| per 10-inch Cartridge |
| Materials of Construction |
| Filter Membrane | Hydrophilic PVDF |
| Prefilter (Vitipore II Plus only) | Mixed cellulose esters |
| Structural Components | Polypropylene |
| Filter Supports | Polypropylene |
| O-rings | Silicone |
| Filtration Area, m2 | 0.78 |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C. Reverse: 3.5 (50) @ 25 °C, intermittent |
| Maximum Operating Temperature, °C | 80 |
| Bubble Point at 23 °C |
| CVBW | ≥3100 mbar (45 psig) air with water |
| CVBB, CVPB | ≥1930 mbar (28 psig) air with water |
| CVBY, CVPY | ≥965 mbar (14 psig) air with water |
| CVBA | ≥620 mbar (9 psig) air with water |
| Air Diffusion at 23 °C |
| CVBW | ≤15.2 mL/min @ 2.75 bar (40 psig) in water |
| CVBB, CVPB | ≤17.1 mL/min @ 1.5 bar (22 psig) in water |
| CVBY, CVPY | ≤9.1 mL/min @ 620 mbar (9 psig) in water |
| CVBA | ≤6.3 mL/min @ 480 mbar (7 psig) in water |
| Cleanliness | Cartridge effluent meets the requirements for USP sterile water after a water flush of 1 L per 10-inch autoclaved cartridge |
| Sterilization | 100 SIP cycles of 30 min @ 109 °C; hot water sanitized 30 times for 30 min @ 80 °C maximum |
| 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). |
| 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. |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. |
