Merck - SVGLA25NB6 - SVGLA25NB6 Optiscale(R) Capsule Filter Durapore(R) sterile, filtration area 3.5 cm2, pore size 0.22 mum

ITEM #: 11570188
Catalogue Number SVGLA25NB6
Trade Name

• OptiScale ®

Durapore ® 0.22 µm Optiscale ® 25mm NB
Device Configuration Capsule
Connections, Inlet/Outlet Female Luer Lok/ Male Luer Lok
Maximum Inlet Pressure, bar (psi) 4.1 bar (60 psi) @ 25 °C
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality Level MQ400
Bacterial Endotoxins Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Durapore ®
Sterility Other
Sterilization 1 autoclave cycle of 60 min @ 123 °C
Wettability Hydrophilic
Pore Size 0.22 µm
Inlet Connection Female Luer Lok
Outlet Connection Male Luer Lok
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Pressure 60 psi (4.1 bar) Maximum Inlet Pressure at 25 °C: 60 psi (4.1 bar) Maximum Forward Differential Pressure at 25 °C.
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).
Non-Particle Releasing This product was tested and passes the USP  test for particulates in injectables.
TOC/Conductivity After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP and less than 1.3 µS/cm per USP .
USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Length 3.9 cm (1.52 in.)
Diameter 3.1 cm (1.2 in.)
Filtration Area 3.5 cm²
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polypropylene

Support Material Polypropylene
Vent Cap Material Polypropylene (PP)
Material Size 6