CTGB01TP3

Aerex^® 0.2 µm, Cartridge

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Synonym(s): Aerex CTGB 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: Aerex^®
• feature: hydrophobic
• manufacturer/tradename: Aerex^®
• parameter: ≤15 mL/min nitrogen diffusion at 690 mbar (10 psig) and 23 °C (in 60/40% IPA/water); 0.35 bar max. differential pressure (5 psid) at 145 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 145 °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); 5.2 bar max. differential pressure (75 psid) at 25 °C (Reverse; intermittent); 5.2 bar max. inlet pressure (75 psi) at 25 °C (Reverse); 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward); 7 bar max. inlet pressure (100 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: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤35 mg/cartridge
• matrix: Aerex^®
• pore size: 0.2 μm pore size
• input: sample type gas
• bubble point: ≥900 mbar (13 psig), nitrogen with 60/40% IPA/water at 23 °C
• cartridge code: Code 0 (2-222; O-rings)

Description

General description

Device Configuration: Cartridge

Features and Benefits

This product has been qualified to retain a ΦX174 virus aerosol challenge of 10⁸ to 10¹⁰ PFU at an air flow rate of 50 SCFM per 10-inch cartridge after 50 steam-in-place cycles at 145 °C.

Packaging

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.

Quality

The membrane has been qualified to retain bacteria when challenged for 21 days with a minimum Brevundimonas diminuta aerosol concentration of 1 x 10⁷ CFU/cm².

Preparation Note

Sterilization Method
200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 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

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

HydroCorr: ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig)

Legal Information

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