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KVGLA2ZTT1 Opticap® XLT 20 with Durapore® - 20" 0.22 µm TC/TC, w/ gauge port 1pk

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KVGLA2ZTT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKVGLA2ZTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT 20 with Durapore® - 20" 0.22 µm TC/TC, w/ gauge port 1pk
      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; 3/4 in. Gauge Port
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.4 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.
      T-line/Gauge PortT-line with 3/4 in. Gauge Port T-line side
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityOther
      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 Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤26.6 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 50 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 Length20 in. (50 cm)
      Length62.5 cm (24.6 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area1.4 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size20 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polypropylene
      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 ≥2 L
      Global Trade Item Number
      Catalog Number GTIN
      KVGLA2ZTT1 04053252484995

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Opticap XLT 20 Capsule Durapore Membrane C0JB89018Z
      Opticap XLT 20 Capsule Durapore Membrane - C8AA22636
      Opticap XLT 20 Capsule Durapore Membrane - C8BA31305
      Opticap XLT 20 Capsule Durapore Membrane - C8DA37956
      Opticap XLT 20 Capsule Durapore Membrane - C9HA51657
      Opticap XLT 20 Capsule Durapore Membrane C1MB42460
      Opticap XLT 20 Capsule Durapore Membrane C2EB67715
      Opticap XLT 20 Capsule Durapore Membrane C3DB09178
      Opticap XLT 20 Capsule Durapore Membrane C3MB52163
      Opticap XLT 20 Capsule Durapore Membrane C3SB68067
      Show more

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules