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Millipak-20 Filter Unit
Description:
Gamma Compatible Millipak-20 Filter Unit 0.22 µm 3/4 in. TC/TC sterile
Trade Name:
Millipak
Qty/Pk:
2
Key Applications:
Laboratory Filtration
Outlet Connection Diameter (in):
3/4
Inlet Connection Diameter (in):
3/4
Outlet Connection:
Sanitary Flange
Maximum Inlet Pressure, bar (psi):
5.2 (75) @ 25 °C
Maximum Differential Pressure, bar (psid):
Forward: 4.1 (60) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 123 °C. Reverse: 0.7 (10) @ 25 °C
Inlet Connection:
Sanitary Flange
Oxidizable Substances:
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Bubble Point at 23 °C:
≥3450 mbar (50 psig) air with water
Process Volume, L:
10
Pore Size (µm):
0.22
Wettability:
Hydrophilic
Sterilization:
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
Good Manufacturing Practices:
This product was manufactured in a facility which adheres to Good Manufacturing Practices.
Vent Cap Material:
PVDF
Bacterial Retention:
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables:
The extractables level was equal to or less than 1 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
Product Name:
Millipak-20 Filter Unit
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).
Filtration Area, cm²:
100
Sterility:
Sterile
Bacterial Endotoxins:
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Device Material:
Polycarbonate
Connections, Inlet/Outlet:
19 mm (3/4 in.) Sanitary Flange
Configuration:
Stack Disk
Chemistry:
Hydrophilic PVDF
Media:
Durapore®
Flow Rate, L/min:
1.5 @ 1.75 bar ΔP
Support Material:
Polycarbonate
Packaging:
Blister