Our company routinely supports manufacturing organisations by addressing complex and urgent identification issues related to particulate matter, foreign matter, unknown particles, and impurities detected in a controlled manufacturing process.

Whatever the origin is of these events, they may lead to a serious impact on quality, production process and product release. This creates a high financial impact and pressure on QA/QC teams to quickly identify the root cause of the problem.

We offer access to a broad scope of analytical methods (FT-IR microscopy, SEM-EDX, XRF-microscopy, NMR, LC-MS, ICP-OES/MS, GC-MS, XRPD) within our laboratory and via established partnerships in order to provide a solution for your needs.

Typical Case Studies include:

• Particle identification, particles observed on filters in upstream/downstream production or floating in injectable vials
• Aggregates, crystals, precipitate observed in buffers, fermentation, intermediates, or end products
• Foreign matter, stain, unknown powder discovered in production area or in raw material containers