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KGW9A05FF1 Opticap® XL5 Polysep® II 2.0/1.2 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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KGW9A05FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKGW9A05FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Polysep® II 2.0/1.2 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 Size2.0 / 1.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 61 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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.19 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size2.0 / 1.2 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 ≥2 L
      Global Trade Item Number
      Catalogue Number GTIN
      KGW9A05FF1 04053252386596

      Documentation

      Opticap® XL5 Polysep® II 2.0/1.2 µm 3/4 in. TC/TC SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Polysep II Media C8AA16098
      Opticap XL 5 Capsule Polysep II Media C8HA94221
      Opticap XL 5 Capsule Polysep II Media - C8DA46079
      Opticap XL 5 Capsule Polysep II Media - C9CA96707
      Opticap XL 5 Capsule Polysep II Media C7HA07442
      Opticap XL 5 Capsule Polysep II Media C8KA14694

      Technical Info

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

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules