Merck - KPHLA2TTT1 - Opticap XLT20 Durapre 0.45µm without prefilter 1-1/2in. TC/TC without gauge port

ITEM #: 11562347
Catalogue Number KPHLA2TTT1
Trade Name

• Opticap ®

Opticap ® XLT20 Durapre 0.45 µm without prefilter 1-1/2 in. TC/TC without gauge port
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: 3.4 bar (50 psid) @ 25 °C. Reverse: 3.4 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
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.
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 Other
Sterilization 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Wettability Hydrophilic
Pore Size 0.45 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Bubble Point at 23 °C ≥1930 mbar (28 psig) air with water
Gravimetric Extractables The extractables level was equal to or less than 50 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 20 in. (50 cm)
Diameter 10.7 cm (4.2 in.)
Filtration Area 1.4 m²
Device Size 20 in.
Inlet Connection Diameter 1-1/2 in.
Outlet Connection Diameter 1-1/2 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polypropylene

Seal Material Silicone (SI)
Support Material Polypropylene
Vent Cap Material Polypropylene (PP)
Material Size 1
Material Package Double Easy-Open bag