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KHGEG2FHH1 Opticap® Gamma Compatible XLT 20 Millipore Express® SHC 0.5/0.2 µmum HH/HH 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.
KHGEG2FHH1
1  Double Easy-Open bag
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Aperçu

Replacement Information
Description
Catalogue NumberKHGEG2FHH1
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XLT 20 Millipore Express® SHC 0.5/0.2 µmum HH/HH 1pk w/3/4" TC top
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
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
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.
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
SterilityNon-sterile, Gamma compatible
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 ConnectionHose Barb
Outlet ConnectionHose Barb
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 42 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 Length20 in. (50 cm)
Length62.5 cm (24.6 in.)
Diameter19.8 cm (7.8 in.)
Filtration Area1.09 m²
Device Size20 in.
Inlet Connection Diameter5/8 in.
Outlet Connection Diameter5/8 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 ≥4 L
Global Trade Item Number
Référence GTIN
KHGEG2FHH1 04053252563348

Documentation

Material Qualification Dossier

TitreVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificats de qualité

Titre
OPTICAP XLT 20 Capsule Millipore Express SHC membrane C3DB07985
Opticap XLT 20 Capsule Express SHC Membrane C1CB88045
Opticap XLT 20 Capsule Milliopore Express SHC Membrane C7CA74285
Opticap XLT 20 Capsule Millipore Express SHC Membrane
Opticap XLT 20 Capsule Millipore Express SHC Membrane C1AB92712
Opticap XLT 20 Capsule Millipore Express SHC Membrane C2AB10769
Opticap XLT 20 Capsule Millipore Express SHC Membrane C8HA67358
Opticap XLT 20 Capsule Millipore Express SHC Membrane C9PA10076
Opticap XLT 20 Capsule Millipore Express SHC Membrane - C0AB83942
Opticap XLT 20 Capsule Millipore Express SHC Membrane - C9MA76707
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Manuels d'utilisation

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