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MFHL04SH3 Gamma sterilized Millipak® Final Fill 40 Filter Unit 0.45  µm 1/4  in. HB/HB

MFHL04SH3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Panoramica

Replacement Information
Description
Catalogue NumberMFHL04SH3
Trade Name
  • Millipak®
DescriptionGamma sterilized Millipak® Final Fill 40 Filter Unit 0.45  µm 1/4  in. HB/HB
References
Product Information
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet6  mm (¼  in.) stepped hose barb inlet and outlet
Maximum Differential Pressure, bar (psid)Foward:80 psi (5.5 bar) at 25 °C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm); Reverse: 10 psi (0.7 bar) at 25 °C
Maximum Inlet Pressure, bar (psi)80 psi (5.5 bar) at 25 °C
Good Manufacturing PracticesThese products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
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.
MediaDurapore®
Sterilitysterilized by gamma irradiation
SterilizationDevice integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤ 40  kGy gamma exposure.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionStepped Hose Barb
Outlet ConnectionStepped Hose Barb
Bubble Point at 23 °C≥ 26 psi (1790 mbar) air with water
Flow Rate1.0 L/min @ 0.69   bar ∆P
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections
USP 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.
Dimensions
Filtration Area200 cm²
Process Volume40 L
Inlet Connection Diameter1/4 in.
Outlet Connection Diameter1/4 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polysulfone
Support MaterialPolysulfone
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size3
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Numero di catalogo GTIN
MFHL04SH3 04054839378492

Documentation

Material Qualification Dossier

TitoloVersione
1.0

Operational Excellence Dossier

Title

Certificati di Qualità

Titolo
Millipak Final Fill Capsule Durapore Membrane C3AB36801
Millipak Final Fill Capsule Durapore Membrane - C9SA80025
Millipak Final Fill Capsule Durapore Membrane C3NB66576

Informazioni tecniche

Titolo
Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest
Reduce Contamination Risks and Simplify Filtration System Design and Operation

Scheda tecnica

Titolo
Durapore® Family Guide

Manuali d'uso

Titolo
Wetting Instructions for Filter Units with Durapore Membrane

Prodotti e applicazioni correlate

Linee di prodotti

Millipak® Final Fill Filters

Stacked disc filters designed to maximize recovery and enhance protection of your high value product
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