Annex 1 requires for aseptic processes that indirect contact product parts are sterilized. However, based on the current design of RABS or Isolators, certain stopper bowls are either fixed build-in or extremely heavy, which would require significant re-design of existing lines. Therefore, a risk-based approach is needed to understand the risk of contamination during the preparation of the stopper bowl for the aseptic production to develop appropriate measures and controls which will be included in the company CCS document. The presentation focuses on the options to mitigate the risk of contamination during the preparation of the stopper bowl for the aseptic production when the stopper bowl can be dismantled and when it cannot be dismantled. A benchmarking on stopper bowl cleaning, disinfection or biodecontamination chemical agents will be shared.