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KPGES015FF3 Opticap® XL 150 Millipore Express® PHF Sterile 0.2 µm 3/4 in. TC/TC

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KPGES015FF3
3  Double Easy-Open bag
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      Übersicht

      Replacement Information
      Description
      Catalogue NumberKPGES015FF3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 150 Millipore Express® PHF Sterile 0.2 µm 3/4 in. TC/TC
      OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
      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 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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤1.4 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 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 Area220 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
      • 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
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
      Global Trade Item Number
      Bestellnummer GTIN
      KPGES015FF3 04055977295399

      Documentation

      Qualitätszertifikate

      Titel
      Opticap XL 10 Capsule Millipore Express PHF Membrane C3DB17310
      Opticap XL 150 Capsule Millipore Express PHF Membrane C0BB37142
      Opticap XL 150 Capsule Millipore Express PHF Membrane -C9CA83856
      Opticap XL 150 Capsule Millipore Express PHF Membrane C2KB04841
      Opticap XL 150 Capsule Millipore Express PHF Membrane C2KB14693
      Opticap XL 150 Capsule Millipore Express PHF Membrane C2MB24909
      Opticap XL 150 Capsule Millipore Express PHF Membrane-C8SA66441
      Opticap Xl 150 Capsule Millipore Express PHF Membrane C8PA59018

      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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      Verwandte Produkte nach: Brand Facete

      Millipore Express®

      Kategorien

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