Bioquell was approached by a multinational bio-pharmaceutical company to provide remediation planning in case of a breach of sterility or contamination event across their 4 European sites. A Bioquell specialist visited each production site in turn in order to establish an emergency Hydrogen Peroxide Vapor decontamination protocol to be implemented in the event of a contamination incident.
Working with key client stakeholders, a custom decontamination strategy was developed for each process critical area taking into account all the pertinent physical factors that may affect the RBDS decontamination process, i.e., ventilation and pressure regimes, power availability, room topology, access restrictions, etc.
In addition to the physical factors, the process flows within each area were considered from the point of view of contamination containment. The protocol contained relatively simple measures that can be quickly taken in the event of an incident to mitigate the risk of cross contamination into unaffected areas.
Ten remediation plans were produced over the 4 European sites along with the associated supply chain arrangements ensuring that in the event of a contamination event the plans can be actioned immediately. The initial containment of the contamination, followed by the rapid and effective recovery of the areas allows production to be restarted sooner minimizing lost production time and the associated lost opportunity costs.