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MPGL20CA3 Gamma Compatible Millipak®-200 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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MPGL20CA3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMPGL20CA3
Trade Name
  • Millipak®
DescriptionGamma Compatible Millipak®-200 Filter Unit 0.22 µm 9/16 in. HB/HB
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
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®
SterilityOther
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 Rate19 L/min @ 2.8 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 5 mg per device after 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
Length13.0 cm (5.1 in.)
Diameter7.6 cm (3.0 in.)
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
Catalog Number GTIN
MPGL20CA3 04053252461125

Documentation

Operational Excellence Dossier

Title

Gamma Compatible Millipak®-200 Filter Unit 0.22 µm 9/16 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Durapore Cartridge - C8SA70419
Durapore Membrane C0SB78050
Milipak 200 Capsule Durapore Membrane - C8CA47117
Millap 200 Capsule Durapore Membrane C3SB67086
Milliapk 200 Capsule Durapore Membrane C3KB56396
Millidisk 20 Capsule Durapore membrane C3CB59676
Millidisk 200 Capsule Durapore Membrane- C7NA75596
Millipak 100 Capsule Durapore Membrane C3CB59652
Millipak 200 Capsule Durapore Membrane C8PA51682
Millipak 200 Capsule Durapore C1AB96656Z
Show more

Technical Info

Title
Best Practices for Managing Reverse Pressure Filter Impact
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane