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KVGLS10TT1 | Opticap® Sterile XL10 Durapore® 0.22 µm 1-1/2 in. TC/TC

KVGLS10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Tabla espec. clave

      Description
      Catalogue NumberKVGLS10TT1
      ReplacesKVGL01TC1
      Trade Name
      • Opticap®
      DescriptionOpticap® Sterile XL10 Durapore® 0.22 µm 1-1/2 in. TC/TC
      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: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      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 Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤14 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
      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 Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.73 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Gamma-stable polypropylene
      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

      Certificados de calidad

      Cargo
      Opticap XL 10 Capsule Durapore Membrane
      Opticap XL 10 Capsule Durapore Membrane C4NA29588
      Opticap XL 10 Capsule Durapore Membrane C5KA44297
      Opticap XL 10 Capsule Durapore Membrane - C3BA50300
      Opticap XL 10 Capsule Durapore Membrane - C3CA79201
      Opticap XL 10 Capsule Durapore Membrane - C3DA94347
      Opticap XL 10 Capsule Durapore Membrane - C3EA26933
      Opticap XL 10 Capsule Durapore Membrane - C3JA72753
      Opticap XL 10 Capsule Durapore Membrane - C3NA44358
      Opticap XL 10 Capsule Durapore Membrane - C3NA63497
      Opticap XL 10 Capsule Durapore Membrane - C3SA83904
      Opticap XL 10 Capsule Durapore Membrane - C4AA95915
      Opticap XL 10 Capsule Durapore Membrane - C4AA96481
      Opticap XL 10 Capsule Durapore Membrane - C4DA44365
      Opticap XL 10 Capsule Durapore Membrane - C6AA07252
      Opticap XL 10 Capsule Durapore Membrane - C6AA15554
      Opticap XL 10 Capsule Durapore Membrane - C6JA90743
      Opticap XL 10 Capsule Durapore Membrane C4JA83347
      Opticap XL 10 Capsule Durapore Membrane C5BA63147
      Opticap XL 10 Capsule Durapore Membrane C5HA23854
      Opticap XL 10 Capsule Durapore Membrane C5HA26119
      Opticap XL 10 Capsule Durapore Membrane C5NA73249
      Opticap XL 10 Capsule Durapore Membrane C5PA85144
      Opticap XL 10 Capsule Durapore Membrane C5SA03821
      Opticap XL 10 Capsule Durapore Membrane C6CA27368
      Opticap XL 10 Capsule Durapore Membrane C6CA41249
      Opticap XL 10 Capsule Durapore Membrane C6EA66600
      Opticap XL 10 Capsule Durapore Membrane C6JA82882
      Opticap XL 10 Capsule Durapore Membrane C6JA89933
      Opticap XL 10 Capsule Durapore Membrane C6JA93158
      Opticap XL 10 Capsule Durapore Membrane C6KA06215
      Opticap XL 10 Capsule Durapore Membrane C6KA99411
      Opticap® XL 10 Capsule Durapore® Membrane - C5DA93316
      Opticap® XL 10 Capsule Durapore® Membrane C5JA33305
      Opticap® XL 10 Capsule Durapore® Membrane C5KA50353
      Opticap® XL 10 Capsule Durapore® Membrane C5PA82135
      Opticap® XL 10 Capsule Durapore® Membrane C6BA18557
      Opticap® XL 10 Capsule Durapore® Membrane C6DA48096
      Opticap® XL 10 Capsule Durapore® Membrane C6EA58284
      Opticap® XL 10 Capsule Durapore® Membrane C6EA60916
      Opticap® XL 10 Capsule Durapore® Membrane C6EA70816
      Opticap® XL 10 Capsule Durapore® Membrane - C4CA35161
      Opticap® XL 10 Capsule Durapore® Membrane - C4KA06568
      Opticap® XL 10 Capsule Durapore® Membrane - C4KA97492
      Opticap® XL 10 Capsule Durapore® Membrane - C4MA12902
      Opticap® XL 10 Capsule Durapore® Membrane - C4MA18310
      Opticap® XL 10 Capsule Durapore® Membrane - C5CA82320
      Opticap® XL 10 Capsule Durapore® Membrane - C5EA12576
      Opticap® XL 10 Capsule Multilayer Durapore® Membrane - C4MA14624
      Opticap® XLT 10 Capsule Durapore® Membrane C5HA19618
      Sterile Opticap XL 10 Capsule Filter with Hydrophilic Durapore Membrane - C0PA03627
      Sterile Opticap® XL 10 Capsule Filter with Hydrophilic Durapore® Membrane - C1KA04992
      Sterile Opticap® XL 10 Capsule Filter with Hydrophilic Durapore® Membrane - C1PA39099
      Sterile Opticap® XL 10 Capsule Filter with Hydrophilic Durapore® Membrane - C2DA08960

      Ficha técnica

      Cargo
      Sterile and Gamma Compatible Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Filters
      Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Hydrophilic Filters