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KTGRA10FF1 Aervent KTGR Opticap XL10 Capsule

Aervent KTGR Opticap XL10 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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KTGRA10FF1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKTGRA10FF1
      Trade Name
      • Aervent®
      DescriptionAervent KTGR Opticap XL10 Capsule
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 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), 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, 2014/68/EU of 15 May 2014. This product has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, 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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤24 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water
      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 per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.75 mL/min @ 2.6 bar (38 psig) per sample
      Nitrogen Diffusion at 23 °C≤24 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).
      USP Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      Dimensions
      Cartridge Nominal Length10 in. (25 cm)
      Length33.0 cm (13.0 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.65 m²
      Inlet to Outlet Width33.0 cm (13.0 in.)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 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
      KTGRA10FF1 04053252603686

      Documentation

      Certificados de qualidade

      Título
      Opticap XL 10 Capsule Aervent Membrane C7HA24962
      Opticap XL 10 Capsule Aervent Membrane C7PA85203
      Opticap XL 10 Capsule Aervent Membrane C7EA07307
      Opticap XL 10 Capsule Aervent Membrane C8EA81409
      Opticap XL 10 Capsule Aervent Membrane C9MA91610
      Opticap XL 10 Capsule Aervent Membrane - C7DA01363
      Opticap XL 10 Capsule Aervent Membrane - C7NA70250
      Opticap XL 10 Capsule Aervent Membrane - C8CA38911
      Opticap XL 10 Capsule Aervent Membrane - C8NA50004
      Opticap XL 10 Capsule Aervent Membrane C1MB51498
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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