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KVGBA10TT1 Opticap Sterilizing Grade XL10 Durapore Hydrophobic 0.22 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KVGBA10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKVGBA10TT1
      ReplacesSN2M027A6
      Trade Name
      • Opticap®
      DescriptionOpticap Sterilizing Grade XL10 Durapore Hydrophobic 0.22 µm 1-1/2 in. TC/TC
      References
      Product Information
      HS Code8421 22 00
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      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: 3.4 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      Sterilization20 autoclave cycles of 30 min @ 126 °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.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥1240 mbar (18 psig) nitrogen with 60/40 % IPA/water
      Nitrogen Diffusion at 23 °C≤10 mL/min @ 1.7 bar (25 psig) with 60/40 % IPA/water
      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)
      Length33.5 cm (13.2 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • 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
      Global Trade Item Number
      Catalogue Number GTIN
      KVGBA10TT1 04053252491047

      Documentation

      Certificates of Quality

      Title
      Opticap XL 10 Capsule Durapore Membrane C8DA65883
      Opticap XL 10 Capsule Durapore Membrane C7EA12179
      Opticap XL 10 Capsule Durapore Membrane C7MA60815
      Opticap XL 10 Capsule Durapore Membrane C9HA34751
      Opticap XL 10 Capsule Durapore Membrane C1HB07881
      Opticap XL 10 Capsule Durapore Membrane C7JA44940
      Opticap XL 10 Capsule Durapore Membrane C7KA52916
      Opticap XL 10 Capsule Durapore Membrane C7MA70244
      Opticap XL 10 Capsule Durapore Membrane C8CA40267
      Opticap XL 10 Capsule Durapore Membrane C9SA80994Z
      Show more

      Technical Info

      Title
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Vent Filter Sizing for Mobius®Single-use Mixing Solution

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules