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MPGL20CB3 Gamma Compatible Millipak®-200 Filter Unit 0.22 µm 1/4 in. NPTM

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPGL20CB3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMPGL20CB3
Trade Name
  • Millipak®
DescriptionGamma Compatible Millipak®-200 Filter Unit 0.22 µm 1/4 in. NPTM
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet6 mm (1/4 in.) NPTM
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 Discs200 discs
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 ConnectionNPT
Outlet ConnectionNPT
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Flow Rate18 L/min @ 3.0 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 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
Length13.0 cm (5.1 in.)
Diameter7.6 cm (3.0 in.)
Filtration Area1000 cm²
Process Volume100 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 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
Catalog Number GTIN
MPGL20CB3 04053252302442

Documentation

Operational Excellence Dossier

Title

Gamma Compatible Millipak®-200 Filter Unit 0.22 µm 1/4 in. NPTM SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Millipak 20 capsule durapore Membrane
Millipak 200 Capsule Durapore Membrane C0DB61746
Millipak 200 Capsule Durapore Membrane - C7NA75601
Millipak 200 Capsule Durapore Membrane C2CB85785Z
Millipak 200 Capsule Durapore Membrane C2HB85963Z
Millipak 200 Capsule Durapore Membrane C3KB53716
Millipak 200 Capsule Durapore Membrane C4AB85676
Millipak 200 Capsule Durapore Membrane C4DB12692
Millipak 200 Capsule Durapore Membrane C4JB66674
Millipak 200 Capsule Durapore Membrane C8PA57142
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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