Product approval in real time? Producers of pharmaceuticals and machine manufacturers worldwide are working on this vision. Thanks to Continuous Manufacturing (CM), delays attributable to separate production processes, complex conversions and long offline analyses could soon be a thing of the past. Pilot plants are already available but it's still early days for technology in the area of commercial pharmaceutical production. In an interview, Dr. Martin Schöler from Fette Compacting outlines the discoveries made by these pilot projects and how the CM vision is to become a reality.
Dr. Schöler, what advantages does Continuous Manufacturing offer for the production of solids?
Continuous Manufacturing offers possibilities to significantly increase efficiency in pharmaceutical production, whereby time as a factor plays a key role. The focus is on simplifying pharmaceutical development and reducing manufacturing times from the first stage of the production chain through to approval of the product. In tableting, this process could easily take one to two months starting with mixing of the active and auxiliary agents through to approval by Quality Assurance of the pressed and packaged tablets. But in a continuous production plant, manufacturers achieve processing times of only a few hours - as demonstrated by pilot projects. Overall, this improves plant availability, enabling users to react more flexibly to changes in pharmaceutical requirements. Other advantages include the high degree of process reliability, reduced space requirements and low product losses.
What current developments are you observing on the market?
Continuous Manufacturing is currently the top issue in the pharmaceutical market. All major pharmaceutical manufacturers have started projects aimed at tapping this future trend for themselves. Initially, the focus was primarily on cooperations with renowned third-level education facilities. Meanwhile, these researching pharmaceutical companies are concentrating on installing pilot plants in order to produce real pharmaceuticals on a commercial scale. In the area of solids production, Fette Compacting is involved in various such projects where the major economic potential of Continuous Manufacturing has been confirmed.
What are the next steps to be taken?
What is important now is that everyone involved collaborates closely - from machine manufacturers through pharmaceutical companies to the regulatory authorities. In the past, for example, coordination between the granulation and tableting product segments was not strictly necessary for machine manufacturers. Continuous Manufacturing changes this as the processes and technologies are directly linked. Depending on the respective application, the granulate automatically flows through a drier or mixer on its way to the tablet press, making these process steps part of a consistent overall process. To ensure this success, machine manufacturers are obliged to collaborate more intensively among themselves as well as with customers and the authorities. This new type of cooperation is ultimately the key for successful continuous production.