Merck - CLGL71TP3 - Durapore 0.22 µm High Area Cartridge 10 in. Code 7

ITEM #: 11558131
Catalogue Number CLGL71TP3
Trade Name

• Durapore ®

Durapore ® 0.22 µm High Area Cartridge 10 in. Code 7
Device Configuration Cartridge
Cartridge Code Code 7 (2-226) O-rings w/locking-tabs
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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Durapore ®
Sterility Other
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
Pore Size 0.22 µm
Air Diffusion at 23 °C ≤20.6 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C ≥3450 mbar (50 psig) air with water
Gravimetric Extractables The extractables level was equal to or less than 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
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).
USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Cartridge Nominal Length 10 in. (25 cm)
Diameter 6.9 cm (2.7 in.)
Filtration Area 1.07 m²
Device Size 10 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material Polypropylene
Material Size 3
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL