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參考價(jià)	面議

Description
Catalogue Number	MPGL1GCA3
Trade Name	Millipak®
Description	Sterile Millipak®-100 Filter Unit 0.22µm 9/16in. HB/HB

Product Information
Device Configuration	Gamma Gold Capsule
Connections, Inlet/Outlet	14mm (9/16in.) Hose Barb
Maximum Differential Pressure, bar (psid)	Forward: 4.1 bar (60 psid) @ 25°C; 1.7 bar (25 psid) @ 80°C; 0.35 bar (5 psid) @ 123°C; Reverse: 0.7 bar (10 psid) @ 25°C
Maximum Inlet Pressure, bar (psi)	5.2 bar (75 psi) @ 25°C
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Biological Information
Bacterial Endotoxins	Aqueous extraction contains ≤0.5EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media	Durapore®
Sterility	Sterile
Sterilization	3 autoclave cycles of 90min @ 123°C; not in-line steam sterilizable
Bacterial Retention	Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10?CFU/cm2 using ASTM®F838 methodology.
Wettability	Hydrophilic

Physicochemical Information
Pore Size	0.22 µm
Inlet Connection	Hose Barb
Outlet Connection	Hose Barb
Bubble Point at 23°C	≥3450mbar (50psig) air with water
Flow Rate	11 L/min @ 2.8bar ΔP
Gravimetric Extractables	The extractables level was equal to or less than 2.5mg per sterilized device after a 200mL flush and 24hours in water at controlled room temperature.
Non-Fiber Releasing	This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
USP Bacterial Endotoxins	A sample aqueous extraction contains less than 0.5EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Dimensions
Filtration Area	500 cm2
Process Volume	50 L
Inlet Connection Diameter	9/16 in.
Outlet Connection Diameter	9/16 in.

Materials Information
Chemistry	Polyvinylidene Fluoride (PVDF)
Device Material	Polycarbonate
Support Material	Polycarbonate
Vent Cap Material	Polyvinylidene fluoride (PVDF)

Packaging Information
Material Size	3
Material Package	Blister

Specifications
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200mL

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