For the renowned customer from the pharmaceutical industry, the factory is the “centre of excellence” for culture-based vaccines and viral vaccines. The main vaccines produced at the site are influenza vaccines, tetanus/pertussis/diphtheria/rabies vaccines and vaccines against tick-borne encephalitis (in short: TBE).
In this project, Testo Industrial Services was involved in the qualification straight after the basic engineering phase and through the structural works phase of the building. After the qualification concept had been drawn up, the qualification measures for the entire manufacturing facility were carried out. This included the implementation of FATs at the system suppliers, the integration of the SAT documentation as well as the preparation of the qualification documentation.
Within a period of three years, the qualification measures of the entire manufacturing facility were carried out, including the implementation of FATs at the system suppliers and the integration of the SAT documentation. The use of a large number of highly accurate measuring systems and experienced staff enabled a high degree of flexibility in the processing of qualification plans.