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VPMG202NB1 Viresolve® Pro Magnus 2.2 Device

Viresolve® Pro Magnus 2.2 Device MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
VPMG202NB1
1  
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Overview

Replacement Information
Description
Catalogue NumberVPMG202NB1
Trade Name
  • Viresolve®
DescriptionViresolve® Pro Magnus 2.2 Device
References
Product Information
Device ConfigurationMagnus 2.2 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
Height9.50 cm (3.74 in.)
Width20.96 cm (8.25 in.)
Length34.29 cm (13.50 in.)
Filtration Area1.53 m²
Device Size2.2 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
VPMG202NB1 04053252603136

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
C0MB23350
Viresilve Pro Magnus 2.2 Device C8MA24274
Viresole Pro Magnus 2.2 Device C1NB71056
Viresolve Pro Magnes 2.2 Device C1SB71017
Viresolve Pro Magnu 2.2 Device C2CB71177
Viresolve Pro Magnus 2.2 Device C0HB77145
Viresolve Pro Magnus 2.2 Device C0MB23308
Viresolve Pro Magnus 2.2 Device C9HA45311
Viresolve Pro Magnus 2.2 Device
Viresolve Pro Magnus 2.2 Device C0BB03063
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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