KWSSA05FF1

Capsule Opticap^® XL Capsule, con filtri Milligard^® di grado 0,5/0,2 µm nominale

Opticap^® XL 5, inlet connection diam. 3/4 in., pore size 0.5/0.2 μm, cartridge nominal length 5 in. (12.5 cm)

• Sinonimo/i: Opticap XL5 Milligard 0.5/0.2 μm 3/4 in. TC/TC
• Codice UNSPSC: 23151806
• eCl@ss: 32031610

Proprietà

• Materiali: mixed cellulose esters (MCE) ; polyester support; polypropylene ; 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: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible
• Nome Commerciale: Opticap^® XL 5
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Opticap^®
• Parametri: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 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; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• tecniche: prefiltration: suitable
• Lunghezza: 21.6 cm (8.5 in.)
• Larghezza: 4.2 in.
• Lunghezza nominale della cartuccia: 5 in. (12.5 cm)
• Diametro: 14.5 cm (5.7 in.)
• Superficie filtrante: 0.26 m²
• Diam. connessione ingresso: 3/4 in.
• Amp. ingresso/ uscita: 21.6 cm (8.5 in.)
• Diam. connessione uscita: 3/4 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): ≤25 mg/capsule
• Matrice: Milligard^®
• pore size: 0.5/0.2 μm nominal pore size; 0.5/0.2 μm pore size
• input: sample type liquid
• Raccordi: inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Descrizione

Descrizione generale

Device Configuration: Capsule

Caratteristiche e vantaggi

Format: Double Layer

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 installation section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Specifiche

Filter Grade: Standard Milligard^® Media

Nota sulla preparazione

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Risultati analitici

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Note legali

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

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

Esclusione di responsabilità

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

Informazioni sulla sicurezza

• Codice della classe di stoccaggio: 4.1B - Flammable solid hazardous materials
• Classe di pericolosità dell'acqua (WGK): WGK 3