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KVVLG2TTH1 | Opticap® Gamma Compatible Sterilizing Grade XLT20 Durapore® 0.1 µm 1-1/2 in. TC-5/8 in. HB

KVVLG2TTH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVVLG2TTH1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Sterilizing Grade XLT20 Durapore® 0.1 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 Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤42.2 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 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 XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1KA97174
      Gamma OPticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1NA16798
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilc Durapore Membrane - C2EA15595
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore - C0NA92914
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0AA80377
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0BA92615
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0DA17166
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0EA30970
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0JA59725
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0JA63268
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0NA85545
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0PA12699
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C0SA21286
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1AA30823
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1CA47780
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C1EA69914
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2AA50602
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2BA59285
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2CA03750
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2KA55232
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C2MA58212
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C9SN75944
      Gamma Opticap XLT 20 Capsule Filter with Hydrophilic Durapore Membrane - C9SN77636
      Gamma Opticap® XLT 20 Capsule Filter with Hydrophiic Durapore® Membrane - C1DA60794
      Gamma Opticap® XLT 20 Capsule Filter with Hydrophilic Durapore® Membrane - C0HA50700
      OPticap XLT 20 Capsule Durapore Membrane - C4CA39775
      Opticap XLT 20 Capsule Durapore Membrane
      Opticap XLT 20 Capsule Durapore Membrane - C2PA08158
      Opticap XLT 20 Capsule Durapore Membrane - C2PA95745
      Opticap XLT 20 Capsule Durapore Membrane - C3AA40060
      Opticap XLT 20 Capsule Durapore Membrane - C3JA23322
      Opticap XLT 20 Capsule Durapore Membrane - C3MA21340
      Opticap XLT 20 Capsule Durapore Membrane - C3NA41181
      Opticap XLT 20 Capsule Durapore Membrane - C3NA58389
      Opticap XLT 20 Capsule Durapore Membrane - C4AA06459
      Opticap XLT 20 Capsule Durapore Membrane - C4DA48111
      Opticap XLT 20 Capsule Durapore Membrane - C4DA48112
      Opticap XLT 20 Capsule Durapore Membrane - C6AA98804
      Opticap XLT 20 Capsule Durapore Membrane C4JA87142
      Opticap XLT 20 Capsule Durapore Membrane C4KA98989
      Opticap XLT 20 Capsule Durapore Membrane C5BA72269
      Opticap XLT 20 Capsule Durapore Membrane C5KA44140
      Opticap XLT 20 Capsule Durapore Membrane C5MA58372
      Opticap XLT 20 Capsule Durapore Membrane C5NA60390
      Opticap XLT 20 Capsule Durapore Membrane C6DA47673
      Opticap XLT 20 Capsule Durapore Membrane C6HA74970
      Opticap XLT 20 Capsule Durapore Membrane/C5CA83012
      Opticap XLT 20 Capsule Durapore Membrane/C5HA12335
      Opticap® SLT 20 Capsule Durapore Membrane - C3MA85803
      Opticap® XLT 20 Capsule Durapore® Membrane - C4MA19842
      Opticap® XLT 20 Capsule Durapore® Membrane - C4SA46869

      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