| Opticap XLT10 | Opticap XLT20 | Opticap XLT30 |
| Filtration Area, m2 | 0.54 | 1.09 | 1.63 |
| Materials of Construction |
| Filter | Hydrophilic Polyethersulfone | Hydrophilic Polyethersulfone | Hydrophilic Polyethersulfone |
| Film Edge | Polyethylene | Polyethylene | Polyethylene |
| Supports | Polyester | Polyester | Polyester |
| Structural Components | Polypropylene/Polysulfone | Polypropylene/Polysulfone | Polypropylene/Polysulfone |
| Vent O-ring | Silicone | Silicone | Silicone |
| Vent/Drain | 1/4 in. Hose Barb with double O-ring seal |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent |
| Bubble Point | ≥4000 mbar (58 psig) air with water |
| Air Diffusion | ≤31.2 mL/min @ 2.75 bar (40 psig) in water | ≤62.5 mL/min @ 2.75 bar (40 psig) in water | ≤93.7 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 |
| TOC/Conductivity 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: 21 liters | 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: 42 liters | 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: 63 liters |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤4 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤6 L |
| Sterilization |
| Gamma compatible capsules | Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable |
| Sterile capsules | 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable |
| Sterility | Sterile |
| 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. |
| USP Toxicity | Non-toxic per MEM elution ISO® 10993-5 |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| Particle Shedding | Passes USP test for particulates in injectables. |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. |