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CGEP75TE3 Millipore Express® SHF Cartridge Filter 5 in. 0.2 µm Code 7 EPDM

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CGEP75TE3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCGEP75TE3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHF Cartridge Filter 5 in. 0.2 µm Code 7 EPDM
      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 7
      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≤16.4 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 5.5 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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length5 in. (12.5 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.29 m²
      Device Size5 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene/Polysulfone
      Seal MaterialEPDM
      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
      CGEP75TE3 04053252454066

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Millipore Express® SHF Cartridge Filter 5 in. 0.2 µm Code 7 EPDM SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Millipore Express SHF Cartridge C0NB27716
      Millipore Express SHF Cartridge C7MA55296
      Millipore Express SHF Cartridge - C7DA05249
      Millipore Express SHF Cartridge - C7PA88891
      Millipore Express SHF Cartridge - C8AA10718
      Millipore Express SHF Cartridge - C9AA82066
      Millipore Express SHF Cartridge - C9DA17852
      Millipore Express SHF Cartridge C0PB54200
      Millipore Express SHF Cartridge C1BB14232
      Millipore Express SHF Cartridge C1PB25854
      Show more

      Technical Info

      Title
      1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization
      Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
      Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters
      Scalable Process Filtration with Opticap® XL 150, 300 and 600 Capsules with Millipore Express® Membranes
      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