KGEPS10TT1

Millipore Express^® SHF 0.2µm, Opticap^® XL 10 Capsule

Fittings 1-1/2 in. TC/TC, Sterile

• Synonym(e): Opticap XL 10 Millipore Express SHF Sterile 0.2 m 1-1/2 in. TC/TC, Millipore Express^® SHF, Opticap^® XL Capsule
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Millipore Express^® SHF, Opticap^® XL Kapsel, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange Max Operating Pressure: 80 psi @ 25 °C
• Quality Segment: 400
• material: polyester support, polyethersulfone membrane, polypropylene housing, polypropylene vent cap, silicone O-ring, silicone seal
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: sterile
• sterilization compatibility: autoclavable compatible
• product line: Opticap^® XL
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: 1 bar max. differential pressure (15 psi) at 80 °C, 1 bar max. inlet pressure (15 psi) at 80 °C, 2.8 bar max. inlet pressure (40 psi) at 60 °C, 5.5 bar max. differential pressure (80 psi) at 25 °C, 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; Intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (Intermittent)
• technique(s): sterile filtration: suitable
• L: 33.5 cm (13.2 in.)
• cartridge nominal length: 10 in. (25 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.57 m² (6.1 ft²)
• inlet connection diam.: 1.5 in.
• inlet to outlet W: 33.5 cm (13.2 in.)
• outlet connection diam.: 1.5 in.
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHF
• pore size: 0.2 μm
• bubble point: ≥4000 mbar (58 psig), air with water at 23 °C
• fitting: 38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

Beschreibung

General description

Device Configuration: Filtereinheit

Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

Packaging

Leicht zu öffnender Doppelbeutel

Preparation Note

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).

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 ≥1,5 l Wasser

TOC/Conductivity
After sterilization and a controlled water flush of 11 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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 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.

Legal Information

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

Disclaimer

EMD Millipore Corporation bestätigt, dass dieses Produkt der europäischen Druckgeräterichtlinie 97/23/EG vom 29. Mai 1997 entspricht. Dieses Produkt wurde unter Artikel 3 § 3 der Druckgeräterichtlinie klassifiziert. Das Produkt wurde in Übereinstimmung mit anerkannten technischen Methoden entwickelt und hergestellt, um einen sicheren Betrieb zu gewährleisten. In Konformität mit Artikel 3 § 3 dieser Druckgeräterichtlinie besitzt dieses Produkt kein CE-Zeichen.