Industry
Pharma / Biotech
Bacterial Retention
Quantitative Retention of 1 × E7 CFU/cm²
Bacterial Endotoxins
< 0.25 EU/mL as determined by the LAL test
Extractables
The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connector Inlet
2-Flange Bayonet Adapter with 226 Double O-ring (25)
Connector Outlet
Filter Size
10"(0.75 m² / 8.1 ft²)
Filtration Area
0.75 m²
Capsule/Cartridge Format
Cartridges
Maximum Diffusion
11 mL/min at 0.7 bar
Minimum Required Bubble Point
1.0 bar | 14.5 psi
Housing Material
Polypropylene (PP)
Material o-ring | seal
Silicone (SI)
Support Fleece
Maximum Differential Pressure
20 °C: 5 bar; 80 °C: 2 bar
Non-Fiber Releasing
This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
Pore Size Final-filter
0.2 µm
Brand
Sortopore
Sterilization Method
In-Line Steam Sterilizable
Sterilization Procedures
In-Line Steam Sterilization: Min. 150 cycles at 134 °C, 20 min. at max differential pressure of 0.5 bar | 7 psi