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MPVL1GCF3 Sterile Millipak®-100 Filter Unit 0.1 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPVL1GCF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMPVL1GCF3
Trade Name
  • Millipak®
DescriptionSterile Millipak®-100 Filter Unit 0.1 µm 3/4 in. TC/TC
References
Product Information
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
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 ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
Flow Rate3.8 L/min @ 2.45 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 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 Area500 cm²
Process Volume50 L
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 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
Catalogue Number GTIN
MPVL1GCF3 04053252252709

Documentation

Certificates of Quality

Title
Millipak 100 Gamma Gold Capsule Durapore Membrane C0CB50140
Millipak 100 Gamma Gold Capsule Durapore Membrane C0KB68839Z
Millipak 100 Gamma Gold Capsule Durapore Membrane C0NB24729Z
Millipak 100 Gamma Gold Capsule Durapore Membrane C2MB97392Z
Millipak 100 Gamma Gold Capsule Durapore Membrane C4MB89755
Millipak 100 Gamma Gold Capsule Durapore Membrane C4MB90026
Millipak 100 Gamma Gold Capsule Durapore Membrane- C2PB31860Z
Millipak 100 Gamma Gold Capsule Durapore Membrane- C8BA34708
Millipak 100 Gamma Gold Capsule Durapore Membrane- C9EA29876

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