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KVEPG015FF3 Opticap® Gamma Compatible XL 150 Millipore Express® SHR single layer 0.1 µm 3/4 in. TC/TC

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KVEPG015FF3
3  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKVEPG015FF3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XL 150 Millipore Express® SHR single layer 0.1 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: 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; 3 autoclave 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 ConnectionSanitary Flange
      Air Diffusion at 23 °C≤1.4 mL/min @ 3.45 bar (50 psig) in water
      Bubble Point at 23 °C≥4000 mbar (58 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 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 2.0 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 Length3.8 in. (9.7 cm)
      Length9.7 cm (3.8 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area250 cm²
      Inlet to Outlet Width9.7 cm (3.8 in.)
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      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 ≥1 L
      Global Trade Item Number
      Référence GTIN
      KVEPG015FF3 04053252609671

      Documentation

      Material Qualification Dossier

      TitreVersion
      6.0

      Operational Excellence Dossier

      Title

      Operational Excellence Dossier (Second Sterilization)

      Title

      Certificats de qualité

      Titre
      OPTICAP XL 150 Capsule Millipore Express SHR C3PB72605
      Opticap XL 150 Capsule Millipore Express SHR Membrane C0CB15402Y
      Opticap XL 150 Capsule Millipore Express SHR Membrane C4EB45973
      Opticap XL 150 Capsule Millipore Express SHR Membrane - C0EB58540
      Opticap XL 150 Capsule Millipore Express SHR Membrane C0PB34208
      Opticap XL 150 Capsule Millipore Express SHR Membrane C1DB81230
      Opticap XL 150 Capsule Millipore Express SHR Membrane C1NB46538
      Opticap XL 150 Capsule Millipore Express SHR Membrane C1SB02086
      Opticap XL 150 Capsule Millipore Express SHR Membrane C4HB51319
      Opticap XL 150 Capsule Millipore Express SHR Membrane- C4DB28493

      Manuels d'utilisation

      Titre
      Opticap® XL Capsules and Opticap® XLT Capsules