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SHGEA25NB6 Millipore Express® SHC Optiscale® 25mm 0.5/0.2 µm NB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
SHGEA25NB6
6  
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Overview

Replacement Information
Description
Catalogue NumberSHGEA25NB6
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHC Optiscale® 25mm 0.5/0.2 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® SHC
Sterilization1 autoclave cycle of 60 min @ 123 °C
WettabilityHydrophilic
Physicochemical Information
Pore Size0.5 / 0.2 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
SHGEA25NB6 04053252679728

Documentation

Certificates of Quality

Title
OpiScale 25 Capsule Millipore Express SHC Membrane C9KA75133
OpotiScale 25 Capsule MIllipore Express SHC Membrane C4CB14363
OptScale 25 Capsule Millipore Express SHC Membrane C8CA48356
OptiScale 25 Capsule Millipore Express SHC Membrane C2NB24057
OptiScale 25 Capsule Millipore Express SHC Membrane C3KB34449
OptiScale 25 Capsule Millipore Express SHC Membrane C1JB27740
OptiScale 25 Capsule Millipore Express SHC C1EB09128
OptiScale 25 Capsule Millipore Express SHC Membrane C2NB24059
OptiScale 25 Capsule Millipore Express SHC Membrane C2NB24067
OptiScale 25 Capsule Millipore Express SHC Membrane C2PB24076
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Brochure

Title
The science of managing change for filters

Data Sheet

Title
Millipore Express®PHF Hydrophilic Filters
Millipore Express®SHC Hydrophilic Filters
Millipore Express®SHR Hydrophilic Filters

Posters

Title
Quality by Design (QbD) Principles in Aseptic Processing

User Guides

Title
OptiScale 25 Capsule Filter User Guide
Vmax Constant Pressure

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