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| Materials of Construction |
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| | Hydrophilic polyethersulfone |
| | Hydrophilic polyethersulfone |
| | Hydrophilic polyethersulfone |
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| | Polypropylene/Polysulfone |
| | Polypropylene/Polysulfone |
| | Polypropylene/Polysulfone |
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| | 1/4 in. Hose Barb with double O-ring seal |
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| 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 |
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| | ≥4000 mbar (58 psig) air with water |
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| | ≤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 |
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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 |
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| 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 at 25 °C
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| 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 at 25 °C
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| 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 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 ≤4 L |
| | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤6 L |
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| Gamma compatible capsules |
| | Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable |
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| | 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable |
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| | Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle |
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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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| | Non-toxic per MEM elution ISO® 10993-5 |
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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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| | Passes USP test for particulates in injectables |
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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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| | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177182. |
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