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MPHL06GH2 Sterile Millipak®-60 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.
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MPHL06GH2
2  Blister
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Overview

Replacement Information
Description
Catalogue NumberMPHL06GH2
Trade Name
  • Millipak®
DescriptionSterile Millipak®-60 Filter Unit 0.45 µm 1/4 in. HB/HB w/bell
References
Product Information
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 Rate10.5 L/min @ 2.45 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 2 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 Area300 cm²
Process Volume30 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
Catalog Number GTIN
MPHL06GH2 04053252451805

Documentation

Sterile Millipak®-60 Filter Unit 0.45 µm 1/4 in. HB/HB w/bell SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Millipak 60 Gamma GOld Capsule Durapore Membrane C7PA01236
Millipak 60 Gamma Gold Capsule Durapore Membrane C0HB74432
Millipak 60 Gamma Gold Capsule Durapore Membrane C0EB68835
Millipak 60 Gamma Gold Capsule Durapore Membrane C0HB82126
Millipak 60 Gamma Gold Capsule Durapore Membrane C3HB37500
Millipak 60 Gamma Gold Capsule Durapore Membrane C7HA31276
Millipak 60 Gamma Gold Capsule Durapore Membrane C9NA17115
Millipak 60 Gamma Gold Capsule Durapore Membrane - C0DB57755
Millipak 60 Gamma Gold Capsule Durapore Membrane C1CB03559
Millipak 60 Gamma Gold Capsule Durapore Membrane C1SB47321
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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