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CLVL02TP3 Durapore® 0.1 µm High Area Cartridge 20 in. Code 0

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
CLVL02TP3
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Replacement Information
Description
Catalogue NumberCLVL02TP3
Trade Name
  • Durapore®
DescriptionDurapore® 0.1 µm High Area Cartridge 20 in. Code 0
References
Product Information
Device ConfigurationCartridge
Cartridge CodeCode 0 (2-222) O-rings
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Biological Information
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 Size0.1 µm
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 Length20 in. (50 cm)
Device Size20 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size3
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Référence GTIN
CLVL02TP3 04053252354809