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CHGE75TF3 Millipore Express® SHC Cartridge Filter 5 in. 0.5/0.2 µm Code 7 Fluorocarbon

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CHGE75TF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCHGE75TF3
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHC Cartridge Filter 5 in. 0.5/0.2 µm Code 7 Fluorocarbon
References
Product Information
Device ConfigurationCartridge
Maximum Inlet Pressure, bar (psi)Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 1.0 bar (15 psi) @ 135 °C; Reverse - 2.07 bar (30 psi) @ 25 °C; 0.07 bar (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
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SHC
Sterilization25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C and 0.35 bar (5) or 3 forward SIP cycles of 30 min @ 135 °C and 1 bar (15 psid); 25 autoclave cycles of 60 min @ 126 °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≤13.3 mL/min @ 2.8 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 9.5 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)
Diameter6.9 cm (2.7 in.)
Filtration Area0.23 m²
Device Size5 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polypropylene/Polysulfone
Seal MaterialFluorocarbon rubber
Support MaterialPolypropylene
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 ≥2 L
Global Trade Item Number
Catalog Number GTIN
CHGE75TF3 04053252574122

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Millipore Express® SHC Cartridge Filter 5 in. 0.5/0.2 µm Code 7 Fluorocarbon SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Millipore Express SHC Cartridge - C7JA45054
Millipore Express SHC Cartridge C2NB30814
Millipore Express SHC Cartridge C3JB45809
Millipore Express SHC Cartridge C4BB94084
Millipore Express SHC Cartridge C8CA57555

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

Posters

Title
Quality by Design (QbD) Principles in Aseptic Processing

User Guides

Title
User Guide - Filters with Millipore Express®Membrane
Vmax Constant Pressure