Abstract
Currently, there are four BSL-4 facilities built or planned in Germany, all falling under the legal regulations for recombinant DNA. The authorization of these facilities is the responsibility of the local authorities of the Federal States.
This article reports on the commissioning of a high-containment facility in Hamburg expected to go into service in 2011. A matrix of about 100 critical containment components has been compiled by the local authority that led the inspectorate through the commissioning process. In cases where no acceptance criteria for certain tests were specified in neither the German nor the European regulations, the commissioning authority had to determine the international state-of-the-art standards which are often set by North American guidelines and regulations.
This article describes in detail some typical findings from the commissioning process: inter alia filter testing, room integrity tests, and validation of gaseous room decontamination.