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KPGEG003FF3 Opticap® XL 300 Millipore Express® PHF Gamma Compatible 0.2 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KPGEG003FF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKPGEG003FF3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 300 Millipore Express® PHF Gamma Compatible 0.2 µm 3/4 in. TC/TC
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
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 ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 Diameter3/4 in.
Outlet Connection Diameter3/4 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
KPGEG003FF3 04055977295047

Documentation

Certificates of Quality

Title
Opticap XL 300 Capsule Millipore Express PHF Membrane C8JA08782
Opticap XL 300 Capsule Millipore Express PHF Membrane - C9DA21701
Opticap XL 300 Capsule Millipore Express PHF Membrane - C9KA76524
Opticap XL 300 Capsule Millipore Express PHF Membrane - C9KA82370
Opticap XL 300 Capsule Millipore Express PHF Membrane - C9SA20631
Opticap XL 300 Capsule Millipore Express PHF Membrane 10.00
Opticap XL 300 Capsule Millipore Express PHF Membrane C2PB44656
Opticap XL 300 Capsule Millipore Express PHF Membrane C4BB98836
Opticap XL 300 Capsule Millipore Express PHF Membrane C8HA51961
Opticap XL 300 Capsule Millipore Express PHF Membrane C8MA14737

Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters