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CVGL75S01 Durapore® Cartridge Filter 5 in. 0.22 µm Code 7

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CVGL75S01
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCVGL75S01
      Trade Name
      • Durapore®
      DescriptionDurapore® Cartridge Filter 5 in. 0.22 µm Code 7
      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 7 (2-226) O-rings w/locking-tabs
      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®
      SterilityOther
      Sterilization30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 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.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Air Diffusion at 23 °C≤6.6 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate25 L/min @ 1.4 bar 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.
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
      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 Length5 in. (12.5 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.35 m²
      Device Size5 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

      Documentation

      Material Qualification Dossier

      TitleLot Number
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Durapore® Cartridge Filter 5 in. 0.22 µm Code 7 SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      DURAPORE CARTRIDGE
      DURAPORE CARTRIDGE
      DURAPORE CARTRIDGE
      DURAPORE CARTRIDGE - F3SA76311
      DURAPORE CARTRIDGE - F4BA92763
      DURAPORE CARTRIDGE - F4CA26549
      DURAPORE CARTRIDGE - F4NA20768Q
      DURAPORE CARTRIDGE - F5CA83106
      DURAPORE CARTRIDGE - F5DA79233
      DURAPORE CARTRIDGE - F5DA79234

      Technical Info

      Title
      Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Hydrophilic Durapore® Cartridges and Capsules User Guide
      Wetting Instructions for Filter Units with Durapore Membrane