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MPGL2GCA3 Sterile Millipak®-200 Filter Unit 0.22 µm 9/16 in. HB/HB

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MPGL2GCA3
3  Blister
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Overview

Replacement Information
Description
Catalogue NumberMPGL2GCA3
Trade Name
  • Millipak®
DescriptionSterile Millipak®-200 Filter Unit 0.22 µm 9/16 in. HB/HB
References
Product Information
HS Code8421 29 90
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
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 ConnectionHose Barb
Outlet ConnectionHose Barb
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 Diameter9/16 in.
Outlet Connection Diameter9/16 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
Catalog Number GTIN
MPGL2GCA3 04053252258237

Documentation

Operational Excellence Dossier

Title

Sterile Millipak®-200 Filter Unit 0.22 µm 9/16 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
MIllipak 200 Gamma Gold Capsule Durapore Membrane C1DB97111Z
Millipak 20 Gamma Gold Capsule Durapore Membrane C2DB63797Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C3MB61321
Millipak 200 Capsule Durapore Membrane C1JB85597Z
Millipak 200 Capsule Durapore Membrane C2CB52606Z
Millipak 200 Gamma Gold C4AB69824
Millipak 200 Gamma Gold Capsule Durapor Membrane C0DB60926
Millipak 200 Gamma Gold Capsule Durapore Membrane C0NB32530
Millipak 200 Gamma Gold Capsule Durapore Membrane C2EB58936Z
Millipak 200 Gamma Gold Capsule Durapore Membrane 200.00

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