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KGW6A10FF1 Opticap® XL10 Polysep® II 1.0/0.5 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW6A10FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKGW6A10FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Polysep® II 1.0/0.5 µm 3/4 in. TC/TC
      References
      Product Information
      FormatDouble Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 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)
      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 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)
      Length33.5 cm (13.2 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.46 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size1.0 / 0.5 µm
      Outlet Connection Diameter3/4 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
      KGW6A10FF1 04053252346804

      Documentation

      Opticap® XL10 Polysep® II 1.0/0.5 µm 3/4 in. TC/TC SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      OPTICAP XL 10 Capsule Polysep II Media C3KB50816
      Opticap XL 10 Capsule Polyseop Media C0KB04023
      Opticap XL 10 Capsule Polysep II Media C0DB49505
      Opticap XL 10 Capsule Polysep II Media C9KA63616
      Opticap XL 10 Capsule Polysep II Media C0SB83101
      Opticap XL 10 Capsule Polysep II Media C1KB51417
      Opticap XL 10 Capsule Polysep II Media C2BB26128
      Opticap XL 10 Capsule Polysep II Media C2PB43486
      Opticaqp XL 10 Capsule Polysep II Media C3MB60785

      Technical Info

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

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules