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CVGL75S01 Durapore® Cartridge Filter 5 in. 0.22 µm Code 7

CVGL75S01
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberCVGL75S01
Trade Name
  • Durapore®
DescriptionDurapore® Cartridge Filter 5 in. 0.22 µm Code 7
References
Product Information
HS Code8421 29 90
Device ConfigurationCartridge
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 25 °C
Cartridge CodeCode 7 (2-226) O-rings w/locking-tabs
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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilityOther
Sterilization30 SIP cycles of 30 min @ 135 °C; 30 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 Size0.22 µm
Air Diffusion at 23 °C≤6.6 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Flow Rate25 L/min @ 1.4 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 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 Area0.35 m²
Device Size5 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
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
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Global Trade Item Number
Katalogové číslo GTIN
CVGL75S01 04053252457111

Documentation

Material Qualification Dossier

TitleVersion
6.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
DURAPORE CARTRIDGE
DURAPORE CARTRIDGE
DURAPORE CARTRIDGE
DURAPORE CARTRIDGE - F4BA92763
DURAPORE CARTRIDGE - F4CA26549
DURAPORE CARTRIDGE - F4NA20768Q
DURAPORE CARTRIDGE - F5CA83106
DURAPORE CARTRIDGE - F5DA79233
DURAPORE CARTRIDGE - F5DA79234
DURAPORE CARTRIDGE - F5DA98734

Technical Info

Title
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Integrity Test Troubleshooting - Beyond Rewet and Retest
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Hydrophilic Durapore® Cartridges and Capsules User Guide
Wetting Instructions for Filter Units with Durapore Membrane