millipore,
密理博,MPGL1GCL3,Sterile Millipak-100 Filter Unit 0.22 µm 1-1/2 in. TC/TC
重要规格表
| Description
|
| Catalogue Number | MPGL1GCL3 |
| Trade Name |
|
| Description | Sterile Millipak®-100 Filter Unit 0.22 µm 1-1/2 in. TC/TC |
| Product Information
|
| Device Configuration | Gamma Gold Capsule |
| Connections, Inlet/Outlet | 38 mm (1-1/2 in.) Sanitary Flange |
| Maximum Differential Pressure, bar (psid) | Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C |
| Maximum Inlet Pressure, bar (psi) | 5.2 bar (75 psi) @ 25 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Quality Level | MQ400
|
| Biological Information
|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Durapore® |
| Sterility | Sterile |
| Sterilization | 3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable |
| 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 | 0.22 µm |
| Inlet Connection | Sanitary Flange |
| Outlet Connection | Sanitary Flange |
| Bubble Point at 23 °C | ≥3450 mbar (50 psig) air with water |
| Flow Rate | 11 L/min @ 2.8 bar ΔP |
| Gravimetric Extractables | The extractables level was equal to or less than 2.5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature. |
| Non-Fiber Releasing | This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). |
| USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| Dimensions
|
| Filtration Area | 500 cm² |
| Process Volume | 50 L |
| Inlet Connection Diameter | 1-1/2 in. |
| Outlet Connection Diameter | 1-1/2 in. |
| Materials Information
|
| Chemistry |
- Polyvinylidene Fluoride (PVDF)
|
| Device Material |
|
| Support Material | Polycarbonate |
| Vent Cap Material | Polyvinylidene fluoride (PVDF) |
| Packaging Information
|
| Material Size | 3 |
| Material Package | Blister |
| Specifications
|
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL |
