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Email ：PharmaSources@imsinoexpo.com
Whatsapp ：+86-13621645194
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Sample Provided: no
Imported double-layer PES filter membrane is adopted in the product as filter media. The product is produced by overall structure sweat welding. It has excellent filtration performance and ability of completely intercepting bacteria. Features:
●The filter membrane is hydrophilic with absolute filtration accuracy;
● Low protein adsorption performance;
● Wide chemical compatibility;
● Extremely low precipitates;
● High strength design;
Typical applications:
● Sterile filtration of vaccine;
●Sterile filtration of blood products;
● Sterile filtration of raw material medicine, injections, infusion and other drugs;
● Filter elements are flushed and pass integrity test before filter elements are left from the factory;
● The batch passes through bacterial challenge test for confirming 100% bacteria interception ability;
Biological safety:
Biological Safety: The product materials comply with USP in-vivo VI-121 ℃ plastic biological response test.
Endotoxin: <0.25EU/ml;
Cleanliness: The product is in line with 2010 GMP requirements on injection of particles;
Readily oxidizable substance: the substance should be in line with 2010 GMP test requirements of particle contents in injections after water rinsing for 2000ml;
TOC/conductivity: after the product is flushed with 20L injection water at 25 ℃ (10〃) . It is in line with requirements of 2010 GMP on total organic carbon contents and conductivity in injection water.
Five years of qualification
Audited Supplier
Pharma Sources Insight June 2024: Globalization on the Go
