Merck - KVVLS3TTT1 - Sterile Opticap XLT 30 w/Phil Dur - 30" 0.1µm TC/TC 1pk

ITEM #: 11590927
Catalogue Number KVVLS3TTT1
Trade Name

• Opticap ®

Sterile Opticap ® XLT 30 w/Phil Dur - 30" 0.1 µm TC/TC 1pk
Device Configuration Capsule
Connections, Inlet/Outlet 38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain 1/4 in. Hose Barb with double O-ring Seal
Housing Material Polypropylene (PP)
Maximum Differential Pressure, bar (psid) Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi) 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
T-line/Gauge Port T-line
Quality Level MQ400
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Durapore ®
Sterility Sterile
Sterilization 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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 0.1 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Bubble Point at 23 °C ≥4830 mbar (70 psig) air with water
Gravimetric Extractables The extractables level was equal to or less than 75 mg per capsule 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.
Maximum Inlet Pressure (psig) 80 psig
Maximum Inlet Temperature 25 °C
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 30 in. (75 cm)
Length 87.1 cm (34.3 in.)
Diameter 10.7 cm (4.2 in.)
Filtration Area 2.17 m²
Inlet to Outlet Width 15.2 cm (6.0 in.)
Device Size 30 in.
Inlet Connection Diameter 1-1/2 in.
Outlet Connection Diameter 1-1/2 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Gamma-stable polypropylene

Seal Material Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Support Material Polyester
Vent Cap Material Polypropylene (PP)
Material Size 1
Material Package Double Easy-Open bag
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L