| Per 10-inch Cartridge Filter |
| Filtration Area, m2 | 0.65 |
| Materials of Construction |
| Filter media | Hydrophobic PTFE |
| Supports | Polypropylene |
| Structural Components | Polypropylene |
| O-rings | Silicone |
| Outer support ring | Stainless steel |
| Integrity Test |
| Bubble Point | ≥1100 mbar (16 psig) nitrogen with 70//30 % IPA/water |
| Diffusion | ≤24 mL/min @ 965 mbar (14 psig) in 70//30 % IPA/water |
| HydroCorr Test | ≤0.75 mL/min @ 2.6 bar (38 psig) |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C. Reverse: 4.1 (60), intermittent |
| NVR Gravimetric Extractables | ≤35 mg in 70//30 % IPA/water |
| Bacterial Endotoxins | Aqueous extraction contains <0.5 EU/mL as determined by the LAL test |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. |
| Sterilization | 150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °C |
| Toxicity | Non-toxic per MEM elution ISO® 10993-5 |
| 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). |
| 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. |