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3M™ Dyneon™ Perfluoroelastomer PFE 7502BZ meets FDA standards

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O-Rings made of 3M Dyneon Perfluoroelastomer PFE 7502BZ

05. May. 2014

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After rigorous testing in accordance with standards set by United States safety regulators, 3M Dyneon Perfluoroelastomer PFE 7502BZ can now be used for sealing applications in production and handling processes for food and pharma. For these demanding applications very high production standards are mandatory in order to meeting health and safety requirements for the wellbeing of our society.

The product has been tested as part of compliance procedures laid down by the Food and Drug Administration (FDA), the US government agency responsible for regulating the safety of food, drugs, cosmetics, biological products, medical devices and consumer products that emit radiation.

PFE 7502BZ ChemShield is now suitable for use in sealing applications in production and handling processes for food and pharma that require FDA compliance. In addition, the material also meets USP VI requirements.

The full compliance of the test results have been confirmed by an external law consultant with the following statement:

“PFE 7502BZ has a suitable FDA status for use in O-rings and other sealing rings for food processing equipment for repeated use, food contact applications in connection with all food types under Condition of Use A (High temperature, heat sterilised or retorted at about 121 °C), and more specifically under maximum sterilisation temperatures of up to 150 °C for short periods of time (less than two hours). This status is based on extremely low levels of maximum potential migration for all components of PFE 7502BZ based on surface to volume ratio typical of these industrial applications.”

It remains the responsibility for the manufacturer of the finished article, which is intended to be brought into contact with food, to verify if that finished article causes any deterioration to the organoleptic properties of the food with which it is in contact in the application concerned.

 

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