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CGEP01TF3 Millipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 0 Fluorocarbon

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CGEP01TF3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCGEP01TF3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 0 Fluorocarbon
      References
      Product Information
      Device ConfigurationCartridge
      Maximum Inlet Pressure, bar (psi)Forward - 7 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 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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHF
      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 Size0.2 µm
      Air Diffusion at 23 °C≤30 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥4000 mbar (58 psig) air with water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Differential PressureForward: 6900 mbar (100 psi) @ 25 °C; 1700 bar (25 psi) @ 80 °C; 340 mbar (5 psi) @ 135 °C. Reverse: 2100 mbar (30 psi) @ 25 °C, 69 mbar (1 psi) @ 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 Area0.54 m²
      Device Size10 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene/Polysulfone
      Seal MaterialFluorocarbon rubber
      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
      CGEP01TF3 04053252490002

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Millipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 0 Fluorocarbon SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Millipore Express SHF Cartidge C1MB64281
      Millipore Express SHF Cartridge C7JA49894
      Millipore Express SHF Cartridge C0HB81442
      Millipore Express SHF Cartridge C8DA57559
      Millipore Express SHF Cartridge - C9HA44553
      Millipore Express SHF Cartridge C0MB23431
      Millipore Express SHF Cartridge C1BB10640
      Millipore Express SHF Cartridge C4BB81965
      Millipore Express SHF Cartridge- C7MA67164
      Millipore Express SHF Cartridge- C9PA28913

      FAQ

      QuestionAnswer
      How is Durapore membrane different than Millipore Express SHF?Durapore membrane is made from a different polymer (polyvinylidene fluoride (PVDF) versus the polyethersulfone membrane of Millipore Express SHF) and has a different pore structure. These give Millipore SHF a flow advantage.
      How is the Millipore Express SHF membrane different than the Millipore Express and Express Plus membranes used for Life Science filtration?Millipore Express SHF was designed specifically for pharmaceutical applications, as a sterilizing grade, high flux, and caustic compatible membrane for large scale devices.

      Millipore Express and Express Plus membranes were designed for sterile filtration of tissue culture media and are not compatible with caustics. Millipore Express and Espress Plus are available only in laboratory scale devices.
      Are integrity tests are run on Millipore Express SHF cartridges prior to release?All Millipore Express SHF filters are 100% integrity tested prior to release.
      How do I integrity test this filter?For diffusion testing, cartridge integrity can be measured either: 1) .visually with a downstream mass flow monitor, or 2). with an inverted graduated cylinder, or 3). using an automated integrity tester. For bubble point testing, an enhanced bubble point test (diffusion test followed by a bubble point test) using an automated integrity tester is recommended.