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

Area of Science:

• Regenerative Medicine
• Cell Therapy Manufacturing
• Occupational Psychology

Background:

• Regenerative medicine is advancing, leading to more approved cell therapies.
• Cell processing facilities (CPFs) largely depend on manual operations by cell processing operators (CPOs).
• Stringent sterility requirements and complex cell cultures create psychological stress for CPOs, especially concerning contamination.

Purpose of the Study:

• To investigate the psychological impact of contamination risk on CPOs in cell culture.
• To identify concerns about contamination and current mitigation strategies in CPFs.
• To examine operational practices like material handling and biological safety cabinet (BSC) use.

Main Methods:

• An online survey was distributed to CPOs across 47 sites.
• The survey assessed contamination concerns, personal experiences with contamination, and implemented risk mitigation strategies.
• Operational practices, including material handling and BSC utilization, were also examined.

Main Results:

• 72% of CPOs reported concerns about contamination, while 18% had experienced it directly.
• Perceived contamination risk appears higher than reported incidents.
• Significant variations in BSC utilization and material handling practices were observed across facilities.

Conclusions:

• Implementing site-specific risk assessments and evidence-based data can mitigate contamination risks.
• Addressing these operational challenges can reduce psychological strain on CPOs.
• Improving facility practices enhances cell therapy product quality and CPO well-being.