CLGL73TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Sinonimo/i: Durapore^® II Cartridge Filter 30 in. 0.22 m Code 7
• Codice UNSPSC: 23151806
• eCl@ss: 32031690

Proprietà

• Materiali: PVDF ; polypropylene ; polypropylene support; silicone seal
• 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^®
• Parametri: ≤61.8 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
• tecniche: sterile filtration: suitable
• Lunghezza: 30 in.
• Larghezza: 2.7 in.
• Lunghezza nominale della cartuccia: 30 in. (75 cm)
• Diametro: 6.9 cm (2.7 in.)
• Superficie filtrante: 3.3 m²
• Impurezze: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Estraibili (gravimetria): ≤90 mg/cartridge
• Matrice: Durapore^® High Area
• Dimensione pori: 0.22 μm pore size
• input: sample type liquid
• Punto di bolla: ≥3450 mbar (50 psig), air with water at 23 °C
• Codice cartuccia: Code 7 (2-226; O-rings w/locking-tabs)

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL

Note legali

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

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