Materials of Construction |
Membrane | Double Layer Hydrophilic PES |
Support | PP |
Core, Cage and Drainage | PP |
End Caps | PP (222/226 with encapsulated stainless steel reinforcing ring) |
O-rings/Gasket | Silicone/EPDM/Viton |
Sealing technology | Thermal Bonding, No Adhesives |
Dimensions |
Diameter | Φ70 |
Length | 5 inch, 10 inch, 20 inch, 30 inch |
Filtration Area, ft2 |
≥ 4.9 per 10-inch cartridge |
Pore Size, μm |
0.45+0.22 |
Maximum Differential Pressure |
Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85 ℃ |
Integrity Test at 23 ℃ |
Water bubble point | ≥ 3500 mbar (50 psig) |
Diffusive flow | ≤ 30ml/min/10”@2.8bar |
Bacterial Retention |
Passed the bacterial challenge testing using Brevundimonas diminuta (ATCC19146) at a minimum challenge concentration of 1 x 107 CFU/cm2. |
Extractables, per 10-inch cartridge |
≤ 10 mg after 24-h soak in water |
Effluent Particle Level |
Meets the requirements of Chinese Pharmacopoeia 2010, Volume Ⅱ, appendix Ⅸ C. |
Non-Fiber Releasing |
Meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). |
Toxicity |
Component materials meet GB/T 14233.2<2005>of Chinese National Standard for Safety Tests. |
TOC |
< 500 ppb after a water flush of 60 liters per 10-inch cartridge |
Multiple Sterilization Cycles |
40 steam-in-place sterilization or autoclave cycles of 30 min at 123℃ |
Oxidizable Substances |
Meets the criteria of Chinese Pharmacopoeia 2010, volume Ⅱ for purified water. |
Bacterial Endotoxins |
< 0.25 EU/ml as determined by the LAL test |
