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AC464-90020 NovaSeptum®, Accurate Volume Application, 5 x 20 ml Aseptiquik®

Sterility testing, Bioburden, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications or any other routine lab testing

AC464-90020
4  
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Overview

Replacement Information
Description
Catalogue NumberAC464-90020
Trade Name
  • NovaSeptum®
DescriptionNovaSeptum®, Accurate Volume Application, 5 x 20 ml Aseptiquik®
References
Product Information
HS Code9018 39 99
Device ConfigurationMulti-sampling
Fitting InletAseptiquik® connector
Fitting OutletMale Luer
Maximum Sampling Pressure0.5 bar (7.25 psi)
Maximum Operating Temperature4-40 °C temp. range (39 -104 °F)
Quality LevelMQ400
Applications
ApplicationSterility testing, Bioburden, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications or any other routine lab testing
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤2.15 EU/sampling device as determined by the Limulus Amebocyte Lysate (LAL) Test
SterilitySterile
SterilizationGamma irradiation minimum 25 kGy according to ISO 11141
Physicochemical Information
Dimensions
Volume5*20mL
Materials Information
Device Material
  • polycarbonate
Tubing MaterialMedical grade, platinum-cured silicone;Inlet C-Flex®
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Bag Materialdrainage bag: polyethylene film
Material Size4
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
AC464-90020 04065269844921

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

Title

Certificates of Quality

Title
NovaSeptum® Multi Sampling - 240207-555
NovaSeptum® Multi Sampling - 251002-552
NovaSeptum® Multi Sampling - 251125-552
This product was manufactured by a facility whicadheres to Good Manufacturing Practices guidelinesSpecial emphasis has been placed on cleanliness anenvironmental control conditions. ® - 260116-556

Data Sheet

Title
Data Sheet -NovaSeptum® SURe

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