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KGW9A02TT3 Opticap® XL2 Polysep® II 2.0/1.2 µm 1-1/2 in. TC/TC

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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KGW9A02TT3
3  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKGW9A02TT3
      ReplacesSN1M043A8
      Trade Name
      • Opticap®
      DescriptionOpticap® XL2 Polysep® II 2.0/1.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatDouble Layer
      HS Code7019 90 00
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 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.
      Prefilter MaterialBorosilicate Glass Fiber (BGF)
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolysep™ II
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size2.0 / 1.2 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 45 mg per capsule after a 600 mL flush and 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 media combination 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 Length2 in. (5 cm)
      Length14.2 cm (5.6 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.06 m²
      Inlet to Outlet Width14.2 cm (5.6 in.)
      Device Size2 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size2.0 / 1.2 µm
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      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 Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
      Global Trade Item Number
      Número de catálogo GTIN
      KGW9A02TT3 04053252656439

      Documentation

      Opticap® XL2 Polysep® II 2.0/1.2 µm 1-1/2 in. TC/TC MSDS

      Título

      Ficha de Segurança de Produtos (MSDS) 

      Certificados de qualidade

      Título
      Opticap XL 2 Capsule Polysep 11 Media C1SB05830
      Opticap XL 2 Capsule Polysep II Media C7DA92119
      Opticap XL 2 Capsule Polysep II Media C7HA24917
      Opticap XL 2 Capsule Polysep II Media C1DB12208
      Opticap XL 2 Capsule Polysep II Media C3HB26747
      Opticap XL 2 Capsule Polysep II Media C9CA96625
      Opticap XL 2 Capsule Polysep II Media C1KB51422
      Opticap XL 2 Capsule Polysep II Media C1NB82499
      Opticap XL 2 Capsule Polysep II Media C2KB68838
      Opticap XL 2 Capsule Polysep II Media C3AB82162
      Show more

      Informações técnicas

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

      Manuais do usuário

      Título
      Opticap® XL Capsules and Opticap® XLT Capsules