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| Description | |
|---|---|
| Catalogue Number | MPGL1GCA3 |
| Trade Name |
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| Description | Sterile Millipak®-100 Filter Unit 0.22µm 9/16in. HB/HB |
| Product Information | |
|---|---|
| Device Configuration | Gamma Gold Capsule |
| Connections, Inlet/Outlet | 14mm (9/16in.) Hose Barb |
| 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. |
| Biological Information | |
|---|---|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Durapore® |
| Sterility | Sterile |
| Sterilization | 3 autoclave cycles of 90min @ 123°C; not in-line steam sterilizable |
| 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 | Hose Barb |
| Outlet Connection | Hose Barb |
| Bubble Point at 23°C | ≥3450mbar (50psig) air with water |
| Flow Rate | 11 L/min @ 2.8bar ΔP |
| Gravimetric Extractables | The extractables level was equal to or less than 2.5mg 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 | |
|---|---|
| Filtration Area | 500 cm² |
| Process Volume | 50 L |
| Inlet Connection Diameter | 9/16 in. |
| Outlet Connection Diameter | 9/16 in. |
| Materials Information | |
|---|---|
| Chemistry |
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| 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 ≥200mL |
