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CLGL71TP3 Durapore® 0.22 µm High Area Cartridge 10 in. Code 7

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CLGL71TP3
3  
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Overview

Description
Catalogue NumberCLGL71TP3
Trade Name
  • Durapore®
DescriptionDurapore® 0.22 µm High Area Cartridge 10 in. Code 7
Product Information
Device ConfigurationCartridge
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
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilityOther
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≤20.6 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 30 mg per 10-inch cartridge after a 1.5 L flush and 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.
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 Length10 in. (25 cm)
Diameter6.9 cm (2.7 in.)
Filtration Area1.07 m²
Device Size10 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
Packaging Information
Material Size3
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL
Global Trade Item Number
Catalogue Number GTIN
CLGL71TP3 04053252261435