Overview
WLY-01M Microscopic Counting Method - Insoluble Particle Meter is a professional equipment launched by TEELEN for the detection of insoluble particles in samples such as intravenous injections. The product is designed according to the provisions of the microscopic counting method (the second method) in the pharmacopoeia of various countries, and is suitable for clarifying the insoluble particles of various types of injections such as transparent, colored, high viscosity, emulsion, suspension, etc. and sterile APIs. When the photoresist method (the first method) fails the test, this method can be used as the final judgment basis.
Features
1. Meet the test requirements of national pharmacopoeias for microscopic counting (second method).
2. The test range is extensive, covering particles from 1 μm to 600 μm.
3. Equipped with high definition digital camera (5 million pixels) and a variety of magnification objectives (5 times, 10 times, 20 times, 40 times, 100 times) to ensure clear imagery.
4. The repeatability error is less than 5%, and the test results are reliable.
5. Optional imported brand Microscope (such as OLYMPUS, Lycra, Nikon, etc.) to meet different user requests.
6. Provide complete supporting consumables and accessories, including filtrating device, blank filter membrane, metal bath drying system, etc., to form a complete test plan.
Principle
The instrument works based on the principle of microscopic counting method. First, the sample to be tested is passed through the filtrate device, so that the insoluble particles in the sample are trapped on the special grid filter membrane. Subsequently, the filter membrane with particles is dried to remove moisture. The dried filter membrane is placed on the motorized scanning platform of Microscope, and the entire filter membrane is automatically scanned by the objective lens and camera imagery. Finally, the special analysis software automatically recognizes, counts and sizes the images obtained by scanning, and generates test reports according to preset standards.
Applications
Intravenous injection (solution injection, sterile powder for injection, concentrated solution for injection), sterile API for intravenous injection, Color injection, high viscosity injection, emulsion, liposome, suspension, easy to produce bubble injection, contrast agent, vaccine, trace samples, biological drugs, intraocular injection, drug packaging materials, etc
Standards
United States Pharmacopoeia USP787, USP788, USP789, European Pharmacopoeia EP6.0, EP7.0, EP7.8, EP8.0, British Pharmacopoeia BP2013, BP2012, 2010, 2009, Japanese Pharmacopoeia JP16, JP15, JP14, Chinese Pharmacopoeia CP0903
Steps
1. Sample filtrate: Place the clean 25mm filter membrane in the appropriate Filter, so that all the samples to be tested are filtrated by the filtrate membrane.
2. Filter drying: The filtered membrane is placed in a clean culture dish with dust-free forceps, and the appropriate temperature is selected for drying in a metal bath.
3. Scanning filter: Place the dried filter under the Microscope objective and automatically scan the entire filter.
4. Data analysis: The software automatically analyzes all the filter pictures after scanning to generate a final test report.
Notice
• Please read the manual carefully before operation and ensure that the operator has received relevant training.
• When filtrating, transferring and drying the filter membrane, use matching dust-free forceps and other tools, and pay attention to the cleanliness of the environment to avoid the introduction of foreign particle pollution.
• Choose the appropriate test method (first or second method) according to the characteristics of the sample (such as viscosity, Color, easy to produce bubbles, etc.).
• Instruments need to be calibrated and maintained regularly to ensure the accuracy of test results.
• Optional accessories (such as imported brand Microscope, specific software, computers, etc.) can be configured according to actual needs.
