Merck - LAGL04TP6 - Optiseal Durapore Cartridge Filter 0.22µm

ITEM #: 11563163
Catalogue Number LAGL04TP6
Trade Name

• Optiseal ®

Optiseal ® Durapore ® Cartridge Filter 0.22 µm
Device Configuration Cartridge
Maximum Differential Pressure, bar (psid) Forward: 5.5 bar (80 psid) @ 25 °C; 3.5 bar (50 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C KEEP
Maximum Inlet Pressure, bar (psi) Forward - 5.5 bar (80 psi) @ 25 °C; 3.5 bar (50 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 25 °C
Cartridge Code Not Applicable
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; 10 autoclave cycles of 30 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 ≤5 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C ≥3450 mbar (50 psig) air with water
Flow Rate 15 L/min @ 850 mbar ΔP
Gravimetric Extractables The extractables level was equal to or less than 10 mg per 4-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.
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 4 in. (10 cm)
Filtration Area 0.18 m²
Device Size 4 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material Polypropylene
Material Size 6
Material Package Double Easy-Open bag
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL