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KGEPS003FF3 | Opticap® XL 300 Millipore Express® SHF Sterile 0.2 µm 3/4 in. TC/TC

KGEPS003FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Tabla espec. clave

      Description
      Catalogue NumberKGEPS003FF3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 300 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≤2.8 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 2.5 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 Area480 cm²
      Inlet to Outlet Width11.9 cm (4.7 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

      Certificados de calidad

      Cargo
      Opticap XL 300 Capsule Millipore Express SHF Membrane
      Opticap XL 300 Capsule Millipore Express SHF Membrane C6BA24280
      Opticap XL 300 Capsule Millipore Express SHF Membrane C6BA98820
      Opticap XL 300 Capsule Millipore Express SHF Membrane - C3JA77252
      Opticap XL 300 Capsule Millipore Express SHF Membrane - C3MA18840
      Opticap XL 300 Capsule Millipore Express SHF Membrane - C4EA66264
      Opticap XL 300 Capsule Millipore Express SHF Membrane - C6JA92655
      Opticap XL 300 Capsule Millipore Express SHF Membrane C4NA28937
      Opticap XL 300 Capsule Millipore Express SHF Membrane C4PA34329
      Opticap XL 300 Capsule Millipore Express SHF Membrane C4SA45372
      Opticap XL 300 Capsule Millipore Express SHF Membrane C5AA57832
      Opticap XL 300 Capsule Millipore Express SHF Membrane C5EA10008
      Opticap XL 300 Capsule Millipore Express SHF Membrane C5JA22752
      Opticap XL 300 Capsule Millipore Express SHF Membrane C5JA34847
      Opticap XL 300 Capsule Millipore Express SHF Membrane C5MA58383
      Opticap XL 300 Capsule Millipore Express SHF Membrane C6CA31309
      Opticap XL 300 Capsule Millipore Express SHF Membrane C6KA00657
      Opticap XL 300 Capsule Millipore express SHF Membrane C5KA40612
      Opticap® XL 150 Capsule Millipore Express® SHR w/Prefilter Membrane C6EA63632
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane C5HA21902
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane C6DA50556
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane C6HA78146
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C4NA19903
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C4NA21171
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C5AA50623
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C5BA64117
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C5BA74009
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C5CA79652
      Opticap® XL 300 Capsule Millipore Express® SHF Membrane - C5EA06314
      Opticap® XL 300 Capsule Millipore Express® SHFG Membrane C6HA81815
      Opticap® XL 300 capsule Millipore Express® SHF Membrane - C4DA48605
      Sterile Opticap XL 300 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0KA68522
      Sterile Opticap XL 300 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C1MA18421

      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