Merck - CGW604S03 - Polysep II Cartridge Filter 40in. 0.5µm Code 0

ITEM #: 11557968
Catalogue Number CGW604S03
Trade Name

• Polysep ®

Polysep ® II Cartridge Filter 40 in. 0.5 µm Code 0
Format Double Layer
Device Configuration Cartridge
Maximum Differential Pressure, bar (psid) 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi) 3.5 bar (50 psi) @ 25 °C
Cartridge Code Code 0 (2-222) O-rings
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Prefilter Material Borosilicate Glass Fiber (BGF)
Quality Level MQ400
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Polysep™ II
Sanitization 30 min with hot water @ 80 °C
Sterilization 10 autoclave cycles or SIP @ 121 °C for 30 min
Pore Size 1.0 / 0.5 µm
Gravimetric Extractables The extractables level was equal to or less than 140 mg per 10-inch cartridge after 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. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Non-Fiber Releasing This product was manufactured with a media combination 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 40 in. (100 cm)
Diameter 7.1 cm (2.8 in.)
Filtration Area 1.84 m²
Device Size 40 in.
Nominal Pore Size 1.0 / 0.5 µm
Chemistry

• Mixed Cellulose Esters (MCE)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material Spun bonded polypropylene
Material Size 3
Material Package Double Easy-Open bag
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥20 L