LAGRM1S02

Aervent^® 0.2 µm, Optiseal^® Cartridge

OptiSeal^® 4 in., pore size 0.2 μm, filtration area 0.05 m², matrix Aervent^®

• Synonym(s): Optiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PTFE ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: OptiSeal^® 4 in.
• feature: hydrophobic
• manufacturer/tradename: OptiSeal^®
• parameter: 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) (Reverse); 4.1 bar max. inlet pressure (60 psi) (Reverse;); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• technique(s): gas filtration: suitable
• cartridge nominal length: 1 in. (2.5 cm)
• filtration area: 0.05 m²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤2.5 mg/cartridge
• matrix: Aervent^®
• pore size: 0.2 μm pore size
• input: sample type liquid
• bubble point: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• cartridge code: not applicable

Description

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Other Notes

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

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C

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

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