Merck - K030A10HH1 - Opticap XL10 Clarigard 3.0µm 9/16in. HB/HB

ITEM #: 11561321
Catalogue Number K030A10HH1
Trade Name

• Opticap ®

Opticap ® XL10 Clarigard ® 3.0 µm 9/16 in. HB/HB
Device Configuration Capsule
Connections, Inlet/Outlet 14 mm (9/16 in.) Hose Barb
Housing Material Polypropylene (PP)
Maximum Differential Pressure, bar (psid) 4.8 bar (70 psid) @ 20 °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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Clarigard ®
Sterilization 3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Pore Size 3.0 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 0.25 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.)
Inlet to Outlet Width 33.5 cm (13.2 in.)
Device Size 10 in.
Inlet Connection Diameter 9/16 in.
Nominal Pore Size 3.0 µm
Outlet Connection Diameter 9/16 in.
Chemistry

• Polypropylene (PP)

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 ≥3 L