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KPGEA03TH3 Opticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC-9/16 in. HB

Opticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC-9/16 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KPGEA03TH3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKPGEA03TH3
      Trade Name
      • Millipore Express®
      DescriptionOpticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC-9/16 in. HB
      References
      Product Information
      HS Code8421 22 00
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Inlet Pressure, bar (psi)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® PHF
      Sterilization3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
      Bacterial RetentionSamples of membrane used in this filter 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
      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 Pressure5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C
      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 3.0 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 Area0.16 m²
      Inlet to Outlet Width17.3 cm (6.8 in.)
      Device Size3 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      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
      KPGEA03TH3 04055977296112

      Documentation

      Certificates of Quality

      Title
      Opticap XL 3 Capsule Millipore Express PHF Membrane C3MB60678
      Opticap XL 3 Capsule Millipore Express PHF Membrane C4DB09828
      Opticap XL 3 Capsule Millipore Express PHF Membrane C8DA44739
      Opticap XL 3 Capsule Millipore Express PHF Membrane C9HA09263
      Opticap XL 3 Capsule Millipore Express PHF Membrane - C8PA41318
      Opticap XL 3 Capsule Millipore Express PHF Membrane - C9SA81010
      Opticap XL 3 Capsule Millipore Express PHF Membrane C0CB38033
      Opticap XL 3 Capsule Millipore Express PHF Membrane C3DB03188