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KVEPG05TH1 Opticap® Gamma Compatible XL 5 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC-9/16 in. HB

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KVEPG05TH1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKVEPG05TH1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XL 5 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC-9/16 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHR
      SterilityNon-sterile, Gamma compatible
      SterilizationGamma Compatible to 45 kGy. May be autoclaved for 3 cycles of 60 min @ 123 °C; 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
      Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/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 Differential Pressure80 psi (5.5 bar) continuous
      100 psi (6.9 bar) intermittent
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a Millipore Express® 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 of 6.0 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.31 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • 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 ≥1 L
      Global Trade Item Number
      Référence GTIN
      KVEPG05TH1 04053252392047

      Documentation

      Material Qualification Dossier

      TitreVersion
      6.0

      Certificats de qualité

      Titre
      Opticap XL 5 Capsule Millipore Express SHR Membrane C0PB03246
      Opticap XL 5 Capsule Millipore Express SHR Membrane C3KB48993
      Opticap XL 5 Capsule Millipore Express SHR Membrane C7EA07409
      Opticap XL 5 Capsule Millipore Express SHR Membrane C7EA07409
      Opticap XL 5 Capsule Millipore Express SHR Membrane C8KA14057
      Opticap XL 5 Capsule Millipore Express SHR Membrane C9DA22307Y
      Opticap XL 5 Capsule Millipore Express SHR Membrane - C8DA48046
      Opticap XL 5 Capsule Millipore Express SHR Membrane C4DB33861
      Opticap XL 5 Capsule Millipore Express SHR Membrane C8SA65706
      Opticap XL 5 Capsule Millipore Express SHR Membrane C9BA74941
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      Manuels d'utilisation

      Titre
      Opticap® XL Capsules and Opticap® XLT Capsules