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KHGEG3TTT1H Gamma Compatible High Area Opticap® XLT 30 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KHGEG3TTT1H
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKHGEG3TTT1H
Trade Name
  • Millipore Express®
DescriptionGamma Compatible High Area Opticap® XLT 30 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC
References
Product Information
HS Code8421 22 00
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 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 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
Key Applications
  • Laboratory Filtration
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
SterilityNon-sterile, Gamma compatible
SterilizationGamma compatible to 45 kGy; 3 autoclave 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 Size0.5 / 0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤169.2 mL/min @ 2.75 bar (40 psig) in water
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
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.
Dimensions
Cartridge Nominal Length30 in. (75 cm)
Length87.1 cm (34.3 in.)
Diameter10.7 in. (4.2 cm)
Filtration Area30000 cm2
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size30 in.
Outlet Connection Diameter1.5 in.
Materials Information
Chemistry
  • Hydrophilic 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
KHGEG3TTT1H 04054839167898

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 Area membrane C3CB04898
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane - C9PA13177
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C2KB07534
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C0AB82251
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C0JB84307
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C1DB22031
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C1PB84095
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C3DB85426
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C3SB66009
Opticap XLT 30 Capsule Millipore Express SHC High Area Membrane C4PB15999
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Informations techniques

Titre
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

Fiche technique

Titre
Millipore Express®SHC Hydrophilic Filters

Manuels d'utilisation

Titre
User Guide - Polygard®and Clarigard® Cartridges
User Guide - Filters with Millipore Express®Membrane
User Guide - Opticap® XL Capsules and Opticap® XLT Capsules

Produits & Applications associés

Familles de produits

Millipore Express® SHC 0.5/0.2 μm Capsule Filters

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Produits associés classés par : Brand Facete

Opticap®

Catégories

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHC