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KGEPS006HH3 | Opticap® XL 600 Millipore Express® SHF Sterile 0.2 µm 9/16 in. HB/HB

KGEPS006HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKGEPS006HH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 600 Millipore Express® SHF 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 Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHF
      SterilitySterile
      Sterilization3 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.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤5.8 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥4000 mbar (58 psig) air with 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 Pressure80 psi (5.5 bar) continuous
      100 psi (6.9 bar) intermittent
      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 3.0 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 Length6.5 in. (16.5 cm)
      Length16.5 cm (6.5 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area970 cm²
      Inlet to Outlet Width16.5 cm (6.5 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 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

      Documentation

      Certificates of Quality

      Title
      Opticap XL 600 Capsule Miilipore Express SHF Membrane C6MA13998
      Opticap XL 600 Capsule Miilipore Express SHF Membrane C6NA26740
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C3MA16689
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4AA71071
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4DA51669
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4EA60077
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4EA62826
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4JA90620
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C6BA27130
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5BA65556
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5HA23850
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5JA34844
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5JA40034
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5MA50972
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5PA82138
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5PA85149
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5PA88295
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5SA97088
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6AA13394
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6KA99771
      Opticap® XL 600 Capsule Millipore Express® SHC Membrane C6EA70962
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C4MA18266
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C5NA68991
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6AA09081
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6CA42918
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6DA51835
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6EA61324
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6HA81211
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C4DA39868
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C4MA14111
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5CA78393
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5DA92266
      Opticap® XL 600 Capsule Millipore Express®SHF Membrane C6CA35184

      Technical Info

      Title
      Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters

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      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHF