LAGB04TP6 Optiseal® Durapore® Cartridge Filter 0.22 µm hydrophobic

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LAGB04TP6
6  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberLAGB04TP6
      Trade Name
      • Optiseal®
      DescriptionOptiseal® Durapore® Cartridge Filter 0.22 µm hydrophobic
      References
      Product Information
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 3.5 bar (50 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C KEEP
      Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 3.5 bar (50 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 25 °C
      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
      MediaDurapore®
      Sterilization30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °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 Size0.22 µm
      Bubble Point at 23 °C≥1240 mbar (18 psig) nitrogen with 60/40 % 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.
      Nitrogen Diffusion at 23 °C≤2 mL/min @ 1.0 bar (15 psig) in 60/40 % IPA/water
      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 Length4 in. (10 cm)
      Filtration Area0.18 m²
      Device Size4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      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

      Documentation

      Certificates of Quality

      Title
      Opteseal 4 Cartridge Durapore Membrane C5DA84671
      Opticap 4 Cartridge Durapore Membrane - C4AA79991
      Opticap 4 Cartridge Durapore Membrane - C4AA89099
      Opticap 4 Cartridge Durapore Membrane C7AA67636
      Opticap® XL 10 Capsule Durapore® Membrane C5SA90507
      Opticeal 4 Cartridge Durapore Membrane C5KA39330
      Opticseal $ Cartridge Durapore Membrane C5MA50421
      Optiiseal 4 Cartridge Durapore Membrane - C3BA47507
      Optiseal 4 C artridge Durapore Membrane C6BA21963
      Optiseal 4 Capsule Durapore Membrane - C7BA69603

      Technical Info

      Title
      Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
      Filter Integrity Test Methods

      Data Sheet

      Title
      Sterilizing-grade Durapore® 0.22 µm Hydrophobic Filters