According to GMP Annex 1, an automatic, validated and controlled decontamination process is required. This presentation will look at how this can be implemented for sterility test isolators and what influence it has on the risk assessment. By automating the decontamination process, it can be completely excluded from the risk assessment and the focus can therefore only be placed on the preparation, loading, execution and evaluation of the sterility test. However, if the decontamination process is not automated, all intermediate steps must be described and evaluated individually, which leads to a significantly higher level of complexity in the risk assessment.