Materials of Construction

Membrane

Hydrophilic Nylon66

Support

PP

Core, Cage and Drainage

PP

End Caps

PP (222/226 with encapsulated stainless steel reinforcing ring)

O-rings/Gasket

Viton/Silicone/EPDM/ TEV

Sealing Technology

Thermal Bonding, No Adhesives

Dimensions

Diameter

Φ68

Length

5 inch, 10 inch, 20 inch, 30 inch, 40 inch

Filtration Area, ft2

≥ 6.4 per 10-inch element

Pore Size, μm       

0.1, 0.22, 0.45, 0.65, 1.0, 3.0, 5.0

Maximum Differential Pressure

Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85 ℃

Flow Rate & Pressure Drop, per 10-inch cartridge

0.1 μm

≥ 5 L/min at 210 mbar

0.22 μm

≥ 7 L/min at 210 mbar

0.45 μm

≥ 15 L/min at 210 mbar

Particle Removal Efficiency (%)

> 99.9

Extractables, per 10-inch cartridge

≤ 50 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).

TOC

< 500 ppb after a water flush of 60 liters per 10-inch cartridge

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