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KPHLG1TTH1 Opticap® Gamma Compatible XLT10 Durapore® 0.45 µm TC/HB 5/8" without gauge port

KPHLG1TTH1
1  
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Descripción

Replacement Information
Description
Catalogue NumberKPHLG1TTH1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible XLT10 Durapore® 0.45 µm TC/HB 5/8" without gauge port
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange Inlet and 16 mm (5/8 in.) Hose Barb Outlet
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @25 ˚C. Reverse: 2.1 bar (30 psid) @ 4-40 °C
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
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
T-line/Gauge PortT-line
Quality LevelMQ400
Applications
Application
  • Prefiltration / Bioburden reduction in single use assemblies
  • Bioburden reduction before final sterilization
  • Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilityNon-sterile, Gamma compatible
SterilizationGamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤15 mL/min @ 3.9 bar (56 psig) in water
Bubble Point at 23 °C≥1930 mbar (28 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
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).
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 Length14.8 in. (37.6 cm)
Length37.6 cm (14.8 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.62 m²
Inlet to Outlet Width37.6 cm (14.8 in.)
Device Size10 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter5/8 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)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL
Global Trade Item Number
Número de referencia GTIN
KPHLG1TTH1 04055977275681

Documentation

Material Qualification Dossier

CargoVersión
2.0

Certificados de calidad

Cargo
OPTICAP XLT 10 Capsule Durapore Membrane C3KB45410
Opticap XLT 10 Capsule Durapore Membrane C1PB86812
Opticap XLT 10 Capsule Durapore Membrane C9EA38804
Opticap XLT 10 Capsule Durapore Membrane C9NA04933
Opticap XLT 10 Capsule Durapore Membrane C2DB43677
Opticap XLT 10 Capsule Durapore Membrane C3AB53064
Opticap XLT 10 Capsule Durapore Membrane C3JB27690
Opticap XLT 10 Capsule Durapore Membrane C3PB62975
Opticap XLT 10 Capsule Durapore Membrane C7DA96095
Opticap XLT 10 Capsule Durapore Membrane- C0NB26203

Licencias necesarias e Información técnica

Cargo
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

Ficha técnica

Cargo
Durapore® Family Guide

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Categorías

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