| Per 10-inch Cartridge |
| Materials of Construction |
| Filter medium | Polypropylene |
| Structural components | Polypropylene |
| O-rings | Silicone |
| Code F gaskets | Polyethylene |
| Maximum Differential Pressure, bar (psid) | 4.8 (70) @ 25 °C |
| Gravimetric Extractables | ≤50 mg after 24-h soak in water |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤5 L |
| Bacterial Endotoxins | <0.5 EU/mL as determined by the LAL test |
| Sterilization |
| Code 0, Code 5, Code 7, Code M | 10 autoclave cycles or SIP @ 126 °C for 30 min |
| Code F | 10 autoclave cycles or SIP @ 126 °C for 30 min |
| Sanitization | 30 min with hot water @ 80 °C |
| 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. |