Operator stress factors and cell contamination risks in cell processing facilities: An online survey-based analysis.

The field of regenerative medicine is rapidly evolving, with an increasing number of approved cell preparations. However, cell processing facilities (CPFs) still heavily rely on manual operations by cell processing operators (CPOs). The intricate nature of cell culture and stringent sterility requirements impose a considerable psychological burden on CPOs, particularly the risk of cell contamination. This study delves into the psychological aspects experienced by CPOs in relation to the risk of contamination during cell culture. An online survey was conducted across 47 sites to investigate concerns regarding contamination and the strategies implemented to mitigate contamination risk in cell processing facilities. The survey findings revealed that 72 % of operators expressed concern about contamination, with 18 % reporting direct experiences of contamination. This indicates that the perceived contamination risk in CPFs is higher than the actual reported incidents. Furthermore, this study examines operational practices, such as material handling, and the utilization of biological safety cabinets (BSCs). The results highlight variations in BSC utilization and material handling practices, underscoring potential operational challenges. Implementing risk assessments and leveraging evidence-based data at each site could help address these challenges and alleviate the psychological strain on CPOs. This, in turn, would enhance the quality of cell therapy products and improve the well-being of CPOs.