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KVEPG3TTT1 Opticap® Gamma Compatible XLT 30 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC/TC without gauge port

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
KVEPG3TTT1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Descripción

Replacement Information
Description
Catalogue NumberKVEPG3TTT1
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XLT 30 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC/TC without gauge port
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 Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 23 °C; 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
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SHR
SterilityNon-sterile, Gamma compatible
SterilizationGamma Compatible to 45 kGy. May be autoclaved for 3 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 Size0.1 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/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 Pressure80 psi (5.5 bar) continuous
100 psi (6.9 bar) intermittent
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)
Length87.2 cm (34.3 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area2.06 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
  • Polypropylene
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
KVEPG3TTT1 04053252453922

Documentation

Material Qualification Dossier

CargoVersión
6.0

Operational Excellence Dossier

Title

Certificados de calidad

Cargo
OPTICAP XLT 30 Capsule Millipore Express SHR Membrane C3AB59791
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Opticap XLT 30 Capsule Millipore Express SHR Membrane C8JA82845Y
Opticap XLT 30 Capsule Millipore Express SHR Membrane C0SB39909
Opticap XLT 30 Capsule Millipore Express SHR Membrane C1EB80781
Opticap XLT 30 Capsule Millipore Express SHR Membrane C8HA58182
Opticap XLT 30 Capsule Millipore Express SHR Membrane C9DA96542Y
Opticap XLT 30 Capsule Millipore Express SHR Membrane C9EA37155Y
Opticap XLT 30 Capsule Millipore Express SHR Membrane C9PA13173Y
Opticap XLT 30 Capsule Millipore Express SHR Membrane - C9NA88346Y
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Licencias necesarias e Información técnica

Cargo
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Cell Culture Media Microfiltration and Mixing: Reducing Risk with Single-use Technology
Mycoplasma clearance by Millipore Express SHR filters at pilot and production scales
Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

Ficha técnica

Cargo
Millipore Express®SHR Hydrophilic Filters

Manuales del usuario

Cargo
Opticap® XL Capsules and Opticap® XLT Capsules
User Guide - Filters with Millipore Express®Membrane