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KEGBG003FF3 Gamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange

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KEGBG003FF3
3  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKEGBG003FF3
      Trade Name
      • Opticap®
      DescriptionGamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange
      References
      Product Information
      HS Code8421 39 90
      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: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)4.1 bar (60 psi) @ 23 °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
      Key Applications
      • Small scale single-use applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SPG
      SterilityGamma
      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.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥1210 mbar (17.5 psig) air with 70/30 % IPA/water
      Gravimetric ExtractablesThe extractables level was equal to or less than 3 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.16 mL/min @ 2.6 bar (38 psig)
      Maximum Inlet Pressure (psig)60 psig
      Maximum Differential Pressure60 psi (4.1 bar) continuous
      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 gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Length11.9 cm (4.7 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area0.048 m²
      Inlet to Outlet Width11.9 cm (4.7 in.)
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolyethylene
      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
      Global Trade Item Number
      Número de referencia GTIN
      KEGBG003FF3 04053252970405

      Documentation

      Certificados de calidad

      Cargo
      OPTICAP XL 300 Capsule Millipore Express SPG Membrane C3SB90743
      Opticap XL 300 Ca[sule Millipore Express SPG Membrane C2AB08586
      Opticap XL 300 Capsule MIllipore Express SPG Membrane C0CB38544
      Opticap XL 300 Capsule MIllipore Express SPG Membrane C0DB48095
      Opticap XL 300 Capsule Millipore Excpress SPG Membrane C8NA43773
      Opticap XL 300 Capsule Millipore Express SPG Membrane C2SB52510
      Opticap XL 300 Capsule Millipore Express SPG Membrane
      Opticap XL 300 Capsule Millipore Express SPG Membrane
      Opticap XL 300 Capsule Millipore Express SPG Membrane C7KA35664
      Opticap XL 300 Capsule Millipore Express SPG Membrane C8MA24344
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      Licencias necesarias e Información técnica

      Cargo
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Performance of Gamma Stable Opticap®XL 50 Capsule Filter with Millipore Express®SPG Membrane vs. Competitor’s 50 mm Gamma Stable Hydrophobic PVDF Membrane Filter for a Typical Fed Batch Cell Culture Process
      Vent Filter Sizing for Mobius®Single-use Mixing Solution

      Ficha técnica

      Cargo
      Gamma Stable Opticap®XL Capsule Filters with Millipore Express®SPG Hydrophobic Membrane