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LAGRM1S02 Optiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic

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LAGRM1S02
2  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberLAGRM1S02
      Trade Name
      • Optiseal®
      DescriptionOptiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic
      References
      Product Information
      HS Code8421 99 99
      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
      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.
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      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 Length1 in. (2.5 cm)
      Filtration Area0.05 m²
      Device Size1 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 Size2
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      LAGRM1S02 04053252249112

      Documentation

      Certificates of Quality

      Title
      Opticap 1 Cartridge Aervent Membrane C7EA10631
      Optiseal 1 Cartidge Aervent Membrane C8AA07958
      Optiseal 1 Cartriddge Aervent Membrane C1CB42861
      Optiseal 1 Cartridge Aervent C9MA7@$!)R
      Optiseal 1 Cartridge Aervent Membane C9MA72411R
      Optiseal 1 Cartridge Aervent Membrane C1CB42858
      Optiseal 1 Cartridge Aervent Membrane C1DB94855
      Optiseal 1 Cartridge Aervent Membrane C1EB00536
      Optiseal 1 Cartridge Aervent Membrane C2EB75259
      Optiseal 1 Cartridge Aervent Membrane C9CA03033
      Show more

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      Categories

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