Merck - KVSXA10FF1 - Opticap Sterilizing Grade XL10 Multimedia 1.2/0.2/0.22µm 3/4in. TC/TC

ITEM #: 11562877
Catalogue Number KVSXA10FF1
Trade Name

• Opticap ®

Opticap ® Sterilizing Grade XL10 Multimedia 1.2/0.2/0.22 µm 3/4 in. TC/TC
Device Configuration Capsule
Connections, Inlet/Outlet 19 mm (3/4 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; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi) 5.5 bar (80 psi) @ 25 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Operating Temperature 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.
Prefilter Material Mixed Cellulose Esters (MCE)
Quality Level MQ400
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Multimedia 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 1.2 / 0.2 / 0.22 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Air Diffusion at 23 °C ≤10.8 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C ≥3450 mbar (50 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 10 in. (25 cm)
Length 33.0 cm (13.0 in.)
Diameter 10.7 cm (4.2 in.)
Filtration Area 0.56 m²
Device Size 10 in.
Inlet Connection Diameter 3/4 in.
Outlet Connection Diameter 3/4 in.
Chemistry

• Mixed Cellulose Esters (MCE)
• 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
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L