CHGE71TS

Millipore Express^® SHC 0.5/0.2µm Cartridge 10

Code 7 Silicone, Autoclavable and SIP

• Synonym(e): Millipore Express^® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Produktname: Millipore Express^® SHC, Kartusche, pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal
• Quality Segment: 400
• material: polyethersulfone , polypropylene , polypropylene support, polysulfone , 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; steam-in-place compatible
• product line: EMPROVE^® Filter, Millipore Express^®
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤28.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water), 0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse), 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward), 1700 bar max. differential pressure (25 psi) at 80 °C (Forward), 2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse), 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse), 340 mbar max. differential pressure (5 psi) at 135 °C (Forward), 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse), 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward), 7 bar max. inlet pressure (100 psi) at 25 °C (Forward)
• technique(s): sterile filtration: suitable
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 0.49 m²
• impurities: ≤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
• input: sample type liquid
• bubble point: ≥4000 mbar (58 psig), air with water at 23 °C
• cartridge code: Code 7

Beschreibung

General description

Device Configuration: Filterelement

Packaging

Leicht zu öffnender Doppelbeutel

Preparation Note

Sterilization Method
25 In-situ-Dampfsterilisationszyklen in Fließrichtung oder 22 Zyklen in Fließrichtung und 3 gegen die Fließrichtung von 30 min bei 135 °C; 25 Autoklavenzyklen von 60 min bei 126 °C

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 ≥2 l Wasser

TOC/Conductivity
After sterilization and a controlled water flush of 20 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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• 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

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

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