millipore,
密理博,KR99A05FF1,Opticap XL5 Polygard-CR 100 µm 3/4 in. TC/TC
重要规格表
| Description
|
| Catalogue Number | KR99A05FF1 |
| Trade Name |
|
| Description | Opticap® XL5 Polygard®-CR 100 µm 3/4 in. TC/TC |
| Product Information
|
| Format | Single Layer |
| Device Configuration | Capsule |
| Connections, Inlet/Outlet | 19 mm (3/4 in.) Sanitary Flange |
| Housing Material | Polypropylene (PP) |
| Maximum Differential Pressure, bar (psid) | 4.8 bar (70 psid) @ 20 °C |
| Maximum Inlet Pressure, bar (psi) | 5.5 bar (80 psi) @ 25 °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. |
| Quality Level | MQ400
|
| Biological Information
|
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Media | Polygard®-CR |
| Sterilization | 3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable |
| Physicochemical Information
|
| Pore Size | 100.0 µm |
| Inlet Connection | Sanitary Flange |
| Outlet Connection | Sanitary Flange |
| Gravimetric Extractables | The extractables level was equal to or less than 30 mg per capsule after 24 hours in water at controlled room temperature. |
| 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 |
| USP Bacterial Endotoxins | A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| Dimensions
|
| Cartridge Nominal Length | 5 in. (12.5 cm) |
| Length | 21.6 cm (8.5 in.) |
| Diameter | 10.7 cm (4.2 in.) |
| Inlet to Outlet Width | 21.6 cm (8.5 in.) |
| Device Size | 5 in. |
| Inlet Connection Diameter | 3/4 in. |
| Nominal Pore Size | 100.0 µm |
| Outlet Connection Diameter | 3/4 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 ≥2.5 L |
