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SGEPA25NB6 Millipore Express® SHF Optiscale® 25mm 0.2 µm NB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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SGEPA25NB6
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Overview

Replacement Information
Description
Catalogue NumberSGEPA25NB6
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHF Optiscale® 25mm 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® SHF
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
SGEPA25NB6 04053252679711

Documentation

Certificates of Quality

Title
Opitscale 25 Capsule Millipore Express SHF Membrane C0EB74484
OptiScale 2 Capsule Millipore Express SHF Membrane C0AB18271
OptiScale 25 Capsule Millipore Express SHF Membrane C0CB32402
OptiScale 25 Capsule Millipore Express SHF Membrane C0HB81080
OptiScale 25 Capsule Millipore Express SHF Membrane C0KB10764
OptiScale 25 Capsule Millipore Express SHF Membrane C0PB60571
OptiScale 25 Capsule Millipore Express SHF Membrane C1EB09132
OptiScale 25 Capsule Millipore Express SHF Membrane C3AB57708
OptiScale 25 Capsule Millipore Express SHF Membrane C9PA22639
OptiScale 25 Capsule Millipore Express SHF Membrane C9SA80089
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Technical Info

Title
Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters
Scalable Process Filtration with Opticap® XL 150, 300 and 600 Capsules with Millipore Express® Membranes

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

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Categories

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