We are pleased to share that a new edition of ISO 10993-1, the cornerstone standard for the biological evaluation of medical devices, has reached the Final Draft International Standard (FDIS) stage. This means the updated version — ISO/FDIS 10993-1:2025 — is now out...
Helen Friis-Mikkelsen and Martin Friis-Mikkelsen will be representing SAXOCON at Pharmapack Europe 2025, stand S23, on 22 &23 January. Stop by our stand and find out how we can help you ensure your packaging is safe and compliant. Containers and other primary...
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....
SAXOCON provides microscopic particle count testing in accordance with Method 2 in USP-NF (788). Testing is conducted in our Class N2 clean workspace according to our internal protocols to guarantee the precise identification and measurement of particles that satisfy...
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),...
