Merck - KP20A10FF1 - Opticap XL10 Lifegard 2.0µm 3/4in. TC/TC

ITEM #: 11590873
Catalogue Number KP20A10FF1
Trade Name

• Opticap ®

Opticap ® XL10 Lifegard™ 2.0 µm 3/4 in. TC/TC
Format Single Layer
Device Configuration Capsule
Connections, Inlet/Outlet 19 mm (3/4 in.) Sanitary Flange
Filter Grade AP20
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 ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Lifegard™
Sterilization 3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Pore Size 2.0 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Gravimetric Extractables The extractables level was equal to or less than 225 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
USP Bacterial Endotoxins A sample aqueous extraction contains less than 1.0 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 10.7 cm (4.2 in.)
Filtration Area 0.46 m²
Inlet to Outlet Width 33.5 cm (13.2 in.)
Device Size 10 in.
Inlet Connection Diameter 3/4 in.
Nominal Pore Size 2.0 µm
Outlet Connection Diameter 3/4 in.
Chemistry

• Borosilicate Glass Fiber (BGF)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material Polypropylene
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