Pore Size | 0.45 µm |
Air Diffusion at 23 °C | ≤30 mL/min @ 1.5 bar (22 psig) in water |
Bubble Point at 23 °C | ≥1930 mbar (28 psig) air with water |
Gravimetric Extractables | The extractables level was equal to or less than 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. |
Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food. |
Non-Fiber Releasing | This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). |
USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |