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MPGL2GCL3 Sterile Millipak®-200 Filter Unit 0.22 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPGL2GCL3
3  Blister
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Overview

Replacement Information
Description
Catalogue NumberMPGL2GCL3
Trade Name
  • Millipak®
DescriptionSterile Millipak®-200 Filter Unit 0.22 µm 1-1/2 in. TC/TC
References
Product Information
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet38 mm (1-1/2 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
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Flow Rate19 L/min @ 2.8 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 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 Area1000 cm²
Process Volume100 L
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 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 Size3
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
MPGL2GCL3 04053252257520

Documentation

Operational Excellence Dossier

Title

Certificates of Quality

Title
Miillpak 200 Gamma gold capsule Durapore membrane C3NB64664
Millipak 200 Gamma Gold Capsule Durapore Membrane C3PB67088
Millipak 200 Gamma Gold Capsule Durapore Membrane C1EB85240Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C0BB19708
Millipak 200 Gamma Gold Capsule Durapore Membrane C0CB26292
Millipak 200 Gamma Gold Capsule Durapore Membrane C0DB52671
Millipak 200 Gamma Gold Capsule Durapore Membrane C0KB07790
Millipak 200 Gamma Gold Capsule Durapore Membrane C1JB85179Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C3CB00446
Millipak 200 Gamma Gold Capsule Durapore Membrane C3CB00519
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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