Identifying anomalies. Formulating resolutions.

Minimising disruption.

Unexpected anomalies in pharmaceutical production, such as floating particles, discolouration, or aggregates, can bring critical operations to a standstill. Whether the issue is a visible defect, an unknown contaminant, or a chemical impurity, the financial pressure on QA/QC teams to pinpoint the cause 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 offers a comprehensive Troubleshooting and Root Cause Investigation service designed to deliver rapid, reliable answers. We work alongside your team from the very moment an anomaly is detected. 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
  • Chemical impurities in drug substance or drug product
  • High TOC levels following cleaning and sterilisation

With our broad analytical capabilities, including FT-IR microscopy, 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 Investigative Approach

  • Immediate consultation upon notification of the issue
  • Clear action planning within hours, including cost and timelines
  • Priority sample testing with initial results in 2–5 days
  • Conclusive reporting to support your internal investigation

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 uncover the cause and guide the resolution with accuracy and urgency.