Shanghai Zimeng Technology Co., LtdMicroscopic Counting Insoluble Particle AnalyzerZMP930,The equipment is equipped with software that complies withregulation21CFR Part11requirement,strictly in accordance withChinese Pharmacopoeia, United States PharmacopoeiaUSP788TheUSP789Japanese Pharmacopoeia and European PharmacopoeiaRequirements for insoluble particle inspection,Provide a pharmacopoeia report.

Widely applicable for the detection of insoluble particles in injections in the pharmaceutical industry (large infusion, small injection, freeze-dried powder, protein solution, emulsion, inhalation formulation, liposome, suspension, high viscosity formulation, colored formulation, etc.) Insoluble particle testing for ophthalmic injections, vaccines, etc., as well as medical devices and packaging materials.

Test Process:

1) Sample filtration: Place a clean 25mm filter membrane on an appropriate filter to ensure that all samples are filtered through the membrane.

2) Membrane drying: Use dust-free tweezers to place the filtered membrane in a clean culture dish, and use a metal bath to select the appropriate temperature for drying.

3) Scanning filter membrane: Place the dried filter membrane under a microscope objective and scan the entire filter membrane.

4) Data analysis: Conduct data analysis on all scanned filter membrane images and finally obtain a report.