CTGR75S01

Aervent^® 0.2 µm, Cartridge

pore size 0.2 μm, cartridge nominal length 5 in. (13 cm), Code 7

• Synonim(y): Aervent CTGR Cartridge Filter 5 in. 0.2 µm Code 7
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: PTFE ; polypropylene ; polypropylene support; silicone seal
• Poziom jakości: 400
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: steam-in-place compatible
• linia produktu: Aervent^®
• Właściwości: hydrophobic
• producent / nazwa handlowa: Aervent^®
• Parametry: ≤12 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)
• metody: gas filtration: suitable
• Długość: 5 in.
• Szerokość: 2.7 in.
• długość nominalna kartridża: 5 in. (13 cm)
• Średnica: 6.9 cm (2.7 in.)
• powierzchnia filtracyjna: 0.32 m²
• zanieczyszczenia: <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤17.5 mg/cartridge
• Matryca: Aervent^®
• wielkość porów: 0.2 μm pore size
• moc wejściowa: sample type gas
• punkt pęcherzykowania: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• kod wkładu: Code 7

Opis

Opis ogólny

Device Configuration: Cartridge

Cechy i korzyści

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.

Opakowanie

Double Easy-Open bag

Jakość

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

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

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: ≤0.38 mL/min @ 2.6 bar (38 psig) per 5 in cartridge

Inne uwagi

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.

Informacje prawne

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

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

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