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CVVL01TP3 | Durapore® Cartridge Filter 10 in. 0.1 µm Code 0

CVVL01TP3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberCVVL01TP3
      Trade Name
      • Durapore®
      DescriptionDurapore® Cartridge Filter 10 in. 0.1 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.
      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; 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 Size0.1 µm
      Air Diffusion at 23 °C≤20 mL/min @ 3.9 bar (56 psig) in water
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Flow Rate15 L/min @ 700 mbar 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 3.5 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

      Documentation

      Certificates of Quality

      Title
      Durapoer® Cartridge - C2PA05732
      Durapore Cartridge
      Durapore Cartridge C5CA82885
      Durapore Cartridge - C2NA91286
      Durapore Cartridge - C2SA16402
      Durapore Cartridge - C2SA18512
      Durapore Cartridge - C3CA90014
      Durapore Cartridge - C3HA56336
      Durapore Cartridge - C3HA66398
      Durapore Cartridge - C3MA08115
      Durapore Cartridge - C3NA44756
      Durapore Cartridge - C4DA41582
      Durapore Cartridge - C6BA25563
      Durapore Cartridge - C6JA97824
      Durapore Cartridge C4KA03047
      Durapore Cartridge C5BA72248
      Durapore Cartridge C5EA06782
      Durapore Cartridge C5HA18542
      Durapore Cartridge C5MA56233
      Durapore Cartridge C5SA04636
      Durapore Cartridge C6NA28500
      Durapore Cartridge C6PA37124
      Durapore Cartridge- C5EA13582
      Durapore Hydrophilic Cartridge Filter - C0BA93508
      Durapore Hydrophilic Cartridge Filter - C0CA17842
      Durapore Hydrophilic Cartridge Filter - C0EA37166
      Durapore Hydrophilic Cartridge Filter - C0JA60486
      Durapore Hydrophilic Cartridge Filter - C0KA72782
      Durapore Hydrophilic Cartridge Filter - C0NA88843
      Durapore Hydrophilic Cartridge Filter - C0SA10768
      Durapore Hydrophilic Cartridge Filter - C1AA33992
      Durapore Hydrophilic Cartridge Filter - C1CA51725
      Durapore Hydrophilic Cartridge Filter - C1EA64825
      Durapore Hydrophilic Cartridge Filter - C1SA57225
      Durapore Hydrophilic Cartridge Filter - C2BA82428
      Durapore Hydrophilic Cartridge Filter - C2HA28714
      Durapore Hydrophilic Cartridge Filter - C2JA39839
      Durapore Hydrophilic Cartridge Filter - C9NN49448
      Durapore® Cartridge C6HA66997
      Durapore® Cartridge - C2NA80341
      Durapore® Cartridge - C4MA05246
      Durapore® Hydrophilic Cartridge Filter - C1NA42962
      Durapore® Hydrophilic Cartridge Filter - C2AA71796
      Durapore® Hydrophilic Cartridge Filter - C2DA06624

      Technical Info

      Title
      Bubble Point Ratio Determination for 60/40 and 70/30 IPA

      Data Sheet

      Title
      Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Hydrophilic Filters

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      Categories

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