KVVLA3THH1

Durapore^® 0.1 µm, Opticap^® XLT Capsule

Opticap^® XLT 30, inlet connection diam. 5/8 in., cartridge nominal length 30 in. (75 cm)

• Synonym(e): Opticap XLT30 Durapore 0.1 μm 5/8 in. HB/HB, Durapore^® 0.1 µm, Opticap^® XLT Capsule
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Durapore^®, 0,1 µm, Opticap^®-XLT-Kapsel, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 5/8 in. Hose BarbOutlet: 5/8 in. Hose BarbT-lineMax Operating Pressure: 80 psi @ 25 °C
• Quality Segment: 400
• material: PVDF , polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible
• product line: Opticap^® XLT 30
• feature: hydrophilic
• manufacturer/tradename: Opticap^®
• parameter: ≤60 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
• technique(s): sterile filtration: suitable
• L: 87.1 cm (34.3 in.)
• cartridge nominal length: 30 in. (75 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 2.06 m²
• inlet connection diam.: 5/8 in.
• inlet to outlet W: 19.8 cm (7.8 in.)
• outlet connection diam.: 5/8 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤75 mg/capsule
• matrix: Durapore^®
• pore size: 0.1 μm
• input: sample type liquid
• bubble point: ≥4830 mbar (70 psig), air with water at 23 °C
• fitting: 1/4 in. drain/vent hose barb (with double O-ring Seal), (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

Beschreibung

General description

Device Configuration: Filtereinheit

T-line/Gauge Port: T-line

Packaging

Leicht zu öffnender Doppelbeutel

Preparation Note

Sterilization Method
3 Autoklavenzyklen von 60 min bei 126 °C; nicht inline dampfsterilisierbar

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).

Analysis Note

Bacterial Retention
Quantitative Rückhaltung von Brevundimonas diminuta bei einer Mindestbeaufschlagung von 1 x 10⁷ KBE/cm² unter Anwendung der ASTM^® F838-Methode.

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥3 l Wasser

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

Other Notes

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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.

Legal Information

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