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KHPSG003HH3 | Gamma Opticap® XL 300 Millipore Express® HPF 0.5/0.3 µm HB/HB

KHPSG003HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKHPSG003HH3
      Trade Name
      • Millipore Express®
      DescriptionGamma Opticap® XL 300 Millipore Express® HPF 0.5/0.3 µm HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb inlet/outlet
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (15 psid) @ 80 °C. Reverse: 1.4 bar (20 psid) @ 25 °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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® HPF
      SterilityGamma
      SterilizationGamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.5 / 0.3 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤4.0 mL/min @ 2.07 bar (30 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 PressureForward:
      100 psi (6.9 bar) intermittent
      80 psi (5.5 bar) continuous

      Reverse:
      20 psi (1.4 bar)
      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 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 Length4.7 in. (11.9 cm)
      Length11.9 cm (4.7 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area388 cm²
      Inlet to Outlet Width11.9 cm (4.7 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 MaterialPolyethylene
      Vent Cap MaterialGamma stable polypropylene (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

      Documentation

      Certificates of Quality

      Title
      Gamma Opticap XL 300 Capsule Filter with Millipore Express HPF Hydrophilic Membrane - C1NA25533
      Gamma Opticap® XL 300 Capsule Filter with Millipore Express® HPF Hydrophilic Membrane - C1SA61377
      Gamma Opticap® XL 300 Capsule Filter with Millipore Express® HPF Hydrophilic Membrane - C2DA14769
      Opticap XL 300 Capsule Millipore Express HPF Membrane C4NA33345
      Opticap XL 300 Capsule Millipore Express HPF Membrane C5EA09955
      Opticap XL 300 Capsule Millipore Express HPF Membrane C5MA52227
      Opticap XL 300 Capsule Millipore Express HPF Membrane C6HA71639
      Opticap XL 300 Capsule Millipore Express HPF Membrane C6JA89860
      Opticap XL300 Capsule Millipore Express HPF Membrane - SAMPLE2439

      Technical Info

      Title
      Technical Brief: Millipore Express® HPF filter devices

      Data Sheet

      Title
      Millipore Express® HPF Hydrophilic Filters

      User Guides

      Title
      Vmax Constant Pressure

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      Categories

      Biopharmaceutical Manufacturing > Upstream Processing > Bioburden Reduction / Particulate Control > Membrane based > Millipore Express > Millipore Express HPF