重要规格表
| Description
|
| Catalogue Number | CHVE01TF3 |
| Trade Name |
|
| Description | millipore Express® SHR Cartridge Filter 10 in. 0.5/0.1 µm Code 0 Fluorocarbon |
| Product Information
|
| Device Configuration | Cartridge |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C. Reverse: 2.07 bar (30 psi) @ 25 °C; 0.07 bar (1 psi) @ 135 °C |
| Cartridge Code | Code 0 (2-222) O-rings |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Quality Level | MQ400
|
| Applications
|
| Key Applications |
|
| Biological Information
|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | millipore Express® SHR w/Prefilter |
| Sterilization | 25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C, or 3 forward cycles, 30 min., 135 °C at ≤ 1000 mbar (15 psid); 25 autoclave cycles of 60 min @ 126 °C |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. |
| Wettability | Hydrophilic |
| Physicochemical Information
|
| Pore Size | 0.5 / 0.1 µm |
| Air Diffusion at 23 °C | ≤27.1 mL/min @ 3.45 bar (50 psig) in water |
| Bubble Point at 23 °C | ≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/water |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. |
| Maximum Differential Pressure | Forward:
100 psi (6.9 bar) at 25 °C
25 psi (1.7 bar) at 80 °C
15 psi (1.0 bar) at 135 °C
Reverse:
30 psi (2.1 bar) at 25 °C
<1.0 psi (69 mbar) at 135 °C |
| Non-Fiber Releasing | This product was manufactured with a millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). |
| TOC/Conductivity | After sterilization and a controlled water flush of 20 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C. |
| USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| Dimensions
|
| Cartridge Nominal Length | 10 in. (25 cm) |
| Diameter | 6.9 cm (2.7 in.) |
| Filtration Area | 0.49 m² |
| Device Size | 10 in. |
| Materials Information
|
| Chemistry |
|
| Device Material |
- Polypropylene/Polysulfone
|
| Seal Material | Fluorocarbon rubber |
| Support Material | Polypropylene |
| Packaging Information
|
| Material Size | 3 |
| Material Package | Double Easy-Open bag |
| Specifications
|
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L |
