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KVGLG04FF3 Opticap® Gamma Compatible XL4 Durapore® 0.22 µm 3/4 in. TC/TC

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
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KVGLG04FF3
3  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKVGLG04FF3
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible XL4 Durapore® 0.22 µm 3/4 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 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.
      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 Size0.22 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 Diameter3/4 in.
      Outlet Connection Diameter3/4 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
      Référence GTIN
      KVGLG04FF3 04053252374401

      Documentation

      Material Qualification Dossier

      TitreVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificats de qualité

      Titre
      OPTICAP XL 4 Capsule Durapore Membrane C3BB94694
      OPTICAP XL 4 Capsule Durapore Membrane C3JB33898
      OPTICAP XL 4 Capsule Durapore Membrane C4KB71894
      Opticap XL 4 Capsule Durapore Membrane C7DA92089
      Opticap XL 4 Capsule Durapore Membrane C7EA14674
      Opticap XL 4 Capsule Durapore Membrane C0CB41374Z
      Opticap XL 4 Capsule Durapore Membrane C8BA23066
      Opticap XL 4 Capsule Durapore Membrane C0DB61788Z
      Opticap XL 4 Capsule Durapore Membrane C1DB07757
      Opticap XL 4 Capsule Durapore Membrane C7HA23521
      Show more

      Informations techniques

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

      Fiche technique

      Titre
      Durapore® Family Guide

      Manuels d'utilisation

      Titre
      Opticap® XL Capsules and Opticap® XLT Capsules

      Produits & Applications associés

      Familles de produits

      Filtres Durapore® 0,1 µm et 0,22 µm de grade stérilisant compatibles avec une stérilisation au rayonnement gamma

      Enhanced process efficiency and cost-effectiveness from reduced cleaning and validation requirements
      En savoir plus >>

      Durapore® 0.1 µm and 0.22 µm Capsule Filters

      0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes for sterile liquid filtration
      En savoir plus >>

      Produits associés classés par : Brand Facete

      Opticap®

      Catégories

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