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....
From October 21–25, SAXOCON’s Chief Technical Officer, Carsten Baun Senholt, will participate in the ISO Technical Committee 194 (ISO TC 194) plenary meeting in Paris. Carsten is one of the many experts contributing to the scientific and technical collaboration...
Pharmaceutical and medical device manufacturers need to ensure the safety of the materials used in their products. Particulate contamination is a risk in production facilities. Good Manufacturing Practice (GMP) and proper risk management require the identification of...
Last fall, the European Chemicals Agency (ECHA) won a decisive judgement at the European Court of Justice. This judgement allows the ECHA to classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT),...
Medical device manufacturers must ensure the biosafety of their medical implant products to comply with relevant regulations. Medical implants have intimate contact with the human body for durations lasting a few hours to permanently. As such, they are subject to...
Whether you are a pharmaceutical or medical device manufacturer, you need to comply with several layers of guidelines and regulations to bring your products to market and keep them there. Having suppliers you can trust is crucial to your ability to concentrate on...
