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KPGEG015HH3 Opticap® XL 150 Millipore Express® PHF Gamma Compatible 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.
KPGEG015HH3
3  Double Easy-Open bag
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Aperçu

Replacement Information
Description
Catalogue NumberKPGEG015HH3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 150 Millipore Express® PHF Gamma Compatible 0.2 µm 9/16 in. HB/HB
References
Product Information
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
SterilityGamma
Sterilization3 autoclave cycles of 60 min @ 123 °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≤1.4 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 2.0 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 Length3.8 in. (9.7 cm)
Length9.7 cm (3.8 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area220 cm²
Inlet to Outlet Width9.7 cm (3.8 in.)
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolyethylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size3
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
KPGEG015HH3 04055977295115

Documentation

Certificats de qualité

Titre
Opticap XL 150 Capsule Millipore Express PHF Membrane C0DB58532
Opticap XL 150 Capsule Millipore Express PHF Membrane C1CB48059
Opticap XL 150 Capsule Millipore Express PHF Membrane C8NA29122
Opticap XL 150 Capsule Millipore Express PHF Membrane C9HA48738
Opticap XL 150 Capsule Millipore Express PHF Membrane C9NA11156
Opticap XL 150 Capsule Millipore Express PHF Membrane - C0AB88205
Opticap XL 150 Capsule Millipore Express PHF Membrane - C0BB33302
Opticap XL 150 Capsule Millipore Express PHF Membrane - C8AA19345
Opticap XL 150 Capsule Millipore Express PHF Membrane - C8BA29937
Opticap XL 150 Capsule Millipore Express PHF Membrane - C9DA21704
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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®PHF Hydrophilic Filters

Manuels d'utilisation

Titre
User Guide - Filters with Millipore Express®Membrane

Produits & Applications associés

Familles de produits

Millipore Express® PHF Capsule Filters

Sterilizing-grade PES filters for fast, efficient, and economical buffer filtration
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Produits associés classés par : Brand Facete

Millipore Express®

Catégories

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express®
Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express