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MPVL02GH2 Sterile Millipak®-20 Filter Unit 0.1 µm 1/4 in. HB/HB w/bell

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MPVL02GH2
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Overview

Replacement Information
Description
Catalogue NumberMPVL02GH2
Trade Name
  • Millipak®
DescriptionSterile Millipak®-20 Filter Unit 0.1 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 Size0.1 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb with Bell
Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
Flow Rate0.7 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
MPVL02GH2 04053252497377

Documentation

Certificates of Quality

Title
Milipak 20 Gamma Gold Capsule Durapore Membrane C4MB85050
Millipak 20 Gamma Gold Capsule Durapore Membrane C0CB33101
Millipak 20 Gamma Gold Capsule Durapore Membrane C0MB91899Z
Millipak 20 Gamma Gold Capsule Durapore Membrane C1DB84498Z
Millipak 20 Gamma Gold Capsule Durapore Membrane C5BB50110
Millipak 20 Gamma Gold Capsule Durapore Membrane C7HA31275
Millipak 20 Gamma Gold Capsule Durapore Membrane - C9HA55073
Millipak 20 Gamma Gold Capsule Durapore Membrane - C9NA19977
Millipak 20 Gamma Gold Capsule Durapore Membrane C1HB84704Z
Millipak 20 Gamma Gold Capsule Durapore Membrane C1SB47328Z
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Technical Info

Title
Best Practices for Managing Reverse Pressure Filter Impact
Integrity Test Troubleshooting - Beyond Rewet and Retest

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane