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SMP8A25NB6 OptiScale® 25 Milligard PES 1.2/0.8 µm NB

SMP8A25NB6
6  
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Overview

Replacement Information
Description
Catalogue NumberSMP8A25NB6
Trade Name
  • OptiScale®
DescriptionOptiScale® 25 Milligard PES 1.2/0.8 µm NB
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/OutletFemale Luer Lok/ Male Luer Lok
Maximum Inlet Pressure, bar (psi)60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 25 °C.
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 / 0.8 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
Catalogue Number GTIN
SMP8A25NB6 04054839564413

Documentation

Certificates of Quality

Title
OptiScale 25 Capsule Millgard PES Membrane C2CB54394
OptiScale 25 Capsule Milligard PES Membrane C0AB93511
OptiScale 25 Capsule Milligard PES Membrane C0MB15330
OptiScale 25 Capsule Milligard PES Membrane C1BB12945
OptiScale 25 Capsule Milligard PES Membrane C1EB02389
OptiScale 25 Capsule Milligard PES Membrane C1NB77909
OptiScale 25 Capsule Milligard PES Membrane C9SA42305
OptiScale 25 Capsule Milligard PES Membrane - C0AB89540
OptiScale 25 Capsule Milligard PES Membrane - C8HA81561
OptiScale 25 Capsule Milligard PES Membrane - C8MA27235

Technical Info

Title
Bioburden Reduction and Particulate Retention Using Milligard®PES Filters
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency

User Guides

Title
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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