| 5-inch Cartridge Filter | Per 10-inch Cartridge Filter |
| Filtration Area, m2 | 0.29 | 0.54 |
| Materials of Construction |
| Filter membrane | Hydrophilic Polyethersulfone | Hydrophilic Polyethersulfone |
| Film Edge | Polypropylene | Polypropylene |
| Membrane Supports | Polypropylene | Polypropylene |
| Structural Components | Polypropylene/Polysulfone | Polypropylene/Polysulfone |
| O-rings | Silicone or EPDM or Fluorocarbon rubber | Silicone or EPDM or Fluorocarbon rubber |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 (100) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C. Reverse: 2.07 (30) @ 25 °C; 0.07 (1) @ 135 °C |
| Integrity Test |
| Bubble Point at 23 °C | ≥4000 mbar (58 psig) air with water | ≥4000 mbar (58 psig) air with water |
| Air Diffusion at 23 °C | ≤16.4 mL/min @ 2.75 bar (40 psig) in water | ≤30 mL/min @ 2.75 bar (40 psig) in water |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. |
| Bacterial Endotoxins | <0.25 EU/mL as determined by the LAL test | <0.25 EU/mL as determined by the LAL test |
| TOC/Conductivity | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 5.5 L at 25 °C. | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 10 L at 25 °C. |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤1 L |
| Sterilization | 25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 autoclave cycles of 60 min @ 126 °C |
| Particle Shedding | Passes USP test for particulates in injectables. |
| USP Toxicity | Non-toxic per MEM elution ISO® 10993-5 |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| 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. |
| 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. |