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CVEP71TS1 Millipore Express® SHR Cartridge Filter 10 in. 0.1 µm Code 7 Silicone

Millipore Express® SHR Cartridge Filter 10 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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CVEP71TS1
1  Double Easy-Open bag
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      개요

      Replacement Information
      Description
      Catalogue NumberCVEP71TS1
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHR Cartridge Filter 10 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 SegmentMQ400
      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≤33.3 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 10 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 Length10 in. (25 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.6 m²
      Device Size10 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 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 ≥1 L
      Global Trade ITEM Number
      카탈로그 번호 GTIN
      CVEP71TS1 04053252608155

      Documentation

      Material Qualification Dossier

      TitleVersion
      5.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Durapore Cartridge C2AB14213
      Millipore Express SHR Cartridge C9MA93842Y
      Millipore Express SHR Cartridge C3PB64164
      Millipore Express SHR Cartridge C7MA66413
      Millipore Express SHR Cartridge C8AA11337Y
      Millipore Express SHR Cartridge C9AA87122Y
      Millipore Express SHR Cartridge - C9NA09312Y
      Millipore Express SHR Cartridge C1DB73566
      Millipore Express SHR Cartridge C1EB00346
      Millipore Express SHR Cartridge C2EB79364
      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

      Data Sheet

      Title
      Millipore Express®SHR Hydrophilic Filters

      Posters

      Title
      Quality by Design (QbD) Principles in Aseptic Processing

      User Guides

      Title
      User Guide - Filters with Millipore Express®Membrane