Specifications
Suzhou factory Hydrophilic PES pleated filter catridge1.imported PES filter membrane
2.high intercepting bacteria
Suzhou factory Hydrophilic PES pleated filter catridge
Imported doublelayer 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.
1.The filter membrane is hydrophilic with absolute filtration accuracy
2.Low protein adsorption performance
3.Wide chemical compatibility
4.Extremely low precipitates
5.High strength design
1.Sterile filtration of vaccine
2.Sterile filtration of blood products
3.Sterile filtration of raw material medicine, injections, infusion and other drugs
4.Filtration of cell culture medium
Filter element material composition:
| filter memebrane | PES filter membrane |
| diversion material | polyproplene(PP) |
| outer shell | polyproplene(PP) |
| seal ring | please see filter element modle selection table |
| center rod | polyproplene or 316L stainless steel |
Intergrity test:
| aperture(um) | 0.1 | 0.2 | 0.45 | 0.65 |
| the lowest bubbling point in pure water(MPa) | ≥0.48 | ≥0.34 | ≥0.25 | ≥0.16 |
Water flow capacity-pressure difference curve(10'' filter element)
Main application technical indicators:
| maximum operating temperature | 85°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.