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K010A51HH1 | Opticap® XL1 Clarigard® 1.0 µm 9/16 in. HB/HB

K010A51HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberK010A51HH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL1 Clarigard® 1.0 µm 9/16 in. HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      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) @ 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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaClarigard®
      Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
      Physicochemical Information
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Gravimetric ExtractablesThe extractables level was equal to or less than 10 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
      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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length1 in. (2.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size1 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size1.0 µm
      Outlet Connection Diameter9/16 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 ≥1 L

      Documentation

      Certificates of Quality

      Title
      OPticap XL 1 Capsule Clarigard Media C5HA18621
      Opticap XL 1 Capsule Clarigard Media - C2NA92803
      Opticap XL 1 Capsule Clarigard Media - C2PA02198
      Opticap XL 1 Capsule Clarigard Media - C3HA42451
      Opticap XL 1 Capsule Clarigard Media - C3NA45095
      Opticap XL 1 Capsule Clarigard Media - C3PA70099
      Opticap XL 1 Capsule Clarigard Media - C6CA15539
      Opticap XL 1 Capsule Clarigard Media - C6JA90305
      Opticap XL 1 Capsule Clarigard Media C5NA66660
      Opticap XL 1 Capsule Filter with Clarigar Media - C1EA78729
      Opticap XL 1 Capsule Filter with Clarigard Media - C1DA65520
      Opticap XL 1 Capsule Filter with Clarigard Media - C1DA72565
      Opticap XL 1 Capsule Filter with Clarigard Media - C1HA90715
      Opticap XL 1 Capsule Filter with Clarigard Media - C1PA45351
      Opticap XL 1 Capsule Filter with Clarigard Media - C2HA33108
      Opticap XL 1 Capsule Filter with Clarigard Media - C2MA52438
      Opticap® XL 1 Capsule - C3BA51693
      Opticap® XL 1 Capsule Clarigard® Media - C3MA26503
      Opticap® XL 1 Capsule Clarigard® Media - C4BA26103
      Opticap® XL 1 Capsule Clarigard® Media - C5CA73194
      Opticap® XL 1 Capsule Filter with Clarigard® Media - C2CA01191