CLGL01TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Synonim(y): Durapore II Cartridge Filter 10 in. 0.22 m Code 0
• Kod UNSPSC: 23151806
• eCl@ss: 27293007

Właściwości

• Materiały: PVDF
• Poziom jakości: 400
• zgodność regionalna: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible; steam-in-place compatible
• linia produktu: Durapore^®
• Właściwości: hydrophilic
• producent / nazwa handlowa: Durapore^® II
• metody: sterile filtration: suitable
• Długość: 10 in.
• Szerokość: 2.7 in.
• długość nominalna kartridża: 10 in. (25 cm)
• powierzchnia filtracyjna: 1.1 m²
• zanieczyszczenia: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤30 mg/cartridge
• macierz: Durapore^® High Area
• wielkość porów: 0.22 μm pore size
• moc wejściowa: sample type liquid
• kod wkładu: Code 0 (2-222; O-rings)

Opis

Opis ogólny

Device Configuration: Cartridge

Inne uwagi

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Uwaga dotycząca przygotowania

This product was manufactured with a Durapore^® 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 a 1.5 L flush and 24 hours in water at controlled room temperature

Informacje prawne

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

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

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