FluorPure-SG Series PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements

Description

FluorPure-SG using nature hydrophobic and high carrying amount PTFE membrane, along with reasonable configuration which make full use of the advantages of membrane, result to have long service life and long steam accumulated time. FluorPure-SG can be optimized for applications requiring sterilization for air, gas or aggressive solvents and chemicals.

• Reliability

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

• Compatibility

FluorPure-SG filter cartridges are sealed using thermal bonding process, with no adhesive and surfactant. The components of FluorPure-SG filters have broad chemical compatibility,can be used to filter the most of gases and chemicals and have very low precipitation.

• 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 Severe High Temperature Sterilizing

FluorPure-SG 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-SG can provide excellent filtration service for your process. For applications requiring autoclaving and sterilization, MS recommends the use of Code 5 adaptor to ensure filter sealing after cooling. Cartridges should be cooled to system operating temperature prior to use.

• Longer Service Time and Lower Cost

FluorPure-SG filters using high velocity and high carrying amount PTFE membrane, can effectively delay filter blocking rate, prolong the service life. In filtration process, FluorPure-SG can effectively reduce the total cost of filtering system, and the cost of purchasing replacement. Following is the contrast figure of service life among FluorPure-SG 0.22μm and the similar products.

Features

• Extensive chemical compatibility

• Proven sterilization efficiency

• High reliability

• Water intrusion test can be used

Applications

• Sterilizing filtration of compressed air/nitrogen

• Sterilizing 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 Liquid Challenge Test TR≥10¹¹

Technical Parameters

Typical Liquid Flow Rates

Typical Air Flow Rates

Ordering Information