I have a question about the risk assessment of air flow visualization (smoke) study.
Last year we performed this study one of our aseptic areas and on some points saw that the air flow could not change because of the area conditions.
This year some additional components were put to the area on these specific points. Because of that I thought that it is not necessary to repeat the study. However, I have to proove this by a risk assessment.
At this point I need help to prepare a good risk assessment.
Do you have any opinion about this issue?