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KAFTS015HH3 Millipore Express® Ace 0.2µm, Opticap XL 150 Capsule; Fittings 9/16 in. HB/HB, Sterile

KAFTS015HH3
3  double easy-open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberKAFTS015HH3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® Ace 0.2µm, Opticap XL 150 Capsule; Fittings 9/16 in. HB/HB, Sterile
      References
      Product Information
      Device ConfigurationCapsule
      Maximum Inlet Pressure, bar (psi)6900 mbar (100 psi) intermittent @ 4 °C and 25 °C; 5500 mbar (80 psi) @ 4 °C and 25 °C; 1724 mbar (25 psi) @ 80 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Key Applications
      • Sterile Filtration
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® Ace
      SterilizationSterile capsules may be autoclaved for 3 cycles of 60 minutes at 123 °C. (Cannot be steam sterilized in-line)
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta ATCC 19146 challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.2 µm
      Air Diffusion at 23 °C≤2.6 cc/min @ 2.8 bar (40 psig) through a water wet membrane
      Bubble Point at 23 °C≥4140 mbar (60 psi) air with water
      ≥1320 mbar (19.1 psi) nitrogen with 70/30% IPA/water mixture
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Differential PressureForward: 6900 mbar (100 psi) intermittent @ 25 °C; 5500 mbar (80 psi) @ 25 & °C; 1000 mbar (15 psi) @ 80 °C. Reverse: 2100 mbar (30 psi) @ 25 °C
      Non-Fiber ReleasingMillipore Express® Ace 0.2µm membrane meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      TOC/ConductivityIrradiated filter effluent meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a water flush of: 2 L
      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)
      Diameter5.6 cm (2.2 in.)
      Filtration Area0.025 m² (0.269 ft²)
      Device SizeOpticap XL 150
      Materials Information
      Chemistry
      • Hydrophilic Polyethersulfone (PES)
      Device Material
      • Membrane: Hydrophilic PES
        Core: Polysulfone
        Structural Components: Irradiation compatible polypropylene
        O-ring: silicone
      Seal MaterialSilicone (SI)
      Support MaterialPolyethylene
      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
      KAFTS015HH3 04065272943284

      Documentation

      Material Qualification Dossier

      CargoVersión
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificados de calidad

      Cargo
      Opticap XL 150 Capsule Millipore Express Ace Membrane C6BB75184
      Opticap XL 150 Capsule Millipore Express Ace Membrane C5NB44022
      Opticap XL 150 Capsule Millipore Express Ace Membrane C6DB88150

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