Merck - KWLCA10FF1 - Opticap XL10 Milligard Low Protein Binding 1.2/0.5µm 3/4in. TC/TC

ITEM #: 11563057
Catalogue Number KWLCA10FF1
Trade Name

• Opticap ®

Opticap ® XL10 Milligard ® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC
Format Double Layer
Device Configuration Capsule
Connections, Inlet/Outlet 19 mm (3/4 in.) Sanitary Flange
Filter Grade Low Protein Binding Milligard ® Media
Housing Material Polypropylene (PP)
Maximum Differential Pressure, bar (psid) 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi) 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
European Pressure Equipment Directive EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
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 Milligard ® LPB
Sterilization 3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Pore Size 1.2 / 0.5 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Gravimetric Extractables The extractables level was equal to or less than 355 mg per capsule after a 5 L flush and 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 media combination 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 10 in. (25 cm)
Length 33.5 cm (13.2 in.)
Diameter 14.5 cm (5.7 in.)
Filtration Area 0.69 m²
Inlet to Outlet Width 33.5 cm (13.2 in.)
Device Size 10 in.
Inlet Connection Diameter 3/4 in.
Nominal Pore Size 1.2 / 0.5 µm
Outlet Connection Diameter 3/4 in.
Chemistry

• Low Protein-Binding Mixed Cellulose Esters (MCE)

Device Material

• Polypropylene

Seal Material Silicone (SI)
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 ≥5 L