ZM-MIP insoluble particle analyzer

ZM-MIP 01Z insoluble particle microscopic counting method is higher than the requirements of the 2020 edition of the Chinese Pharmacopoeia, with built-in pharmacopoeia, anesthesia equipment, and other instrument detection standards. It can directly perform particle contamination filtration rate detection for various dosages of injections, sterile powders, and medical equipment;

　　Execution standard:

1. USP787, USP788, USP789, USP729 in the United States Pharmacopeia;

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

3. Chinese Pharmacopoeia CP0903, 2015 edition, 2020 edition, etc.

　　Application of Micro Counting Insoluble Particle Analyzer Product:

1. Detection of insoluble particles used in large infusion and small injections;

2. It is also applied to special protein solutions, emulsions, liposomes, suspensions, high viscosity formulations, and colored formulations;

3. Detection of insoluble particles such as eye injections and vaccines.

4. Non soluble particle analyzer detection using microscopic counting method for medicinal packaging materials.

　　Technical parameters of insoluble particle analyzer using microscopic counting method:

1. Customization requirements: various liquid testing requirements;

2. According to the Chinese Pharmacopoeia 2020 edition CP0903, issue a test report

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

4. The software automatically scans the entire filter membrane

5. Test range: 1 μ m-500 μ m

6. Magnification: 40X to 1000X times

7. Maximum resolution: 0.1 μ m

8. Microscopic error small: 0.02 (excluding errors caused by sample preparation factors)

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

10. High definition digital camera (CCD): ≥ 5 million pixels

11. Scale scale: 0.1 μ m

12. Analysis items: particle counting, particle size distribution, aspect ratio distribution, circularity distribution, etc

13. Automatic segmentation speed:<1 second<>

14. Segmentation success rate:>93%

15. Software operating environment: Win10

16. Interface mode: RS232 or USB mode

17. Supply period: In stock

18. Accuracy:<± 3%; <>

19. Coincidence accuracy: 10000 particles/mL (5% coincidence error);

20. Resolution:>95% (calibrated according to the Chinese Pharmacopoeia 2020 edition); <10% (calibrated according to the United States Pharmacopeia and ISO 21501). <>