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CVGL01TP3 Durapore® Cartridge Filter 10 in. 0.22 µm Code 0

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CVGL01TP3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCVGL01TP3
      Trade Name
      • Durapore®
      DescriptionDurapore® Cartridge Filter 10 in. 0.22 µm Code 0
      References
      Product Information
      HS Code8421 29 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: 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
      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≤13.3 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate50 L/min @ 1.4 bar ΔP
      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).
      TOC/ConductivityAfter sterilization and a controlled water flush of 5.5 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      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 Length10 in. (25 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.69 m²
      Device Size10 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 Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
      Global Trade Item Number
      Catalog Number GTIN
      CVGL01TP3 04053252717567

      Documentation

      Material Qualification Dossier

      TitleVersion
      6.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Durapore® Cartridge Filter 10 in. 0.22 µm Code 0 SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      DURAPORE CARTRIDGE C4BB94095
      DURAPORE CARTRIDGE C4KB77962
      Durapore Cartgridge C8EA74363
      Durapore Cartridge C7JA20889
      Durapore Cartridge C0MB27500Z
      Durapore Cartridge C8CA33697
      Durapore Cartridge C0AB89444Z
      Durapore Cartridge C0CB39732Z
      Durapore Cartridge C0DB55548Z
      Durapore Cartridge C0NB41895Z

      FAQ

      QuestionAnswer
      Can Durapore 0.22 micron cartridges be used in the reverse direction?Durapore filters are bidirectionally supported. If the filter is inadvertently used in the reverse direction, a post-use integrity test will identify whether or not the filter cartridge was integral during processing. The specification for theis filter is > 50.0 psi for a water bubble point test and < 13.3 ml/minute per 10"element for a diffusion test. If the filter passes this test, no damage occured during use.

      Please note that the maximum allowable pressure specification is different in the reverse direction - 50 psid vs. 80 psid in the forward direction.

      User Guides

      Title
      Hydrophilic Durapore® Cartridges and Capsules User Guide