| Kulpsville, PA (March 2004) - Quality, compliance and safety are critical in the pharmaceutical industry. Because these factors weigh heavily in daily pharmaceutical operations, engineers are forced to re-examine the seals and sealing materials used in their plants as they develop new drugs and the processes needed to manufacture them. Fluoraz®, a tetrafluoroethylene/propylene (TFE/P) based elastomer by Greene, Tweed, withstands the challenges facing the pharmaceutical industry in these key applications.
Fluoraz has been an essential component of Greene, Tweed's product portfolio for two decades. With more than a century of rubber compounding expertise, Greene, Tweed leads the industry in bringing existing products to new markets. Jonathan Pledger, general manager of Fluid Handling at Greene, Tweed, says, "While the pharmaceutical industry is based on innovation, they are sometimes hesitant to use new and innovative materials for their processing equipment. Fluoraz has been a core compound within Greene, Tweed for a number of years; we just took the next logical step in the evolution of this unique compound."
Fluoraz combines the steam and caustic resistance of EPDM with the heat resistance of a fluoroelastomer, providing the ideal sealing solution for SIP (steam-in-place) and CIP (clean-in-place) applications. Fluoraz is well suited for pharmaceutical companies who are looking to use higher temperature steam and stronger caustic cleaning agents but have been struggling to find an elastomer able to outlast these harsh environments.
Fluoraz 784 and 890 are FDA compliant, making Greene, Tweed the first and only seal supplier globally to obtain FDA compliance for use of a TFE/P elastomer for repeated contact with food. Both compounds, along with Fluoraz 799, are USP Class VI compliant. Fluoraz 799, a high-durometer compound, is also complaint to USP Cytotoxicity <87> and USP Physicochemical Complete <661> and has been tested to USP Elastomeric Enclosures <381>.
In addition to improved SIP and CIP performance, Fluoraz offers lower extractables. Recent third-party test results show Fluoraz has six times lower total organic carbon extractables than premium peroxide-cured EPDM and ten times lower metals extractables than the best "steam-resistant" FKM formulations.
Greene, Tweed is a leading global manufacturer of high-performance seals and engineered components. The company specializes in developing customized solutions for applications in aerospace, medical and biotechnology, fluid handling, industrial, oilfield and semiconductor industries. Greene, Tweed combines over a century of technical expertise and commercial knowledge to provide customers with engineered solutions for their applications. Greene, Tweed products are sold and distributed worldwide.
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