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KHVEA3THH1 | Opticap® Autoclavable XLT 30 Millipore Express® SHR with Prefilter 0.5/0.1 µm 5/8 in. HB

KHVEA3THH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKHVEA3THH1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Autoclavable XLT 30 Millipore Express® SHR with Prefilter 0.5/0.1 µm 5/8 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 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
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      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 ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤81.3 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 60 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 Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.48 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size30 in.
      Inlet Connection Diameter5/8 in.
      Outlet Connection Diameter5/8 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 ≥6 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane - C4EA57121
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane - SL0607O050
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C5SA94115
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C6AA00110
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C6CA24692
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C6HA73808
      Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C6KA03377

      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