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MFGL06SH3 Gamma sterilized Millipak® Final Fill 60 Filter Unit 0.22  µm 1/4  in. HB/HB

MFGL06SH3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberMFGL06SH3
Trade Name
  • Millipak®
DescriptionGamma sterilized Millipak® Final Fill 60 Filter Unit 0.22  µm 1/4  in. HB/HB
References
Product Information
Device ConfigurationGamma Gold Capsule
Connections, Inlet/Outlet6  mm (¼  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®
Sterilitysterilized by gamma irradiation
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 Rate1.51 L/min @ 0.86   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 Area300 cm²
Process Volume60 L
Inlet Connection Diameter1/4 in.
Outlet Connection Diameter1/4 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
MFGL06SH3 04054839378515

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Millipak Final FIll Capsule Durapore Membrane- C1DB03715
Millipak Final Fill Capsule Durapore Membrane C1HB93087
Millipak Final Fill Capsule Durapore Membrane C3DB59654
Millipak Final Fill Capsule Durapore Membrane C3NB64640
Millipak Final Fill Capsule Durapore Membrane C2KB10970
Millipak Final Fill Capsule Durapore Membrane C2NB30932
Millipak Final Fill Capsule Durapore Membrane C3NB61354
Millipak Final Fill Capsule Durapore Membrane C9SA19524
Millipak Final Fill Capsule Durapore Membrane- C1AB90310

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