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KPGEA10HH1 Opticap® XL 10 Millipore Express® PHF Autoclavable 0.2 µm 9/16 in. HB/HB

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KPGEA10HH1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKPGEA10HH1
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 10 Millipore Express® PHF Autoclavable 0.2 µm 9/16 in. HB/HB
References
Product Information
HS Code8421 22 00
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 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.
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≤30 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 10 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.54 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 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 ≥1 L
Global Trade Item Number
Référence GTIN
KPGEA10HH1 04055977296167

Documentation

Certificats de qualité

Titre
OPTICAP XL 10 Capsule Millipore Express PHF Membrane C3KB48326
OPTICAP XL 10 Capsule Millipore Express PHF Membrane C4CB17630
Opticap XL 10 Capsule Express PHF Membrane C1SB03854
Opticap XL 10 Capsule Millipore Express PHF Membrane C8JA05957
Opticap XL 10 Capsule Millipore Express PHF Membrane C8JA93831
Opticap XL 10 Capsule Millipore Express PHF Membrane C1KB50670
Opticap XL 10 Capsule Millipore Express PHF Membrane C2JB84400
Opticap XL 10 Capsule Millipore Express PHF Membrane C9JA90060
Opticap XL 10 Capsule Millipore Express PHF Membrane - C8DA42553
Opticap XL 10 Capsule Millipore Express PHF Membrane -C8SA65259
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