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SPHLA25NB6 Durapore® 0.45 µm Optiscale® 25mm NB

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
SPHLA25NB6
6  
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Descripción

Replacement Information
Description
Catalogue NumberSPHLA25NB6
Trade Name
  • OptiScale®
DescriptionDurapore® 0.45 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
MediaDurapore®
SterilityOther
Sterilization1 autoclave cycle of 60 min @ 123 °C
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 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 15 mL, 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
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
Número de referencia GTIN
SPHLA25NB6 04053252679841

Documentation

Certificados de calidad

Cargo
OptScale 25 Capsule Durapore Membrane C8DA65861
OptiScale 25 Capsule Durapore Membrane - C8HA96391
OptiScale 25 Capsule Durapore Membrane C0EB74487
OptiScale 25 Capsule Durapore Membrane C0HB76857
OptiScale 25 Capsule Durapore Membrane C0MB15343
OptiScale 25 Capsule Durapore Membrane C1HB17134
OptiScale 25 Capsule Durapore Membrane C8AA23433
OptiScale 25 Capsule Durapore Membrane C8MA29732
OptiScale 25 Capsule Durapore Membrane C9CA06061
OptiScale 25 Capsule Durapore Membrane C9SA80079
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Ficha técnica

Cargo
Durapore® Family Guide