millipore,
密理博,KPHLG10TT1,Opticap Gamma Compatible XL10 Durapore 0.45 µm TC/TC
重要规格表
| Description
|
| Catalogue Number | KPHLG10TT1 |
| Trade Name |
|
| Description | Opticap® Gamma Compatible XL10 Durapore® 0.45 µm TC/TC |
| Product Information
|
| Device Configuration | Capsule |
| Connections, Inlet/Outlet | 38 mm (1-1/2 in.) Sanitary Flange |
| Connections, Vent/Drain | 1/4 in. Hose Barb with double O-ring Seal |
| Housing Material | Polypropylene (PP) |
| Maximum Differential Pressure, bar (psid) | Forward: 4.1 bar (60 psid) @25 ˚C. Reverse: 2.1 bar (30 psid) @ 4-40 °C |
| Maximum Inlet Pressure, bar (psi) | 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Quality Level | MQ400
|
| Applications
|
| Application | - Prefiltration / Bioburden reduction in single use assemblies
- Bioburden reduction before final sterilization
- Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein
|
| Biological Information
|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Durapore® |
| Sterility | Gamma |
| Sterilization | Gamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable |
| Wettability | Hydrophilic |
| Physicochemical Information
|
| Pore Size | 0.45 µm |
| Inlet Connection | Sanitary Flange |
| Outlet Connection | Sanitary Flange |
| Air Diffusion at 23 °C | ≤15 mL/min @ 3.9 bar (22 psig) in water |
| Bubble Point at 23 °C | ≥1930 mbar (28 psig) air with water |
| Gravimetric Extractables | The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature. |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. |
| Maximum Inlet Pressure (psig) | 80 psig |
| Maximum Inlet Temperature | 25 °C |
| 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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| Dimensions
|
| Cartridge Nominal Length | 13.2 in. (33.5 cm) |
| Length | 33.5 cm (13.2 in.) |
| Diameter | 10.7 cm (4.2 in.) |
| Filtration Area | 0.62 m² |
| Inlet to Outlet Width | 33.5 cm (13.2 in.) |
| Device Size | 10 in. |
| Inlet Connection Diameter | 1-1/2 in. |
| Outlet Connection Diameter | 1-1/2 in. |
| Materials Information
|
| Chemistry |
- Polyvinylidene Fluoride (PVDF)
|
| Device Material |
|
| Seal Material | Silicone (SI) |
| Support Material | Gamma-Stable Polypropylene |
| Vent Cap Material | Polypropylene (PP) |
| Packaging Information
|
| Material Size | 1 |
| Specifications
|
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL |
