CLGL02TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Sinonimo/i: Durapore^® II Cartridge Filter 20 in. 0.22 m Code 0
• Codice UNSPSC: 23151806
• eCl@ss: 27293007

Proprietà

• Materiali: PVDF
• Livello qualitativo: 400
• Conformità normativa: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilità: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible; steam-in-place compatible
• Nome Commerciale: Durapore^®
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Durapore^® II
• tecniche: sterile filtration: suitable
• Lunghezza: 20 in.
• Larghezza: 2.7 in.
• Lunghezza nominale della cartuccia: 20 in. (50 cm)
• Superficie filtrante: 2.2 m²
• Impurezze: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Estraibili (gravimetria): ≤60 mg/cartridge
• Matrice: Durapore^® High Area
• Dimensione pori: 0.22 μm pore size
• input: sample type liquid
• Codice cartuccia: Code 0 (2-222; O-rings)

Descrizione

Descrizione generale

Device Configuration: Cartridge

Altre note

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.

Nota sulla preparazione

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).

Risultati analitici

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

Note legali

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

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