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Annual Report 201
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23 good manufacturing practice ?in practice 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 pro- duction hall of a pharmaceutical man- ufacturing 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 experi- enced 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 compa- nies 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 medi- cine, you cannot allow even the smallest mistake. ?erefore,
gmp
is implemented into all steps of production from the raw material, to the design of the equipment and building, to the manufacturing pro- cesses, 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. ?e
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. ?is 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 technol- ogies. 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 pro- scribing the best design of production equipment, the equipment will o?en vary from company to company and many construction details may be con- sidered. 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 parame- ters 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. pilot
plant
?
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