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KGW9A3ZTT1 Oticap XLT 30 Polysep® II - 30" 2.0/1.2 µm TC/TC 1pk

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
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KGW9A3ZTT1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKGW9A3ZTT1
      Trade Name
      • Opticap®
      DescriptionOticap XLT 30 Polysep® II - 30" 2.0/1.2 µm TC/TC 1pk
      References
      Product Information
      FormatDouble Layer
      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
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Prefilter MaterialBorosilicate Glass Fiber (BGF)
      T-line/Gauge PortT-line with 3/4 in. Gauge Port T-line side
      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 435 mg per capsule after a 15 L 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 Length30 in. (75 cm)
      Device Size30 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 Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Référence GTIN
      KGW9A3ZTT1 04053252344626

      Documentation

      Oticap XLT 30 Polysep® II - 30" 2.0/1.2 µm TC/TC 1pk FDS

      Titre

      Fiche de données de sécurité des matériaux (FDS) 

      Certificats de qualité

      Titre
      Opticap XLT 30 Capsile Polysep II Media - C8NA16241
      Opticap XLT 30 Capsule Polysep 11 Media C4EB26214
      Opticap XLT 30 Capsule Polysep II Media C8DA35370
      Opticap XLT 30 Capsule Polysep II Media C8AA04848
      Opticap XLT 30 Capsule Polysep II Media C9AA82515
      Opticap XLT 30 Capsule Polysep II Media C1PB99841
      Opticap XLT 30 Capsule Polysep II Media C2PB30841
      Opticap XLT 30 Capsule Polysep II Media C3AB77189
      Opticap XLT 30 Capsule Polysep II Media C3HB20461
      Opticap XLT 30 Capsule Polysep II Media C9HA44756

      Manuels d'utilisation

      Titre
      Opticap® XL Capsules and Opticap® XLT Capsules