| | | | Per 10-inch Cartridge Filter |
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| | |
| Materials of Construction |
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| | Hydrophilic polyethersulfone |
| | Hydrophilic polyethersulfone |
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| | |
| | Polypropylene/Polysulfone |
| | Polypropylene/Polysulfone |
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| Silicone or EPDM or Fluoroelastomer
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| Silicone or EPDM or Fluoroelastomer
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| Maximum Differential Pressure, bar (psid) |
| | Forward - 7 (100) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C; Reverse - 2.07 (30) @ 25 °C; 0.07 (1) @ 135 °C |
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| | ≥4000 mbar (58 psig) air with water |
| | ≥4000 mbar (58 psig) air with water |
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| | ≤13.3 mL/min @ 2.8 bar (40 psig) in water |
| | ≤28.2 mL/min @ 2.8 bar (40 psig) in water |
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| | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. |
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| | <0.25 EU/mL as determined by the LAL test |
| | <0.25 EU/mL as determined by the LAL test |
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| Autoclaved cartridges meet the WFI requirements of USP (643) for Total Organic Carbon and USP (645) for Water Conductivity after a WFI water flush of 9.5 L at 25 °C.
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| Autoclaved cartridges meet the WFI requirements of USP (643) for Total Organic Carbon and USP (645) for Water Conductivity after a WFI water flush of 20 L at 25 °C.
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| | 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 ≤2 L |
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| | 25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 autoclave cycles of 60 min @ 126 °C |
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| | Passes USP test for particulates in injectables. |
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| | Non-toxic per MEM elution ISO® 10993-5 |
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| | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
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| 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. |
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| Good Manufacturing Practices |
| | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
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| | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177182. |
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