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KTGRA05HH1 Aervent KTGR Opticap XL5 Capsule

Aervent KTGR Opticap XL5 Capsule: Ficha de dados de segurança do material (FDSM) ou ficha de segurança do material (FSM), certificado de análise (CA) e certificado de qualidade (CQ), dossiês e outros documentos disponíveis.
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KTGRA05HH1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKTGRA05HH1
      Trade Name
      • Aervent®
      DescriptionAervent KTGR Opticap XL5 Capsule
      References
      Product Information
      HS Code8421 99 99
      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: 4.1 bar (60 psid), intermittent
      Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C; Reverse - 4.1 bar (60 psi), Intermittent
      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.
      Quality LevelMQ400
      Applications
      Biological Information
      MediaAervent®
      Sterilization30 autoclave cycles of 30 min @ 135 °C
      Bacterial Grow-ThroughRetains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²
      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 ConnectionHose Barb
      Outlet ConnectionHose Barb
      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 28 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.38 mL/min @ 2.6 bar (38 psig) per sample
      Nitrogen Diffusion at 23 °C≤12 mL/min @ 970 mbar (14 psig) in 70/30 % IPA/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).
      Virus Aerosol RetentionRated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.
      USP Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      Dimensions
      Cartridge Nominal Length5 in. (13 cm)
      Length21.3 cm (8.4 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.32 m²
      Inlet to Outlet Width21.3 cm (8.4 in.)
      Device Size5 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 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
      Global Trade Item Number
      Número de catálogo GTIN
      KTGRA05HH1 04053252558788

      Documentation

      Certificados de qualidade

      Título
      OPTI XL 5 Capsule Aervent Membrane C2PB43499
      OPTICAP XL 5 Capsule Aervent Membrane C4DB11313
      Opticap XL 5 Capsule Aervent Membrane C2NB23600
      Opticap XL 5 Capsule Aervent Membrane C7CA86139
      Opticap XL 5 Capsule Aervent Membrane C0CB86703R
      Opticap XL 5 Capsule Aervent Membrane C1CB07847
      Opticap XL 5 Capsule Aervent Membrane C1NB73341
      Opticap XL 5 Capsule Aervent Membrane C7EA07294
      Opticap XL 5 Capsule Aervent Membrane C7HA12031
      Opticap XL 5 Capsule Aervent Membrane C8EA80042
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      Informações técnicas

      Título
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Bubble Point Test Method Using Aervent 0.2 µm Hydrophobic Membrane with 60/40 IPA

      Ficha de dados

      Título
      Sterilizing-Grade Aervent®Filters

      Manuais do usuário

      Título
      Opticap® XL Capsules and Opticap® XLT Capsules