LAGR04TP1

Cartouche Optiseal^®, Aervent^® 0,2 µm

pore size 0.2 μm, OptiSeal^® 4 in., matrix Aervent^®

• Synonyme(s) : Optiseal^® 0.2 µm 4′ Cartridge
• Code UNSPSC : 23151806
• eCl@ss : 27293007

Propriétés

• Matériaux: PTFE
• Niveau de qualité: 400
• Stérilité: non-sterile
• Mode de stérilisation compatible: steam-in-place compatible
• Gamme de produits: OptiSeal^® 4 in.
• Caractéristiques: hydrophobic
• Technique(s): gas filtration: suitable
• Longueur nominale des cartouches: 4 in.
• Impuretés: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Extractibles par gravimétrie: ≤10 mg/cartridge
• Matrice: Aervent^®
• Dimension de pores: 0.2 μm pore size
• Code de la cartouche: not applicable

Description

Description générale

Device Configuration: Cartridge

Autres remarques

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Notes préparatoires

This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Remarque sur l'analyse

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

Informations légales

AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany

ASTM is a registered trademark of American Society for Testing and Materials

OPTISEAL is a registered trademark of Merck KGaA, Darmstadt, Germany