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VPPS101NB1 Viresolve® Pro Modus 1.1 Shield

VPPS101NB1
1  
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Replacement Information
Description
Catalogue NumberVPPS101NB1
DescriptionViresolve® Pro Modus 1.1 Shield
References
Product Information
Device ConfigurationModus 1.1 Shield
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/medium 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 100 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
Device Size1.1 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
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
VPPS101NB1 04053252250279

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Viresolve Pro Magnus 1.1 Shield C2AB71111
Viresolve Pro Modus 1.1 Shield
Viresolve Pro Modus 1.1 Shield C1SB35892
Viresolve Pro Modus 1.1 Shield C1JB84191
Viresolve Pro Modus 1.1 Shield C1KB35889
Viresolve Pro Modus 1.1 Shield C1SB84188
Viresolve Pro Modus 1.1 Shield C2AB84187
Viresolve Pro Modus 1.1 Shield C3PB78644
Viresolve Pro Modus 1.1 Shield C9JA62789V
Viresolve Pro Modus 1.1 Shield - C7EA95133