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KVGLG2TTH1 | Opticap® Gamma Compatible XLT20 Durapore® 0.22 µm 1-1/2 in. TC-5/8 in. HB

KVGLG2TTH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVGLG2TTH1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible XLT20 Durapore® 0.22 µm 1-1/2 in. TC-5/8 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 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.
      T-line/Gauge PortT-line
      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 Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤28 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 50 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 Length20 in. (50 cm)
      Length62.5 cm (24.6 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.45 m²
      Inlet to Outlet Width17.5 cm (6.9 in.)
      Device Size20 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter5/8 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Gamma-stable 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 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 ≥2 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Gamma Opticap XL 20 Capsule Filter with Hydrophilic Durapore Membrane - C1HA83667
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0BA92617
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0HA40144
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0JA48232
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0JA59748
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0MA75571
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1AA36563
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1CA49984
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1JA99593
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1KA09589
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1MA24655
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2CA90923
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2EA12423
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2KA52435
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2NA69414
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durpapore Membrane - C2AA65721
      Gamma Opticap® XLT 20 Capsule Filter with Hydrophilic Durapore® Membrane - C1HA92065
      Gamma Opticap® XLT 20 Capsule Filter with Hydrophilic Durapore® Membrane - C2DA11294
      Opticap SLT 20 Capsule Durapore Membrane C5DA92332
      Opticap XLT 20 Capsule Durapore Membrane
      Opticap XLT 20 Capsule Durapore Membrane C4SA38223
      Opticap XLT 20 Capsule Durapore Membrane C6MA99089
      Opticap XLT 20 Capsule Durapore Membrane - C3BA41287
      Opticap XLT 20 Capsule Durapore Membrane - C3CA49059
      Opticap XLT 20 Capsule Durapore Membrane - C3DA02092
      Opticap XLT 20 Capsule Durapore Membrane - C3KA83473
      Opticap XLT 20 Capsule Durapore Membrane - C3KA85493
      Opticap XLT 20 Capsule Durapore Membrane - C3NA28117
      Opticap XLT 20 Capsule Durapore Membrane - C5SA97086
      Opticap XLT 20 Capsule Durapore Membrane - C6BA19158
      Opticap XLT 20 Capsule Durapore Membrane - C6CA43980
      Opticap XLT 20 Capsule Durapore Membrane - C6KA67029
      Opticap XLT 20 Capsule Durapore Membrane C5DA95515
      Opticap XLT 20 Capsule Durapore Membrane C5HA22060
      Opticap XLT 20 Capsule Durapore Membrane C5KA49098
      Opticap XLT 20 Capsule Durapore Membrane C6DA43983
      Opticap® XLT 20 Capsule Durapore® Membrane - C4BA22066
      Opticap® XLT 20 Capsule Durapore® Membrane - C4CA39832
      Opticpa XLT 20 Capsule Durapore Membrane - C4DA43574
      jGamma Opticap® XLT 20 Capsule Filter with Hydrophilic Durapore® Membrane - C2KA44483

      Data Sheet

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