Merck - KEGBG003HH3 - Gamma Phobic Opticap XL 300 Express SPG 0.2 hose barb

ITEM #: 11561329
Catalogue Number KEGBG003HH3
Trade Name

• Opticap ®

Gamma Phobic Opticap ® XL 300 Express SPG 0.2 hose barb
Device Configuration Capsule
Connections, Inlet/Outlet 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: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi) 4.1 bar (60 psi) @ 23 °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
Key Applications

• Small scale single-use applications

Bacterial Endotoxins Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Millipore Express ® SPG
Sterility Gamma
Sterilization Gamma compatible to 45 kGy; 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 Hydrophobic
Pore Size 0.2 µm
Inlet Connection Hose Barb
Outlet Connection Hose Barb
Bubble Point at 23 °C ≥1210 mbar (17.5 psig) air with 70/30 % IPA/water
Gravimetric Extractables The extractables level was equal to or less than 3 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
HydroCorr ≤0.16 mL/min @ 2.6 bar (38 psig)
Maximum Inlet Pressure (psig) 60 psig
Maximum Differential Pressure 60 psi (4.1 bar) continuous
Maximum Inlet Temperature 25 °C
Non-Fiber Releasing This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
TOC/Conductivity After gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.
USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Length 11.9 cm (4.7 in.)
Diameter 5.6 cm (2.2 in.)
Filtration Area 0.048 m²
Inlet to Outlet Width 11.9 cm (4.7 in.)
Inlet Connection Diameter 9/16 in.
Outlet Connection Diameter 9/16 in.
Chemistry

• Polyethersulfone (PES)

Device Material

• Gamma stable polypropylene/Polysulfone

Seal Material Silicone (SI)
Support Material Polyethylene
Vent Cap Material Polypropylene (PP)
Material Size 3
Material Package Double Easy-Open bag