Static image method insoluble particle analyzer

Product Introduction:

new generationYH-0205-PlusStatic image method insoluble particle analyzerNot only does it solveThe traditional microscope method has problems such as insufficient data accuracy, cumbersome operation, significant harm to the human eye, and untraceable detection results. It has achieved automatic scanning, automatic counting, and automatic report generation, and the software meets the requirements21CFR Part11andGMPRequirements for data integrity.

moreUnder the existing technological advantages of the previous generation of instruments, a new upgrade has been made. In addition to the original functions of automatic scanning, automatic testing, and automatic counting, new functions such as automatic filtering, automatic drying, and automatic sample loading have been added. At the same time, on the basis of the original super-resolution algorithm, new features have been addedAIIntelligent algorithms facilitate customers to better classify and organize insoluble sources, achieving true fully automated inspection!

YH-0205-PlusStatic image method insoluble particle analyzer

Instrument model:YH-0205-Plus

Working Principle:Microscopic counting method/Image method

Detection scope:1 μm-500 μm

Static image method insoluble particle analyzer-Parameters of fully automatic microscope counting method insoluble particle analyzer

Static image method insoluble particle analyzer-Fully automatic microscope counting methodInnovation points:

1.It can complete multiple processes such as automatic filtration, automatic drying, automatic sample loading, automatic testing, and automatic report issuance;

2.Super-resolution algorithmAIThe combination of intelligent algorithms and other algorithms can effectively ensure the accuracy of test data;

3.inWhile compensating for the shortcomings of conventional microscopy in detecting insoluble particles, it can accurately retain every particle in the sample

4.The original morphology of individual particles serves as a warning for the source or formation mechanism of insoluble particles;

5.Complies with the instrument requirements for insoluble particle testing in various pharmacopoeias such as the Chinese Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, and the Japanese Pharmacopoeia;

6.comply with21CFR Part11andGMPRequirements for data integrity.

Static image method insoluble particle analyzerChoose microscopic counting methodInsoluble particle analyzerCheck for insoluble particles in injectionsReason for:

Pharmacopoeia of the People's Republic of China2020Version regulations:

Firstly, when the results of the photoresist method do not meet the requirements or the test sample is not suitable for photoresist measurement, the microscopic counting method should be used for measurement, and the results of the microscopic counting method should be used as the basis for judgment.

Secondly, the photoresist method is not suitable for formulation products that are prone to bubble formation and high viscosity. When detecting insoluble particles, the second method (microscopic counting method) should be used for detection.

Static image method insoluble particle analyzer--Microscopic counting methodInsoluble particle analyzerWidely used: emulsions, liposomes, suspensions, eye drops, vaccines, protein injections, colored injections, medical devices, etc