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MFGB02SH3 Gamma sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 1/4  in. HB/HB

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MFGB02SH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMFGB02SH3
Trade Name
  • Millipak®
DescriptionGamma sterilized Millipak® Final Fill 20 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)Forward:60 psi (4.1 bar) at 25 °C; 50 psi(3.5 bar) at 25 °C; (5 µm) 25 psi (1.7 bar) at 80 °C; Reverse: 10 psi (0.7 bar) at 25 °C
Maximum Inlet Pressure, bar (psi)60 psi (4.1 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.
WettabilityHydrophobic
Physicochemical Information
Pore Size0.22 µm
Inlet ConnectionStepped Hose Barb
Outlet ConnectionStepped Hose Barb
Flow Rate0.51 L/min @ 0.69 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 Area100 cm²
Process Volume20 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
MFGB02SH3 04054839378607

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