KHGES3THH1

Millipore Express^® SHC 0.5/0.2µm, Opticap^® XLT 30 Capsule

Fittings 5/8 in. HB, Sterile

• Synonym(e): Opticap Sterile XLT 30 Millipore Express SHC 0.5/0.2 μm 5/8 in. HB
• UNSPSC-Code: 23151806

Eigenschaften

• Produktname: Millipore Express^® SHC, Opticap^®-XLT-Kapsel, Opticap^® XLT 30, sterile, inlet connection diam. 5/8 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)
• Materialien: polyester support; polyethersulfone ; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilität: irradiated; sterile
• Produktlinie: Opticap^® XLT 30
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipore Express^®
• Parameter: ≤93.7 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 100 psi max. differential pressure (6.9 bar) (intermittent); 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• Methode(n): sterile filtration: suitable
• Länge: 87.1 cm (34.3 in.)
• Nennlänge Kartusche: 30 in. (75 cm)
• Durchmesser: 10.7 cm (4.2 in.)
• Filtrationsfläche: 1.63 m²
• Durchm. Einlassanschluss: 5/8 in.
• Breite Einlass bis Auslass: 19.8 cm (7.8 in.)
• Durchm. Auslassanschluss: 5/8 in.
• Verunreinigungen: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• Blasenpunkt: ≥4000 mbar (58 psig), air with water at 23 °C
• Fitting: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet hose barb; outlet hose barb; (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filtereinheit

T-line/Gauge Port: T-line

Verpackung

Leicht zu öffnender Doppelbeutel

Angaben zur Herstellung

Sterilization Method
3 Autoklavenzyklen von 60 min bei 123 °C; nicht inline dampfsterilisierbar

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

Hinweis zur Analyse

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 ≥6 l Wasser

TOC/Conductivity
After sterilization and a controlled water flush of 63 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Sonstige Hinweise

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 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

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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