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MFSL20GT3 MilliporeNon-sterilized Millipak^® Final Fill 200 Filter Unit 5.0 µm 1 1/2 in. TC/TC

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Description
Catalogue Number	MFSL20GT3
Trade Name	Millipak^®
Description	Non-sterilized Millipak^® Final Fill 200 Filter Unit 5.0 µm 1 1/2 in. TC/TC

Product Information
Device Configuration	Capsule
Connections, Inlet/Outlet	38 mm (1½ in.) sanitary flange 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 Practices	These products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
Quality Level	MQ400

Biological Information
Bacterial Endotoxins	Aqueous 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.
Media	Durapore^®
Sterility	non-sterilized
Sterilization	Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 °C. Devices can withstand a dose ≤ 40 kGy gamma exposure.
Wettability	Hydrophilic

Physicochemical Information
Pore Size	5.0 µm
Inlet Connection	Sanitary Flange
Outlet Connection	Sanitary Flange
Bubble Point at 23 °C	≥ 2.0 psi (138 mbar) air with water
Flow Rate	7.6 L/min @ 0.69 bar ∆P
Non-Fiber Releasing	This 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 Endotoxins	Aqueous 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.

Materials Information
Chemistry	Polyvinylidene Fluoride (PVDF)
Device Material	Polysulfone
Support Material	Polysulfone

Packaging Information
Material Size	3
Material Package	Double Easy-Open bag

Global Trade Item Number
Catalogue Number	GTIN
MFSL20GT3	04054839379574

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