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CCGL02TP1 Charged Durapore® Cartridge 20 in. 0.22 µm Code 0

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CCGL02TP1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCCGL02TP1
      Trade Name
      • Durapore®
      DescriptionCharged Durapore® Cartridge 20 in. 0.22 µm Code 0
      References
      Product Information
      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: 3.5 bar (50 psid) @ 25 °C
      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 - 3.5 bar (50 psi) @ 25 °C
      Cartridge CodeCode 0 (2-222) O-rings
      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
      MediaCharged Durapore®
      SterilityOther
      Sterilization10 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.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Air Diffusion at 23 °C≤20 mL/min @ 2.1 bar (30 psig) in water
      Bubble Point at 23 °C≥3100 mbar (45 psig) air with water
      Flow Rate45 L/min @ 600 mbar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
      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)
      Diameter6.9 cm (2.7 in.)
      Filtration Area1.38 m²
      Device Size20 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 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 ≥500 mL
      Global Trade Item Number
      Catalogue Number GTIN
      CCGL02TP1 04053252306570

      Documentation

      Certificates of Quality

      Title
      CHARGED DURAPORE CARTRIDGE C3CB84696
      Cahrged Durapore Cartridge C8MA07154
      Charged Durapore Cartridge C0CB36147
      Charged Durapore Cartridge C3KB51030
      Charged Durapore Cartridge C8NA32918
      Charged Durapore Cartridge - C7EA88949
      Charged Durapore Cartridge - C8SA70408
      Charged Durapore Cartridge C0KB00962
      Charged Durapore Cartridge C0KB14933
      Charged Durapore Cartridge C0NB37528
      Show more

      Technical Info

      Title
      Bubble Point Test Method Using Durapore® 0.22 µm Hydrophilic Membrane with 60/40 IPA

      User Guides

      Title
      Hydrophilic Durapore® Cartridges and Capsules User Guide

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore