material Insoluble Particle Testing Method and other industry standards, as well as international standards such as ISO 14708-1 and ISO 8871-3. Built in user-defined standards can meet the requirements of different industries for particle pollution detection. Compliant with FDA's 21CFR Part 11 electronic record and signature requirements.

The ZMP930 fully automatic insoluble particle analyzer is based on the principle of microscope counting, using a magnification of 50 or 100 times to statistically count the particles filtered onto the filter membrane, and issue a report according to the standard. The device is equipped with an automatic moving platform, automatic Z-axis focusing, and automatic photography system. Through intelligent analysis software, all captured images are pieced together into a complete filter membrane, and the particles on the entire filter membrane are analyzed. And conduct statistical analysis and provide a report based on values greater than 10 μ m, greater than 25 μ m, 51 μ m-100 μ m, and greater than 100 μ m. Fully automatic scanning statistics avoid errors caused by human statistical factors, as well as false results caused by bubbles and large particles sticking to the wall during the photoresist testing process. Microscopic counting particle counter testing results are more accurate.

Technical features:

Execution standards: United States Pharmacopeia USP787, USP788, USP789, USP1788;

European Pharmacopoeia EP8.0; British Pharmacopoeia BP2013; Japanese Pharmacopoeia JP16;

Chinese Pharmacopoeia CP0903 2025 edition, ISO 16232 cleanliness testing standards, etc.

X. Y-axis and Z-axis automatic platforms scan the entire filter membrane.

Automatically identify white and non white particles at once, and recognize all particles in one scan.

Intelligent AI recognizes and distinguishes irregular particles such as fibers and spherical particles.

The ultra depth of field function with Z-axis autofocus ensures clear and accurate analysis of particles in each image.

Scan the entire filter membrane and save the complete image.

The software meets regulatory requirements and has functions such as audit tracking and permission grading.

Provide Chinese and English pharmacopoeia reports in accordance with the requirements of the pharmacopoeia report.

9-megapixel high-definition color camera

Microscopic Counting Method - Medical Packaging Material Particle Detector

Technical Specifications:

Customization requirements: various liquid testing requirements;

Provide test reports in accordance with USP788, Chinese Pharmacopoeia 2025 edition CP0903, etc

The software has functions such as audit tracking, permission grading, and user grading settings

The software automatically scans the entire filter membrane

Automatically distinguish between white particles and non white particles, elongated particles and irregularly shaped particles

Super depth of field function Z-axis autofocus ensures that every particle is clearly visible

Test range: 1 μ m-3000 μ m

Magnification factor: 10-100X times

Maximum resolution: 0.1 μ m

The operating software complies with the requirements of 21CFR Part 11 regulations

Analysis items: insoluble particles, particle counting, particle size distribution, aspect ratio distribution, roundness distribution, can provide D10, D50, D90, etc

Interface mode: RS232 or USB mode

Accuracy:<± 3%;

Scale scale: 0.1 μ m

Repetitive error:<5% (excluding errors caused by sample preparation factors)

High definition digital camera: 9-megapixel color camera

Testing time: 2-8 minutes