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Specifications
Efficient PTFE filter catridge1.imported efficient PTFE filter membrane
2.overall structure sweat welding
Efficient PTFE filter catridge
Imported efficient PTFE filter membrane is adopted in the product as filter media. The product is produced by overall structure sweat welding. It has absolute filtration aperture, which belongs to ideal substitute of similar imported filter element.
1.The filter membrane has strong hydrophobicity
2.Absolute filtration precision, 0.2um in liquid (0.01um in gas)
3.Reliable interception effect
4. Excellent heat resistance
5.Low pressure drop and high flow rate
6.Integrity test by water inversion method
1.Sterile filtration of air in fermentation tank
2.Sterile filtration of gas for production in pharmaceutical industry
3.Filtration of high purity gas in electronics industry
4.Filtration of organic solvents
Filter element material composition:
| filter memebrane | Hydrophilic PTFE filter membrane |
| diversion material | polypropylene(PP) |
| outer shell | enhanced polypropylene(PP) |
| seal ring | please see filter element modle selection table |
| center rod | polypropylene or 316L stainless steel |
Intergrity test:
| aperture(um) | 0.2 | 0.45 |
| the lowest bubbling point in pure water(MPa) | ≥0.08 | ≥0.05 |
Gass flow-pressure different curve(10'' filter element)
Main application technical indicators:
| maximum operating temperature | 90°c/0.1MPa |
| maximum operating pressure difference | 0.42MPa/25°c |
| recommended operating pressure difference | 0.1~0.2MPa/25°c |
| maximum back-pressure difference | 0.2MPa/25°c |
| effective filtration are(10 inches) | ≥0.6m² |
| forward online steam sterilization(135°c) | 30min/time |
| disinfection by disinfection cabinet(121°c) | 30min/time |
Quality assurance:
1.ISO9001: 2008 guaranteed quality management system
2.Traceability management system of each filter
3.Filter elements are flushed and pass integrity test before filter elements are left from the factory
4.The batch passes through bacterial challenge test for confirming 100% bacteria interception ability
Biological safety:
1.Biological Safety: The product materials comply with USP in-vivo VI-121 ℃ plastic biological response test
2.Endotoxin: <0.25EU/ml
3.Cleanliness: The product is in line with 2010 GMP requirements on injection of particles
4.Readily oxidizable substance: the substance should be in line with 2010 GMP test requirements of particle contents in injections after water rinsing for 2000ml
5.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.
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