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KGEPG006FH3 | Opticap® XL 600 Millipore Express® SHF Gamma Compatible 0.2 µm 3/4 in. TC-9/16 in. HB

KGEPG006FH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKGEPG006FH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 600 Millipore Express® SHF Gamma Compatible 0.2 µm 3/4 in. TC-9/16 in. HB
      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/14 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
      SterilityGamma
      SterilizationGamma compatible to 45 kGy; 3 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 ConnectionSanitary Flange
      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 Diameter3/4 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
      Gamma Opticap XL 600 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C2NA38376
      Gamma Opticap® XL 600 Capsule Filter with Millipore Express® SHF Hydophilic Membrane - C1HA94936
      Opticap XL 600 Capsule Millipore Express SHF Membr
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6EA60596
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4AA82277
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C6HA71635
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C6HA79552
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C6MA11436
      Opticap XL 600 Capsule Millipore Express SHF Membrane - SL0603O077
      Opticap XL 600 Capsule Millipore Express SHF Membrane C4JA90128
      Opticap XL 600 Capsule Millipore Express SHF Membrane C4PA33562
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5AA52102
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5BA65926
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5BA65927
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5EA10007
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5EA13064
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5HA26300
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5HA26305
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5JA34849
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5KA49068
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5MA68438
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5PA85194
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6KA04974
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6KA99885
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6MA14988
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6NA29317
      Opticap XL 600 Capsule Millipore rSHF Membrane C5BA65928
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5BA65536
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5BA69774
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5CA79249

      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