Activity continuity plan for Aseptic preparations
5 October 2023F Sadeghipour (Lausanne)
Aseptic preparations are not only essential, but it is also unthinkable to consider stopping them to the unavailability of our controlled atmosphere zones, with no alternative solution. It is therefore crucial to plan for continuity, especially in this field. To do so, it will be necessary to identify the premises or areas that can replace the current clean rooms, how to potentially move the current equipment there, or even determine possible substitute equipment. In addition to this work, it is essential to qualify and validate new equipment and procedures, perform relevant risk analyses, and consequently highlight weaknesses and be able to overcome or strengthen them by implementing appropriate measures to maintain aseptic conditions as robust as possible, despite certain potential degraded conditions. The purpose of this presentation is to propose solutions and focus key considerations in implementing a continuity plan for aseptic preparation activities.