Materials of Construction

Membrane

Hydrophobic PVDF

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, 1.0, 3.0, 5.0

Maximum Differential Pressure

Forward: 4.2 bar @ 23 °C; 1.5 bar @ 85 °C

Flow Rate & Pressure Drop, per 10-inch cartridge

0.1 μm

≥ 5 L/min at 210 mbar

0.22 μm

≥ 6.2 L/min at 210 mbar

0.45 μm

≥ 7 L/min at 210 mbar

Bacterial Retention (for 0.1 and 0.22 μm only)

Passed the bacterial challenge testing using Brevundimonas diminuta(ATCC19146) at a minimum challenge concentration of 1 x 105 CFU/cm2.

Extractables, per 10-inch cartridge

≤ 50 mg after 24-h soak in water

Effluent Particle Level

Meets the requirements of Chinese Pharmacopoeia 2010, Volume 2,appendix 4 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

15 steam-in-place sterilization or autoclave cycles of 30 min at 123°C

Oxidizable Substances

Meets the criteria of Chinese Pharmacopoeia 2010, volume 2 for purified water.

Bacterial Endotoxins

< 0.25 EU/ml as determined by the LAL test

Good Manufacturing Practices

Manufactured in an ANOW facility which adheres to Good Manufacturing Practices.