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(e): Aerex CTGB Cartridge Filter 10 in. 0.2 µm Code 0, Aerex^® 0.2 µm, Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Aervent^®, 0,2 µm, Kartusche, Chemistry: 0.2 µm Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 10 in. Code 0
• Quality Segment: 400
• material: PTFE , polypropylene , polypropylene support, silicone seal
• 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)

Beschreibung

General description

Device Configuration: Filterelement

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

Leicht zu öffnender Beutel

Preparation Note

Dieses Produkt enthält eine PTFE-Membran, die den Richtlinien für „nicht faserabgebende“ Filter gemäß 21 CFR 210.3 (b) (6) entspricht.

Sterilization Method
200 (150 in Fließrichtung/50 gegen die Fließrichtung) In-situ-Dampfsterilisationszyklen von 30 min bei 145 °C

Analysis Note

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

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.

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

Other Notes

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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

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