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KGEPS015HH3 | Opticap® XL 150 Millipore Express® SHF Sterile 0.2 µm 9/16 in. HB/HB

KGEPS015HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Tabla espec. clave

      Description
      Catalogue NumberKGEPS015HH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 150 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≤1.4 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 2.0 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 Length3.8 in. (9.7 cm)
      Length9.7 cm (3.8 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area220 cm²
      Inlet to Outlet Width9.7 cm (3.8 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

      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 150 Capsule Millipore Express SHF Membr
      Opticap XL 150 Capsule Millipore Express SHF Membrane
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5AA58176
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C4AA81998
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C4BA25116
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C6AA15527
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C6BA27160
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C6BA31237
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C6CA32956
      Opticap XL 150 Capsule Millipore Express SHF Membrane C4JA90126
      Opticap XL 150 Capsule Millipore Express SHF Membrane C4NA26673
      Opticap XL 150 Capsule Millipore Express SHF Membrane C4NA28964
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5CA88243
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5JA30802
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5JA39925
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5MA58984
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6AA10489
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6CA35115
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6HA80590
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6JA93056
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6KA99465
      Opticap XL 1500 Capsule Millipore Express SHF Membrane
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C5HA20225
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C5HA24150
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C5KA49071
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C5MA64566
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C5SA77155
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6AA00540
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6CA42920
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6CA44375
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6DA50762
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6DA55871
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6HA66525
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6HA81122
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6KA06206
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C4DA39865
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C4MA13548
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C4NA20436
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C4SA48097
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5AA52094
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5BA69773
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5BA69895
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5CA72351
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5CA79287
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5CA84379
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5DA00569
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5DA92268
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5DA93632
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5EA06495
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5EA10005
      Opticap® XL 150 Capsule Millipore Express® SHR Membrane - C4MA15954
      Opticap® XL 1500 Capsule Millipore Express® SHF Membrane C6EA56838
      Opticap® XL150 Capsule Millipore Express® SHF Membrane C5KA54092
      Opticap® XL150 Capsule Millipore Express® SHF Membrane - C5BA61357

      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