CTGR01TP1

Aervent^® 0.2 µm, Cartridge

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 0

• Synonym(s): Aervent CTGR Cartridge Filter 10 in. 0.2 µm Code 0
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PTFE ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• sterility: non-sterile
• Sterilization Compatibility: steam-in-place compatible
• product line: Aervent^®
• feature: hydrophobic
• manufacturer/tradename: Aervent^®
• parameter: ≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 °C (in 70/30% IPA/water); 1.7 bar max. inlet pressure (25 psi) at 80 °C; 1.8 bar max. differential pressure (25 psid) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) (Reverse; intermittent); 4.1 bar max. inlet pressure (60 psi) (Reverse; Intermittent); 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
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 0.65 m²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• gravimetric extractables: ≤35 mg/cartridge
• matrix: Aervent^®
• pore size: 0.2 μm pore size
• input: sample type gas
• bubble point: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• cartridge code: Code 0

Description

General description

Device Configuration: Cartridge

Features and Benefits

Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.

Packaging

Double Easy-Open bag

Quality

Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²

Preparation Note

Sterilization Method
150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °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

HydroCorr: ≤0.75 mL/min @ 2.6 bar (38 psig) per 10 in cartridge

Other Notes

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.

Legal Information

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

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