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MFGL02GF3 Non-sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 3/4  in. TC/TC

MFGL02GF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMFGL02GF3
Trade Name
  • Millipak®
DescriptionNon-sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 3/4  in. TC/TC
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet19  mm (¾ in.) sanitary flange inlet and outlet
Maximum Differential Pressure, bar (psid)Forward:60 psi (4.1 bar) at 25 °C; 50 psi(3.5 bar) at 25 °C; (5 µm) 25 psi (1.7 bar) at 80 °C; Reverse: 10 psi (0.7 bar) at 25 °C
Maximum Inlet Pressure, bar (psi)60 psi (4.1 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.
Bacterial RetentionQuantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
Flow Rate0.51 L/min @ 0.69 bar ΔP
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 Area100 cm²
Process Volume20 L
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 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
Catalogue Number GTIN
MFGL02GF3 04054839378645

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificates of Quality

Title
Millipak Final Fill Capsule Durapore Membrane C0CB46433
Millipak Final Fill Capsule Durapore Membrane C3EB23932
Millipak Final Fill Capsule Durapore Membrane C3HB37498
Millipak Final Fill Capsule Durapore Membrane C3KB48955
Millipak Final Fill Capsule Durapore Membrane C3MB52122
Millipak Final Fill Capsule Durapore Membrane C1JB93078
Millipak Final Fill Capsule Durapore Membrane C1NB93056
Millipak Final Fill Capsule Durapore Membrane C3PB67033
Millipak Final Fill Capsule Durapore Membrane C4DB14518
Millipak Final Fill Capsule Durapore Membrane- C9HA47335
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