The race to bring effective vaccines and therapies for COVD-19 to market has dramatically reshaped the planning and execution of pharmaceutical manufacturing capital projects. In these unprecedented times, project execution timelines have been compressed to a degree that until recently would have been considered unfeasible. In drug product formulation, where the equipment functionality required is highly dependent on the drug product type, modularization is proving a decisive design advantage to help meet the need for both process flexibility and exceedingly short delivery times.
Syntegon’s Pharmatec SVP pre-configured solutions for batch sizes ranging from 150-600 liters – delivered in six months or less – are suitable for all manner of vaccine and therapy formulations, including most COVID-19 candidates in development. The versatility and short lead time of the SVP is enabled by the use of an extensive library of pre-designed and pre-tested functional modules for the design, construction, and qualification of each system. In all, over 70 pre-tested functional modules are available to process batch sizes from 13 to 3,000 liters. And just as important, the SVP features a prefabricated integrated cleanroom design with all peripheral technology outside the cleanroom in a technical skid. The highest degree of flexibility is provided, in both the layout of the customer’s room concept and the configuration of the production units themselves. The customer receives the precise functionality required for the intended range of products in a drop-in configuration that can be rapidly installed, qualified, and put into operation.