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CHGE71TS3 Millipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CHGE71TS3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCHGE71TS3
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone
References
Product Information
HS Code8421 29 90
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≤28.2 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 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 Area0.49 m²
Device Size10 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polypropylene/Polysulfone
Seal MaterialSilicone (SI)
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
CHGE71TS3 04053252575389

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Millipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
DURAPORE CARTRIDGE C3NB64179
Durapore Cartridge C1SB04547
Durapore Cartridge C2SB42091
Durapore Express SHC Cartridge C3BB79272
Millipore Espress SHC Cartridge C3CB07384
Millipore Express SHC Cartridge
Millipore Express SHC Cartridge
Millipore Express SHC Cartridge C9BA94694
Millipore Express SHC Cartridge C0DB42331
Millipore Express SHC Cartridge C2PB20635
Show more

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