This European Standard specifies design requirements for plant buildings used for the safe handling of micro-organisms and the product itself if it presents a biohazard.
NOTE 1. When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements.
Plant buildings include buildings intended, if necessary, to contain all the fermentors and downstream processing apparatus. Plant building design includes design of equipment linked to the building itself and excludes specific production equipment.
NOTE 2. Equipment implementation is covered by a standard Equipment implementation according to the degree of hazard which is being prepared (see annex B [3]).
This European Standard is not applicable to design requirements which affect good manufacturing practice (see annex B [6]) or product quality, for which attention is drawn to relevant codes of practice and national regulations. It would be advisable to consider both aspects simultaneously.
BS EN 1620:1997 history
1997BS EN 1620:1997 Biotechnology - Large-scale process and production - Plant building according to the degree of hazard