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CGEP71TP3 Millipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 7 Silicone

CGEP71TP3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCGEP71TP3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 7 Silicone
      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≤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 MaterialSilicone (SI)
      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

      Material Qualification Dossier

      TitleLot Number
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Millipore Express® SHF Cartridge Filter 10 in. 0.2 µm Code 7 Silicone SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Durapore Cartridge C1KB01963
      Millipore Express SHF Cartidge C1PB87428
      Millipore Express SHF Cartridge C7BA52563
      Millipore Express SHF Cartridge C7DA85246
      Millipore Express SHF Cartridge C7JA37635
      Millipore Express SHF Cartridge C8DA49629
      Millipore Express SHF Cartridge C8HA61843
      Millipore Express SHF Cartridge C0BB24898
      Millipore Express SHF Cartridge C0BB24899
      Millipore Express SHF Cartridge C0CB36151

      Technical Info

      Title
      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