| | | 10 in. Disposable Capsules |
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| Materials of Construction |
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| | |
| | Polyester; film edge HDPE |
| | Polyester; film edge HDPE |
|
| | Gamma-stable Polypropylene |
| | Gamma-stable Polypropylene |
|
| | |
| Maximum Inlet Pressure, bar (psid) |
| | 5.5 (80) @ 25 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C |
|
| | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology |
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| | <0.5 EU/mL as determined by the LAL test |
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| NVR Gravimetric Extractables |
| | ≤10 mg after 24-h soak in water |
| | ≤25 mg after 24-h soak in water |
|
| | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL |
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| | Component materials meet the requirements of the USP Class VI Biological Test for Plastics. The cartridges also meet the requirements of the USP General (Mouse) Safety Test. |
|
| | Shipped sterile by gamma radiation @ >25 kGray |
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| Integrity Test - 0.22 µm Units |
|
| | ≥3450 mbar (50 psig) air with water |
| | ≥3450 mbar (50 psig) air with water |
|
| | | ≤14 mL/min @ 2.8 bar (40 psig) in water |
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| Integrity Test - 0.1 µm Units |
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| | ≥4830 mbar (70 psig) air with water |
| | ≥4830 mbar (70 psig) air with water |
|
| | | ≤21.1 mL/min @ 3.9 bar (56 psig) in water |
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