When unexpected particles, fibres, powders, or other foreign materials are detected in manufacturing processes, every delay can impact production continuity and batch disposition. The financial pressure on QA/QC teams to pinpoint the cause of a visible defect and resume production is immense. Time is of the essence, as delays can compromise product quality, regulatory compliance, and commercial timelines. The Eurofins BioPharma Product Testing (BPT) network of laboratories delivers rapid, expert analytical support, empowering QA and manufacturing investigation teams to act with confidence. This helps minimise downtime, avoid unnecessary batch rejection, and enable clear, effective communication with regulators.

Our scientific experts deploy advanced analytical techniques to identify the issue with precision and speed and support investigations into:

• Particles observed in filters or injectable vials
• Aggregates, crystals, or precipitates in buffers or end products
• Foreign matter or stains found in production environments
• Discolouration of the drug product

With our broad analytical capabilities, including FT-IR microscopy, Raman, SEM-EDX, LC-MS, ICP-OES, NMR, XRPD, and micro-XRF, we can customise investigations to your unique manufacturing context. Our facilities operate under rigorous GMP conditions, ensuring data integrity and regulatory compliance.

The Eurofins BPT critical investigations approach

• Rapid support when issues arise
• Reduce batch rejection & unplanned downtime
• Strengthen QA response to regulators
• Fast turnaround time (typically 2–5 working days)

The Eurofins BPT network of laboratories gives you access to a multidisciplinary team of analytical experts, fast turnaround times, robust reporting that supports regulatory scrutiny. When product quality is on the line, our clients trust us to support confident decisions to keep production moving and batches on track.