KAFTS003FF3

Millipore Express^® Ace 0.2µm, Opticap^® XL 300 Capsule

Fittings 3/4 in. TC/TC, Sterile

Eigenschaften

• material: (Structural components: gamma compatible polypropylene), polyethersulfone membrane (hydrophilic), polyethylene support, polysulfone (core), silicone O-ring
• reg. compliance: meets FDA Indirect Food Additive requirements cited in CFR 177-182 (all component materials)
• sterility: sterile
• sterilization compatibility: autoclavable compatible
• product line: Millipore Express^®
• feature: hydrophilic
• Quality Level: 400
• sustainability: Greener Alternative Product
• parameter: 1000 mbar max. differential pressure (15 psi) at 80 °C, 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse; Intermittent), 5500 mbar max. differential pressure (80 psi) at 25 °C, 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward; Intermittent)
• technique(s): sterile filtration: suitable
• D: 5.6 cm (2.2 in.)
• L: 11.9 cm (4.7 in.)
• filtration area: 0.050 m² (0.538 ft²)
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® Ace
• pore size: 0.2 μm pore size
• bubble point: ≥1320 mbar (19.1 psi), nitrogen with 70/30% IPA/water, ≥4140 mbar (60 psi), air with water
• greener alternative category: DfS-Developed

Beschreibung

General description

Device Configuration: Capsule

We are committed to bringing you Greener Alternative Products. This product is a Design for Sustainability (DfS) developed product, which belongs to one of the four categories of greener alternatives. Click here to view its DfS scorecard.

Application

Millipore Express^® Ace 0.2 µm filters deliver exceptional sterile filtration performance for a wide range of bioprocessing applications. These filters contain a cutting edge, single-layer, hydrophilic polyethersulfone (PES) sterilizing-grade membrane that delivers unmatched flux and throughput.

This innovative membrane design means more membrane area for standard filter formats, resulting in exceptional filtration capacity with minimal footprint.

Features and Benefits

• High-capacity single layer membrane reducing the required membrane area
• Non cytotoxic to cells for upstream applications
• Easily wets to facilitate integrity testing
• High yields achieved due to low protein binding surface chemistry
• Made with non-per- and polyfluoroalkyl substances (PFAS) materials for enhanced sustainability
• Broad chemical compatibility making it suitable for use with ADCs

Packaging

Double Easy-Open bag

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

TOC/Conductivity
Irradiated filter effluent meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a water flush of: 2,5 L.

Other Notes

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 to the Opticap^® XL and XLT Capsule User Guide.
• Storage Statement: Please refer to the Opticap^® XL and XLT Capsule User Guide.
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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