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

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Cell processing operators face significant psychological burden due to contamination risks in regenerative medicine facilities. Addressing these risks through better practices can improve both operator well-being and cell therapy product quality.

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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.