Requirements and instrument recommendations for detecting insoluble particles and foreign objects in therapeutic protein injections in the United States Pharmacopeia（USP787）-Yinhuang Technology provides corresponding solutions

Solution:

Yinhuang TechnologyTherapeutic protein injectionThe insoluble particle detection in provides the following products:

1YH-LEIP-0201Optical Resistance Insoluble Particle Analyzer

LEIPThe series of insoluble particle detectors meet the instrument requirements for detecting insoluble particles using the photoresist method in pharmacopoeias of various countries. They can directly detect the content and size of insoluble particles in injection solutions, sterile powders, infusion equipment, and drug packaging materials. The instrument adopts high-performance imported laser light source and compensation circuit to ensure the testing accuracy of various colorless and colored samples. The injection slit and pipeline are imported316LAnd importsPTFEThe material can directly detect special solutions such as organic solvents and oil matrices.

2TheYH-MIP-0103Microscopic Counting Insoluble Particle Analyzer

Technical advantages:

A fully automated testing system that automatically scans, counts, and issues reports, reducing human error in operation

√ Fully automatic detection system, reducing eye damage to testers during use

√ Can distinguish particle properties, identify the source of insoluble particles, whether they are metals or fibers

√ Complies with the pharmacopoeias of various countries such as the Chinese Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, and the Japanese PharmacopoeiaChineseForMicroscopic counting methodInsoluble particle inspectioninstrumentrequirement

3TheYH-MIP-0205ProMicroscopic Counting Insoluble Particle Analyzer

YH-MIP-0205 ProThe Type Micro Counting Insoluble Particle Analyzer is a new generation of insoluble particle analyzer that can automatically detect insoluble particles in samplesAutomatic filtering, drying, testing, and report issuanceWaiting for multiple processes; Super-resolution algorithmAIThe introduction of various image processing methods such as intelligent algorithms can effectively ensure the accuracy of test data. Complies with the instrument requirements for insoluble particle detection using microscopic counting method in pharmacopoeias of various countries such as the Chinese Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, and the Japanese Pharmacopoeia.