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SPGEA25NB6 Millipore Express® PHF Optiscale® 25mm 0.2 µm NB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
SPGEA25NB6
6  
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Overview

Replacement Information
Description
Catalogue NumberSPGEA25NB6
Trade Name
  • Millipore Express®
DescriptionMillipore Express® PHF Optiscale® 25mm 0.2 µm NB
References
Product Information
HS Code8421 22 00
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® PHF
Sterilization1 autoclave cycle of 60 min @ 123 °C
WettabilityHydrophilic
Physicochemical Information
Pore Size0.2 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
Catalogue Number GTIN
SPGEA25NB6 04055977295634

Documentation

Certificates of Quality

Title
OptiScale 25 Capsule Millipore Express PFH Membrane C9AA79421
OptiScale 25 Capsule Millipore Express PHF Membane C8MA27153
OptiScale 25 Capsule Millipore Express PHF Membrane C1AB96351
OptiScale 25 Capsule Millipore Express PHF Membrane C3JB44250
OptiScale 25 Capsule Millipore Express PHF Membrane - C7EA10807
OptiScale 25 Capsule Millipore Express PHF Membrane - C7JA45879
OptiScale 25 Capsule Millipore Express PHF Membrane - C8AA14112
OptiScale 25 Capsule Millipore Express PHF Membrane - C8BA34668
OptiScale 25 Capsule Millipore Express PHF Membrane - C8BA34670
OptiScale 25 Capsule Millipore Express PHF Membrane - C8MA29731
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User Guides

Title
OptiScale 25 Capsule Filter User Guide
OptiScale®-25 Capsule Filter with Millipore Express® PHF Membrane

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