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

Durapore® Cartridge Filter 10 in. 0.1 µm Code 0 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CVVL01TP3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      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.
      Quality SegmentMQ400
      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 Size0.1 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
      Global Trade ITEM Number
      Catalogue Number GTIN
      CVVL01TP3 04053252651717

      Documentation

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Duraore Cartridge C7JA40534
      Duraore Cartridge C7MA67162
      Durapore Cartridge C0AB86749
      Durapore Cartridge C1MB52862Z
      Durapore Cartridge C5BB33726
      Durapore Cartridge C5CB52171
      Durapore Cartridge C7NA76545
      Durapore Cartridge C8AA18433
      Durapore Cartridge C8JA96081
      Durapore Cartridge - C7CA94799
      Show more

      Technical Info

      Title
      Bubble Point Ratio Determination for 60/40 and 70/30 IPA
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

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