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KPGEA05TH1 Opticap® XL 5 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC-9/16 in. HB

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KPGEA05TH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKPGEA05TH1
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 5 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC-9/16 in. HB
References
Product Information
HS Code8421 22 00
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/14 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 ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤16.4 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 5.5 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 Length5 in. (12.5 cm)
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.29 m²
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size5 in.
Inlet Connection Diameter1-1/2 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
Catalogue Number GTIN
KPGEA05TH1 04055977296143

Documentation

Certificates of Quality

Title
Opticap XL 5 Capsule Millipore Express PHF Membrane C7JA36237
Opticap XL 5 Capsule Millipore Express PHF Membrane C7EA16337
Opticap XL 5 Capsule Millipore Express PHF Membrane C9NA13425
Opticap XL 5 Capsule Millipore Express PHF Membrane - C7CA90393
Opticap XL 5 Capsule Millipore Express PHF Membrane - C7HA24918
Opticap XL 5 Capsule Millipore Express PHF Membrane C2HB80409
Opticap XL 5 Capsule Millipore Express PHF Membrane C3NB45424
Opticap XL 5 Capsule Millipore Express PHF Membrane C7EA07005