KPHLS3TTH1

Durapore^® 0.45 µm, Opticap^® XLT Capsule

Opticap^® XLT 30, cartridge nominal length 34.3 in. (87.1 cm), filter diam. 4.2 in. (10.7 cm)

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: polyester support; polyethylene support; polypropylene filter; polypropylene housing; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: FDA 21CFR177-182 (all component materials)
• Sterilität: sterile; irradiated
• Produktlinie: Opticap^® XLT 30
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Opticap^®
• Parameter: ≤45.0 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water); 1 bar max. inlet pressure (15 psi) at 80 °C; 2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse:); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward:); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Methode(n): bioburden reduction: suitable
• Nennlänge Kartusche: 34.3 in. (87.1 cm)
• device L: 87.1 cm (34.3 in.)
• device size: 30 in.
• Filterdurchm.: 4.2 in. (10.7 cm)
• filter filtration area: 1.86 m²
• Durchm. Einlassanschluss: 1-1/2 in.
• inlet to outlet width: 87.1 cm (34.3 in.)
• Durchm. Auslassanschluss: 5/8 in.
• Verunreinigungen: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Durapore^®
• Porengröße: 0.45 μm pore size
• Blasenpunkt: ≥1930 mbar (28 psig), air with water at 23 °C
• Fitting: 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and 16 mm (5?8 in.) Hose Barb Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Capsule

Angaben zur Herstellung

Sterilization Method:
Minimum sterilization up to 25 kGy. 3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable

Hinweis zur Analyse

Gravimetric Extractables: ≤ 25 mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 4500 mL

Sonstige Hinweise

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

Rechtliche Hinweise

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

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