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KWSCA02FF3 | Opticap® XL2 Milligard® 1.2/0.5 µm 3/4 in. TC/TC

KWSCA02FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKWSCA02FF3
      ReplacesKWSC04FF3
      Trade Name
      • Opticap®
      DescriptionOpticap® XL2 Milligard® 1.2/0.5 µm 3/4 in. TC/TC
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      Filter GradeStandard Milligard® Media
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      European Pressure Equipment DirectiveEMD 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 PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMilligard®
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 15 mg per capsule after 24 hours in water at controlled room temperature.
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Inlet Pressure (psig)80 psig
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length2 in. (5 cm)
      Length14.2 cm (5.6 in.)
      Diameter12.5 cm (4.9 in.)
      Filtration Area0.07 m²
      Inlet to Outlet Width14.2 cm (5.6 in.)
      Device Size2 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size1.2 / 0.5 µm
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 2 Capsule Milligard Media C5CA80076
      Opticap XL 2 Capsule Milligard Media
      Opticap XL 2 Capsule Milligard Media C5JA23859
      Opticap XL 2 Capsule Milligard Media C6NA26730
      Opticap XL 2 Capsule Milligard Media - C3JA50847
      Opticap XL 2 Capsule Milligard Media - C3NA51294
      Opticap XL 2 Capsule Milligard Media - C4AA95378
      Opticap XL 2 Capsule Milligard Media - C4EA63415
      Opticap XL 2 Capsule Milligard Media - C6DA51822
      Opticap XL 2 Capsule Milligard Media - C6JA89976
      Opticap XL 2 Capsule Milligard Media - SAMPLE1846
      Opticap XL 2 Capsule Milligard Media C4JA78612
      Opticap XL 2 Capsule Milligard Media C4SA48197
      Opticap XL 2 Capsule Milligard Media C5NA69647
      Opticap XL 2 Capsule Milligard Media C6BA18475
      Opticap XL 2 Capsule Milligard Media C6DA53381
      Opticap XL 2 Capsule Milligard Media C6MA09581
      Opticap XL 2 Capsule Milligard Media C6NA16950
      Opticap XL 2 Capsule Milligard media - C4AA99428
      Opticap XL Capsule Filter with Milligard Media - C0AA90528
      Opticap XL Capsule Filter with Milligard Media - C0BA00122
      Opticap XL Capsule Filter with Milligard Media - C0JA60678
      Opticap XL Capsule Filter with Milligard Media - C0MA79121
      Opticap XL Capsule Filter with Milligard Media - C0SA25279
      Opticap XL Capsule Filter with Milligard Media - C1HA89074
      Opticap XL Capsule Filter with Milligard Media - C1MA20519
      Opticap XL Capsule Filter with Milligard Media - C2BA84803
      Opticap XL Capsule Filter with Milligard Media - C2HA31484
      Opticap XL capsule Filter with Milligard Media - C9MN47014
      Opticap XL2 Cappsule Milligard Media - C3CA88650
      Opticap® XL 2 Capsule Milligard® Media C5SA97197
      Opticap® XL 2 Capsule Milligard® Media - C4CA32096
      Opticap® XL Capsule Filter with Milligard® Media - C2AA69416

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard