Materials of Construction

Membrane

Hydrophilic PVDF

Support Material

polypropylene

End Caps

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

Core, Cage and End Caps

polyester

O-Rings

Silicone/EPDM/Viton

Sealing technology

Thermal Bonding

Diameter

2.7 inches (6.8 cm)

Length

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

Typical Effective Filtration Area, ft2,≥5.8 ft2 (0.54 m2) per 10 inch

Nominal Pore Size(μm):0.1 and 0.65

Maximum Pressure

Forward: 4 bar at 23 °C; 2.4 bar at 70 °C

Flow Rate & Pressure Drop, per 10-inch cartridge

0.1 μm

≥ 5 L/min at 0.2bar

0.22 μm

≥ 6.5 L/min at 0.2 bar

0.45 μm

≥ 8 L/min at 0.2bar

0.65 μm

≥ 10 L/min at 0.2 bar

Bacterial Retention

for more information, please contact us

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).

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

20 (B type support) / 15 (N type support) steam-in-place sterilization or autoclave cycles of 30 min at 121°C

Oxidizable Substances: filtrate meets USP XXII requirements for purified water with <1 L flush after autoclaving

Endotoxins Level:< 0.25 EU/ml as determined by the LAL test

Good Manufacturing Practices

Manufactured in HONGSHUN facility which adheres to Good Manufacturing Practices.