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KHGLG3TTT1 Opticap® Gamma Compatible Multilayer XLT30 Durapore® 0.45/0.22 µm 1-1/2 in. TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KHGLG3TTT1
1  Double Easy-Open bag
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Description
Catalogue NumberKHGLG3TTT1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible Multilayer XLT30 Durapore® 0.45/0.22 µm 1-1/2 in. TC
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.05 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
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
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
T-line/Gauge PortT-line
Quality LevelMQ400
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMultilayer Durapore®
SterilityNon-sterile, Gamma compatible
SterilizationGamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 / 0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤45.0 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig)80 psig
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis 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/ConductivityAfter sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length30 in. (75 cm)
Length87.1 cm (34.3 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.81 m²
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size30 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Support MaterialPolyester/Polyethylene
Vent Cap MaterialPolypropylene (PP)
Packaging Information
Material Size1
Material PackageDouble Easy-Open bag
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
Global Trade Item Number
Katalogové číslo GTIN
KHGLG3TTT1 04053252496677