Photo: Thorkild Christensen

Good Manufacturing Practice - in practice

Friday 17 Feb 17
by Lotte Grandorf


Lars Georg Kiørboe
DTU Chemical Engineering
+45 45 25 28 57

Main activities of the PILOT PLANT-Centre for Experimental Process and Equipment Design

Research and teaching focused on experimental work with large-scale equipment and processes. These activities are conducted with a strong focus on industrial practice. As a result the main activities include unit operations, reaction engineering, process control, process and plant design, instrumentation, automation, and industrial measuring technology, scale-up and scale-down as well as batch versus continuous processes. New focus areas are fermentation mainly from a process point of view and particle technology.

Current projects

The project portfolio of the PILOT PLANT research centre currently includes, for instance, microbial conversion of slaughterhouse waste, syngas fermentation, and downstream processing of the liquids products, ammonia enhanced biogas production, along with fermentation experiments for the new bio-tech cluster BIOPRO and research on flowability of bulk solids and coating of particles.

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.

Practical GMP

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.

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