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MPVL10CA3 Gamma Compatible Millipak®-100 Filter Unit 0.1 µm 9/16 in. HB/HB

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MPVL10CA3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMPVL10CA3
Trade Name
  • Millipak®
DescriptionGamma Compatible Millipak®-100 Filter Unit 0.1 µm 9/16 in. HB/HB
References
Product Information
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 Size0.1 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
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 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
Catalogue Number GTIN
MPVL10CA3 04053252256028

Documentation

Certificates of Quality

Title
Millipak 100 Capsule Durapore C1CB03644Z
Millipak 100 Capsule Durapore Membrane C3EB20642
Millipak 100 Capsule Durapore Membrane - C9SA80004
Millipak 100 Capsule Durapore Membrane C4EB29047
Millipak 100 Capsule Durapore Membrane C4NB02692
Millipak 100 Capsule Durapore Membrane C4NB07988
Millipak 100 Capsule Durapore Membrane- C7NA74428
Millipak 100 Capsule Durapore Membrane- C8HA84432
Millipak 100 Capsule Durapore Membrane- C8SA59186

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