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KHVEG03HH3 | Opticap® Gamma Compatible XL 3 Millipore Express® SHR with prefilter 0.5/0.1 µm 9/16 in. HB/HB

KHVEG03HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKHVEG03HH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XL 3 Millipore Express® SHR with prefilter 0.5/0.1 µm 9/16 in. HB/HB
      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 @ 25 °C; 5.5 bar (80 psi) @ 25 °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
      SterilityGamma
      SterilizationGamma compatible to 45 kGy; 3 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 Size0.5 / 0.1 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤7.3 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 5.5 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 Length3 in. (7.5 cm)
      Length17.3 cm (6.8 in.)
      Diameter12.4 cm (4.12 in.)
      Filtration Area0.13 m²
      Inlet to Outlet Width17.3 cm (6.8 in.)
      Device Size3 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 MaterialPolyester
      Vent Cap MaterialGamma stable polypropylene (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 ≥2 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR HYdrophilic Membrane with Prefilter - C1BA43580
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0JA50144
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0NA91209
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0PA12720
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1AA29246
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1CA55653
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1EA83288
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C1KA10670
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C2BA83051
      Gamma Opticap XL 3 Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C9MN43126
      Gamma Opticap XL Capsule Filter with Millipore Express SHR Hydrophilic Membrane with Prefilter - C0JA59963
      Gamma Opticap® XL 3 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C1DA70297
      Gamma Opticap® XL 3 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C1SA58106
      Gamma Opticap® XL 3 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C2HA04945
      Gamma Opticap® XL 3 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C2JA22442
      Gamma Opticap® XL3 Capsule Filter with Millipore Express® SHR Hydrophilic Membrane with Prefilter - C0PA10090
      Gamma Opticap® XL3 Capsule Filter with Millipore Express® XHR Hydrophilic Membrane with Prefilter - C1HA90093
      Opticap XL 3 Capsule Miliipore Express SHR w/Prefilter Membrane - C4AA94952
      Opticap XL 3 Capsule Millipore Express SHR Membrane C6BA98767
      Opticap XL 3 Capsule Millipore Express SHR w/ Prefilter Membrane - C3DA97487
      Opticap XL 3 Capsule Millipore Express SHR w/ Prefilter Membrane - C6EA56062
      Opticap XL 3 Capsule Millipore Express SHR w/ Prefilter Membrane C5KA44582
      Opticap XL 3 Capsule Millipore Express SHR w/Prefi
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C5JA39553
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3DA05964
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3HA30740
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3HA71154
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3KA87857
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3NA29873
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3NA46664
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3SA78802
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C3SA87886
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C4AA05141
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C4DA42675
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C6CA31281
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - C6DA48464
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane - SL0612O006
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C4JA77809
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C4KA07852
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C4NA22164
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C4PA37163
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C4SA39536
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C5AA53988
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C5CA77774
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C5CA80376
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane C5HA24491
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter Membrane/C6JA89194
      Opticap XL 3 Capsule Millipore Express SHR w/Prefilter MembraneC5NA60401
      Opticap XL 3 Capsuule Millipore Express SHR w/Prefilter Membrane C5BA70374
      Opticap XL3Capsule Millipore Express SHR w/Prefilter Membrane
      Opticap® XL 3 Capsule Millipore Express® SHR w/Prefilter Membrane - C3MA23525
      Opticap® XL 3 Capsule Millipore Express® SHR w/Prefilter Membrane - C5EA08555

      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