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K010A05HH1 Opticap® XL5 Clarigard® 1.0 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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K010A05HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberK010A05HH1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL5 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.
      Quality LevelMQ400
      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
      Pore Size1.0 µm
      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 Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 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 ≥2 L
      Global Trade Item Number
      Catalog Number GTIN
      K010A05HH1 04053252608438

      Documentation

      Opticap® XL5 Clarigard® 1.0 µm 9/16 in. HB/HB SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Opticap XL 5 Capsule Clarigard Media C0CB48803
      Opticap XL 5 Capsule Clarigard Media C8JA93927
      Opticap XL 5 Capsule Clarigard Media - C0BB90100
      Opticap XL 5 Capsule Clarigard Media - C0DB60702
      Opticap XL 5 Capsule Clarigard Media C0KB03625
      Opticap XL 5 Capsule Clarigard Media C1AB04013
      Opticap XL 5 Capsule Clarigard Media C3AB44270
      Opticap XL 5 Capsule Clarigard Media C3NB60672
      Opticap XL 5 Capsule Clarigard Media C3PB71694
      Opticap XL 5 Capsule Clarigard Media C8NA41312
      Show more

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules