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MPGL06CL1 Millipak®-60 Filling Machine Filter Unit 0.22 µm 1-1/2 in. TC-1/4 in.HB

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MPGL06CL1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMPGL06CL1
Trade Name
  • Millipak®
DescriptionMillipak®-60 Filling Machine Filter Unit 0.22 µm 1-1/2 in. TC-1/4 in.HB
References
Product Information
HS Code8421 21 00
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/6 mm (1/4 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.
Stacked Discs60 discs
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 ConnectionSanitary Flange
Outlet ConnectionHose Barb
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Flow Rate7.6 L/min @ 2.9 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 2 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
Filtration Area300 cm²
Process Volume30 L
Inlet Connection Diameter1-1/2 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 Size1
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
MPGL06CL1 04053252345890

Documentation

Certificates of Quality

Title
Milliapak 60 Capsule Durapore Membrane C3EB23237
Millipak 60 Capsule Durapore Membrane C0KB91837
Millipak 60 Capsule Durapore Membrane C1MB85735
Millipak 60 Capsule Durapore Membrane C0HB81543
Millipak 60 Capsule Durapore Membrane C0MB14260
Millipak 60 Capsule Durapore Membrane C1EB03701
Millipak 60 Capsule Durapore Membrane C1NB47272
Millipak 60 Capsule Durapore Membrane C1SB85643Z
Millipak 60 Capsule Durapore Membrane C2DB34395Z
Millipak 60 Capsule Durapore Membrane C2EB34394Z
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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