Technically Unavoidable Particles (TUPs) are always present in excipients. Concern regarding their presence has increased dramatically in recent years due to several US FDA warning letters to pharmaceutical companies, highlighting adverse findings during inspections....
To know your materials is the beginning of wisdom. One key aspect of manufacturing is materials screening. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with your materials throughout your supply...
Are you a manufacturer? Do you know what particles your workers are exposed to in your working environment? Whether it’s additive manufacturing, assembly, welding or any other process that produces dust or fumes, your workers are being exposed to particles....
Are you responsible for the production of pharmaceutical products such as vaccines? What if you suddenly find something unexpected? What if there is some foreign material or particles in one of the vials in your production? Sudden unexpected findings of particulate...
Are you using 3D printers to produce mock-ups or in manufacturing? What kind and how many particles are produced while using a 3D printer? Particles produced during 3D printing pose a health risk. In fact, they are almost as harmful as the exhaust produced by Diesel...
The deadline, 26 May 2021, for EU MDR is fast approaching. The Danish Medicines Agency (Lægemiddelstyrelsen) recently published guidance regarding the new regulations and their consequences for both industry and Danish authorities. Read their guidance here (Danish...
