| Per 10-inch Cartridge Filter |
| Materials of Construction |
| Filter Media | Borosilicate Glass Fiber |
| Supports | Polypropylene |
| Structural Components | Polypropylene |
| O-rings | Silicone |
| Filtration Area, m2 | 0.46 |
| Maximum Differential Pressure, bar (psid) | 3.5 (50) @ 25 °C |
| Bacterial Endotoxins | <1 EU/mL as determined by the LAL test |
| Gravimetric Extractables | ≤250 mg after 24-h soak in water and 5 L flush |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of 5 L |
| 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. |
| Sterilization | 10 autoclave cycles or SIP @ 121 °C for 30 min |
| Sanitization | 30 min with hot water @ 80 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. |