CTGR02TP1

Cartouche Aervent^® 0,2 µm

pore size 0.2 μm, cartridge nominal length 20 in. (51 cm), Code 0 (2-222; O-rings)

• Synonyme(s) : Aervent CTGR Cartridge Filter 20 in. 0.2 µm Code 0
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PTFE ; polypropylene ; polypropylene support; silicone seal
• Niveau de qualité: 400
• Stérilité: non-sterile
• Mode de stérilisation compatible: steam-in-place compatible
• Gamme de produits: Aervent^®
• Caractéristiques: hydrophobic
• Fabricant/nom de marque: Aervent^®
• Paramètres: ≤48 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
• Longueur: 20 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 20 in. (51 cm)
• Diamètre: 6.9 cm (2.7 in.)
• Surface de filtration: 1.3 m²
• Impuretés: <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• Extractibles par gravimétrie: ≤70 mg/cartridge
• Matrice: Aervent^®
• Dimension de pores: 0.2 μm pore size
• Entrée: sample type gas
• Point de bulle: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• Code de la cartouche: Code 0 (2-222; O-rings)

Description

Description générale

Device Configuration: Cartridge

Caractéristiques et avantages

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.

Conditionnement

Double Easy-Open bag

Qualité

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

Notes préparatoires

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).

Remarque sur l'analyse

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: ≤1.5 mL/min @ 2.6 bar (38 psig) per 20 in cartridge

Autres remarques

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.

Informations légales

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

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