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CHGE71HE1 Millipore Express® SHC High Area Cartridge Filter 10 in. 0.5/0.2 µm Code 7 EPDM

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CHGE71HE1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCHGE71HE1
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHC High Area Cartridge Filter 10 in. 0.5/0.2 µm Code 7 EPDM
References
Product Information
Device ConfigurationCartridge
Maximum Inlet Pressure, bar (psi)Forward: 6900 mbar (100 psi) @ 25 °C; 1700 bar (25 psi) @ 80 °C; 340 mbar (5 psi) @ 135 °C. Reverse: 2100 mbar (30 psi) @ 25 °C, 69 mbar (1 psi) @ 135 °C
Cartridge CodeCode 7
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Key Applications
  • Sterile Filtration
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SHC High Area
Sterilization5 autoclave cycles of 60 min @ 126 °C or 5 forward SIP cycles of 30 min @ 135 °C
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.5 / 0.2 µm
Air Diffusion at 23 °C≤56.4 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥4000 mbar (58 psig) air with water
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Differential PressureForward: 6900 mbar (100 psi) @ 25 °C; 1700 bar (25 psi) @ 80 °C; 340 mbar (5 psi) @ 135 °C. Reverse: 2100 mbar (30 psi) @ 25 °C, 69 mbar (1 psi) @ 135 °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 20 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 Length10 in. (25 cm)
Diameter6.9 cm (2.7 in.)
Filtration Area1.0 m²
Device Size10 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polypropylene/Polyethersulfone
Seal MaterialEPDM
Support MaterialPolypropylene
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
Global Trade Item Number
Catalog Number GTIN
CHGE71HE1 04055977306811

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
DURAPORE CARTRIDGE C3CB37066
Millipore Express SHC High Area Cartridge C0AB23085
Millipore Express SHC High Area Cartridge C0AB23088
Millipore Express SHC High Area Cartridge C0BB23089
Millipore Express SHC High Area Cartridge C3DB07938

Technical Info

Title
Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
Steam-in-Place Method in the Reverse Direction for Millipore Express® PES Filters

Data Sheet

Title
Millipore Express®SHC Hydrophilic Filters

User Guides

Title
User Guide - Filters with Millipore Express®Membrane