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KHGES3FTT1 Sterile Opticap® XLT 30 Millipore Express® SHC 0.5/0.2 µm TC/TC 1pk w/3/4" TC top

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KHGES3FTT1
1  Double Easy-Open bag
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Aperçu

Replacement Information
Description
Catalogue NumberKHGES3FTT1
Trade Name
  • Millipore Express®
DescriptionSterile Opticap® XLT 30 Millipore Express® SHC 0.5/0.2 µm TC/TC 1pk w/3/4" TC top
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; 3/4 in. Gauge Port
Housing MaterialPolypropylene (PP)
Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 25 °C; 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 with 3/4 in. Gauge Port
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SHC
SterilitySterile
Sterilization3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 Size0.5 / 0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥4000 mbar (58 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 Differential PressureForward: 5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C; 6900 mbar (100 psi) @ 25 °C, intermittent. Reverse: 2100 bar (30 psi) @ 25 °C, 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 63 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.)
Diameter19.8 cm (7.8 in.)
Filtration Area1.63 m²
Device Size30 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • 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 ≥6 L
Global Trade Item Number
Référence GTIN
KHGES3FTT1 04053252303869

Documentation

Material Qualification Dossier

TitreVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificats de qualité

Titre
OPTICAP XLT 30 Capsule Millipore Express SHC Membrane C4DB01512
OPTICAP XLT 30 Capsule Millipore Express SHC membrane C4AB01469
Opticap XLT 30 Capsule Millipore Express SHC Membrane C2AB10106
Opticap XLT 30 Capsule Millipore Express SHC Membrane C9CA87808
Opticap XLT 30 Capsule Millipore Express SHC Membrane C9SA26277
Opticap XLT 30 Capsule Millipore Express SHC Membrane - C7CA77666
Opticap XLT 30 Capsule Millipore Express SHC Membrane - C8MA23009
Opticap XLT 30 Capsule Millipore Express SHC Membrane C0CB28746
Opticap XLT 30 Capsule Millipore Express SHC Membrane C1BB33777
Opticap XLT 30 Capsule Millipore Express SHC Membrane C3PB65742
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Manuels d'utilisation

Titre
Opticap® XL Capsules and Opticap® XLT Capsules
Vmax Constant Pressure