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MFGL20GB3 Non-sterilized Millipak® Final Fill 200 Filter Unit 0.22  µm 1/2  in. HB/HB

MFGL20GB3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Aperçu

Replacement Information
Description
Catalogue NumberMFGL20GB3
Trade Name
  • Millipak®
DescriptionNon-sterilized Millipak® Final Fill 200 Filter Unit 0.22  µm 1/2  in. HB/HB
References
Product Information
HS Code8421 29 90
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
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 ConnectionStepped Hose Barb
Outlet ConnectionStepped Hose Barb
Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
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 Diameter1/2 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
Référence GTIN
MFGL20GB3 04054839378386

Documentation

Material Qualification Dossier

TitreVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificats de qualité

Titre
Millipak Final Fill Capsule Durapore Membrane C2CB49146
Millipak Final Fill Capsule Durapore Membrane C0CB22243
Millipak Final Fill Capsule Durapore Membrane C3AB55405
Millipak Final Fill Capsule Durapore Membrane C3DB86311
Millipak Final Fill Capsule Durapore Membrane C4JB66728
Millipak Final Fill Capsule Durapore Membrane C4PB08064
Millipak Final Fill Capsule Durapore Membrane C1CB70144
Millipak Final Fill Capsule Durapore Membrane C2HB60645
Millipak Final Fill Capsule Durapore Membrane C2KB07813
Millipak Final Fill Capsule Durapore Membrane C2MB18997
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Informations techniques

Titre
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

Fiche technique

Titre
Durapore® Family Guide

Manuels d'utilisation

Titre
Wetting Instructions for Filter Units with Durapore Membrane

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