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KGEPG03TB3 Opticap® XL3 Millipore Express® SHF Gamma Compatible 0.2 µm 1-1/2 in. TC-1 in. HB

Opticap® XL3 Millipore Express® SHF Gamma Compatible 0.2 µm 1-1/2 in. TC-1 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGEPG03TB3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKGEPG03TB3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL3 Millipore Express® SHF Gamma Compatible 0.2 µm 1-1/2 in. TC-1 in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/25 mm (1 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 25 °C; 5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
      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
      SterilityGamma
      SterilizationGamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      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
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤9.5 mL/min @ 2.8 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 Inlet Pressure (psig)80 psig
      Maximum Differential Pressure80 psi (5.5 bar) continuous
      100 psi (6.9 bar) intermittent
      Maximum Inlet Temperature25 °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 3.5 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 Length3 in. (7.5 cm)
      Length17.3 cm (6.8 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.17 m²
      Inlet to Outlet Width17.3 cm (6.8 in.)
      Device Size3 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      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
      Catalogue Number GTIN
      KGEPG03TB3 04053252309014

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Opticap XL 3 Capsule Millipore Express SHF Membrane C0NB19589
      Opticap XL 3 Capsule Millipore Express SHF Membrane C1SB46981
      Opticap XL 3 Capsule Millipore Express SHF Membrane C4DB36396
      Opticap XL 3 Capsule Millipore Express SHF Membrane - C8DA49919
      Opticap XL 3 Capsule Millipore Express SHF Membrane C2PB47256
      Opticap XL 3 Capsule Millipore Express SHF Membrane C3CB85025
      Opticap XL 3 Capsule Millipore Express SHF Membrane C4DB09821
      Opticap XL 3 Capsule Millipore Express SHF Membrane C9BA75042