KTGRA10TT1 | Opticap Sterilizing Grade XL10 Aervent 0.2 µm 1-1/2 in. TC/TC

KTGRA10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Spec Table

      Description
      Catalogue NumberKTGRA10TT1
      ReplacesSN2M027A6
      Trade Name
      • Opticap®
      DescriptionOpticap Sterilizing Grade XL10 Aervent 0.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      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: 4.1 bar (60 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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaAervent®
      Sterilization30 autoclave cycles of 30 min @ 135 °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 Size0.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
      Gravimetric ExtractablesThe extractables level was equal to or less than 45 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.75 mL/min @ 2.6 bar (38 psig)
      Nitrogen Diffusion at 23 °C≤10 mL/min @ 1.7 bar (25 psig) in water
      Maximum Inlet Pressure (psig)80 psig
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a PTFE 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.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.65 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
      • Polytetrafluoroethylene (PTFE)
      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

      Documentation

      Certificates of Quality

      Title
      KTGRA10TT1 - C3AA39897
      KTGRA10TT1 - C3CA87600
      OPticap XL 10 Capsule Aervent Membrane C4NA22196
      Opticap XL 10 Capsule Aervent Membrane C4KA08460
      Opticap XL 10 Capsule Aervent Membrane C7BA71287
      Opticap XL 10 Capsule Aervent Membrane C7JA35298
      Opticap XL 10 Capsule Aervent Membrane C7KA47752
      Opticap XL 10 Capsule Aervent Membrane C7KA47752
      Opticap XL 10 Capsule Aervent Membrane C7NA78748
      Opticap XL 10 Capsule Aervent Membrane C8EA78457

      Data Sheet

      Title
      Sterilizing-grade Aervent® Filters