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KGW1A05HH1 | Opticap® XL5 Polysep® II 1.0/0.2/0.1 µm 9/16 in. HB/HB

KGW1A05HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKGW1A05HH1
      ReplacesSN1M016A01
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 Polysep® II 1.0/0.2/0.1 µm 9/16 in. HB/HB
      References
      Product Information
      FormatTriple Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 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
      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)
      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
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      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.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.17 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size1.0 / 0.2 / 0.1 µm
      Outlet Connection Diameter9/16 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

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Polysep II Media - C3HA34433
      Opticap XL 5 Capsule Polysep II Media - C3PA78415
      Opticap XL 5 Capsule Polysep II Media - C4BA26916
      Opticap XL 5 Capsule Polysep II Media - SAMPLE1446
      Opticap XL 5 Capsule Polysep II Media C4NA33483
      Opticap XL 5 Capsule Polysep II Media C5JA28985
      Opticap XL Capsule Filter with Polygard II Media - C2HA27802
      Opticap XL Capsule Filter with Polysep II Media - C0AA89245
      Opticap XL Capsule Filter with Polysep II Media - C0BA91126
      Opticap XL Capsule Filter with Polysep II Media - C0BA95225
      Opticap XL Capsule Filter with Polysep II Media - C0MA82758
      Opticap XL Capsule Filter with Polysep II Media - C0NA85886
      Opticap XL Capsule Filter with Polysep II Media - C1BA44783
      Opticap XL Capsule Filter with Polysep II Media - C1CA53170
      Opticap XL Capsule Filter with Polysep II Media - C1CA61492
      Opticap XL Capsule Filter with Polysep II Media - C1CA62851
      Opticap XL Capsule Filter with Polysep II Media - C1DA64433
      Opticap XL Capsule Filter with Polysep II Media - C1EA76673
      Opticap XL Capsule Filter with Polysep II Media - C1EA82322
      Opticap XL Capsule Filter with Polysep II Media - C1PA46671
      Opticap XL Capsule Filter with Polysep II Media - C2MA63573
      Opticap® XL Capsule Filter with Polysep™ II Media - C1MA17892
      Opticap® XL Capsule Filter with Polysep™ II Media - C1MA23481
      Opticap® XL Capsule Filter with Polysep™ II Media - C1NA41715