KVVLG3TTT1

Durapore^® 0.1 µm, Opticap^® XLT Capsule

Opticap^® XLT 30, inlet connection diam. 1.5 in., cartridge nominal length 30 in. (75 cm)

• Sinonimo/i: Opticap Gamma Compatible Sterilizing Grade XLT30 Durapore 0.1 μm 1-1/2 in. TC/TC
• Codice UNSPSC: 23151806

Proprietà

• Materiali: PVDF ; polyester support; polyethylene support; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; silicone seal
• Livello qualitativo: 400
• Conformità normativa: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilità: irradiated; non-sterile
• Compatibilità con la sterilizzazione: gamma compatible
• Nome Commerciale: Opticap^® XLT 30
• Caratteristiche: gamma compatible; hydrophilic
• Produttore/marchio commerciale: Opticap^®
• Parametri: ≤63.3 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• tecniche: sterile filtration: suitable
• Lunghezza: 87.1 cm (34.3 in.)
• Larghezza: 6.0 in.
• Lunghezza nominale della cartuccia: 30 in. (75 cm)
• Diametro: 10.7 cm (4.2 in.)
• Superficie filtrante: 2.17 m²
• Diam. connessione ingresso: 1.5 in.
• Amp. ingresso/ uscita: 15.2 cm (6.0 in.)
• Diam. connessione uscita: 1.5 in.
• 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): ≤75 mg/capsule
• Matrice: Durapore^®
• Dimensione pori: 0.1 μm
• input: sample type liquid
• Punto di bolla: ≥4830 mbar (70 psig), air with water at 23 °C
• Raccordi: 1/4 in. drain/vent hose barb (with double O-ring Seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descrizione

Descrizione generale

Device Configuration: Capsule

T-line/Gauge Port: T-line

Confezionamento

Double Easy-Open bag

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

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable

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 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

Note legali

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

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

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