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产品简介
| Description | |
|---|---|
| Catalogue Number | MPGL04GK2 |
| Description | Millipak® 40 Gamma Gold Filter |
| Overview | Sterile unit. Delivered hermetically sealed, with its Certificate of Quality |
| Product Information | |
|---|---|
| Device Configuration | Gamma Gold Capsule |
| Maximum Differential Pressure, bar (psid) | Forward: 4.1 bar @ 25 °C; 1.7 bar @ 80 °C; 0.35 bar @ 123 °C; Reverse: 0.7 bar @ 25 °C |
| Maximum Inlet Pressure, bar (psi) | 5.2 bar @ 25 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Applications | |
|---|---|
| Application | Sterile 0.22 µm membrane filter for particulate-free and bacteria-free water at the point of dispense |
| Biological Information | |
|---|---|
| Media | Durapore® |
| Sterility | Sterile |
| 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 | NPTM |
| Outlet Connection | Stepped Hose Barb with Bell |
| Gravimetric Extractables | The extractables level was equal to or less than 1.5 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 | |
|---|---|
| Inlet Connection Diameter | 1/4 in. |
| Outlet Connection Diameter | 1/4 in. |
| Materials Information | |
|---|---|
| Chemistry |
|
| Device Material |
|
| Packaging Information | |
|---|---|
| Material Size | 2 |
