Membrane

Hydrophobic Polytetrafluoroethylene Membrane (PTFE)

Support

PP

Color

White

Filter Surface

Plain

Thickness, μm

150~250

Diameter

Φ47, Φ60, Φ90, Φ142, Φ150, Φ200, Φ250, Φ293, Φ300

Pore Size, μm

0.01(for air), 0.05, 0.1, 0.22, 0.45, 1.0, 3.0, 5.0, 10

Maximum Operating Pressure

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

Liquid

≥ 6 mL/min/cm²at 1 bar

≥ 30 mL/min/cm²at 1 bar

Integrity Test-60% IPA/water bubble point at 23 °C

0.22 μm

≥ 1000 mbar

0.45 μm

≥ 600 mbar

Bacterial Retention

Passed the bacterial challenge testing usingBrevundimonas diminuta(ATCC19146)(0.22 μm) /Serratia marcescens(ATCC14041)(0.45 μm) at a minimum challenge concentration of 1 x 10⁷CFU/cm².

Extractables

< 0.5%

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).

Biological Safety

Component materials meet the requirements of USP <88> Biological Reactivity Tests for Class VI Plastics.

TOC

< 500 ppb

Sterilization

By autoclave at 123°C or EO

Oxidizable Substances

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

Bacterial Endotoxins

< 0.5 EU/ml as determined by the LAL test

Good Manufacturing Practices

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