LAGR04TP1

Optiseal^® Cartridge Media: Aervent^® 0.2 µm

Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 4 in.

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

Properties

• Product Name: Optiseal^® Cartridge Media: Aervent^® 0.2 µm, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 4 in.
• material: PTFE
• Quality Level: 400
• sterility: non-sterile
• sterilization compatibility: steam-in-place compatible
• product line: OptiSeal^® 4 in.
• feature: hydrophobic
• technique(s): gas filtration: suitable
• cartridge nominal length: 4 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤10 mg/cartridge
• matrix: Aervent^®
• pore size: 0.2 μm pore size
• cartridge code: not applicable

Description

General description

Device Configuration: Cartridge

Preparation Note

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).

Analysis Note

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

Other Notes

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

Legal Information

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