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KPGEG3TTT1 Opticap® XLT 30 Millipore Express® PHF Gamma Compatible 0.2 µm 1-1/2 in. TC

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
KPGEG3TTT1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Descripción

Replacement Information
Description
Catalogue NumberKPGEG3TTT1
Trade Name
  • Millipore Express®
DescriptionOpticap® XLT 30 Millipore Express® PHF Gamma Compatible 0.2 µm 1-1/2 in. TC
References
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 Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °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
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® PHF
SterilityGamma
SterilizationGamma compatible to 40 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Bacterial RetentionSamples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤98.2 mL/min @ 2.8 bar (40 psig) in 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 Differential Pressure5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis 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/ConductivityAfter sterilization and a controlled water flush of 33 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
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 Area1.71 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
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolyester
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
Global Trade Item Number
Número de referencia GTIN
KPGEG3TTT1 04055977295344

Documentation

Certificados de calidad

Cargo
OPTICAP XLT 30 Capsule Millipore Express PHF Membrane C3KB48886
OPTICAP XLT 30 Capsule Millipore Express PHF Membrane C3MB56793
OPTICAP XLT 30 Capsule Millipore Express PHF Membrane C4AB76517
Opticap XLT 30 Capsule Millipore Expres PHF Membrane
Opticap XLT 30 Capsule Millipore Express PHF Membrane C1EB71706
Opticap XLT 30 Capsule Millipore Express PHF Membrane C3BB85489
Opticap XLT 30 Capsule Millipore Express PHF Membrane C3EB14084
Opticap XLT 30 Capsule Millipore Express PHF Membrane - C0DB37597
Opticap XLT 30 Capsule Millipore Express PHF Membrane C2PB31867
Opticap XLT 30 Capsule Millipore Express PHF Membrane C3KB40245
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Licencias necesarias e Información técnica

Cargo
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Ficha técnica

Cargo
Millipore Express®PHF Hydrophilic Filters

Manuales del usuario

Cargo
User Guide - Filters with Millipore Express®Membrane

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Categorías

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express®
Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express