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KW03A02HH3 | Opticap® XL2 Milligard® 0.2 µm 9/16 in. HB/HB

KW03A02HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKW03A02HH3
      ReplacesKW0304FF3
      Trade Name
      • Opticap®
      DescriptionOpticap® XL2 Milligard® 0.2 µm 9/16 in. HB/HB
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      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 ConnectionHose Barb
      Outlet ConnectionHose Barb
      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 Area0.1 m²
      Inlet to Outlet Width14.2 cm (5.6 in.)
      Device Size2 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size0.2 µm
      Outlet Connection Diameter9/16 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
      Opticap XL 2 Capsule Milligard Media C6MA02234
      Opticap XL 2 Capsule Milligard Media - C2PA11186
      Opticap XL 2 Capsule Milligard Media - C3AA37899
      Opticap XL 2 Capsule Milligard Media - C3CA59181
      Opticap XL 2 Capsule Milligard Media - C3PA70227
      Opticap XL 2 Capsule Milligard Media - C6CA32961
      Opticap XL 2 Capsule Milligard Media C6JA89969
      Opticap XL Capsule Filter with Milligard Media - C0AA88775
      Opticap XL Capsule Filter with Milligard Media - C0HA43385
      Opticap XL Capsule Filter with Milligard Media - C0KA64641
      Opticap XL Capsule Filter with Milligard Media - C0SA25277
      Opticap XL Capsule Filter with Milligard Media - C1AA36543
      Opticap XL Capsule Filter with Milligard Media - C1DA60815
      Opticap XL Capsule Filter with Milligard Media - C1DA74257
      Opticap XL Capsule Filter with Milligard Media - C1HA86468
      Opticap XL Capsule Filter with Milligard Media - C2AA70880
      Opticap XL Capsule Filter with Milligard Media - C2CA93847
      Opticap® XL 2 Capsule Milligard® Media - C5CA86949
      Opticap® XL Capsule Filter with Milligard® Media - C1JA97993
      Opticap® XL Capsule Filter with Milligard® Media - C1KA12970

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      Categories

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