millipore,
密理博,KHGLS10FH1,Sterile Multilayer Durapore Opticap XL 10 in. 0.45 / 0.22 µm
重要规格表
| Description
|
| Catalogue Number | KHGLS10FH1 |
| Trade Name |
|
| Description | Sterile Multilayer Durapore® Opticap® XL 10 in. 0.45 / 0.22 µm |
| Product Information
|
| Device Configuration | Capsule |
| Connections, Inlet/Outlet | Sanitary Flange/Hose Barb |
| 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. |
| Quality Level | MQ400
|
| Biological Information
|
| Media | Multilayer Durapore® |
| Sterility | Sterile |
| 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 | 0.45 / 0.22 µm |
| Inlet Connection | Sanitary Flange |
| Outlet Connection | Hose Barb |
| 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). |
| TOC/Conductivity | After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC. |
| 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 | 10 in. (25 cm) |
| Device Size | 10 in. |
| Inlet Connection Diameter | 3/4 in. |
| Outlet Connection Diameter | 9/16 in. |
| Materials Information
|
| Chemistry |
- Polyvinylidene Fluoride (PVDF)
|
| Packaging Information
|
| Material Size | 1 |
