| | | Per 10-inch Cartridge Filter |
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| Materials of Construction |
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| | ≥1100 mbar (16 psig) with 70//30 % IPA/water |
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| | ≤24 mL/min @ 965 mbar (14 psig) in 70//30 % IPA/water |
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| | ≤0.75 mL/min @ 2.6 bar (38 psig) |
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| Maximum Differential Pressure, bar (psid) |
| | Forward - 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; Reverse - 4.1 (60), intermittent |
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| NVR Gravimetric Extractables |
| | ≤35 mg in 70//30 % IPA/water |
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| Aqueous extraction contains <0.5 EU/mL as determined by the LAL test
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| | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. |
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| | 150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °C |
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| | 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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| | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
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| | Rated for aerosol retention of a total challenge of 1081010 plaque forming units of FX174 virus particles at 85 Nm3/h (50 SCFM) per cartridge. |
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| | Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 107 CFU/cm2. |
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