At DTU Chemical Engineering we have many years of experience teaching Good Manufacturing Practice or ‘GMP’ to students. This year, we added a continuing education course to our programme portfolio. The new GMP course has been adapted to companies in the pharma and food industry and combines theoretical aspects with practical experience using our pilot plant equipment.
In a corner of the large pilot plant of DTU Chemical Engineering, a student is scratching his head, looking at a mobile washing station connected to a model process plant made of transparent plastic which ensures that everything going on inside is visible. A moment ago his supervisor, Lars Kiørboe, Head of the centre PILOT PLANT, pointed to a large stain of mustard stuck in one of the valves.
“Pretend you’re standing in the big production hall of a pharmaceutical manufacturing factory. You have discovered that the CIP facility has not been able to clean the process plant entirely and every delayed second before the next batch of medicine can be produced count—what do you do?” the experienced teacher asks.
Creating a realistic scenario tops the agenda in the Good Manufacturing Practice (GMP) courses which the centre offers to undergraduates and now also to small, medium, and large companies in Denmark. In addition to the large body of theory that goes hand in hand with the GMP world, these courses are especially focused on practical learning aspects.
According to Lars Kiørboe, the GMP philosophy states that you cannot base the product quality on chemical analysis of the finished drug alone— GMP activities have to completely permeate the entire production process. So GMP is very comprehensive.
“If your company is producing medicine, you cannot allow even the smallest mistake. Therefore, GMP is implemented into all steps of production from the raw material, to the design of the equipment and building, to the manufacturing processes, the education of employees further on to storage and transport of the finished products and the documentation. With our courses we want to ensure a workforce that can solve the practical challenges of GMP in the medical, food and biotech industry” says Lars Kiørboe.
The GMP courses cover general quality standards, hygienic design, cleaning technology, documentation practice in combination with work in the pilot plant and visit to industrial sites. Since GMP is so important to large Danish companies various aspects are also applied in other courses at the department. This includes the experimental courses in chemical unit operations where the students can work with the CIP unit and include CIP cleaning in the operation of, for instance, ultrafiltration and evaporation technologies. So the students are given a much more realistic study with experiences they can use directly in their future engineer jobs.
Companies can test their cleaning methods
Although there are standards proscribing the best design of production equipment, the equipment will often vary from company to company and many construction details may be considered. In the pilot plant it is possible for companies to come and use our facilities for testing and developing equipment and processes, where easy changing of design and process parameters can go hand in hand with modelling and test of various raw materials. In this way, the companies can get a better understanding of the challenges they may meet and how to better solve them in the future.
Read more about the course here.