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KPGES10HH1 Opticap® XL 10 Millipore Express® PHF Sterile 0.2 µm 9/16 in. HB/HB

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KPGES10HH1
1  Double Easy-Open bag
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      Übersicht

      Replacement Information
      Description
      Catalogue NumberKPGES10HH1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 10 Millipore Express® PHF Sterile 0.2 µm 9/16 in. HB/HB
      OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °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® PHF
      SterilitySterile
      Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤32.7 mL/min @ 2.8 bar (40 psig) in 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 Pressure5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C
      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 11 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 Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.57 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      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 ≥1.5 L
      Global Trade Item Number
      Bestellnummer GTIN
      KPGES10HH1 04055977295825

      Documentation

      Qualitätszertifikate

      Titel
      Opticap XL 10 Capsule Millipore Express PHF Membrane C0AB07551
      Opticap XL 10 Capsule Millipore Express PHF Membrane C0HB77847
      Opticap XL 10 Capsule Millipore Express PHF Membrane C9NA92179
      Opticap XL 10 Capsule Millipore Express PHF Membrane C3DB10398
      Opticap XL 10 Capsule Millipore Express PHF Membrane C4AB87713
      Opticap XL 10 Capsule Millipore Express PHF Membrane C7DA01300
      Opticap XL 10 Capsule Millipore Express PHF Membrane C7DA07314
      Opticap XL 10 Capsule Millipore Express PHF Membrane C8KA14045
      Opticap XL 10 Capsule millipore Express PHF Membrane C1EB09896

      Technische Informationen

      Titel
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      Datenblatt

      Titel
      Millipore Express®PHF Hydrophilic Filters

      Gebrauchsanleitungen

      Titel
      User Guide - Filters with Millipore Express®Membrane

      Verwandte Produkte & Anwendungen

      Produktfamilien

      Millipore Express® PHF Capsule Filters

      Sterilizing-grade PES filters for fast, efficient, and economical buffer filtration
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      Millipore Express®

      Kategorien

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express®
      Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express