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MPGL10CL3 Gamma Compatible Millipak®-100 Filter Unit 0.22 µm 1-1/2 in. TC/TC

Gamma Compatible Millipak®-100 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.
MPGL10CL3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberMPGL10CL3
Trade Name
  • Millipak®
DescriptionGamma Compatible Millipak®-100 Filter Unit 0.22 µm 1-1/2 in. TC/TC
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
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®
SterilityOther
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 Rate11 L/min @ 2.8 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 mg per device after 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
Length13 cm (5.12 in.)
Diameter7.6 cm (3.0 in.)
Filtration Area500 cm²
Process Volume50 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 PackageDouble Easy-Open bag
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
Katalogové číslo GTIN
MPGL10CL3 04053252384790

Documentation

Operational Excellence Dossier

Title

Certificates of Quality

Title
MILLIPAK 100 CAPSULE DURAPORE MEMBRANE C1EB85485Z
Millidisk 100 Capsule Durapore membrane C3BB59664
Millipak 100 Capsule Durapore Membrane C0PB39717
Millipak 100 Capsule Durapore C1BB03592
Millipak 100 Capsule Durapore Membrane C7DA99128
Millipak 100 Capsule Durapore Membrane C7MA68360
Millipak 100 Capsule Durapore Membrane C0CB26274
Millipak 100 Capsule Durapore Membrane C0DB58169
Millipak 100 Capsule Durapore Membrane C0PB39721
Millipak 100 Capsule Durapore Membrane C2BB89234Z
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Technical Info

Title
Best Practices for Managing Reverse Pressure Filter Impact
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane