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KPGES015HH3 Opticap® XL 150 Millipore Express® PHF Sterile 0.2 µm 9/16 in. HB/HB

Opticap® XL 150 Millipore Express® PHF Sterile 0.2 µm 9/16 in. HB/HB: MSDS (material safety data sheet) o SDS, certificato d’analisi (CoA) e certificato di qualità (CoQ), dossier, brochure e altri documenti disponibili.
KPGES015HH3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKPGES015HH3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 150 Millipore Express® PHF Sterile 0.2 µm 9/16 in. HB/HB
OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
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
SterilitySterile
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
Numero di catalogo GTIN
KPGES015HH3 04055977295412

Documentation

Certificati di Qualità

Titolo
OPTICAP XL 150 Capsule Millipore Express PHF Membrane C4HB51317
OPTICAP XL 150 Capsule Millipore Express PHF Membrane C4JB72768
Opticap XL 150 Capsule Millipore Express PHF membrane C3AB75840
Opticap XL 150 Capsule Millipore Express PHF Membrane C0SB70104
Opticap XL 150 Capsule Millipore Express PHF Membrane C2KB18147
Opticap XL 150 Capsule Millipore Express PHF Membrane C4PB00177
Opticap XL 150 Capsule Millipore Express PHF Membrane C7DA07308
Opticap XL 150 Capsule Millipore Express PHF Membrane C7HA11878
Opticap XL 150 Capsule Millipore Express PHF Membrane C7MA60792
Opticap XL 150 Capsule Millipore Express PHF Membrane C8NA29125
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Informazioni tecniche

Titolo
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

Scheda tecnica

Titolo
Millipore Express®PHF Hydrophilic Filters

Manuali d'uso

Titolo
User Guide - Filters with Millipore Express®Membrane