This European Standard specifies design requirements for plant buildings used for the safe handling of microorganisms 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 fermenton and downstream processing apparatus. Plant building design indudes 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" is being prepared (see annex B PI).
This European Standard is not applicable to design requirements which affect good manufacturing practice (see annex B) product quality, for which attention is drawn to relevant codes of practice and national regulations. It would be advisable to consider both
aspects simultaneously.
Diese ÖNORM gibt Empfehlungen für die Konstruktion von Gebäuden für den sicheren Umgang mit Mikroorganismen und mit dem Produkt selbst, wenn es eine Biogefährdung darstellt. Gebäude sind bauliche Einrichtungen, die dazu vorgesehen sind, gegebenenfalls alle Fermenter und Anlagen für die Produktaufarbeitung aufzunehmen.