Sterilizing Grade Nylon 0.2 Micron Membrane Filter Cartridge


Filters are specially designed for pre-filtration,Bio-burden and final-filtration of pharmaceutical solution.Nylon membrane with positive charged zeta particle is also available .Cartridges are designed to remove contaminants smaller than the rated pore size (including endotoxins) by way of an adsorptive mechanism. Many particles common in water and other liquids have a net negative charge, allowing for enhanced capture by the positively charged nylon membrane in this filter. This charge-based filtration mechanism combined with the traditional particle size exclusion (sieving) mechanism results in an extremely high removal efficiency at and even below the rated pore size. filter cartridges are characterized by hydrophilic Nylon membrane, providing high throughputs, low extractables and good mechanical strength, widely used for sterile filtration in Active Pharmaceutical Ingredients production.

Features and Benefits

• Low extractables and high absorption

• High throughputs and cost-effective as well as longer service life

• Enhanced removal of endotoxins by positive zeta potential

• Low Pressure drop & high flow rates

• 100% integrity testable prior to release

• Cartridges produced in a controlled environment

• Manufactured according to ISO9001 certified Quality Management System

Specifications

Materials of Construction

• Membrane: Hydrophilic Nylon 66

• Membrane Supports: Polypropylene

• Cage, Core, End Caps: Polypropylene

• O-Rings: Silicone, EPDM, Viton, Buna etc.

Dimensions

• Diameter Φ68

• Length 5 inch, 10 inch, 20 inch, 30 inch,40 inch

Operating Conditions

Maximum Forward Differential Pressure:

• 4.6 bar @ 21°C

• 2.2 bar @ 80°C

Filtration Area, ft²

• 7 ft² per 10-inch cartridge

Integrity Testing

• 0.2 µm ≥ 2800 mbar

• 0.45µm ≥ 1200 mbar

Bacterial Retention

• Passed bacterial challenge testing using of Brevundimonasdiminuta (ATCC19146) in accordance with the current HIMA challenge methodology (ASTM F838-83)

  at a minimum challenge concentration of 1 x 107.

• Validation Guide available upon request.

Bio-Safety

• Filter effluent is non-pyrogenic per USP bacterial endotoxin (<0.25 EU/ml)

Sterilization & Autoclaving

Sterilized by autoclaving for up to 15 cycles at 123 °C (257 °F) for 30 minutes. The filters can also be sterilized by steam-in-place procedure up to 15 cycles at 135 °C (275 °F) for 30 minutes . The filters can also sanitized by hot water or common chemicals that are compatible with filter components.

Application –

• Buffer Solution

• LVP & Antibiotics

• WFI

• Active Pharmaceutical Ingredients

• DI Water

• Critical Parts Cleaning

• Fine Chemical

• UltraPure Water

• Endotoxin REMOVAL

• Beverages

• Plating Solutions

• Critical Parts Cleaning

• Acid & Bases

• Biologic Retention

• I nks

• Clarification

• Lacquer

• Dyes