TEELEN WLY-01M Microscopic Counting Method-Insoluble Particulate Meter

Application background

The United States Pharmacopoeia USP788, Chinese Pharmacopoeia CP0903 and other pharmacopeias of various countries have clearly defined regulations on intravenous injections (solution injections, sterile powders for injection, concentrated solutions for injection) and sterile raw materials for intravenous injection, and insoluble particles need to be checked. It is also stipulated that the first method uses the photoresist method, and the second method uses the microscope counting method. When the first method fails to pass the test, the second method - microscopic counting method is used for testing and is the basis for the final judgment.

The Application of the first photoresist method: intravenous injections, including clear and transparent small injections, large infusions, sterile powders, etc.;

Application of the second method of microscopic counting: intravenous injections, including clear and transparent small injections, large infusions, sterile powders, colored injections, large viscosity injections, emulsions, liposomes, suspensions, and injections prone to bubbles , contrast agents, vaccines, trace samples, biological drugs, intraocular injections, etc.

Introduction

 WLY-01 series products are suitable for testing insoluble particles such as various intravenous injections and packaging materials. The main products include microscope host, electric platform, analysis software, computer, etc. The supporting consumables include filter device, blank source membrane, grid filter membrane, raw silver, dust removal brush, drying system, suction filter pump, and dust-free petri dish. wait.

Implementation standards

United States Pharmacopeia USP787, USP788, USP789;

European Pharmacopoeia EP6.0, EP7.0, EP7.8, EP8.0;

British Pharmacopoeia BP2013, BP2012, 201. , 2009;

Japanese Pharmacopoeia JP16, JP15, JP14;

Chinese Pharmacopoeia Cp0903, etc.

Test process

1) Sample filtration: Place a clean 25mm filter membrane on the appropriate filter, so that all samples pass through the warm membrane.

2) Drying the filter membrane: Place the filtered membrane in a clean petri dish with a dust-free inlay, and use a Dry Bath to select an appropriate temperature for drying.

3) Scanning membrane: The dried filter membrane is placed under the microscope objective and the entire membrane is scanned.

4) Data analysis: Perform data analysis on all scanned film images, and finally get a report.

Applications

As shown in the figure below, the red injection solution is filtered using a filtration device. After filtration, the filter membrane is dried, and then the dried filter membrane is placed on a fully automatic scanning microscope platform, and a 10x objective lens is used to scan the entire filter membrane. The software Analyze the scanned filter membrane, and finally issue a data report according to the test requirements.

configuration list

machine X1, manual X1, certificate X1, warranty card X1

[Note] Because the manufacturer's packaging may be updated or upgraded, the detailed packaging list shall be subject to the latest standard configuration of the manufacturer.