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KPGEA03HH3 Opticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KPGEA03HH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKPGEA03HH3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 3 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
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 3.0 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 in. (7.5 cm)
Length17.3 cm (6.8 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.16 m²
Inlet to Outlet Width17.3 cm (6.8 in.)
Device Size3 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 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
KPGEA03HH3 04055977296099

Documentation

Certificates of Quality

Title
OPTICAP XL 3 Capsule Millipore Express PHF Membrane C3KB53578
Opticap XL 3 Capsule Millipore Express PHF Membrane
Opticap XL 3 Capsule Millipore Express PHF Membrane C8NA38017
Opticap XL 3 Capsule Millipore Express PHF Membrane C1HB15218
Opticap XL 3 Capsule Millipore Express PHF Membrane C8CA42573
Opticap XL 3 Capsule Millipore Express PHF Membrane C9HA90053
Opticap XL 3 Capsule Millipore Express PHF Membrane - C7PA86390
Opticap XL 3 Capsule Millipore Express PHF Membrane C0SB74370
Opticap XL 3 Capsule Millipore Express PHF Membrane C1KB51413
Opticap XL 3 Capsule Millipore Express PHF Membrane C2AB23466
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