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MPHL04GF2 Sterile Millipak®-40 Filter Unit 0.45 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MPHL04GF2
2  Blister
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Overview

Replacement Information
Description
Catalogue NumberMPHL04GF2
Trade Name
  • Millipak®
DescriptionSterile Millipak®-40 Filter Unit 0.45 µm 3/4 in. TC/TC
References
Product Information
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)5.2 bar (75 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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilitySterile
Sterilization3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥1790 mbar (26 psig) air with water
Flow Rate8.5 L/min @ 2.45 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 1.5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
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).
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Filtration Area200 cm²
Process Volume20 L
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polycarbonate
Support MaterialPolycarbonate
Vent Cap MaterialPolyvinylidene fluoride (PVDF)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size2
Material PackageBlister
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Global Trade Item Number
Catalogue Number GTIN
MPHL04GF2 04053252342400

Documentation

Certificates of Quality

Title
Millipak 40 Gamma Gold Capsule Durapore Membrane C8JA00271
Millipak 40 Gamma Gold Capsule Durapore Membrane - C7BA77795
Millipak 40 Gamma Gold Capsule Durapore Membrane C1PB85742
Millipak 40 Gamma Gold Capsule Durapore Membrane C3KB51865
Millipak 40 Gamma Gold Capsule Durapore Membrane C4DB24159
Millipak 40 Gamma Gold Capsule Durapore Membrane C9HA47358
Millipak 40 Gamma Gold Capsule Durapore Membrane- C7MA64887
Millipak 40 Gamma Gold Capsule Durapore Membrane- C9AA76937
Millipak 40 Gamma Gold Capsule Durapore Membrane- C9JA68301

Technical Info

Title
Best Practices for Managing Reverse Pressure Filter Impact
Integrity Test Troubleshooting - Beyond Rewet and Retest

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane