millipore,
密理博,KZRVA1TTT1,Opticap XLT10 Viresolve NFR 1-1/2 in. TC/TC
重要规格表
| Description
|
| Catalogue Number | KZRVA1TTT1 |
| Trade Name |
|
| Description | Opticap XLT10 Viresolve NFR 1-1/2 in. 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 |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 bar (80 psid). Reverse: 3.4 bar (50 psid) |
| Maximum Inlet Pressure, bar (psi) | 5.5 bar (80 psi) @ 23 °C |
| European Pressure Equipment Directive | EMD millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark. |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| T-line/Gauge Port | T-line |
| Quality Level | MQ400
|
| Applications
|
| Application | Retrovirus removal |
| Key Applications |
|
| Biological Information
|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Viresolve® NFR |
| Sterilization | After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C, using liquid cycle, slow exhaust. |
| Physicochemical Information
|
| Inlet Connection | Sanitary Flange |
| Outlet Connection | Sanitary Flange |
| Air Diffusion at 23 °C | ≤16 mL/min @ 3.45 bar (50 psig) in water |
| Gravimetric Extractables | The extractables level was equal to or less than 35 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature. |
| Hold-up Volume | 175 mL |
| Maximum Inlet Pressure (psig) | 80 psig |
| Maximum Inlet Temperature | 25 °C |
| Non-Fiber Releasing | This product was manufactured with a Viresolve® 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
|
| Length | 38 cm (15 in.) |
| Filtration Area | 0.43 m² |
| Inlet to Outlet Width | 15.2 cm (6.0 in.) |
| Process Volume | 600 L–1200 L |
| Device Size | 10 in. |
| Inlet Connection Diameter | 1-1/2 in. |
| Outlet Connection Diameter | 1-1/2 in. |
| Materials Information
|
| Chemistry |
|
| Device Material |
|
| Seal Material | Silicone (SI) |
| Support Material | Polypropylene |
| Vent Cap Material | Polypropylene (PP) |
| Packaging Information
|
| Material Size | 1 |
| Material Package | Double Easy-Open bag |
| Specifications
|
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L |