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CVEP03TE3 | Millipore Express® SHR Cartridge Filter 30 in. 0.1 µm Code 0 EPDM

CVEP03TE3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberCVEP03TE3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHR Cartridge Filter 30 in. 0.1 µm Code 0 EPDM
      References
      Product Information
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 6.9 bar bar (100 psi psid) @ 25 °C; 1.7 bar bar (25 psi psid) @ 80 °C; 0.35 bar bar (5 psi psid) @ 135 °C. Reverse: 2.07 bar bar (30 psi psid) @ 25 °C; 0.07 bar bar (1 psi psid) @ 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
      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 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 ≥3 L

      Documentation

      Certificates of Quality

      Title
      Millipore Express SHR Cartridge - SAMPLE1112

      Technical Info

      Title
      1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization (EMD)
      Application Note: Cellvento™ CHO-100 Media Mix and Filtration Optimization (EMD)
      Demonstrating Millipore Express® SHR mycoplasma clearance capability at pilot and production scale over an extended filtration time (EMD)
      Protect Your Process from Mycoplasma Contamination
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      Posters

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

      User Guides

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