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MPHL02GF2 Sterile Millipak®-20 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.
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MPHL02GF2
2  Blister
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Overview

Replacement Information
Description
Catalogue NumberMPHL02GF2
Trade Name
  • Millipak®
DescriptionSterile Millipak®-20 Filter Unit 0.45 µm 3/4 in. TC/TC
References
Product Information
HS Code8421 21 00
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.
Stacked Discs20 discs
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 Rate6.4 L/min @ 2.45 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 1 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 Area100 cm²
Process Volume10 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
MPHL02GF2 04053252246579

Documentation

Certificates of Quality

Title
Millipak 20 Gamma Gold Capsule Durapore Membrane C0EB79177
Millipak 20 Gamma Gold Capsule Durapore Membrane C2JB90111
Millipak 20 Gamma Gold Capsule Durapore Membrane C3AB37230
Millipak 20 Gamma Gold Capsule Durapore Membrane C4HB43451
Millipak 20 Gamma Gold Capsule Durapore Membrane C6BB79857
Millipak 20 Gamma Gold Capsule Durapore Membrane- C7CA86693
Millipak 20 Gamma Gold Capsule Durapore Membrane- C8AA29612
Millipak 20 Gamma Gold Capsule Durapore Membrane- C9PA23333

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