KVGBA10FF1 Opticap Sterilizing Grade XL10 Durapore Hydrophobic 0.22 µm 3/4 in. TC/TC

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KVGBA10FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVGBA10FF1
      Trade Name
      • Opticap®
      DescriptionOpticap Sterilizing Grade XL10 Durapore Hydrophobic 0.22 µm 3/4 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      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.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      Sterilization20 autoclave cycles of 30 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.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥1240 mbar (18 psig) nitrogen with 60/40 % IPA/water
      Nitrogen Diffusion at 23 °C≤10 mL/min @ 1.7 bar (25 psig) with 60/40 % IPA/water
      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 Length10 in. (25 cm)
      Length33.0 cm (13.0 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width33.0 cm (13.0 in.)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 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 Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications

      Documentation

      Certificates of Quality

      Title
      Opitcap XL 10 Capsule Durapore Durapore Membrane - C4EA48386
      Opticap XL 10 Capsule Durapore Membrane
      Opticap XL 10 Capsule Durapore Membrane C7JA40471
      Opticap XL 10 Capsule Durapore Membrane C0BB23785Z
      Opticap XL 10 Capsule Durapore Membrane C7CA87963
      Opticap XL 10 Capsule Durapore Membrane C7PA82639
      Opticap XL 10 Capsule Durapore Membrane C7SA05515
      Opticap XL 10 Capsule Durapore Membrane C8AA15235
      Opticap XL 10 Capsule Durapore Membrane C8BA34865
      Opticap XL 10 Capsule Durapore Membrane C9MA92196

      Technical Info

      Title
      Application Note: Vent Filter Sizing for Mobius® Single-use Mixing Solution
      Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Filter Integrity Test Methods

      Data Sheet

      Title
      Sterilizing-grade Durapore® 0.22 µm Hydrophobic Filters

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules