FluorPure-DG Series Double-layer PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements

Description

FluorPure-DG filers using the double layer PTFE membranes, have great efficiency for applications requiring sterilization of air, gas or aggressive solvents and chemicals. Through the optimization of structure, FluorPure-DG can make full use of the advantages of high velocity and high carrying amount of PTFE membrane, which prolong service life and performance with far more than competitive filters.

• Reliability

From raw materials purchase, transport to production and storage, all operations follow ISO 9001 quality management system. FluorPure-DG is manufactured, tested and packaged in a cleanroom to ensure product cleanliness. FluorPure-DG provides absolute retention based on liquid bacteria challenge, 100% integrity tested after being manufactured, and validation guide is available for compliance with regulatory requirements.

• Compatibility

FluorPure-DG filter cartridges are sealed using thermal bonding process, contain no adhesive and surfactant. The components of FluorPure-DG, include of Polytetrafluoroethylene, Polypropylene and Silicone/EPDM, provide broad chemical compatibility and optimized for long on-stream air service. Especially suitable for gases, as well as with PP and PTFE compatible chemicals, work for a long time and have very low precipitation.

• Economy

High velocity of FluorPure-DG filters, greatly reduce the cost, and its optimized structure can give full play to the performance of membrane. These features ensure the highest process efficiency and minimized filtration costs.

• Regulatory Compliance

ASTM D6394 SP0112

FDA 21 CFR 177.1655

ISO 10993-Part 1, 5

EN 285:2006+A2:2009.

Regulation (EC) No 1935/2004

• Suitable for High Temperature Sterilizing

FluorPure-DG can ensure integrity at temperature up to 140℃ and pressure drop up to 0.3 bar due to the enhanced core and adaptor structure. FluorPure-DG can provide excellent filtration service for your process. For applications requiring autoclaving and sterilization, MS recommends the use of the adaptor with SS insert to ensure filter sealing after cooling. Cartridges should be cooled to system operating temperature prior to use.

Features

• Extensive chemical compatibility

• High sterilization efficiency

• High flux, low pressure drop

• Water intrusion test can be used

Applications

• Sterilizing filtration of compressed air/nitrogen

• Sterilization of fermentation tank, batching tank and breathing filter

• Filtration of aseptic packaging air

• Sterilizing filtration of solvents/disinfectants

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 (Pseudomonas diminuta) Aerosol Challenge Test TR≥10⁸

• Bacteria (Pseudomonas diminuta) Liquid Challenge Test TR≥10¹¹

Technical Parameters