-
Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
-
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
-
Catalogue Number
MPGL02GH2
-
Chemistry
Polyvinylidene Fluoride (PVDF)
-
Device Configuration
Gamma Gold Capsule
-
Device Material
Polycarbonate
-
Diameter
1/4 in.
-
Filtration Area
100 cm²
-
Flow Rate
1.5 L/min @ 1.75 bar ΔP
-
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
-
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.
-
Inlet Connection
Hose Barb
-
Inlet Connection Diameter
1/4 in.
-
Material Package
Blister
-
Material Size
2
-
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
-
Maximum Operating Temperature
25 °C
-
Media
Durapore®
-
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).
-
Outlet Connection
Hose Barb with Bell
-
Outlet Connection Diameter
1/4 in.
-
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
-
Pore Size
0.22 µm
-
Process Volume
10 L
-
Sterility
Sterile
-
Sterilization
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
-
Support Material
Polycarbonate
-
Trade Name
Millipak®
-
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
-
Vent Cap Material
Polyvinylidene fluoride (PVDF)
-
Volume
10 L
-
Wettability
Hydrophilic
+852-3069 6950
css@gugent.com.hk
