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KR10A10FF1 | Opticap® XL10 Polygard®-CR 10.0 µm 3/4 in. TC/TC

KR10A10FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKR10A10FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Polygard®-CR 10.0 µm 3/4 in. TC/TC
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)4.8 bar (70 psid) @ 20 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolygard®-CR
      Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
      Physicochemical Information
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 55 mg per capsule after 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
      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.)
      Diameter10.7 cm (4.2 in.)
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Nominal Pore Size10.0 µm
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polypropylene (PP)
      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

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 10 Capsule Filter with Polygard CR Media - C0KA69768
      Opticap XL 10 Capsule Filter with Polygard CR Media - C1BA34507
      Opticap XL 10 Capsule Filter with Polygard CR Media - C1EA79692
      Opticap XL 10 Capsule Filter with Polygard CR Media - C1MA19977
      Opticap XL 10 Capsule Filter with Polygard CR Media - C1NA44315
      Opticap XL 10 Capsule Polygard -CR Media - C3CA83412
      Opticap XL 10 Capsule Polygard -CR Media - C4CA35774
      Opticap XL 10 Capsule Polygard CR Media C5SA97202
      Opticap XL 10 Capsule Polygard-CR Media - C3AA39891
      Opticap XL 10 Capsule Polygard-CR Media - C3JA76611
      Opticap XL 10 Capsule Polygard-CR Media - C6CA27389
      Opticap XL 10 Capsule Polygard-CR Media - C6DA51799
      Opticap XL 10 Capsule Polygard-CR Media - C6JA72086
      Opticap XL 10 Capsule Polygard-CR Media C5CA86637
      Opticap® XL 10 Capsule Filter with Polygard® CR Media - C1CA54932

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      Product Families

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Depth Filter based > Polygard CR
      Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Polygard Filters > Polygard CR