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MFVL10GB3 Non-sterilized Millipak® Final Fill 100 Filter Unit 0.1  µm 1/2  in. HB/HB

MFVL10GB3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Aperçu

Replacement Information
Description
Catalogue NumberMFVL10GB3
Trade Name
  • Millipak®
DescriptionNon-sterilized Millipak® Final Fill 100 Filter Unit 0.1  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.
Bacterial RetentionQuantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.1 µm
Inlet ConnectionStepped Hose Barb
Outlet ConnectionStepped Hose Barb
Bubble Point at 23 °C≥ 70 psi (4830 mbar) air with water
Flow Rate1.31 L/min @ .86 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 Area500 cm²
Process Volume100 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
MFVL10GB3 04054839378348

Documentation

Material Qualification Dossier

TitreVersion
1.0

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificats de qualité

Titre
Millipak Final Fill Capsule Durapore Membrane C4HB50010

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

Manuels d'utilisation

Titre
Wetting Instructions for Filter Units with Durapore Membrane

Produits & Applications associés

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