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VPMG201NB1 Viresolve® Pro Magnus 2.1 Device

Viresolve® Pro Magnus 2.1 Device MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
VPMG201NB1
1  
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Overview

Replacement Information
Description
Catalogue NumberVPMG201NB1
Trade Name
  • Viresolve®
DescriptionViresolve® Pro Magnus 2.1 Device
References
Product Information
HS Code8421 29 90
Device ConfigurationMagnus 2.1 Device
Connections, Inlet/OutletDisposable 1.5" sanitary TC fittings
Connections, Vent/DrainVent: disposable 3/4" sanitary TC fitting for the port
European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Key Applications
  • Large volume processing
Biological Information
Physicochemical Information
Maximum Inlet Pressure (psig)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
Height4.42 cm (1.74 in.)
Width20.96 cm (8.25 in.)
Length34.29 cm (13.50 in.)
Filtration Area0.51 m²
Device Size2.1 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Materials of ConstructionMembrane: Polyethersulfone (PES); Gaskets: Silicone; Housing: Polyvinylidene fluoride (PVDF)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
VPMG201NB1 04053252654336

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
C8EA82285
Viresolve Pro Magns 2.1 Device C1NB66858
Viresolve Pro Magnus 2.1 Device
Viresolve Pro Magnus 2.1 Device C0BB33754
Viresolve Pro Magnus 2.1 Device C0CB33758
Viresolve Pro Magnus 2.1 Device C0CB43321
Viresolve Pro Magnus 2.1 Device C0EB66883
Viresolve Pro Magnus 2.1 Device C0HB66884
Viresolve Pro Magnus 2.1 Device C0JB72590
Viresolve Pro Magnus 2.1 Device C0JB74471
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Technical Info

Title
Multi-Tier Approach to Assuring Virus Retention and Integrity of Viresolve®Pro Devices

User Guides

Title
Viresolve® Pro Modus and Magnus Devices User Guide