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KGEPS05TT1 | Opticap® XL 5 Millipore Express® SHF Sterile 0.2 µm 1-1/2 in. TC/TC

KGEPS05TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKGEPS05TT1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 5 Millipore Express® SHF Sterile 0.2 µm 1-1/2 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/Outlet38 mm (1-1/2 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 @ 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® 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≤17.4 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 6.0 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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.31 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      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 ≥1 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5AA34948
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5BA65856
      Opticap XL 5 Capsule Millipore Express SHF Membrane C6MA16592
      Opticap XL 5 Capsule Millipore Express SHF Membrane - C4AA94204
      Opticap XL 5 Capsule Millipore Express SHF Membrane - C4EA41883
      Opticap XL 5 Capsule Millipore Express SHF Membrane - C6HA60824
      Opticap XL 5 Capsule Millipore Express SHF Membrane - C6JA89945
      Opticap XL 5 Capsule Millipore Express SHF Membrane C4JA75505
      Opticap XL 5 Capsule Millipore Express SHF Membrane C4NA25509
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5AA42271
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5EA06425
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5JA33270
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5KA44138
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5PA82154
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5PA85141
      Opticap XL 5 Capsule Millipore Express SHF Membrane C5SA97163
      Opticap XL 5 Capsule Millipore Express SHF Membrane C6BA17064
      Opticap XL 5 Capsule Millipore Express SHF Membrane C6NA26748
      Opticap XL 5 Capsule Muillipore Express SHF Membrane C5PA88260
      Opticap XL Capsule Millipore Express SHF Membrane - C3MA22583
      Opticap XLT 5 Capsule Millipore Express SHF Membrane
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C5HA13580
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C5KA51476
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C5SA00569
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C6CA32953
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C6EA60819
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C6EA66128
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C6JA81236
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane C6KA99406
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane - C4CA30877
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane - C4KA04939
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane - C4MA13986
      Opticap® XL 5 Capsule Millipore Express® SHF Membrane - C5EA92636
      Opticap® XL 5 Capsule Millipore Express® SHR Membrane - C5CA81223
      Opticap® XL 5 Capsule Millipore Express® SHR Membrane C6BA23221
      Opticap® XL 5Capsule Millipore Express® SHF Membrane C5MA65470
      Sterile Opticap XL 5 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C9MN41371

      Brochure

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

      Technical Info

      Title
      Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters

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