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KPGES003HH3 Opticap® XL 300 Millipore Express® PHF Sterile 0.2 µm 9/16 in. HB/HB

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KPGES003HH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKPGES003HH3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 300 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
HS Code8421 99 99
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≤2.8 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 2.5 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 Length4.7 in. (11.9 cm)
Length11.9 cm (4.7 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area480 cm²
Inlet to Outlet Width11.9 cm (4.7 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
Catalogue Number GTIN
KPGES003HH3 04055977295801

Documentation

Certificates of Quality

Title
OPTICAP XL 300 Capsule Millipore Express SHF membrane C4NB90590
Opticap XL 300 Capsule Millipore Express PHF Membrane C8CA29939
Opticap XL 300 Capsule Millipore Express PHF Membrane C0DB50088
Opticap XL 300 Capsule Millipore Express PHF Membrane C2MB18127
Opticap XL 300 Capsule Millipore Express PHF Membrane C3PB63650
Opticap XL 300 Capsule Millipore Express PHF Membrane C7JA39737
Opticap XL 300 Capsule Millipore Express PHF Membrane C7KA39738
Opticap XL 300 Capsule Millipore Express PHF Membrane C8AA05080
Opticap XL 300 Capsule Millipore Express PHF Membrane C8HA51963
Opticap XL 300 Capsule Millipore Express PHF Membrane C8PA58358
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Technical Info

Title
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

Data Sheet

Title
Millipore Express®PHF Hydrophilic Filters

User Guides

Title
User Guide - Filters with Millipore Express®Membrane