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KVVLG10TH1 Opticap® Gamma Compatible Sterilizing Grade XL10 Durapore® 0.1 µm 1-1/2 in. TC-9/16 in. HB

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KVVLG10TH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKVVLG10TH1
      ReplacesKVVL01TC1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Sterilizing Grade XL10 Durapore® 0.1 µm 1-1/2 in. TC-9/16 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 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®
      SterilityNon-sterile, Gamma compatible
      Sterilization3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤21.1 mL/min @ 3.9 bar (56 psig) in water
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 25 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 Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.73 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Gamma-stable polypropylene
      Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
      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 Size1
      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
      Global Trade Item Number
      Catalogue Number GTIN
      KVVLG10TH1 04053252393662

      Documentation

      Material Qualification Dossier

      TitleVersion
      2.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      OPTICAP XL 10 Capsule Durapore Membrane C4DB97579
      OPTICAP XL 10 Capsule Durapore Membrane C4JB65578
      Optica XL 10 Capsule Durapore Membrane C0EB56720Z
      Opticap XL 10 Capsule Durapore Membrane C1AB94446Z
      Opticap XL 10 Capsule Durapore Membrane C8JA96354
      Opticap XL 10 Capsule Durapore Membrane C7EA14690
      Opticap XL 10 Capsule Durapore Membrane C7JA41713
      Opticap XL 10 Capsule Durapore Membrane C8EA73097
      Opticap XL 10 Capsule Durapore Membrane C0HB84336Z
      Opticap XL 10 Capsule Durapore Membrane C1AB83321Z
      Show more

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules

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      Categories

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