Description

MinyPure-NZ series nylon pleated filter cartridge is made of lined hydrophilic nylon 66 membrane which can provide enhanced retention of fine particles smaller than the membrane’s rating, such as endotoxins in water. It has excellent chemical compatibility and mechanical strength. After special cleaning steps, the filter membrane has low precipitation and no shedding. It can be widely used in the filtration of strong alkali, weak acid and organic solvents. Due to reasonable structure, MinyPure-NZ offers high flow rate, high flux and low extractables, available in particle and bioreductive grade as well as sterile-grade with low cost.

• Reliability

From raw materials procurement, transportation to production and storage, all operations follow the ISO 9001 quality management system. MinyPure-NZ is manufactured, tested and packaged in a cleanroom to ensure product cleanliness. MinyPure-NZ filter cartridge undergoes 100% integrity testing after production, and validation guide that meets regulatory requirements is available.

• Fine Particles and Endotoxins Removal

MinyPure-NZ filter cartridges (254mm, 10inch) are certified for an LRV≥4 (99.99%) when challenged with 10¹⁰pg/mL (10⁸ EU/mL) of purified E.coli endotoxin in water, LRV≥3 (99.9%) for 0.04μm Polystyrene Beads.

• Regulatory Compliance

ASTM F838-83

FDA 21 CFR 177.1655

Federal Regulations 21 CFR 210.3 (b) (6)

EN 285:2006+A2:2009.

Regulation (EC) No 1935/2004

USP <88> Safety

• Compatibility

MinyPure-NZ filter cartridge is hot melt welded, and does not contain any adhesive or surfactant. The components of MinyPure-NZ, including charged nylon 6,6, polypropylene and Silicone/EPDM, provide broad chemical compatibility from pH range of 3 to 10 and can ensure low precipitation in high-temperature environments.

• Economy

The optimized structure of filter cartridges can take full advantages of the excellent performance of membrane. These features ensure the highest process efficiency and minimized filtration costs.

Features

• Highly hydrophilic, easy to wet

• Positive charge on membrane surface

• Good integrity to ensure the filter sterilizing-grade particle retention efficiency

• No fiber shedding

Applications

• Sterilizing filtration of sterile APIs, antibiotic solutions, etc.

• Sterilizing filtration of intermediates, soft drinks, pure water, etc.

• Filtration of high- purity chemicals and organic solvents

• Sterilizing filtration of physiological saline, reagents and water for injection

• Sterilizing filtration of SVP and LVP

• Sterilizing filtration of bottled water, wine, syrup and fruit wine

Product Assurance

• ISO 9001:2015 quality management system

• 100% integrity test

• Filter cartridge is fully traceable

• All materials comply with relevant requirements of CFR21

• Bacteria Liquid Challenge Test TR≥10¹¹

• Escherichia coli endotoxin challenge η≥99.999%

Technical Parameters

Typical Liquid Flow Rates

Ordering Information