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MPHL04GH2 Sterile Millipak®-40 Filter Unit 0.45 µm 1/4 in. HB/HB w/bell

Sterile Millipak®-40 Filter Unit 0.45 µm 1/4 in. HB/HB w/bell MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MPHL04GH2
2  Blister
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Replacement Information
Description
Catalogue NumberMPHL04GH2
Trade Name
  • Millipak®
DescriptionSterile Millipak®-40 Filter Unit 0.45 µm 1/4 in. HB/HB w/bell
References
Product Information
HS Code8421 21 00
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet6 mm (1/4 in.) Hose Barb with bell
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 ConnectionHose Barb
Outlet ConnectionHose Barb with Bell
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 Diameter1/4 in.
Outlet Connection Diameter1/4 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
Numer katalogowy GTIN
MPHL04GH2 04053252378805

Documentation

Certificates of Quality

Title
Millipak 40 Gamma Gold Capsule Durapore Membrane C8PA59188
Millipak 40 Gamma Gold Capsule Durapore Membrane - C7PA84597
Millipak 40 Gamma Gold Capsule Durapore Membrane - C9HA41365
Millipak 40 Gamma Gold Capsule Durapore Membrane C0AB87113
Millipak 40 Gamma Gold Capsule Durapore Membrane C1CB03829
Millipak 40 Gamma Gold Capsule Durapore Membrane C1SB47320
Millipak 40 Gamma Gold Capsule Durapore Membrane C2HB72930
Millipak 40 Gamma Gold Capsule Durapore Membrane C2PB36802
Millipak 40 Gamma Gold Capsule Durapore Membrane C4AB69843
Millipak 40 Gamma Gold Capsule Durapore Membrane C4DB14482
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Technical Info

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

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane