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KHVEA05TH1 | Opticap® Autoclavable XL 5 Millipore Express® SHR with Prefilter 0.5/0.1 µm 1-1/2 in. TC-9/16 in. HB

KHVEA05TH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKHVEA05TH1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Autoclavable XL 5 Millipore Express® SHR with Prefilter 0.5/0.1 µm 1-1/2 in. TC-9/16 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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® SHR w/Prefilter
      Sterilization3 autoclave cycles of 60 min @ 126 °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 Size0.5 / 0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤12.8 mL/min @ 3.45 bar (50 psig) in water
      Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/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 9.5 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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.23 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C4MA13190
      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0EA37422
      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0MA81189
      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1HA84502
      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1MA27242
      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1SA61988
      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C2JA39738
      Opticap XL 5 Capsule Millipore Express SHR w/Prefi
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C4SA48366
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane - C3NA35067
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane - C4EA53061
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane - C6BA21819
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane - C6CA35603
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane - C6DA51775
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane - C6JA81245
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C4NA33288
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5AA52971
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5AA56394
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5EA01141
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5EA07016
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5JA33281
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C5SA70295
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane C6EA61346
      Opticap XL 5 Capsule Millipore Express SHR w/Prefilter Membrane CPNA19718
      Opticap XL 5 Capsule Millipore Express SHR wPrefilter Membrane - SL0606O107
      Opticap XL 5 Capsule Millipore Express SHRw/Prefilter Membrane C5MA54080
      Opticap® XL 5 Capsule Filter with Millipore Epress® SHR Hydrophilic Membrane with Prefilter - C0EA41318
      Opticap® XL 5 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C2CA94550
      Opticap® XL 5 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C2HA35488
      Opticap® XL 5 Capsule Millipore Express® SHR w/Prefilter Membrane - C4CA33189
      Opticap® XL 600 Capsule Millipore Express® SHR w/Prefilter Membrane C6BA10477

      Brochure

      Title
      Opticap® XL 150, 300 and 600 capsules with Millipore Express® membranes

      Technical Info

      Title
      Demonstrating Millipore Express® SHR mycoplasma clearance capability at pilot and production scale over an extended filtration time (EMD)
      Protect Your Process from Mycoplasma Contamination
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      User Guides

      Title
      Vmax Constant Pressure

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      Categories

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