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KPGEA03TT3 Opticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC/TC

Opticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC/TC MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KPGEA03TT3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKPGEA03TT3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 3 Millipore Express® PHF Autoclavable 0.2 µm 1-1/2 in. TC/TC
References
Product Information
HS Code8421 22 00
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 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
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 ConnectionSanitary Flange
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 Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 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
Katalogové číslo GTIN
KPGEA03TT3 04055977296129

Documentation

Certificates of Quality

Title
OPTICAP XL3 Capsule Millipore Express PHF Membrane C3KB27555
Opticap XL 3 Capsule MIllipore Express PHF Membrane C8BA35673
Opticap XL 3 Capsule Millipore Express PHF Membrane C0DB55991
Opticap XL 3 Capsule Millipore Express PHF Membrane C7SA09640
Opticap XL 3 Capsule Millipore Express PHF Membrane C0BB36808
Opticap XL 3 Capsule Millipore Express PHF Membrane C2MB08872
Opticap XL 3 Capsule Millipore Express PHF Membrane C4MB93193
Opticap XL 3 Capsule Millipore Express PHF Membrane C4NB05105
Opticap XL 3 Capsule Millipore Express PHF Membrane C7HA24930
Opticap XL 3 Capsule Millipore Express PHF Membrane C7PA85168
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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

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Kategorie

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express®
Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Millipore Express