Merck - CVGL01TP3 - Durapore Cartridge Filter 10in. 0.22µm Code 0

ITEM #: 11558841
Catalogue Number CVGL01TP3
Trade Name

• Durapore ®

Durapore ® Cartridge Filter 10 in. 0.22 µm Code 0
Device Configuration Cartridge
Maximum Differential Pressure, bar (psid) Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi) Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 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.
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
Sterilization 30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
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 ≤13.3 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C ≥3450 mbar (50 psig) air with water
Flow Rate 50 L/min @ 1.4 bar ΔP
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 Durapore ® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
TOC/Conductivity After sterilization and a controlled water flush of 5.5 L, samples exhibited less than 500 ppb TOC per USP and less than 1.3 µS/cm per USP at 25 °C.
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 0.69 m²
Device Size 10 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material 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 ≥1 L