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KGEPG015FF3 | Opticap® XL 150 Millipore Express® SHF Gamma Compatible 0.2 µm 3/4 in. TC/TC

KGEPG015FF3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKGEPG015FF3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 150 Millipore Express® SHF Gamma Compatible 0.2 µm 3/4 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/Outlet19 mm (3/4 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 @ 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
      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 Size0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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 Diameter3/4 in.
      Outlet Connection Diameter3/4 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

      Certificates of Quality

      Title
      Gamma Opticap XL 150 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0HA51219
      Gamma Opticap XL 150 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0MA89561
      Gamma Opticap XL 150 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C0PA14420
      Gamma Opticap XL 150 Capsule Filter with Millipore Express SHF Hydrophilic Membrane - C1KA15675
      Gamma Opticap® XL 150 Capsule Filter with Millipore Express® SHF Hydrophilic Membrane - C0KA67061
      OPticap XL 150 Capsule Millipore Express SHF Membr
      Opticap XL 150 Capsule Millipore Express SHF Membr
      Opticap XL 150 Capsule Millipore Express SHF Membr
      Opticap XL 150 Capsule Millipore Express SHF Membr
      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
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5HA18950
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C3AA08641
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C3DA96228
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C3KA94142
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C3PA69436
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C4BA31955
      Opticap XL 150 Capsule Millipore Express SHF Membrane - C6EA56895
      Opticap XL 150 Capsule Millipore Express SHF Membrane - SL0603O080
      Opticap XL 150 Capsule Millipore Express SHF Membrane C4NA28662
      Opticap XL 150 Capsule Millipore Express SHF Membrane C4PA38022
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5AA52082
      Opticap XL 150 Capsule Millipore Express SHF Membrane C5KA40611
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6AA98808
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6EA63604
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6MA14989
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6NA17938
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6NA24814
      Opticap XL 150 Capsule Millipore Express SHF Membrane C6NA29318
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane C6HA76471
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C4AA82364
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C4MA07353
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5CA79270
      Opticap® XL 150 Capsule Millipore Express® SHF Membrane - C5EA14168

      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