Membrane

Hydrophobic Polyvinylidene (PVDF)

Color

White

Filter Surface

Plain

Thickness, μm

90~100

Pore Size, μm

0.1, 0.22, 0.45, 1.0, 3.0, 5.0

Absorption, 0.22 μm

8 μg/cm2 γ-globulin

Maximum Operating Pressure

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

Flow Rate

0.22 μm

≥ 3 mL/min/cm2 at 1 bar

0.45 μm

≥ 7 mL/min/cm2 at 1 bar

Bacterial Retention

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

Toxicity

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.