Journal of Engineering Research

The widespread adoption of disposable systems in biopharmaceutical manufacturing has significantly enhanced production flexibility and cost-effectiveness, yet it has also introduced complex challenges in microbial contamination risk management. To ensure drug quality and production safety, comprehensive contamination risk control strategies must be implemented throughout the entire process, including system design, material selection, process layout, and operational management. Through engineering practice analysis of typical production scenarios, this study proposes an integrated control framework combining risk identification, graded prevention and control measures, online monitoring, and periodic validation. The framework has been validated for its effectiveness in reducing contamination probabilities and improving production stability, providing an actionable technical pathway for the safe application of disposable systems in biopharmaceuticals.

Disposable systems; Biopharmaceuticals; Microbial contamination; Risk control; Engineering practice