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1711-10050 General sampling, high purity application, 50 mL

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1711-10050
50  
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Overview

Replacement Information
Description
Catalogue Number1711-10050
Trade Name
  • NovaSeptum®
DescriptionGeneral sampling, high purity application, 50 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
Volume50 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
Catalog Number GTIN
1711-10050 04053252259029

Documentation

General sampling, high purity application, 50 mL SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
HIGH PURITY APPLICATION - 200728-554
NOVASEPTUM HIFH PUTITY APPLICATION - 210419-352
NOVASEPTUM® HIGH PURITY APPLICATION - 211115-355
NOVASEPTUM® HIGH PURITY APPLICATION - 211118-356
NOVASEPTUM® HIGH PURITY APPLICATION - 211215-352
NOVASEPTUM® HIGH PURITY APPLICATION - 211215-354
NOVASEPTUM® HIGH PURITY APPLICATION - 220125-353
NOVASEPTUM® HIGH PURITY APPLICATION - 220127-353
NOVASEPTUM® HIGH PURITY APPLICATION - 220324-358
NOVASEPTUM® HIGH PURITY APPLICATION - 220520-354

Data Sheet

Title
NovaSeptum®High Purity Sampling Unit

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Product Families

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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