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MFGB20GT3 Non-sterilized Millipak® Final Fill 200 Filter Unit 0.22  µm 1 1/2  in. TC/TC

MFGB20GT3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Descripción

Replacement Information
Description
Catalogue NumberMFGB20GT3
Trade Name
  • Millipak®
DescriptionNon-sterilized Millipak® Final Fill 200 Filter Unit 0.22  µm 1 1/2  in. TC/TC
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38  mm (1½  in.) sanitary flange 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.
Bacterial RetentionQuantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST® F838 methodology.
WettabilityHydrophobic
Physicochemical Information
Pore Size0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Flow Rate7.61 L/min @ 1.1   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 1/2 in.
Outlet Connection Diameter1 1/2 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
Número de referencia GTIN
MFGB20GT3 04054839379406

Documentation

Certificados de calidad

Cargo
Millipak Final Fill Capsule Durapore Membrane C1NB74069
Millipak Final Fill Capsule Durapore Membrane C3MB56900
Millipak Final Fill Capsule Durapore Membrane C4HB40532
Millipak Final Fill Capsule Durapore membrane C4CB98862
Millipak Final Fill Capsule Durapore membrane C4JB74372

Licencias necesarias e Información técnica

Cargo
Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
Reduce Contamination Risks and Simplify Filtration System Design and Operation

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