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KPGEA2THH1 Opticap® XLT 20 Millipore Express® PHF Autoclavable 0.2 µm 5/8 in. HB

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KPGEA2THH1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKPGEA2THH1
Trade Name
  • Millipore Express®
DescriptionOpticap® XLT 20 Millipore Express® PHF Autoclavable 0.2 µm 5/8 in. HB
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
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.
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® PHF
Sterilization3 autoclave cycles of 60 min @ 126 °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 ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤60 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 20 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.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.08 m²
Inlet to Outlet Width19.8 cm (7.8 in.)
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 MaterialPolypropylene
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 ≥2 L
Global Trade Item Number
Référence GTIN
KPGEA2THH1 04055977295733

Documentation

Certificats de qualité

Titre
Opticap XLT 20 Capsule Millipore Express PHF Membrane C1AB38023
Opticap XLT 20 Capsule Millipore Express PHF Membrane - C8DA42053
Opticap XLT 20 Capsule Millipore Express PHF Membrane - C9BA95758
Opticap XLT 20 Capsule Millipore Express PHF Membrane - C9BA96561
Opticap XLT 20 Capsule Millipore Express PHF Membrane C0EB50117
Opticap XLT 20 Capsule Millipore Express PHF Membrane C1EB75073
Opticap XLT 20 Capsule Millipore Express PHF Membrane C2HB84228
Opticap XLT 20 Capsule Millipore Express PHF Membrane-C8SA18808

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Catégories

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Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express