KVEPS2TBB1 | Opticap® Sterile XLT 20 Millipore Express® SHR single
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KVEPS2TBB1 | Opticap® Sterile XLT 20 Millipore Express® SHR single
重要规格表
| De |
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| Catalogue Number | KVEPS2TBB1 |
| Trade Name | Millipore Express® |
| De |
Opticap® Sterile XLT 20 Millipore Express® SHR single |
| Product Information | |
|---|---|
| Device Configuration | Capsule |
| Connections, Inlet/Outlet | 25 mm (1 in.) Hose Barb |
| Connections, Vent/Drain | 1/4 in. Hose Barb with double O-ring Seal |
| Housing Material | Polypropylene (PP) |
| Maximum Differential Pressure, bar (psid) | Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent |
| Maximum Inlet Pressure, bar (psi) | 6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °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 |
| Biological Information | |
|---|---|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Millipore Express® SHR |
| Sterility | Sterile |
| Sterilization | 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable |
| 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 | 0.1 µm |
| Inlet Connection | Hose Barb |
| Outlet Connection | Hose Barb |
| Bubble Point at 23 °C | ≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/water |
| 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 Differential Pressure | 80 psi (5.5 bar) continuous 100 psi (6.9 bar) intermittent |
| Maximum Inlet Temperature | 25 °C |
| Non-Fiber Releasing | This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6). |
| TOC/Conductivity | After sterilization and a controlled water flush of 22 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C. |
| 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 | 20 in. (50 cm) |
| Length | 62.5 cm (24.6 in.) |
| Diameter | 10.7 cm (4.2 in.) |
| Filtration Area | 1.38 m² |
| Inlet to Outlet Width | 19.8 cm (7.4 in.) |
| Device Size | 20 in. |
| Inlet Connection Diameter | 1 in. |
| Outlet Connection Diameter | 1 in. |
| Materials Information | |
|---|---|
| Chemistry | Polyethersulfone (PES) |
| Device Material | Polypropylene |
| Seal Material | Silicone (SI) |
| Support Material | Polyester |
| 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 ≥3 L |
