In May this year, US Pharmacopeia (USP) chapter 665 will come into effect, and mandatory testing for extractables and leachables (E&L) studies of plastic single-use systems are now required. Moreover, the BioPhorum Operations Group (BPOG) industry collaboration...
The FDA has just recognized the recently updated ISO 10993 Part 17 standard covering the toxicological risk assessment of medical device constituents. Apart from a few exceptions, the FDA recognized the standard for its relevance and scientific and technical merit....
Do you use silicone in the medical devices you produce? If so, you need to be aware that the European Chemicals Agency (ECHA) can now classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT), Very...
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...
