重要规格表
| Description
|
| Catalogue Number | LAGR04TP1 |
| Description | Optiseal® 0.2 µm 4' Cartridge |
| Product Information
|
| Device Configuration | Cartridge |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Quality Level | MQ400
|
| Biological Information
|
| Media | Aervent® |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. |
| Wettability | Hydrophobic |
| Physicochemical Information
|
| Pore Size | 0.2 µm |
| Gravimetric Extractables | The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature. |
| Non-Fiber Releasing | This product was manufactured with a PTFE 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
|
| Device Size | 4 in. |
| Materials Information
|
| Chemistry |
- Polytetrafluoroethylene (PTFE)
|
| Packaging Information
|
| Material Size | 1 |
