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MPGL10CA3 Gamma Compatible 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.
MPGL10CA3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberMPGL10CA3
Trade Name
  • Millipak®
DescriptionGamma Compatible Millipak®-100 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 Rate11 L/min @ 2.8 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 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 cm (5.12 in.)
Diameter7.6 cm (3.0 in.)
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 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
Katalogové číslo GTIN
MPGL10CA3 04053252262531

Documentation

Operational Excellence Dossier

Title

Certificates of Quality

Title
MIllipak 100 Capsule Durapore Membrane C1CB82227Z
Millidisk 100 Capsule Durapore membrane C3BB44202
Millipak 100 Capsule Durapore Membrane C0KB91864
Millipak 100 Capsule Durapore Membrane C0MB01177
Millipak 100 Capsule Durapore Membrane C0MB91866
Millipak 100 Capsule Durapore Membrane C0SB47723
Millipak 100 Capsule Durapore Membrane C0SB47724
Millipak 100 Capsule Durapore Membrane C1AB82220
Millipak 100 Capsule Durapore C1AB82223
Millipak 100 Capsule Durapore C1BB82221
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
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane