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MFHL20GB3 Non-sterilized Millipak® Final Fill 200 Filter Unit 0.45  µm 1/2  in. HB/HB

MFHL20GB3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberMFHL20GB3
Trade Name
  • Millipak®
DescriptionNon-sterilized Millipak® Final Fill 200 Filter Unit 0.45  µm 1/2  in. HB/HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet13  mm (½  in.) stepped hose barb inlet and outlet
Maximum Differential Pressure, bar (psid)Foward:80 psi (5.5 bar) at 25 °C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm); Reverse: 10 psi (0.7 bar) at 25 °C
Maximum Inlet Pressure, bar (psi)80 psi (5.5 bar) at 25 °C
Good Manufacturing PracticesThese products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
MediaDurapore®
Sterilitynon-sterilized
SterilizationDevice integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤ 40  kGy gamma exposure.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionStepped Hose Barb
Outlet ConnectionStepped Hose Barb
Bubble Point at 23 °C≥ 26 psi (1790 mbar) air with water
Flow Rate6.0 L/min @ 0.69   bar ∆P
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), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections
USP Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
Dimensions
Filtration Area1000 cm²
Process Volume200 L
Inlet Connection Diameter1/2 in.
Outlet Connection Diameter1/2 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polysulfone
Support MaterialPolysulfone
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
Global Trade Item Number
Katalogové číslo GTIN
MFHL20GB3 04054839378393

Documentation

Material Qualification Dossier

TitleVersion
1.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
Millipak Final Fill Capsule Durapore Membrane C2HB08542
Millipak Final Fill Capsule Durapore Membrane C2KB15735
Millipak Final Fill Capsule Durapore Membrane C4BB85346
Millipak Final Fill Capsule Durapore Membrane C4CB29106
Millipak Final Fill Capsule Durapore Membrane- C4AB80296
Millipak Final Fill Capsule Durapore membrane C4NB94166

Technical Info

Title
Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest
Reduce Contamination Risks and Simplify Filtration System Design and Operation

User Guides

Title
Wetting Instructions for Filter Units with Durapore Membrane

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