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SHGLA25NB6 Multilayer Durapore® 0.45 µm/0.22 µm Optiscale® 25mm NB

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
SHGLA25NB6
6  
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Aperçu

Replacement Information
Description
Catalogue NumberSHGLA25NB6
Trade Name
  • OptiScale®
DescriptionMultilayer Durapore® 0.45 µm/0.22 µm Optiscale® 25mm NB
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/OutletFemale Luer Lok/ Male Luer Lok
Maximum Inlet Pressure, bar (psi)4.1 bar (60 psi) @ 25 °C
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMultilayer Durapore®
SterilityOther
Sterilization1 autoclave cycle of 60 min @ 123 °C
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 / 0.22 µm
Inlet ConnectionFemale Luer Lok
Outlet ConnectionMale Luer Lok
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Pressure60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 25 °C.
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Non-Particle ReleasingThis product was tested and passes the USP <788> test for particulates in injectables.
TOC/ConductivityAfter sterilization and a controlled water flush of 35 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Length3.9 cm (1.52 in.)
Diameter3.1 cm (1.2 in.)
Filtration Area3.5 cm²
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Support MaterialPolypropylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size6
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Référence GTIN
SHGLA25NB6 04053252679766

Documentation

Certificats de qualité

Titre
Millipore Express SHC Cartridge - C0AB18265Z
OPTISCALE 25 Multilayer Durapore membrane C4HB38899
OptScale 25 Capsule Multilayer Durapore Membrane C8DA65859
OptScale 25 Capsule Multilayer Durapore Membrane C8JA05666
OptiScale 25 Capsule Multilayer Durapore Membrane C0PB46616Z
OptiScale 25 Capsule Multilayer Durapore Membrane C1BB12947Z
OptiScale 25 Capsule Multilayer Durapore Membrane C1DB81125Z
OptiScale 25 Capsule Multilayer Durapore Membrane C1EB02386Z
OptiScale 25 Capsule Multilayer Durapore Membrane C1EB02387Z
OptiScale 25 Capsule Multilayer Durapore Membrane C4EB28436
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Fiche technique

Titre
Durapore® Family Guide
Millipore Express®PHF Hydrophilic Filters
Millipore Express®SHC Hydrophilic Filters
Millipore Express®SHR Hydrophilic Filters

Manuels d'utilisation

Titre
OptiScale 25 Capsule Filter User Guide