Medical device manufacturers need to screen the materials used in their products. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with the materials throughout the supply chain. Knowing what is in...
Pharmaceutical manufacturers need to know whether their products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies. Nitrosamines are highly toxic compounds, with some considered even more...
The ISO 10993 standard series covers the biological evaluation of medical devices. Part 17 of this series addresses the toxicological risk of chemical constituents resulting from the chemical characterization of medical devices. In its first major revision in 20...
The Food and Drug Administration (FDA) is updating its guidance regarding Nitrosamine Drug Substance-Related Impurities (NDSRIs). With this update, the FDA acknowledges the leading scientific research by introducing a novel framework for determining the Acceptable...
The European Chemical Agency (ECHA) is launching a project to check the compliance of products sold online with REACH and CLP requirements. Currently, chemical products sold online are largely non-compliant. Starting in 2025, ECHA inspectors will check products sold...
Particulate contamination is a risk in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management requires identifying root causes and evaluating what impact a particulate matter finding has on product safety. Understanding the...
