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CVEP71TF3 Millipore Express® SHR Cartridge Filter 10 in. 0.1 µm Code 7 Fluorocarbon

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CVEP71TF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCVEP71TF3
Trade Name
  • Millipore Express®
DescriptionMillipore Express® SHR Cartridge Filter 10 in. 0.1 µm Code 7 Fluorocarbon
References
Product Information
Device ConfigurationCartridge
Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 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
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® SHR
Sterilization25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 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 Size0.1 µm
Air Diffusion at 23 °C≤33.3 mL/min @ 3.45 bar (50 psig) in water
Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Differential PressureForward:
100 psi (6.9 bar) at 25 °C
25 psi (1.7 bar) at 80 °C
5.0 psi (340 mbar) at 135 °C

Reverse:
30 psi (2.1 bar) at 25 °C
<1.0 psi (69 mbar) at 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 10 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 Area0.6 m²
Device Size10 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 ≥1 L
Global Trade Item Number
Catalog Number GTIN
CVEP71TF3 04053252717994

Documentation

Material Qualification Dossier

TitleVersion
3.0

Operational Excellence Dossier

Title

Technical Info

Title
Cell Culture Media Microfiltration and Mixing: Reducing Risk with Single-use Technology
Mycoplasma clearance by Millipore Express SHR filters at pilot and production scales
Steam-in-Place Method in the Reverse Direction for Millipore Express® PES Filters

Posters

Title
Quality by Design (QbD) Principles in Aseptic Processing

User Guides

Title
User Guide - Filters with Millipore Express®Membrane