LAGR04TP1

Aervent^® 0,2 µm, cartucho Optiseal^®

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

• Sinónimos: Optiseal^® 0.2 µm 4′ Cartridge
• Código UNSPSC: 23151806
• eCl@ss: 27293007

Propiedades

• Materiales: PTFE
• Nivel de calidad: 400
• esterilidad: non-sterile
• Compatibilidad de esterilización: steam-in-place compatible
• Línea del producto: OptiSeal^® 4 in.
• Características: hydrophobic
• técnicas: gas filtration: suitable
• longitud nominal del cartucho: 4 in.
• impurezas: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíbles gravimétricos: ≤10 mg/cartridge
• matriz: Aervent^®
• tamaño de poro: 0.2 μm pore size
• código del cartucho: not applicable

Descripción

Descripción general

Device Configuration: Cartridge

Otras notas

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

Nota de preparación

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).

Nota de análisis

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

Información legal

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