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KVGLA04FH3 | Opticap® XL4 Durapore® 0.22 µm 3/4 in. TC-9/16 in. HB

KVGLA04FH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVGLA04FH3
      Trade Name
      • Opticap®
      DescriptionOpticap® XL4 Durapore® 0.22 µm 3/4 in. TC-9/16 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.4 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 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
      MediaDurapore®
      Sterilization3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤5.5 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 10 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 Durapore® membrane 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 Length4 in. (10 cm)
      Length19.1 cm (7.5 in.)
      Diameter12.5 cm (4.9 in.)
      Filtration Area0.19 m²
      Inlet to Outlet Width19.1 cm (7.5 in.)
      Device Size4 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      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 ≥500 mL

      Documentation

      Certificates of Quality

      Title
      OPticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1CA54938
      Opticap XL 4 Capsule Durapore Membrane
      Opticap XL 4 Capsule Durapore Membrane - C4BA23368
      Opticap XL 4 Capsule Durapore Membrane - SAMPLE3161
      Opticap XL 4 Capsule Durapore Membrane C6BA21871
      Opticap XL 4 Capsule Durapore Membrane C6EA66182
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0BA93996
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0EA32034
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0HA43355
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0JA59330
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0KA61441
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1AA23596
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1BA35234
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1DA69802
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1EA79769
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1EA82790
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1JA97112
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1PA50619
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2BA84092
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2DA88777
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA16293
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA17824
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2JA45067
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2KA49158
      Opticap XL Capsule Filter with Hyrophilic Durapore Membrane - C2DA14022
      Opticap® XL 4 Capsule Durapore® Membrane - C5DA83049
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1CA48486
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1HA86499
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1NA43079
      Opticap® XL Capsule Filter with Hydrophilic Durpore® Membrane - C0PA07752

      Data Sheet

      Title
      Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Hydrophilic Filters

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore