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LAGR04TP6 Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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LAGR04TP6
6  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberLAGR04TP6
      Trade Name
      • Optiseal®
      DescriptionOptiseal Aervent Cartridge Filter 0.2 µm hydrophobic
      References
      Product Information
      HS Code8421 39 90
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 4.1 bar (60 psid)
      Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 4.1 bar (60 psi)
      Cartridge CodeNot Applicable
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaAervent®
      Sterilization80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave cycles of 30 min @ 135 °C
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.2 µm
      Bubble Point at 23 °C≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
      Gravimetric ExtractablesThe extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.20 mL/min with water @ 2.6 bar (38 psig)
      Nitrogen Diffusion at 23 °C≤6 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water
      Non-Fiber ReleasingThis product was manufactured with a PTFE 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 Length4 in. (10 cm)
      Filtration Area0.18 m²
      Device Size4 in.
      Materials Information
      Chemistry
      • Polytetrafluoroethylene (PTFE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size6
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalog Number GTIN
      LAGR04TP6 04053252344305

      Documentation

      Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      OPTISEAL 4 CARTRIDGE AERVENT MEMBRANE C1CB71709
      Opticap 4 Cartridge Aervent Membrane C8EA61361
      Opticap 4 Cartridge Aervent Membrane C8PA55949
      Optiseal 4 Cartidge Aervent Membrane C0JB00125
      Optiseal 4 Cartridge Aervent Meembrane C2SB57893
      Optiseal 4 Cartridge Aervent Membrane C0CB21116R
      Optiseal 4 Cartridge Aervent Membrane C0EB61711
      Optiseal 4 Cartridge Aervent Membrane C0NB26518
      Optiseal 4 Cartridge Aervent Membrane C1BB97621
      Optiseal 4 Cartridge Aervent Membrane C1CB71710
      Show more

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent