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MFHL20SB3 Gamma sterilized Millipak® Final Fill 200 Filter Unit 0.45  µm 1/2  in. HB/HB

MFHL20SB3
3  Double Easy-Open bag
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Description
Catalogue NumberMFHL20SB3
Trade Name
  • Millipak®
DescriptionGamma sterilized Millipak® Final Fill 200 Filter Unit 0.45  µm 1/2  in. HB/HB
Product Information
Device ConfigurationGamma Gold Capsule
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
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.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionStepped Hose Barb
Outlet ConnectionStepped Hose Barb
Bubble Point at 23 °C≥ 26 psi (1790 mbar) air with water
Flow Rate6.0 L/min @ 0.69   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
Packaging Information
Material Size3
Material PackageDouble Easy-Open bag
Global Trade Item Number
Katalogové číslo GTIN
MFHL20SB3 04054839378584