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MPGL02GH2 Sterile Millipak®-20 Filter Unit 0.22 µm 1/4 in. HB/HB w/bell

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MPGL02GH2
2  Blister
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Overview

Replacement Information
Description
Catalogue NumberMPGL02GH2
Trade Name
  • Millipak®
DescriptionSterile Millipak®-20 Filter Unit 0.22 µm 1/4 in. HB/HB w/bell
References
Product Information
HS Code8421 29 90
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet6 mm (1/4 in.) Hose Barb with bell
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
Maximum Operating Temperature25 °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 with Bell
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Flow Rate1.5 L/min @ 1.75 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 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 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
MPGL02GH2 04053252571268

Documentation

Operational Excellence Dossier

Title

Certificates of Quality

Title
Milliapk 20 Gamma Gold Capsule Durapore Membrane C0NB29635
Milliapk 20 Gamma Gold Capsule Durapore Membrane C2PB31833Z
Milliapk 20 Gamma Gold Capsule Durapore Membrane- C9BA78930
Millipak 20 Gamma Gold Capsule Durapore Membrane C1KB85702Z
Millipak 20 Gamma Gold Capsule Durapore C4CB24161
Millipak 20 Gamma Gold Capsule Durapore Media - C7EA13953
Millipak 20 Gamma Gold Capsule Durapore Membrane C0NB29639
Millipak 20 Gamma Gold Capsule Durapore Membrane C7HA27651
Millipak 20 Gamma Gold Capsule Durapore Membrane C7HA27653
Millipak 20 Gamma Gold Capsule Durapore Membrane C7HA31306
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