Customer
The site was mainly producing parenteral specialties (intravenous). In the framework of production switch, a workshop was to be reconverted so as to produce another pharmaceutical specialty. Before the closure of the workshop, it had been producing medicines containing 8 different APIs presenting a high level of toxicity.
Before the conversion, CURIUM analysed the state of contamination of the entire production environment (process installation, clean room, aeraulic network, fluid networks), defining the trackers and contamination thresholds to be reached according to the future use of the equipment, and preparing a sampling plan. The choice of trackers and the methods for sampling and interpreting the results was aimed at the optimisation of project costs and schedules.
CURIUM then defined and drafted the operating procedures for the decontamination of the equipment for which decontamination was required. CURIUM selected and carried out the quality and safety audits of the subcontractors. At the end of the operations, CURIUM carried out the follow-up of the contamination levels in order to validate the decontamination.
