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VBMSPDKNB9 Viresolve® Barrier Micro Process Development Kit

Process Development Kit

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
VBMSPDKNB9
9  
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Aperçu

Replacement Information
Description
Catalogue NumberVBMSPDKNB9
Trade Name
  • Viresolve®
DescriptionViresolve® Barrier Micro Process Development Kit
OverviewThe Viresolve® Barrier Micro Filter PD kit is ideally suited for performing your evaluation, optimization and scaling studies. Viresolve® Barrier Micro Filters are built with two layers of membrane that demonstrate retention of virus, mycoplasma and bacteria. Each kit contains 9 Micro filters from one membrane lot, a user guide and certificate of quality. The air vent prevents air locking within the device.
References
Product Information
Device ConfigurationMicro
Connections, Inlet/OutletInlet – Female Luer fitting;
Outlet – Male Luer fitting
Device ColorTeal
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
ApplicationProcess Development Kit
Key Applications
  • Process development studies
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 40 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
Height3.83 cm (1.51 in.)
Diameter3.07 cm (1.21 in.)
DimensionsHeight: 3.83 cm (1.51 in.); Diameter: 3.07 cm (1.21 in.)
Filtration Area3.3 cm2
Device SizeMicro
Materials Information
Materials of ConstructionMembrane – Polyethersulfone (PES); Molded parts – Polypropylene
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size9
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Référence GTIN
VBMSPDKNB9 04055977360042

Documentation

Certificats de qualité

Titre
Viresolve Barrier Process Development Kit C1SB00987
Viresolve Barrier Process Development Kit C2EB78077
Viresolve Barrier Process Development Kit - C0CB40257
Viresolve Barrier Process Development Kit - C7MA60700
Viresolve Barrier Process Development Kit - C8EA71984
Viresolve Barrier Process Development Kit - C8EA72604
Viresolve Barrier Process Development Kit - C8KA17945
Viresolve Barrier Process Development Kit C2CB49950
Viresolve Barrier Process Development Kit C7EA09798
Viresolve Barrier Process Development Kit- C9KA77756

Brochure

Titre
Viral Safety Assurance: Prevent, Detect, Remove

Fiche technique

Titre
Viresolve®Barrier Filters

Posters

Titre
Implementation of a Virus Barrier Media Filter into Fed-Batch Bioprocesses
Upstream Virus Safety: Protect Your Bioreactor By Media Filtration

Manuels d'utilisation

Titre
Viresolve® Barrier Micro Filter