| Materials of Construction |
| Structural Components | Polycarbonate |
| Filter Support | Polypropylene |
| Seal Ring | Viton® fluoroelastomers |
| Vent Cap | PVDF |
| Filter Material |
| Durapore | Hydrophilic PVDF |
| Milligard | Mixed Cellulose Esters |
| Polysep II | Borosilicate Glass Fiber Mixed Cellulose Esters |
| Lifegard | Borosilicate Glass Fiber |
| Polygard | Polypropylene |
| Filtration Area, cm2 | 17.7 |
| Maximum Operating Pressure, bar (psid) | 5.5 (80) @ 25 °C |
| Bacterial Endotoxins | <0.25 EU/mL as determined by the LAL test |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤100 mL |
| 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 |
| OptiScale with Durapore or Polygard-CN media | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable |
| OptiScale with Milligard, Polysep II or Lifegard media | 3 autoclave cycles of 60 min @ 121 °C; not in-line steam sterilizable |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. |