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KVVLG04FH3 Opticap® Gamma Compatible Sterilizing Grade XL4 Durapore® 0.1 µm 3/4 in. TC-9/16 in. HB

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
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KVVLG04FH3
3  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKVVLG04FH3
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible Sterilizing Grade XL4 Durapore® 0.1 µm 3/4 in. TC-9/16 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 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; 1.0 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.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityNon-sterile, Gamma compatible
      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≤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 Diameter3/4 in.
      Outlet Connection Diameter9/16 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 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
      Global Trade Item Number
      Número de referencia GTIN
      KVVLG04FH3 04053252377044

      Documentation

      Material Qualification Dossier

      CargoVersión
      2.0

      Operational Excellence Dossier

      Title

      Certificados de calidad

      Cargo
      Opticap XL 4 Capsule Durapore Membrane C7EA14687
      Opticap XL 4 Capsule Durapore Membrane C7CA83474
      Opticap XL 4 Capsule Durapore Membrane C7SA13092
      Opticap XL 4 Capsule Durapore Membrane C8BA31050
      Opticap XL 4 Capsule Durapore Membrane C8DA38897
      Opticap XL 4 Capsule Durapore Membrane C8DA63515
      Opticap XL 4 Capsule Durapore Membrane C7CA83689
      Opticap XL 4 Capsule Durapore Membrane C7JA41711
      Opticap XL 4 Capsule Durapore Membrane C7PA86441
      Opticap XL 4 Capsule Durapore Membrane C7PA86442
      Show more

      Licencias necesarias e Información técnica

      Cargo
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      Ficha técnica

      Cargo
      Durapore® Family Guide

      Manuales del usuario

      Cargo
      Opticap® XL Capsules and Opticap® XLT Capsules

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      Opticap®

      Categorías

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore