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KVVLG04TT3 | Opticap® Gamma Compatible Sterilizing Grade XL4 Durapore® 0.1 µm 1-1/2 in. TC/TC

KVVLG04TT3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVVLG04TT3
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Sterilizing Grade XL4 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; 1.0 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 Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤5.7 mL/min @ 3.9 bar (56 psig) in water
      Bubble Point at 23 °C≥4830 mbar (70 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

      Certificates of Quality

      Title
      Gamma Opticap XL 4 Capsule Filter with Hydrophilic Durapore Membrane - C2MA65497
      Gamma Opticap® XL 4 Capsule Filter with Hydrophilic Durapore® Membrane - C2DA02258
      Gamma Opticap® XL 4Capsule Filter with Hydrophilic Durapore® Membrane - C1NA43076
      Opticap XL 4 CApsule Durapore Membrane C5KA48732
      Opticap XL 4 Capsule Druapore Membrane - C6BA09228
      Opticap XL 4 Capsule Durapore Membrane - C3PA78020
      Opticap XL 4 Capsule Durapore Membrane - C4AA20813
      Opticap XL 4 Capsule Durapore Membrane - C4AA95403
      Opticap XL 4 Capsule Durapore Membrane - C6EA61372
      Opticap XL 4 Capsule Durapore Membrane - SAMPLE3281
      Opticap XL 4 Capsule Durapore Membrane C5JA33308
      Opticap XL 4 Capsule Durapore Membrane C5MA54119

      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