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KVSSA10HH1 Opticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 µm 9/16 in. HB/HB

Opticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 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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KVSSA10HH1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKVSSA10HH1
      ReplacesSN2M012A99
      Trade Name
      • Opticap®
      DescriptionOpticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 µm 9/16 in. HB/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      Maximum Operating Temperature80 °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 MaterialMixed Cellulose Esters (MCE)
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMultimedia Durapore®
      SterilitySterile
      Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.5 / 0.2 / 0.22 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤10.8 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 75 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 Durapore® membrane 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 Length10 in. (25 cm)
      Length33.3 cm (13.1 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.56 m²
      Device Size10 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      • Polyvinylidene Fluoride (PVDF)
      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
      Catalogue Number GTIN
      KVSSA10HH1 04053252560248

      Documentation

      Opticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 µm 9/16 in. HB/HB MSDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Multimedia Durapore Membrane C0HB83646
      OPTICAP XL 10 Capsule Multimedia Durapore Membrane C2PB41969Z
      Opticap XL 10 Capsule Multimedia Durapore Membrane C8PA36219
      Opticap XL 10 Capsule Multimedia Durapore Membrane C0MB10103
      Opticap XL 10 Capsule Multimedia Durapore Membrane C0MB49500
      Opticap XL 10 Capsule Multimedia Durapore Membrane C7PA56388
      Opticap XL 10 Capsule Multimedia Durapore Membrane - C7CA75349
      Opticap XL 10 Capsule Multimedia Durapore Membrane - C7DA94272
      Opticap XL 10 Capsule Multimedia Durapore Membrane - C7MA35334
      Opticap XL 10 Capsule Multimedia Durapore Membrane - C9HA31777
      Show more

      Technical Info

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

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules