The changes in the pharmaceutical market have an impact on the engineering industry. The manufacturers of the equipment used in pharmaceutical production are no longer just “machine fitters”, but are involved in the design of the process from the very start. Prof. Dr. Klaus-Jürgen Steffens comments on the future challenges in the engineering industry.
What are the main challenges of the future for pharmaceutical production?
Steffens: We will have a market – at least, in the richer countries – that is divided between generic drugs and highly priced innovative products. When it comes to generic drugs, we are observing a global concentration of production in fewer and fewer locations and increasing pressure on prices. There will be a need for integrated production lines here, preferably ones that work continuously and guarantee high quality at minimal cost through the application of automated in-line controls (PAT). Innovative products are usually characterized by small batch sizes and increasing effectiveness combined with higher risks for production personnel and the environment. Here there will be increased demand for either small versatile machines that can be cleaned easily and safely or dedicated equipment only used to produce one product. If patient-specific drugs should one day come to the fore, new strategies will have to be developed with regard to variable dosages and the release of active ingredients.
In your opinion, which technological developments constitute milestones in pharmaceutical production?
Steffens: Since solid medicines, especially tablets, are by far the most common worldwide, I believe this is also the area where the greatest milestones are to be found: the rotary tablet press, the intensive mixer, the fluid bed system and the pan coater. Especially worthy of note, however, are the mixing and transport containers including handling systems that have made the production of pharmaceutical solids safer and cheaper.
Viewed from the corporate perspective, what role does engineering play in pharmaceutical production?
Steffens: Pharmaceutical machines are part of the specialized engineering sector – in other words, these are not mass products. That is especially demonstrated by the fact that new machines or improvements are often realized in close collaboration between an engineering firm and one or two pharmaceutical companies. In addition, machines often need to be specially adapted to meet the customer’s particular requirements. To that extent, versatile high-precision engineering – as found in Europe – plays an eminently important role in the pharmaceutical production system as a whole, a factor which is unfortunately often underestimated by corporate procurement departments.
Which pressing technological challenges need to be solved? Where is there need for further research?
Steffens: Over the last few decades pharmaceutical machines have become increasingly GMP-compliant. Nevertheless, there is still room for improvement in the direction of simple, smooth-surfaced designs with no “rough edges” but the smallest possible number of components. With regard to quality management and risk reduction, more research is required into the integration of valid in-process control systems that enable safe parametric batch release.
What role does operator training play in efficient pharmaceutical production?
Steffens: Although modern pharmaceutical machines have been made more user-friendly by their digital control systems, and SOPs permit fewer independent interventions in production, the demands made on personnel are increasing all the time. Whereas in the past a large number of trained specialists each carried out and supervised one individual production step, these responsibilities are increasingly being transferred to a single supervisor.
What's next? Which requirements are at the top of the users’ priorities list?
Steffens: They want precise, long-lived, low-maintenance, GMP-compliant, environmentally friendly and cost-effective machines that are embedded within a perfectly functioning service and repair system. Prof. Dr. Klaus-Jürgen Steffens studied pharmacy in Marburg and received his doctorate and habilitated at the Institute of Pharmaceutical Technology. Since 1994, Prof. Dr. Steffens is at the Institute of Pharmaceutical Technology in Bonn. His area of operation: the development and production of additives and pharmaceuticals, physicochemical characterization of raw materials and finished products and process analysis and process control.