According to GMP Annex 1, the decontamination process must be automated, validated, and fully controlled. This presentation discusses how such a process can be implemented in sterility test isolators and how it affects the overall risk assessment. When decontamination is automated, this step can be excluded from the risk analysis, allowing the focus to shift entirely to preparation, loading, test execution, and evaluation. If the process is not automated, however, every intermediate step must be described and assessed individually, resulting in a significantly higher level of complexity within the risk analysis.