| Materials of Construction |
| Filter Material | Cellulose/Inorganic filter aid/Mixed cellulose esters |
| Device Material | Polypropylene |
| Filter Grade |
| LA1H CG6 S2 | 60DE/75DE/RW01 |
| LB1H CG6 S2 | 50DE/75DE/RW01 |
| LA1H CG6 S2 | 30DE/60DE |
| Stack Design | 16 in. diameter, 8-cell |
| Filtration Area, m2 | 1.8 |
| Max Differential Pressure, bar (psid) | 2.1 (30) @ 25 °C; 1 (15) @ 80 °C; 0.2 (3) @ 123 °C |
| Bacterial Endotoxins | <0.25 EU/mL as determined by the LAL test |
| Oxidizable Substances | The effluent of an autoclaved (1 cycle of 30 min @ 123 °C) stacked device meets the requirements for USP sterile water for injection after a WFI flush of 100 L/m2 of media surface area |
| Gravimetric Extractables | Post autoclave (1 cycle of 30 minutes at 123 °C) and pure water flush of 100 L/m2 (10 L/ft2) of media surface area.
NVR: 1.50 – 2.02 mg/m2
TOC: 416– 593 ppb |
| Sterilization | 3 SIP cycles of 30 min @ 123 °C |
| Sanitization | 20 cycles of 30 min with hot water @ 80 °C |
| Conductivity | 5.3 – 6.4µS/cm after a pure water (Type I DI Water) flush of 100L/m2 (10L/ft2) of media surface area per autoclaved 16 |
| 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. |
