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SMP2A25NB6 OptiScale® 25 Milligard PES 1.2/0.2 µm nominal NB

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SMP2A25NB6
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Overview

Replacement Information
Description
Catalogue NumberSMP2A25NB6
Trade Name
  • OptiScale®
DescriptionOptiScale® 25 Milligard PES 1.2/0.2 µm nominal NB
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/OutletFemale Luer Lok/ Male Luer Lok
Cartridge CodeNot Applicable
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 per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
MediaMilligard® PES
SterilizationCapsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.
WettabilityHydrophilic
Physicochemical Information
Pore Size1.2 / 0.2 µm
Inlet ConnectionFemale Luer Lok
Outlet ConnectionMale Luer Lok
Maximum Differential PressureForward: 4.14 bar (60 psi) at 25 °C
Reverse: 0 bar
Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
Non-Particle ReleasingThis product was tested and passes the USP test for particulates in injectables.
Dimensions
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
Catalog Number GTIN
SMP2A25NB6 04054839564390

Documentation

Certificates of Quality

Title
OptiScale 25 Capsule Milligard PES Membrane C0PB59080
OptiScale 25 Capsule Milligard PES Membrane C1DB84598
OptiScale 25 Capsule Milligard PES Membrane C1KB56772
OptiScale 25 Capsule Milligard PES Membrane C3AB80686
OptiScale 25 Capsule Milligard PES Membrane - C0AB22785
OptiScale 25 Capsule Milligard PES Membrane - C0JB96885
OptiScale 25 Capsule Milligard PES Membrane - C8HA81559
OptiScale 25 Capsule Milligard PES Membrane - C8MA27231
OptiScale 25 Capsule Milligard PES Membrane - C9PA07586
OptiScale 25 Capsule Milligard PES Membrane - C9PA22636

Technical Info

Title
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency

User Guides

Title
OptiScale 25 Capsule Filter User Guide
User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules
User Guide - Filters with Milligard®PES Membrane

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