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CVEP73TS3 Millipore Express® SHR Cartridge Filter 30 in. 0.1 µm Code 7 Silicone

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CVEP73TS3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCVEP73TS3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHR Cartridge Filter 30 in. 0.1 µm Code 7 Silicone
      References
      Product Information
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C. Reverse: 2.07 bar (30 psi) @ 25 °C; 0.07 bar (1 psi) @ 135 °C
      Cartridge CodeCode 7
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Key Applications
      • Sterile Filtration
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHR
      Sterilization25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 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≤99.9 mL/min @ 3.45 bar (50 psig) in water
      Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Differential PressureForward:
      100 psi (6.9 bar) at 25 °C
      25 psi (1.7 bar) at 80 °C
      5.0 psi (340 mbar) at 135 °C

      Reverse:
      30 psi (2.1 bar) at 25 °C
      <1.0 psi (69 mbar) at 135 °C
      Non-Fiber ReleasingThis product was manufactured with a Millipore Express® 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 30 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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length30 in. (75 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area1.8 m²
      Device Size30 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene/Polysulfone
      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 ≥3 L
      Global Trade Item Number
      Catalog Number GTIN
      CVEP73TS3 04053252303555

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Durapore Cartridge C2AB14212
      Durapore Cartridge C2BB40768
      Millipore Express SHR Cartridge C7CA83257
      Millipore Express SHR Cartridge C0HB65610
      Millipore Express SHR Cartridge C1HB01862
      Millipore Express SHR Cartridge C1JB31134
      Millipore Express SHR Cartridge C4BB86833
      Millipore Express SHR Cartridge C4CB01272
      Millipore Express SHR Cartridge C7CA95225
      Millipore Express SHR Cartridge C9NA13926Y
      Show more

      Technical Info

      Title
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters
      Steam-in-Place Method in the Reverse Direction for Millipore Express® PES Filters

      Posters

      Title
      Quality by Design (QbD) Principles in Aseptic Processing

      User Guides

      Title
      User Guide - Filters with Millipore Express®Membrane