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KGEPS006FF3 | Opticap® XL 600 Millipore Express® SHF Sterile 0.2 µm 3/4 in. TC/TC

KGEPS006FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Tabla espec. clave

      Description
      Catalogue NumberKGEPS006FF3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 600 Millipore Express® SHF 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 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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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 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

      Documentation

      Ficha datos de seguridad (MSDS)

      Título

      Ficha técnica de seguridad del material (MSDS) 

      Certificados de calidad

      Cargo
      Opticap XL 150 Capsule Millipore Express SHF Membr
      Opticap XL 600 Capsule Millipore Express SHR Membrane C5KA40616
      Opticap XL 600 Capsule Millipor Express SHF Membrane C5BA65553
      Opticap XL 600 Capsule Millipore Express SHF Membr
      Opticap XL 600 Capsule Millipore Express SHF Membrane
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6EA69143
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C3NA31219
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C3NA49678
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4AA69475
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4EA61879
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4EA66266
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C4JA72382
      Opticap XL 600 Capsule Millipore Express SHF Membrane - C6JA92657
      Opticap XL 600 Capsule Millipore Express SHF Membrane C4NA28671
      Opticap XL 600 Capsule Millipore Express SHF Membrane C4SA52097
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5AA57833
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5DA86633
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5DA92263
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5JA34827
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5NA52338
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5NA79315
      Opticap XL 600 Capsule Millipore Express SHF Membrane C5SA90880
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6CA02829
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6HA63606
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6HA79540
      Opticap XL 600 Capsule Millipore Express SHF Membrane C6KA99886
      Opticap® XL 600 Capsule MIllipore Express® SHF Membrane - C4DA46344
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6DA58783
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6HA42389
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6HA84377
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane C6JA92749
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C4BA27940
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C4CA35013
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C4MA13545
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5CA77293
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5CA79673
      Opticap® XL 600 Capsule Millipore Express® SHF Membrane - C5EA10001
      Opticap® XL 600 Capsule Millipore Express® SHf Membrane C5HA23864
      Sterile Opticap XL 600 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0BA80806
      Sterile Opticap XL 600 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0MA73115
      Sterile Opticap XL 600 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0MA86351
      Sterile Opticap® XL 600 Capsule Filter with Millipore Express® SHF Hydrophilic Membrane - C0DA27973

      Licencias necesarias e Información técnica

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

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      Categorías

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