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CGEP01TE3 | Millipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 0 EPDM

CGEP01TE3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberCGEP01TE3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 0 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 0 (2-222) O-rings
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      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 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

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Millipore Express SHF Cartridge - C3MA99585
      Millipore Express SHF Cartridge - SAMPLE1011
      Millipore Express SHF Cartridge C5CA86931

      Technical Info

      Title
      1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization (EMD)
      Application Note: Cellvento™ CHO-100 Media Mix and Filtration Optimization (EMD)
      Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters
      Steam-in-Place Method in the Reverse Direction for Millipore Express® PES Filters

      Data Sheet

      Title
      Millipore Express® SHF Hydrophilic Filters (EMD)

      Posters

      Title
      Quality by Design (QbD) Principles in Aseptic Processing (EMD)

      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.

      User Guides

      Title
      Filters with Millipore Express® Membrane -Wetting Instructions, Integrity Testing and Drying Guidelines