| Per 10-inch Cartridge |
| Filtration Area, m2 |
| Single Layer | 0.8 |
| Double Layer | 0.69 |
| Materials of Construction |
| Filter Material | Mixed Cellulose Esters |
| Support Material | Polyester |
| Device Material | Polypropylene |
| Seal Material | Silicone |
| Maximum Differential Pressure, bar (psid) | 3.5 (50) @ 25 °C |
| Gravimetric Extractables |
| Standard Milligard Media | ≤50 mg after 24-h soak in water |
| Low Protein Binding Milligard Media 0.2 µm | ≤100 mg after 24-h soak in water |
| Low Protein Binding Milligard Media 0.5 µm | ≤105 mg after 24-h soak in water |
| Low Protein Binding Milligard Media 1.2 µm | ≤250 mg after 24-h soak in water |
| Low Protein Binding Milligard Media 0.5/0.2 µm | ≤350 mg after 24-h soak in water |
| Low Protein Binding Milligard Media 1.2/0.5 µm | ≤200 mg after 24-h soak in water |
| Bacterial Endotoxins | <0.5 EU/mL as determined by the LAL test |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤5 L |
| Sterilization | 10 autoclave cycles or SIP @ 121 °C for 30 min |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| Non-fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. |