Merck - KVGLG04TH3 - Opticap Gamma Compatible XL4 Durapore 0.22µm TC/HB

ITEM #: 11562814
Catalogue Number KVGLG04TH3
Trade Name

• Opticap ®

Opticap ® Gamma Compatible XL4 Durapore ® 0.22 µm TC/HB
Device Configuration Capsule
Connections, Inlet/Outlet 38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
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: 2.8 bar (40 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.
Quality Level MQ400
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Durapore ®
Sterility Gamma
Sterilization 3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 0.22 µm
Outlet Connection Hose Barb
Air Diffusion at 23 °C ≤4.6 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C ≥345kPa mbar (50 psig) air with water
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).
TOC/Conductivity After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP and less than 1.3 µS/cm per USP at 25 ºC.
USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Cartridge Nominal Length 4 in. (10 cm)
Length 17.0 cm (6.7 in.)
Diameter 6.1 cm (2.4 in.)
Filtration Area 0.18 m²
Device Size 4 in.
Inlet Connection Diameter 1-1/2 in.
Outlet Connection Diameter 9/16 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Gamma-stable polypropylene

Seal Material Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
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 ≥500 mL