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KGW9A1TTT1 Opticap® XLT10 Polysep® II 2.0/1.2 µm 1-1/2 in. TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW9A1TTT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKGW9A1TTT1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT10 Polysep® II 2.0/1.2 µm 1-1/2 in. TC
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °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.
      Prefilter MaterialBorosilicate Glass Fiber (BGF)
      T-line/Gauge PortT-line
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolysep™ II
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size2.0 / 1.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 145 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature.
      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 Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length10 in. (25 cm)
      Length37.6 cm (14.8 in.)
      Filtration Area0.46 m²
      Inlet to Outlet Width15.2 cm (6.0 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size2.0 / 1.2 µm
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      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 Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
      Global Trade Item Number
      Catalogue Number GTIN
      KGW9A1TTT1 04053252247088

      Documentation

      Opticap® XLT10 Polysep® II 2.0/1.2 µm 1-1/2 in. TC SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XLT 10 Capsule Polysep II Media C7HA24590
      Opticap XLT 10 Capsule Polysep II Media C7MA64960
      Opticap XLT 10 Capsule Polysep II Media C8JA87856
      Opticap XLT 10 Capsule Polysep II Media C8SA16131
      Opticap XLT 10 Capsule Polysep II Media - C7PA85155
      Opticap XLT 10 Capsule Polysep II Media - C7SA06691
      Opticap XLT 10 Capsule Polysep II Media C1PB99787
      Opticap XLT 10 Capsule Polysep II Media C3KB53490
      Opticap XLT 10 Capsule Polysep II Media C3MB62789
      Opticap XLT 10 Capsule Polysep II Media C8DA37952

      Technical Info

      Title
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules