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SMP8A25NB6 OptiScale® 25 Milligard PES 1.2/0.8 µm NB

SMP8A25NB6
6  
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Overview

Description
Catalogue NumberSMP8A25NB6
Trade Name
  • OptiScale®
DescriptionOptiScale® 25 Milligard PES 1.2/0.8 µm NB
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
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)
Packaging Information
Material Size6
Global Trade Item Number
Catalogue Number GTIN
SMP8A25NB6 04054839564413