Microbial contamination : Eurofins BPT Bactup delivers expertise in crisis management and preventive consulting
Raphaël Lavenir, PhD, Managing Director, Eurofins Bactup, RaphaelLavenir@eurofins.com
Eurofins BioPharma Product Testing Bactup (France) intervenes in crisis management when microbial contamination is proven. The impact for customers is direct and immediate in terms of business, if there is a production delay or if the lots cannot be released. It is crucial to act as quickly as possible (often at Day + 1) in order to unlock the situation. Although the consulting approach is customised, it consists of three steps that allow Eurofins to test hypotheses and identify the source of contamination and its treatment.
Step 1: Technical visit to the customer’s site. This investigation lasts on average between 1 and 3 days and allows an accurate view of all the steps at risk in the process in order to identify possible sources.
Step 2: Eurofins Bactup consultants interview multiple stakeholders directly or indirectly related to the process (cleaning operators, line managers, quality assistants, etc.) in order to obtain as much relevant information as possible. This allows Eurofins to fully understand all the steps, cross-check the information, and develop hypotheses, which will be confirmed or refuted by analyses.
Step 3: Analysis in Eurofins BPT laboratories: incubation, identification (Maldi-Tof or sequencing) and strain typing to identify the source of contamination.
Eurofins Bactup not only intervenes in case of urgency, but also in preventive consulting, to make sure that this type of event does not recur in the future. Eurofins’ experts formalise & implement an optimal control strategy, meaning: rational, structured, and reasonable. The goal is not to implement a huge labyrinthine system, but rather to be pragmatic and make the process financially acceptable to customers.
Additional services offered by Eurofins Bactup:
- Data review models: identification of KPIs and models for interpretation
- Strain storage bank service (-80 °C or -150 °C in nitrogen)
- Technical audits (in France or abroad)
- Custom Training
For more information, visit: www.bactup.com/en/accueil_en/