Presentation on The Relevance of ISO 18562 to the Biocompatibility Requirements for Respiratory Drug Delivery

Luminita Moraru, Analytical Chemistry Manager at MET, has been working with ISO 18562 since its publication and is now a committee member for the standard. She will describe how the test methods are applied to respiratory delivery systems and how they compare to the requirements of ISO 10993. Lumi’s career spans work within the medical device sector and the environmental sector. She was educated at the University of Bucharesti and has demonstrated an excellent aptitude for sensible application of analytical chemistry to biological safety and the investigation of ‘unknown materials’ (chemicals unexpectedly, but often found in chemical analysis).

ISO 18562 – Biocompatibility evaluation of breathing gas pathways in healthcare applications, supplements the medical device requirements of ISO 10993 by adding examination of volatile materials (VOCs) and particles release into the airway. The standard gives limits for particle release. The emitted VOC needs to be assessed in a Toxicological Risk Analysis.

MET’s extractables and leachables services provide comprehensive assessment of biological safety, drug container compatibility and formulation stability. It forms part of our comprehensive validation and batch release testing programme for combination devices.