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1461-90005 General sampling, Accurate Volume application, 5 mL

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1461-90005
50  
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      Overview

      Replacement Information
      Description
      Catalogue Number1461-90005
      Trade Name
      • NovaSeptum®
      DescriptionGeneral sampling, Accurate Volume application, 5 mL
      References
      Product Information
      Device ConfigurationSingle sampling
      Fitting InletSeptum unit with a 1 mm needle
      Fitting OutletFemale or Male Luer in PVDF
      Maximum Sampling Pressure0.5 bar (7.25 psi)
      Maximum Operating TemperatureSingle 5mL: -80 to 134 °C (-112 to 273 °F)
      Quality LevelMQ400
      Applications
      ApplicationSterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤2.15 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      SterilitySterile
      SterilizationBeta Irradiation (e-beam) minimum 25 kGy according to ISO 11137 TIR No. 27
      Physicochemical Information
      Dimensions
      Needle Size1.0 mm
      Volume5 mL
      Materials Information
      Device Material
      • Syringe: polycarbonate, medical grade, platinum-cured silicone, medical silicone fluid
      Tubing MaterialMedical grade, platinum-cured silicone
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Animal Origin MaterialsPlease refer to the Animal Origin Statement
      Storage and Shipping Information
      Packaging Information
      Bag MaterialDrainage bag: polyethylene film
      Material Size50
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalog Number GTIN
      1461-90005 04053252479533

      Documentation

      Certificates of Quality

      Title
      NOVASEPTUM? ACCURATE VOLUME APPLICATION - 210812-502
      NOVASEPTUM? ACCURATE VOLUME APPLICATION - 211006-505
      NOVASEPTUM? ACCURATE VOLUME APPLICATION - 211027-503
      NOVASEPTUM® ACCURATE VOLUME APPLICATION - 200226-502
      NOVASEPTUM® ACCURATE VOLUME APPLICATION- 160704-503
      NOVASEPTUM® ACCURATE VOLUME APPLICATION - 200908-501
      NOVASEPTUM® ACCURATE VOLUME APPLICATION - 160219-504
      NOVASEPTUM® ACCURATE VOLUME APPLICATION - 160307-507
      NOVASEPTUM® ACCURATE VOLUME APPLICATION - 160405-508
      NOVASEPTUM® ACCURATE VOLUME APPLICATION - 160511-506

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      Categories

      Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Sampling > NovaSeptum
      Small Molecule Pharmaceuticals > API Synthesis > Sterile Sampling > NovaSeptum
      Biopharmaceutical Manufacturing > Formulation > Sterile Sampling > NovaSeptum
      Biopharmaceutical Manufacturing > Upstream Processing > Sterile Sampling (NovaSeptum) > NovaSeptum
      Biopharmaceutical Manufacturing > Harvest > Sterile Sampling > NovaSeptum
      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Sampling > NovaSeptum
      Biopharmaceutical Manufacturing > Drug Substance > Sterile Sampling > NovaSeptum