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Geschlossene Systeme im biotechnologischen Anlagenbau

Frank Wilde

LSMW GmbH, Stuttgart

Closed Systems in Biotechnological Plants

In biotechnological plants so called „closed systems“ are used to protect the product from contamination. However for certain production processes also personnel and environment need to be protected from the organisms/cells or the products.
According to the EC GMP guide cell culture plants should be designed as closed systems as far as possible. This „containment“ is to be understood as a separation of the plant from the environment by seals and filters. Nevertheless in most cases during operation (of i.e. a bioreactor) the vessels are aerated and vented, media is added or withdrawn. In order to keep the system closed from contaminating substances or organisms it is required to install sterilisable filters or to add presterilised media via closed pipe or tubing systems. The challenge for the design of the plant is to facilitate and guarantee the isolation and complete sterilisation and cleanability of the system. The critical interfaces at the battery limits are the connection points for mobile vessels, agitation systems, sampling points and pipes to one-sided open systems like cell retention installations for continuous fermentation.
For all applications in constructing a plant there are technical solutions and components readily available on the market. Crucial for the functioning of the biotechnological plant is the detail design and integration of the components and equipment into the system.

Key Words Bioreaktor · Containment · Filtration · Kontamination · Reinigung · Sterilisation