Merck - KWSSA02HH3 - Opticap XL2 Milligard 0.5/0.2µm 9/16in. HB/HB

ITEM #: 11563094
Catalogue Number KWSSA02HH3
Replaces KWSS04HB3
Trade Name

• Opticap ®

Opticap ® XL2 Milligard ® 0.5/0.2 µm 9/16 in. HB/HB
Format Double Layer
Device Configuration Capsule
Connections, Inlet/Outlet 14 mm (9/16 in.) Hose Barb
Filter Grade Standard 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 ®
Sterilization 3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Pore Size 0.5 / 0.2 µm
Inlet Connection Hose Barb
Outlet Connection Hose Barb
Gravimetric Extractables The extractables level was equal to or less than 15 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 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 2 in. (5 cm)
Length 14.2 cm (5.6 in.)
Diameter 12.5 cm (4.9 in.)
Filtration Area 0.07 m²
Inlet to Outlet Width 14.2 cm (5.6 in.)
Device Size 2 in.
Inlet Connection Diameter 9/16 in.
Nominal Pore Size 0.5 / 0.2 µm
Outlet Connection Diameter 9/16 in.
Chemistry

• Mixed Cellulose Esters (MCE)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material Polyester
Vent Cap Material Polypropylene (PP)
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