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KP15A10HH1 Opticap® XL10 Lifegard™ 1.0 µm 9/16 in. HB/HB

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KP15A10HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKP15A10HH1
      ReplacesKP1501HB1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Lifegard™ 1.0 µm 9/16 in. HB/HB
      References
      Product Information
      FormatSingle Layer
      HS Code7019 90 00
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      Filter GradeAP15
      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.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaLifegard™
      Sterilization3 autoclave cycles of 30 min @ 121 °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 255 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
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 1.0 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.)
      Filtration Area0.46 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter9/16 in.
      Nominal Pore Size1.0 µm
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Borosilicate Glass Fiber (BGF)
      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
      Global Trade Item Number
      Catalog Number GTIN
      KP15A10HH1 04053252496066

      Documentation

      Certificates of Quality

      Title
      Opticap XL 10 Capsule w/ Lifegard Media C3BB93599
      Opticap XL 10 Capsule Lifegard Media C7KA28139
      Opticap XL 10 Capsule Lifegard Media - C7DA01347
      Opticap XL 10 Capsule Lifegard Media - C7MA59662
      Opticap XL 10 Capsule Lifegard Media - C9CA96618
      Opticap XL 10 Capsule Lifegard Media C1NB77991
      Opticap XL 10 Capsule Lifegard Media C2JB86327
      Opticap XL 10 Capsule Lifegard Media C3KB42703
      Opticap XL 10 Capsule Lifegard Media C8JA94041

      Technical Info

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

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules