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MPGL1GCA3 Sterile Millipak®-100 Filter Unit 0.22 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPGL1GCA3
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Overview

Replacement Information
Description
Catalogue NumberMPGL1GCA3
Trade Name
  • Millipak®
DescriptionSterile Millipak®-100 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 Rate11 L/min @ 2.8 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 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
Catalogue Number GTIN
MPGL1GCA3 04053252259487

Documentation

Operational Excellence Dossier

Title

Certificates of Quality

Title
Millidisk 100 Gamma Gold Capsule Durapore Membrane C8KA03872
Millipak 10 Gamma Gold Capsule Durapore Membrane C1AB96661
Millipak 100 Gamma Gold Capsuel Durapore Membrane C8SA66235
Millipak 100 Gamma Gold Capsule Durapore Membrane C0DB55575
Millipak 100 Gamma Gold Capsule Durapore Membrane C0HB74428
Millipak 100 Gamma Gold Capsule Durapore Membrane C0HB77965
Millipak 100 Gamma Gold Capsule Durapore Membrane C1KB85434Z
Millipak 100 Gamma Gold Capsule Durapore Membrane C2MB21812Z
Millipak 100 Gamma Gold Capsule Durapore Membrane C8CA30755
Millipak 100 Gamma Gold Capsule Durapore Membrane C8DA58017
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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