Merck - LAGB04TP6 - Optiseal Durapore Cartridge Filter 0.22µm hydrophobic

ITEM #: 11563161
Catalogue Number LAGB04TP6
Trade Name

• Optiseal ®

Optiseal ® Durapore ® Cartridge Filter 0.22 µm hydrophobic
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 ®
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 Hydrophobic
Pore Size 0.22 µm
Bubble Point at 23 °C ≥1240 mbar (18 psig) nitrogen with 60/40 % IPA/water
Gravimetric Extractables The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Nitrogen Diffusion at 23 °C ≤2 mL/min @ 1.0 bar (15 psig) in 60/40 % IPA/water
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