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| Description | |
|---|---|
| Catalogue Number | MPGL04GK2 |
| Description | Millipak® 40 Gamma Gold Filter |
| Overview | Sterile unit. Delivered hermetically sealed, with its Certificate of Quality |
| References |
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| 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 10⁷CFU/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 1.5mg per sterilized device after a 200mL flush and 24hours 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 21CFR210.3(b)(6). |
| USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.5EU/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 |
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| Device Material |
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| Packaging Information | |
|---|---|
| Material Size | 2 |
