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MPVL2GCA3 Sterile Millipak®-200 Filter Unit 0.1 µm 9/16 in. HB/HB

MPVL2GCA3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Áttekintés

Replacement Information
Description
Catalogue NumberMPVL2GCA3
Trade Name
  • Millipak®
DescriptionSterile Millipak®-200 Filter Unit 0.1 µm 9/16 in. HB/HB
References
Product Information
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 Size0.1 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
Flow Rate8.5 L/min @ 2.45 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 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
Katalógusszám GTIN
MPVL2GCA3 04053252260711

Documentation

Certificates of Quality

Title
Millipak 200 Gamma Gold Capsule Durapore Membrane C2PB36669Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C3EB20151
Millipak 200 Gamma GOld Capsule Durapore Membrane C1PB85745Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C1KB85670Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C7NA75557
Millipak 200 Gamma Gold Capsule Durapore Membrane C8EA69579
Millipak 200 Gamma Gold Capsule Durapore Membrane C0AB03866
Millipak 200 Gamma Gold Capsule Durapore Membrane C0NB28069Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C0PB37515Z
Millipak 200 Gamma Gold Capsule Durapore Membrane C2EB68865Z

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