重要规格表
| Description
|
| Catalogue Number | SPHLA25NB6 |
| Trade Name |
|
| Description | Durapore® 0.45 µm Optiscale® 25mm NB |
| Product Information
|
| Device Configuration | Capsule |
| Connections, Inlet/Outlet | Female Luer Lok/ Male Luer Lok |
| Maximum Inlet Pressure, bar (psi) | 4.1 bar (60 psi) @ 25 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Quality Level | MQ400
|
| Biological Information
|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Durapore® |
| Sterility | Other |
| Sterilization | 1 autoclave cycle of 60 min @ 123 °C |
| Wettability | Hydrophilic |
| Physicochemical Information
|
| Pore Size | 0.45 µm |
| Inlet Connection | Female Luer Lok |
| Outlet Connection | Male Luer Lok |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. |
| Maximum Pressure | 60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 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). |
| Non-Particle Releasing | This product was tested and passes the USP <788> test for particulates in injectables. |
| TOC/Conductivity | After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>. |
| USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| Dimensions
|
| Length | 3.9 cm (1.52 in.) |
| Diameter | 3.1 cm (1.2 in.) |
| Filtration Area | 3.5 cm² |
| Materials Information
|
| Chemistry |
- Polyvinylidene Fluoride (PVDF)
|
| Device Material |
|
| Support Material | Polypropylene |
| Vent Cap Material | Polypropylene (PP) |
| Packaging Information
|
| Material Size | 6 |
