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KVGLG04TT3 | Opticap® Gamma Compatible XL4 Durapore® 0.22 µm 1-1/2 in. TC/TC

KVGLG04TT3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVGLG04TT3
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible XL4 Durapore® 0.22 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; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.8 bar (40 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®
      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 ConnectionSanitary Flange
      Air Diffusion at 23 °C≤4.6 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with 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).
      TOC/ConductivityAfter sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length4 in. (10 cm)
      Length17.0 cm (6.7 in.)
      Diameter6.1 cm (2.4 in.)
      Filtration Area0.18 m²
      Device Size4 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 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 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

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C0HA36230
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C0JA59919
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C0NA91626
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C1DA65483
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C1DA70295
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C1KA17399
      Gamma Opticap® XL 4 Capsule Filter with Hydrophilic Durapore® Membrane - C1CA51720
      Opricap XL 4 Capsule Durapore Membrane C5SA99834
      Opticap XL 4 Capsule Durapore Membrane
      Opticap XL 4 Capsule Durapore Membrane
      Opticap XL 4 Capsule Durapore Membrane C4PA39549
      Opticap XL 4 Capsule Durapore Membrane - C3HA34073
      Opticap XL 4 Capsule Durapore Membrane - C3HA53850
      Opticap XL 4 Capsule Durapore Membrane - C4DA43218
      Opticap XL 4 Capsule Durapore Membrane - C6CA19252
      Opticap XL 4 Capsule Durapore Membrane - C6KA01397
      Opticap XL 4 Capsule Durapore Membrane C4JA85793
      Opticap XL 4 Capsule Durapore Membrane C4KA07194
      Opticap XL 4 Capsule Durapore Membrane C4MA19467
      Opticap XL 4 Capsule Durapore Membrane C5AA54054
      Opticap XL 4 Capsule Durapore Membrane C5DA83054
      Opticap XL 4 Capsule Durapore Membrane C5EA08690
      Opticap XL 4 Capsule Durapore Membrane C5JA32612
      Opticap XL 4 Capsule Durapore Membrane C5JA32613
      Opticap XL 4 Capsule Durapore Membrane C5MA44720
      Opticap XL 4 Capsule Durapore Membrane C5MA51881
      Opticap XL 4 Capsule Durapore Membrane C6BA05843
      Opticap XL 4 Capsule Durapore Membrane C6EA60724
      Opticap XL 4 Capsule Durapore Membrane C6KA99848
      Opticap XL 4 Capsule Durapore Membrane C6MA11412
      Opticap XL 4 Capsule Durapore Membrane/C5BA70869
      Opticap XL 4 Capsule durapore Membrane C6DA50638
      Opticap XL4 Capsule Durapore Membrane C5PA60412
      Opticap® XL 4 Capsule Durapore® Membrane - C3AA23679
      Opticap® XL 4 Capsule Durapore® Membrane - C3MA15631
      Opticap® XL 4 Capsule Durapore® Membrane - C4KA04668

      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