| Per 10-inch cartridge |
| Materials of Construction |
| Filter Membrane | Hydrophobic PVDF |
| Structural Components | Polypropylene |
| Filter Supports | Polypropylene |
| O-rings | Silicone |
| Filter Pore Size, µm | 0.55 |
| Filtration Area, m2 | 0.75 |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 121 °C. Reverse: 3.5 (50) @ 25 °C, intermittent; 0.35 (5) @ 121 °C |
| Maximum Operating Temperature, °C | 80 |
| Integrity Testing |
| Bubble Point at 23 °C | ≥965 mbar (14 psig) air with water |
| Air Diffusion at 23 °C | ≤7.5 mL/min @ 830 mbar (12 psig) in water |
| Typical Water Flow Rate, L/min at 23 °C | 20 @ 330 mbar ΔP |
| Bacterial Retention | Microbial titer reduction >1011 CFU/cartridge when challenged with Saccharomyces cerevisae; >107 CFU/cartridge with Pediococcus damnosus; >106 CFU/cartridge with Lactobacillus brevis |
| Cleaning | Filter may be regenerated by the use of NaOH, up to 2% for up to 30 minutes, 25 times at 65 °C |
| Sterilization | 100 SIP cycles of 30 min @ 109 °C; hot water sanitized 50 times for 30 min @ 80 °C maximum |
| Cleanliness | Cartridge effluent meets the requirements for USP sterile water after a water flush of 1 L per 10-inch autoclaved cartridge |
| 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). |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
