Merck - CGEP71TP3 - Millipore Express SHF Cartridge Filter 10in. 0.2µm Code 7 Silicone

ITEM #: 11557881
Catalogue Number CGEP71TP3
Trade Name

• Millipore Express ®

Millipore Express ® SHF Cartridge Filter 10 in. 0.2 µm Code 7 Silicone
Device Configuration Cartridge
Maximum Inlet Pressure, bar (psi) Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 2.07 bar (30 psi) @ 25 °C; 0.07 bar (1 psi) @ 135 °C
Cartridge Code Code 7
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 Millipore Express ® SHF
Sterilization 25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 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 0.2 µm
Air Diffusion at 23 °C ≤30 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C ≥4000 mbar (58 psig) air with water
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Differential Pressure Forward: 6900 mbar (100 psi) @ 25 °C; 1700 bar (25 psi) @ 80 °C; 340 mbar (5 psi) @ 135 °C. Reverse: 2100 mbar (30 psi) @ 25 °C, 69 mbar (1 psi) @ 135 °C
Non-Fiber Releasing This product was manufactured with a Millipore Express® 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 10 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 0.25 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 0.54 m²
Device Size 10 in.
Chemistry

• Polyethersulfone (PES)

Device Material

• Polypropylene/Polysulfone

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