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VPMD103NB1 Viresolve® Pro Modus 1.3 Device

VPMD103NB1
1  
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Replacement Information
Description
Catalogue NumberVPMD103NB1
Trade Name
  • Viresolve®
DescriptionViresolve® Pro Modus 1.3 Device
References
Product Information
HS Code8421 29 90
Device ConfigurationModus 1.3 Device
Connections, Inlet/OutletInlet/outlet: 3/4" sanitary TC fittings
Connections, Vent/DrainIntegrated vent: 1/4" Hose barb with double O-ring seal
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
  • Pilot/small volumes
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
Height13.56 cm (5.34 in.)
Width9.22 cm (3.63 in.)
Length18.62 cm (7.33 in.)
Filtration Area0.22 m²
Device Size1.3 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
Katalogové číslo GTIN
VPMD103NB1 04053252720550

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Viresolv Pro Modus 1.3 Device C2JB24711
Viresolve Pro Magnus 1.3 Device C0AB23121
Viresolve Pro Magnus 1.3 Device C1HB71062
Viresolve Pro Magnus 1.3 Device C9JA67595
Viresolve Pro Magnus 1.3 Device C9PA15736
Viresolve Pro Magnus 1.3 Device C9SA43605
Viresolve Pro Modos 1.3 Device C1KB71110
Viresolve Pro Modus 1.3 Device C1MB71086
Viresolve Pro Modus 1.2 Device C2AB70448
Viresolve Pro Modus 1.3 C7EA20251

User Guides

Title
Viresolve® Pro Modus and Magnus Devices User Guide