| per 10-inch Cartridge |
| Materials of Construction |
| Filter Membrane | Hydrophobic PTFE |
| Structural Components | Polypropylene |
| Filter Supports | Polypropylene |
| O-rings | Silicone |
| Filter Pore Size, µm | 0.2 |
| Filtration Area, m2 | 0.65 |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 (100) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 145 °C. Reverse: 5.2 (75) @ 25 °C, intermittent |
| Integrity Testing |
| Bubble Point at 23 °C | ≥900 mbar (13 psig) nitrogen with 60//40 % IPA/water |
| Air Diffusion at 23 °C | ≤15 mL/min @ 690 mbar (10 psig) in 60//40 % IPA/water |
| HydroCorr Test | ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig) |
| Viral Retention | Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge. |
| Bacterial Aerosol Growth | Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 107 CFU/cm2. |
| Sterilization | 208 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to `65 hours in forward direction @ 145 °C |
| 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. |
| Certificate of Quality | Each cartridge is shipped with a Certificate of Quality which summarizes our stringent manufacturing and quality standards. |