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1711-10100 General sampling, high purity application, 100 mL

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1711-10100
50  
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      Overview

      Replacement Information
      Description
      Catalogue Number1711-10100
      Trade Name
      • NovaSeptum®
      DescriptionGeneral sampling, high purity application, 100 mL
      References
      Product Information
      HS Code3926 90 90
      Device ConfigurationSingle sampling
      Fitting InletSeptum unit with a 1 mm needle
      Fitting Outlet3-piece Luer
      Maximum Sampling Pressure0.5 bar (7.25 psi)
      Maximum Operating Temperature-20 to 50 °C
      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
      Volume100 mL
      Materials Information
      Device Material
      • Septum: Medical grade platinum-cured silicone
      • Body: Polyester
      • Cannula: ASTM 316L stainless steel
      Tubing MaterialPolyethylene
      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 MaterialSampling bag: polyethylene film; drainage bag: polyethylene film
      Material Size50
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      1711-10100 04053252247620

      Documentation

      Certificates of Quality

      Title
      NOVASEPTUM? HIGH PURITY APPLICATION - 210701-551
      NOVASEPTUM? HIGH PURITY APPLICATION - 210709-551
      NOVASEPTUM? HIGH PURITY APPLICATION - 210728-557
      NOVASEPTUM® HIGH PURITY APPLICATION - 210426-352
      NOVASEPTUM® HIGH PURITY APPLICATION - 210505-351
      NOVASEPTUM® HIGH PURITY APPLICATION - 210512-352
      NOVASEPTUM® HIGH PURITY APPLICATION - 210707-351
      NOVASEPTUM® HIGH PURITY APPLICATION - 210707-352
      NOVASEPTUM® HIGH PURITY APPLICATION - 210820-355
      NOVASEPTUM® HIGH PURITY APPLICATION - 211022-357

      Data Sheet

      Title
      NovaSeptum®High Purity Sampling Unit

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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