Biosafety Issues

Biosafety assessment of the cell line and process will have impact on the containment design of the culture to control the risk to health or environment posed by the genetically modified organism. Biosafety regulations or guidelines are issued by the National Institute of Health (433) in the United States, the World Health Organisation WHO (434), the European Commission (435,436), and different national authorities. These regulations are relevant for the design of seals, valves, air vents, sampling ports, addition ports, and other parts of a bioreactor where a potential risk for release of hazardous organisms can be assumed. No particular design solutions are prescribed since the focus is on performance of the containment design in order to allow for technical improvement. Detailed technical information valid for the EC is found in the CEN (European Committee for Standardization) standards (437) which are a technical complement to the legislation. Some containment design considerations for bioreactors are described in (438).

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