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KVVLG3TTT1 Opticap® Gamma Compatible Sterilizing Grade XLT30 Durapore® 0.1 µm 1-1/2 in. TC/TC

Opticap® Gamma Compatible Sterilizing Grade XLT30 Durapore® 0.1 µm 1-1/2 in. TC/TC MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KVVLG3TTT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKVVLG3TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Sterilizing Grade XLT30 Durapore® 0.1 µm 1-1/2 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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; 1.7 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
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityGamma
      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 ConnectionSanitary Flange
      Air Diffusion at 23 °C≤63.3 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 75 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 Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area2.17 m²
      Inlet to Outlet Width15.2 cm (6.0 in.)
      Device Size30 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 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 ≥3 L
      Global Trade Item Number
      Catalogue Number GTIN
      KVVLG3TTT1 04053252253126

      Documentation

      Material Qualification Dossier

      TitleVersion
      2.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Opticap XLT 30 Capsule Durapore Membrane C7HA11881
      Opticap XLT 30 Capsule Durapore Membrane C0SB71514
      Opticap XLT 30 Capsule Durapore Membrane C1KB80650Z
      Opticap XLT 30 Capsule Durapore Membrane C2DB39241Z
      Opticap XLT 30 Capsule Durapore Membrane C4JB26212
      Opticap XLT 30 Capsule Durapore Membrane C4PB87117
      Opticap XLT 30 Capsule Durapore Membrane C8CA31308
      Opticap XLT 30 Capsule Durapore Membrane C8DA50306
      Opticap XLT 30 Capsule Durapore Membrane C8PA50589
      Opticap XLT 30 Capsule Durapore Membrane C9MA86774
      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