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Per- und Polyfluoroalkyl substances (PFAS) are widely used in the pharmaceutical and biotech industry as well as by manufacturers of medical devices. In the last years the restrictions of PFAS increased rapidly. Since early 2023 a complete prohibition of PFAS is discussed.
PFAS are organic substances on which two or more Hydrogen atoms are substituted by Fluour atoms. The resulting molecules are verry stable and therefore extremely durable. For this reason, these substances are called “eternal chemicals”. One of the best-known substances of this group is polytetrafluoroethylene (PTFE/Teflon).
Almost all branches of industry rely on the usage of PFAS. This also applies to the branches in which the GMP-regulations are applied. PFAS are used directly as ingredients for pharmaceutical products, as coating for medicinal products and indirectly as sealing material in production lines.
Using of PFAS does not jet directly contrary to the GMP-regulation, especially when it comes to the new revision of Annex 1.
Due to the increased attention across all media, an insufficient consideration of the topic could lead to challenging questions in audit situations.
Check One-Pager about PAFS to find out how Valicare can help you to avoid these unpleasant situations
