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SVEPA25NB6 Millipore Express® SHR Optiscale® 25mm 0.1 µm NB

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
SVEPA25NB6
6  
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Descripción

Replacement Information
Description
Catalogue NumberSVEPA25NB6
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHR Optiscale® 25mm 0.1 µm 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
MediaMillipore Express® SHR
Sterilization1 autoclave cycle of 60 min @ 123 °C
WettabilityHydrophilic
Physicochemical Information
Pore Size0.1 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 Millipore Express® 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
Cartridge Nominal Length1.52 in. (39 mm)
Length3.9 cm (1.52 in.)
Diameter3.1 cm (1.2 in.)
Filtration Area3.5 cm²
Materials Information
Chemistry
  • Polyethersulfone (PES)
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
SVEPA25NB6 04053252679698

Documentation

Certificados de calidad

Cargo
OptiScale 25 Capsule Millipore Express SHR Membrane C8MA18278
OptiScale 25 Capsule Millipore Express SHR Membrane C0MB15345
OptiScale 25 Capsule Millipore Express SHR Membrane C1KB56775
OptiScale 25 Capsule Millipore Express SHR Membrane C8MA29734
OptiScale 25 Capsule Millipore Express SHR Membrane - C0AB18268Y
OptiScale 25 Capsule Millipore Express SHR Membrane - C7DA06277
OptiScale 25 Capsule Millipore Express SHR Membrane - C7KA51055
OptiScale 25 Capsule Millipore Express SHR Membrane - C8MA18275
OptiScale 25 Capsule Millipore Express SHR Membrane - C9NA03165
OptiScale 25 Capsule Millipore Express SHR Membrane C2CB51028
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Licencias necesarias e Información técnica

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Ficha técnica

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Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHR