Root Cause Investigation

Eurofins BioPharma Product Testing Netherlands routinely supports manufacturing organisations by addressing complex and/or urgent identification issues related to particulate matter, foreign matter, unknown particles, and impurities detected in a controlled manufacturing process.

Root Cause Investigation Support

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. Therefore, we offer Root Cause Investigation support. With our fast turn around, we can get you quickly back on track.

Why choose Eurofins Biopharma Product Testing for Root Cause Analysis

Access to broad scope of analytical methods (FT-IR microscopy, SEM-EDX, XRF-microscopy, NMR, LC-MS, ICP-OES/MS, XRPD)
Quality system in place and knowledge of production under a rigorous quality environment
Combination of expertise and capability which can ensure a fast turn around time and with a high chance of a conclusive identification

Our solution

root cause analysis

An unexpected particle or foreign matter is observed during production or in a controlled environment.
The customer communicates to our team the circumstance of the detection and exchange information (i.e., process description, photo).
In a matter of hours, our team of experts will assess the issue with the impacted customer, propose a rapid plan of action and budget.
Samples are sent to our facility immediately after. They are tested as a priority/rush and first test results are reported as soon as available.
Final conclusions are drafted, and a detailed report sent to the customer. In most cases, we typically provide data back to the customer in 2 to 5 working days, so the customer can already move ahead with their internal investigation process.

Typical Case Studies

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
High TOC level detected in bioprocessing vessels following sterilization and cleaning
Chemical impurities detected in Drug Substance or Drug Product (requires longer lead time if compound isolation is required prior to identification)

Read our flyer 'Root Cause Investigation' to learn more about our services. Contact us for support.