Provides guidance on the selecting and analysing of biotechnological equipment and subsequent assembly into a plant so as to reach the appropriate biosafety containment levels. Covers verification of installation, operation and maintenance. In addition, it is applicable when a new process or significant changes are introduced into an existing plant, and if the biotechnological process includes hazardous or potentially hazardous microorganisms and/or if the emitting of such microorganisms into the working place and/or environment are restricted.