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SVPVA25NB9 OptiScale-25 with Viresolve NFP Validation Kit, 3 membrane lots

Parvovirus removal

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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SVPVA25NB9
9  
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Overview

Replacement Information
Description
Catalogue NumberSVPVA25NB9
Trade Name
  • OptiScale®
DescriptionOptiScale-25 with Viresolve NFP Validation Kit, 3 membrane lots
References
Product Information
Device ConfigurationValidation Kit
Connections, Inlet/OutletFemale Luer-Lok/Male Luer slip
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid). Reverse: 0.7 bar (10 psid)
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
ApplicationParvovirus removal
Key Applications
  • Protein Purification
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaViresolve® NFP
SterilizationWater wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
Physicochemical Information
Inlet ConnectionFemale Luer Lok
Outlet ConnectionMale Luer Slip
Non-Fiber ReleasingThis product was manufactured with a Viresolve® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Length2.2 cm (0.87 in.)
Filtration Area3.5 cm²
Process Volume70 mL
Materials Information
Chemistry
  • Modified Polyvinylidene Fluoride (Modified PVDF)
Device Material
  • PVDF
Seal MaterialSilicone (SI)
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
Catalogue Number GTIN
SVPVA25NB9 04053252349966