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VPMKVALNB9 Viresolve® Pro Micro 40 Device Kit

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VPMKVALNB9
9  
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Overview

Replacement Information
Description
Catalogue NumberVPMKVALNB9
Trade Name
  • Viresolve®
DescriptionViresolve® Pro Micro 40 Device Kit
OverviewThe Viresolve® Pro Micro 40 Kit is ideally suited for performing your filter sizing and viral clearance evaluations. Each kit contains 3 sets of 3 Micro 40 Devices from three different membrane layering combinations* and certificate of quality. Every Viresolve® Pro Micro Device undergoes a Binary Gas Test before product release ensuring optimum quality and performance consistency.
*Viresolve® Pro Devices are built with two membrane layers. Each Viresolve® Pro Micro 40 Device is packaged in a blister pack and labeled with the device lot and the top layer membrane lot/roll number.
References
Product Information
HS Code8421 29 90
Device ConfigurationMicro
Connections, Inlet/OutletInlet – Female Luer fitting;
Outlet – Male Luer fitting
Connections, Vent/DrainVent – Female Luer fitting
Device ColorWhite
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to Good Manufacturing Practices.
Quality LevelMQ400
Applications
Key Applications
  • Process development studies
  • viral clearance evaluations
Biological Information
Physicochemical Information
Maximum Inlet Pressure (psig)4.1 bar (60 psig)
Non-Fiber ReleasingThis product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
TOC/ConductivityAfter a controlled water flush of 50 L/m², samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Height4.03 cm (1.59 in.)
Diameter4.37 cm (1.72 in.)
Filtration Area3.4 cm²
Materials Information
Materials of ConstructionMembrane – Polyethersulfone (PES); Molded parts – Polyvinylidene Diflouride (PVDF)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Storage Conditions4°C - 30°C
Packaging Information
Material Size9
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalog Number GTIN
VPMKVALNB9 04061842095919

Documentation

Certificates of Quality

Title
Viresolve Pro Micro 40 Device Kit C0BB24516
Viresolve Pro Micro 40 Device Kit C0NB42373
Viresolve Pro Micro 40 Device Kit C1BB06927
Viresolve Pro Micro 40 Device Kit C1BB96631
Viresolve Pro Micro 40 Device Kit C1CB70860
Viresolve Pro Micro 40 Device Kit C1EB83801
Viresolve Pro Micro 40 Device Kit C1HB83802
Viresolve Pro Micro 40 Device Kit C1JB83803
Viresolve Pro Micro 40 Device Kit C1MB83807
Viresolve Pro Micro 40 Device Kit C1NB33529

Brochure

Title
Vmax Constant Pressure Test for Sizing Viral Clearance Filters

Technical Info

Title
Scalability of the Viresolve®Pro Solution using the Micro 40 Scaling Tool

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