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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
MPVL2GCA3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Gamma Gold Capsule
Device Material
Polycarbonate
Diameter
9/16 in.
Filtration Area
1000 cm²
Flow Rate
8.5 L/min @ 2.45 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 5 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
9/16 in.
Material Package
Double Easy-Open bag
Material Size
3
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
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
Outlet Connection Diameter
9/16 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Pore Size
0.1 µm
Process Volume
100 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.
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
MPGL2GCL3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Gamma Gold Capsule
Device Material
Polycarbonate
Diameter
1-1/2 in.
Filtration Area
1000 cm²
Flow Rate
19 L/min @ 2.8 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 5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
Inlet Connection
Sanitary Flange
Inlet Connection Diameter
1-1/2 in.
Material Package
Blister
Material Size
3
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
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
Sanitary Flange
Outlet Connection Diameter
1-1/2 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
100 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.
Trust Merck membrane filtration devices for the collection and preparation of samples, mobile phases, and buffers to obtain the highest quality results from downstream analysis.
Whether you need to collect, separate, or remove contaminants from air or fluid samples prior to downstream analysis, our broad selection of syringe filters, membranes, filter holders and related filtration devices ensures that we have the right solution for your application.
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