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KGW6A3THH1 Opticap® XLT30 Polysep® II 1.0/0.5 µm 5/8 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW6A3THH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKGW6A3THH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XLT30 Polysep® II 1.0/0.5 µm 5/8 in. HB
      References
      Product Information
      FormatDouble Layer
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
      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
      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 Size1.0 / 0.5 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Gravimetric ExtractablesThe extractables level was equal to or less than 435 mg per capsule after a 15 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 Length30 in. (75 cm)
      Length87.1 cm (34.3 in.)
      Filtration Area1.38 m²
      Inlet to Outlet Width19.8 cm (7.8 in.)
      Device Size30 in.
      Inlet Connection Diameter5/8 in.
      Nominal Pore Size1.0 / 0.5 µm
      Outlet Connection Diameter5/8 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 ≥15 L
      Global Trade Item Number
      Catalogue Number GTIN
      KGW6A3THH1 04053252258497

      Documentation

      Opticap® XLT30 Polysep® II 1.0/0.5 µm 5/8 in. HB SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XLT 30 Capsule Polysep II Media C7MA66961
      Opticap XLT 30 Capsule Polysep II Media C8AA11259
      Opticap XLT 30 Capsule Polysep II Media C8BA31395
      Opticap XLT 30 Capsule Polysep II Media C8DA38615
      Opticap XLT 30 Capsule Polysep II Media C1BB93153
      Opticap XLT 30 Capsule Polysep II Media C3JB46099
      Opticap XLT 30 Capsule Polysep II Media C7MA66958
      Opticap XLT 30 Capsule Polysep II Media C7NA68168
      Opticap XLT 30 Capsule Polysep II Media C8KA93974
      Opticap XLT 30 Capsule Polysep II Media C8MA25741
      Show more

      Technical Info

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

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules