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KPGEG10TT1 Opticap® XL 10 Millipore Express® PHF Gamma Compatible 0.2 µm 1-1/2 in. TC/TC

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
KPGEG10TT1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Descripción

Replacement Information
Description
Catalogue NumberKPGEG10TT1
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 10 Millipore Express® PHF Gamma Compatible 0.2 µm 1-1/2 in. TC/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
European Pressure Equipment DirectiveEMD 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 PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
Sterilization3 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≤32.7 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 11 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.57 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 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 ≥1.5 L
Global Trade Item Number
Número de referencia GTIN
KPGEG10TT1 04055977295214

Documentation

Certificados de calidad

Cargo
OPTICAP XL 10 Capsule Millipore Express PHF Membrane C4MB95146
Opticap XL 10 Capsule Millipore Express PHF Membrane
Opticap XL 10 Capsule Millipore Express PHF Membrane C0PB19582
Opticap XL 10 Capsule Millipore Express PHF Membrane C1DB91305
Opticap XL 10 Capsule Millipore Express PHF Membrane C2HB64073
Opticap XL 10 Capsule Millipore Express PHF Membrane - C8NA35740
Opticap XL 10 Capsule Millipore Express PHF Membrane C0MB65029
Opticap XL 10 Capsule Millipore Express PHF Membrane C1EB03909
Opticap XL 10 Capsule Millipore Express PHF Membrane C3AB75583
Opticap XL 10 Capsule Millipore Express PHF Membrane C3AB83302
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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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Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express®
Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express