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| Materials of Construction |
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| | 1/4 in. hose barb with double O-ring seal |
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| Maximum Inlet Pressure, bar (psid) |
| | 5.5 (80) @ 25 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C |
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| Maximum Differential Pressure, bar (psid) |
| | Forward - 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C; Reverse - 3.5 (50) @ 25 °C, intermittent |
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| Integrity Test, Bubble Point |
| | ≥3450 mbar (50 psig) air with water |
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| Integrity Test, Air Diffusion |
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| | ≤13.3 mL/min @ 2.8 bar (40 psig) in water |
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| | ≤10.8 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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| | <0.5 EU/mL as determined by the LAL test |
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| NVR Gravimetric Extractables |
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| | ≤50 mg after 24-h soak in water |
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| | ≤75 mg after 24-h soak in water |
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| | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤5 L |
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| | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable |
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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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| | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177182. |
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| European Pressure Equipment Directive |
| | Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Equipment Directive, this product does not bear the CE mark. |
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